Adult Psoriasis (PsO)

Smiling man wearing salmon-colored shirt

Hypothetical Patient

Week 12 results

FOR ADULTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS

See the difference Taltz can make in 12 weeks^2-5

Copying, downloading, or other use of patient photos is expressly prohibited.

Psoriasis can impact all areas of the body. The following images are of real adult patients with moderate to severe psoriasis who were treated with Taltz over a 12-week period. Photos at baseline and week 12 can be viewed below. Individual results may vary.

MOVE SLIDER TOOL TO SEE PROGRESSION

PASI 75

PATIENT AT BASELINE
(PASI SCORE=19.2)

PATIENT AT WEEK 12
(PASI SCORE=2.8)

Patients received a 160 mg starting dose of Taltz; then 80 mg of Taltz every 2 weeks.

Trial design

SELECT IMPORTANT SAFETY INFORMATION: INFECTIONS
Taltz may increase the risk of infection. Serious infections have occurred. In clinical trials of adult patients with plaque psoriasis, the Taltz group had a higher rate of infections than the placebo group (27% vs 23%). A similar increase in risk of infection was seen in placebo-controlled trials of adult patients with psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, and pediatric patients with plaque psoriasis. In the post-marketing setting, serious bacterial, viral, and fungal opportunistic infections have been reported in patients receiving IL-17 inhibitors, including Taltz. Instruct patients to seek medical advice if signs or symptoms of clinically important chronic or acute infection occur. If a serious infection develops, discontinue Taltz until the infection resolves.

PASI 90

PATIENT AT BASELINE
(PASI SCORE=32.5)

PATIENT AT WEEK 12
(PASI SCORE=2.3)

Patients received a 160 mg starting dose of Taltz; then 80 mg of Taltz every 2 weeks.

Trial design

SELECT IMPORTANT SAFETY INFORMATION: PRE-TREATMENT EVALUATION FOR TUBERCULOSIS
Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with Taltz. Do not administer to patients with active TB infection. Initiate treatment of latent TB prior to administering Taltz. Consider anti-TB therapy prior to initiating Taltz in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Patients receiving Taltz should be monitored closely for signs and symptoms of active TB during and after treatment.

PASI 100

PATIENT AT BASELINE
(PASI SCORE=13)

PATIENT AT WEEK 12
(PASI SCORE=0)

Patients received a 160 mg starting dose of Taltz; then 80 mg of Taltz every 2 weeks.

Trial design

SELECT IMPORTANT SAFETY INFORMATION: HYPERSENSITIVITY
Serious hypersensitivity reactions, including angioedema and urticaria (each ≤0.1%), occurred in the Taltz group in clinical trials. Anaphylaxis, including cases leading to hospitalization, has been reported in post-marketing use with Taltz. If a serious hypersensitivity reaction occurs, discontinue Taltz immediately and initiate appropriate therapy.

sPGA 0,1

PATIENT AT BASELINE
(sPGA SCORE=4)

PATIENT AT WEEK 12
(sPGA SCORE=1)

Patients received a 160 mg starting dose of Taltz; then 80 mg of Taltz every 2 weeks.

Trial design

SELECT IMPORTANT SAFETY INFORMATION: ECZEMATOUS ERUPTIONS
In the postmarketing setting, cases of severe eczematous eruptions, including atopic dermatitis-like eruptions, dyshidrotic eczema, and erythroderma were reported in patients receiving Taltz; some cases resulted in hospitalization. The onset of eczematous eruptions was variable, ranging from days to months after the first dose of Taltz. Treatment may need to be discontinued to resolve the eczematous eruption. Some patients with limited psoriasis treatment options were successfully treated for eczema while continuing Taltz.

Week 60 results

FOR ADULTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS

Reassure your patients that consistent results can be maintained with Taltz at week 60^1,6

Response rate at week 60 among responders who achieved clear or almost clear skin at week 12 data

In the maintenance period of UNCOVER-1 & -2, 75% of the patients receiving Taltz every 4 weeks who achieved sPGA 0,1 at week 12, maintained that response at week 60 (n=181^*) compared with 7% of patients receiving placebo (n=203^*) (NRI).

Patients who achieved clear or almost clear skin (sPGA 0,1) after initial treatment with Taltz 80 mg every 2 weeks were re-randomized at week 12 to receive either Taltz 80 mg every 4 weeks (n=181^*) or placebo (n=203^*).
^*Evaluable patients at week 60.
NRI=nonresponder imputation.

Trial design

SELECT IMPORTANT SAFETY INFORMATION: INFLAMMATORY BOWEL DISEASE
Patients treated with Taltz may be at an increased risk of inflammatory bowel disease. In clinical trials, Crohn's disease and ulcerative colitis, including exacerbations, occurred at a greater frequency in the Taltz group than the placebo group. During Taltz treatment, monitor patients for onset or exacerbation of inflammatory bowel disease and if IBD occurs, discontinue Taltz and initiate appropriate medical management.

Week 264 results

FOR ADULTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS

Rapid response at week 12 and durable efficacy through 5 years^7-9

UNCOVER-3: PASI 90 and PASI 100 results at week 12 and through 264, observed (induction period and open-label extension)⁸

Line graph of PASI 75/90/100 rapid response rates at week 12 with durable efficacy through year 5

In an observed analysis of UNCOVER-3 (Taltz N=385), at week 12, 72% of patients achieved PASI 90, and 40% of patients achieved PASI 100. Additionally, at weeks 60, 108, 156, 204, and 264, 84%, 81%, 87%, 88%, and 90% of patients, respectively, achieved PASI 90; and 64%, 58%, 65%, 67%, and 66% of patients, respectively, achieved PASI 100.

In an mNRI analysis of UNCOVER-3, at week 12, 70% of patients achieved PASI 90, and 39% of patients achieved PASI 100. Additionally, at weeks 60, 108, 156, 204, and 264, 78%, 71%, 69%, 66%, and 67% of patients, respectively, achieved PASI 90; and 59%, 50%, 49%, 48%, and 46% of patients, respectively, achieved PASI 100.

These were post hoc analyses of ITT population through week 264.

A subset of patients from UNCOVER-3 who received a 160 mg starting dose of Taltz at week 0, followed by 80 mg every 2 weeks through week 12, followed by 80 mg every 4 weeks, is shown.

The open-label phase of the study beginning after week 12 has limitations (eg, no placebo comparison, patients remaining in the extension phase may be those with better results).

mNRI analysis imputes missing data due to study drug (eg, inadequate response, adverse event, lack of efficacy) as nonresponse; whereas missing data due to other reasons (eg, missed visits, lost to follow-up) is included as a predicted value based on statistical modeling of observed data.

mNRI=modified nonresponder imputation; ITT=intent-to-treat; PASI=Psoriasis Area Severity Index; PASI 75/90/100=75%/90%/100% improvement from baseline in PASI criteria.

Trial design

SELECT IMPORTANT SAFETY INFORMATION: IMMUNIZATIONS
Prior to initiating Taltz, consider completion of all age-appropriate immunizations according to current immunization guidelines. Avoid use of live vaccines in patients treated with Taltz.

FOR ADULTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS

Rapid clearance by week 12 that was sustained through week 264^11-13

UNCOVER-3: Mean percentage improvement in PASI from baseline through week 264, observed data

In an observed analysis of UNCOVER-3 (Taltz n=385; placebo n=193), at weeks 2, 4, 8, and 12 (the induction period), patients receiving Taltz achieved mean percentage improvement in PASI from baseline of 56%, 74%, 86%, and 92%, respectively, vs 11%, 13%, 15%, and 14% for placebo, respectively. Additionally, at weeks 36, 48, 60, 108, 156, 204, and 264 (the open-label extension period), patients receiving Taltz achieved 95%, 95%, 96%, 95%, 96%, 97% and 97% of mean percentage improvement in PASI from baseline, respectively.

In an observed analysis of UNCOVER-3 (Taltz n=385; placebo n=193), at baseline and weeks 2, 4, 8, and 12, patients receiving Taltz achieved mean PASI score of 20.7, 9.2, 5.5, 2.8, and 1.6, respectively, vs 21.1, 18.9, 18.4, 17.8 and 17.9 for placebo, respectively. Additionally, at weeks 36, 48, 60, 108, 156, 204, and 264, patients receiving Taltz achieved mean PASI score of 1.0, 1.0, 0.8, 1.1, 0.7, 0.6, and 0.7, respectively.

This was a post hoc observed analysis of intent-to-treat population through week 264.

The open-label extension phase of the study has limitations (eg, no placebo comparison, patients remaining in the extension phase may be those with better results).

Trial design

SELECT IMPORTANT SAFETY INFORMATION: ADVERSE REACTIONS
Most common adverse reactions (≥1%) associated with Taltz treatment are injection site reactions, upper respiratory tract infections, nausea, and tinea infections. Overall, the safety profiles observed in adult patients with psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, and pediatric patients with plaque psoriasis were consistent with the safety profile in adult patients with plaque psoriasis, with the exception of influenza and conjunctivitis in psoriatic arthritis, and conjunctivitis, influenza, and urticaria in pediatric psoriasis.

References:

Taltz. Prescribing Information. Lilly USA, LLC.
Data on file. Lilly USA, LLC. TAL20160222D.
Data on file. Lilly USA, LLC. TAL20160222A.
Data on file. Lilly USA, LLC. TAL20160222E.
Data on file. Lilly USA, LLC. TAL20160222B.
Data on file. Lilly USA, LLC. DOF-IX-US-0274.
Blauvelt A, Lebwohl MG, Mabuchi T, et al. Long-term efficacy and safety of ixekizumab: a 5-year analysis of the UNCOVER-3 randomized controlled trial. J Am Acad Dermatol. 2021;85:360-368.
Blauvelt A, Lebwohl MG, Mabuchi T, et al. Long-term efficacy and safety of ixekizumab: a 5-year analysis of the UNCOVER-3 randomized controlled trial. Supplementary material. J Am Acad Dermatol. 2021;85:360-368.
Data on file. Lilly USA, LLC. DOF-IX-US-0197.
Data on file. Lilly USA, LLC. DOF-IX-US-0209.
Data on file. Lilly USA, LLC. DOF-IX-US-0232.
Data on file. Lilly USA, LLC. DOF-IX-US-0051.
Data on file. Lilly USA, LLC. DOF-IX-US-0272.

For adults with moderate to severe plaque psoriasis

Complete clearance data from head-to-toe ^1-9

TODO — **Week 12 Data** **Long-Term Data**

SCALP PSORIASIS
Mean baseline PSSI=20² Week 12 Data: 80%
PSSI=0, observed
Nx=332⁵
mNRI=78% Long-Term Data: 87%
PSSI=0 at year 5, observed
Nx=173¹
mNRI=69%

NAIL PSORIASIS
Mean baseline NAPSI=27² Week 12 Data: 18%
NAPSI=0, observed
Nx=221⁶
mNRI=18% Long-Term Data: 77%
NAPSI=0 at year 5, observed
Nx=127¹
mNRI=64%

PALMOPLANTAR PSORIASIS
Mean baseline PPAPSI=10² Week 12 Data: 66%
PPASI 100, observed
Nx=92⁷
mNRI=65% Long-Term Data: 90%
PPASI 100 at year 5, observed
Nx=41¹
mNRI=75%

GENITAL PSORIASIS
Mean baseline sPGA-G=3.4³ Week 12 Data: 56%
sPGA-G=0, NRI
n=75⁹ Long-Term Data: 60%
sPGA-G=0 at year 1, NRI
n=75³

	Week 12 Data	Long-Term Data
SCALP PSORIASIS Mean baseline PSSI=20²	Week 12 Data: 80% PSSI=0, observed Nx=332⁵ mNRI=78%	Long-Term Data: 87% PSSI=0 at year 5, observed Nx=173¹ mNRI=69%
NAIL PSORIASIS Mean baseline NAPSI=27²	Week 12 Data: 18% NAPSI=0, observed Nx=221⁶ mNRI=18%	Long-Term Data: 77% NAPSI=0 at year 5, observed Nx=127¹ mNRI=64%
PALMOPLANTAR PSORIASIS Mean baseline PPAPSI=10²	Week 12 Data: 66% PPASI 100, observed Nx=92⁷ mNRI=65%	Long-Term Data: 90% PPASI 100 at year 5, observed Nx=41¹ mNRI=75%
GENITAL PSORIASIS Mean baseline sPGA-G=3.4³	Week 12 Data: 56% sPGA-G=0, NRI n=75⁹	Long-Term Data: 60% sPGA-G=0 at year 1, NRI n=75³

Patients with nail and scalp PsO have a 3x and 4x greater risk of developing PsA^4,8

At week 12, 73% of patients taking Taltz vs 8% of patients taking placebo in IXORA-Q achieved the primary endpoint of sPGA-G 0,1 n=75.⁹

Nail, scalp, and palmoplantar data are from UNCOVER-3 and are post hoc, subgroup analyses of patients who had nail, scalp, and palmoplantar psoriasis at baseline. sPGA-G 0 was a prespecified, exploratory endpoint from IXORA-Q.

The open-label phase of the studies after week 12 has limitations (e.g., no placebo comparison, patients remaining in the extension phase may be those with better results).

At week 12, 10% of patients on placebo achieved PSSI=0 (observed); mNRI=9% (Nx=167 for observed population, n=176 for mNRI, mean baseline=18). At week 12, 4% of patients on placebo achieved NAPSI=0 (observed); mNRI=4% (Nx=113 observed population, n=116 for mNRI, mean baseline=25). At week 12, 29% of patients on placebo achieved PPASI=100 (observed), mNRI=30% (Nx=51 for observed population, n=54 for mNRI, mean baseline=11). At week 12, 5% of patients on placebo achieved sPGA-G=0 (n=74).¹⁰

Even a 6-month delay in PsA diagnosis can cause irreversible structural damage and worse long-term physical function¹⁰

UNCOVER-1, -2, and -3 and IXORA-Q trial designs.

SELECT IMPORTANT SAFETY INFORMATION: CONTRAINDICATIONS
Taltz is contraindicated in patients with a previous serious hypersensitivity reaction, such as anaphylaxis, to ixekizumab or to any of the excipients.

PsO=psoriasis; Nx=observed population; PSSI=Psoriasis Scalp Severity Index; NAPSI=Nail Psoriasis Severity Index; sPGA=static Physician’s Global Assessment; sPGA-G=static Physician’s Global Assessment of Genitalia; NRI=nonresponder imputation; PPASI=Palmoplantar Psoriasis Area Severity Index; PsA=psoriatic arthritis; IL-17A=interleukin-17A; mNRI=modified nonresponder imputation.

Recognizing Predictors of Psoriatic Arthritis in Plaque Psoriasis Patients

00:00-00:46

[Taltz logo with dosage and ISI disclaimers appear on screen.]

Caption:
[On-screen]
SELECT IMPORTANT SAFETY INFORMATION

INDICATIONS
Taltz is indicated for adults with active psoriatic arthritis (PsA), for adults with active ankylosing spondylitis (AS), and for adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation. Taltz is also indicated for patients aged 6 years or older with moderate-to-severe plaque psoriasis (PsO) who are candidates for systemic therapy or phototherapy.

CONTRAINDICATIONS
Taltz is contraindicated in patients with a previous serious hypersensitivity reaction, such as anaphylaxis, to ixekizumab or to any of the excipients. Full Important Safety Information is available at the conclusion of the video.

00:47-00:52

Caption:
Recognizing predictors of psoriatic arthritis in plaque psoriasis patients

00:53-01:01

[On-screen patient with their arms folded. Plaques are present on their arms and scalp. Nail discoloration is present.]

01:02-01:06

[Icon highlighting inflammation in the joints.]

Caption:
Psoriatic Arthritis

1:07-1:15

[Pie graph highlighting 30% in red and 70% in blue. The icon highlighting inflammation in the joints points to the 30% portion.]

Caption:
Up to 30% psoriasis patients will also go on to develop psoriatic arthritis^2-4

01:16-1:23

[Icon highlighting inflammation in the joints. Four person icons under an icon of scalp psoriasis, indicating 4x greater risk. Three person icons under an icon of nail psoriasis, indicating 3x greater risk.]

Caption:
4x greater risk², 3x greater risk²

1:24-1:37

[Timeline with six dots, representing six months.]

Caption:
6-month delay

1:38-1:44

[On-screen patient holding their hand, which appears inflammed.]

1:45-2:07

[Taltz UNCOVER-1, -2, and -3 trial designs.]

Caption:
TALTZ REGISTRATION TRIALS:
Multicenter, randomized, double-blind, placebo-controlled^1,5
UNCOVER-1, UNCOVER-2, UNCOVER-3 FOR ADULTS WITH MODERATE-TO-SEVERE PLAQUE PSORIASIS

Co-primary efficacy endpoints at week 12

Proportion of patients achieving PASI 75
Proportion of patients with sPGA 0,1 with at least a 2-point improvement from baseline

SCREENING RANDOMIZATION
12-WEEK INDUCTION PERIOD
UNCOVER-1 (N=864), Taltz 80 mg every 2 weeks* (n=433), Placebo (n=431)
UNCOVER-2 (N=877), Taltz 80 mg every 2 weeks (n=351)*, Enbrel§ 50 mg twice weekly (n=358), Placebo (n=168)
UNCOVER-3 (N=960), Taltz 80 mg every 2 weeks* (n=385), Enbrel§ 50 mg twice weekly (n=382), Placebo (n=193)

Week 0, Week 12

RE-RANDOMIZATION
At Week 12: Taltz Responders (sPGA 0,1) Re-Randomized to Taltz Q4W (n=221) and PBO (n=211)
Taltz 80 mg every 4 weeks, UNCOVER-1 (n=119)^†, UNCOVER-2 (n=102)^†
Placebo every 4 weeks, UNCOVER-1 (n=117), UNCOVER-2 (n=94)

OPEN-LABEL, LONG-TERM EXTENSION PERIOD
Taltz 80 mg every 4 weeks (n=362)
At Week 12: ALL patients went to Q4W Taltz

Week 60, Week 264

^*Taltz-treated patients received a 160 mg starting dose
^†Intent-to-Treat population: patients RANDOMIZED to receive 160 mg starting dose, 80 mg every 2 weeks for 12 weeks, and 80 mg every 4 weeks in the maintenance period.
^§US-approved etanercept
PASI=Psoriasis Area Severity Index; PBO=placebo; Q4W=every 4 weeks; sPGA=static Physician Global Assessment.

2:08-2:30

[Taltz UNCOVER-1, -2, and -3 PASI 75 and sPGA 0,1 results at Week 12.]

Caption:
TALTZ REGISTRATION TRIALS:
Multicenter, randomized, double-blind, placebo-controlled¹
UNCOVER-1, UNCOVER-2, UNCOVER-3 FOR ADULTS WITH MODERATE-TO-SEVERE PLAQUE PSORIASIS

[Table]
Results at Week 12, NRI, PASI 75, sPGA 0,1
UNCOVER-1 Taltz (80 mg Q2W); n=433, 89%, 82%
Placebo; n=431, 4%, 3%
UNCOVER-2 Taltz (80 mg Q2W); n=351, 90%, 83%
Placebo; n=168, 2%, 2%
UNCOVER-3 Taltz (80 mg Q2W); n=385, 87%, 81%
Placebo; n=193, 7%, 7%

In the maintenance period of UNCOVER-1 and UNCOVER-2, 75% of patients receiving Taltz who achieved sPGA 0,1 at Week 12 maintained that response at Week 60 (n=181*) compared with 7% of patients receiving placebo (n=203*) (NRI analysis).¹
^*Evaluable patients at Week 60.

NRI=nonresponder imputation; PASI=Psoriasis Area Severity Index; Q2W=every 2 weeks; sPGA=static Physician Global Assessment.

2:31-2:46

[Taltz UNCOVER-3 post-hoc analysis of patients with scalp psoriasis.]

Caption:
[Title and subheadings]
Post-hoc subgroup analyses of patients with scalp psoriasis
Inducation period and open-label extension
UNCOVER-3: MEAN PERCENT IMPROVEMENT FROM BASELINE IN PSSI AT WEEKS 12 AND 60, MMRM⁶
FOR ADULTS WITH MODERATE-TO-SEVERE PLAQUE PSORIASIS

[Graph copy]
MEAN CHANGE IN PSSI (%)
Induction Period WEEK 0, 2, 4, 8, 12
Taltz 80 mg every 2 weeks (induction) (n=185); then every 4 weeks (maintenance), 96%, Mean score 1 (SD=4), Baseline score 30 (SD=11)
Placebo for 12 weeks (n=82), 23%, Mean score 22 (SD=13), Baseline score 29 (SD=10)

Open-Label Extension Period WEEK 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60
Taltz 80 mg every 2 weeks, 95%, Mean score 1 (SD=3)

[Body]
Subgroup analyses presented are post hoc. The UNCOVER studies were not powered for these subgroup analyses, nor were analyses error-controlled. Therefore, treatment differences observed in these subgroups cannot be regarded as statistically significant. Baseline severity was not specified in the inclusion criteria.
^*A subset of patients from UNCOVER-3 with moderate to severe plaque psoriasis and scalp psoriasis (defined as PSSI score ≥15 and scalp involvement ≥30%) at baseline.⁶
PSSI score range 0-72.⁷

[Additional graph copy] A positive percent change in PSSI represents a decrease in PSSI score. ADDITIONAL RESULTS: In UNCOVER-1 (Taltz 80 mg every 2 weeks n=210; placebo n=215), patients receiving Taltz achieved a mean PSSI of 2 ( SD=7) (a 93% reduction from the mean Taltz baseline score of 32 (SD=12)) at Week 12. Patients receiving placebo achieved a mean PSSI of 27 (SD=16) (a 15%reduction from the mean baseline score of 32 (SD=14)). In UNCOVER-2 (Taltz 80 mg every 2 weeks n=144; placebo n=77), patients receiving Taltz achieved a mean PSSI of 2 (SD=5) (a 95% reduction from the mean Taltz baseline score of 32 (SD=13)) at Week 12. Patients receiving placebo achieved a mean PSSI of 24 (SD=14) (a 25% reduction from the mean baseline score of 33 (SD=12)).⁶

MMRM=mixed model of repeated measures; PSSI=Psoriasis Scalp Severity Index; SD=standard deviation.

2:47-3:02

[Taltz UNCOVER-3 post-hoc analysis of patients with nail psoriasis.]

Caption:
[Title and subheadings]
Post-hoc subgroup analyses of patients with nail psoriasis
Induction period and open-label extension
UNCOVER-3: MEAN PERCENT IMPROVEMENT FROM BASELINE IN NAPSI AT WEEKS 12 and 60, MMRM⁶
FOR ADULTS WITH MODERATE-TO-SEVERE PLAQUE PSORIASIS

[Graph copy]
MEAN CHANGE IN NAPSI (%)
Induction Period WEEK 0, 2, 4, 8, 12
Taltz 80 mg every 2 weeks (induction) (n=138); then every 4 weeks (maintenance), 39%, Mean score 24 (SD=15), Baseline score 39 (SD=16)
Placebo for 12 weeks (n=71), -5%, Mean score 37 (SD=20), Baseline score 37 (SD=17)

Open-Label Extension Period WEEK 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60
Taltz 80 mg every 2 weeks, 86%, Mean score 5 (SD=10)

[Body]
Subgroup analyses presented are post hoc. The UNCOVER studies were not powered for these subgroup analyses, nor were analyses error-controlled. Therefore, treatment differences observed in these subgroups cannot be regarded as statistically significant. Baseline severity was not specified in the inclusion criteria.
^*A subset of patients from UNCOVER-3 with moderate to severe plaque psoriasis who had nail psoriasis
(defined as NAPSI score ≥16 with ≥4 fingernails involved) at baseline.⁸
NAPSI score range 0-80. Only patients’ fingernails were observed.⁹

[Additional graph copy] A positive percent change in NAPSI represents a decrease from baseline in mean NAPSI. The mean number of fingernails involved at baseline was 9.2 for Taltz and 9.1 for placebo.^8,9

ADDITIONAL RESULTS: In UNCOVER-1 (Taltz 80 mg every 2 weeks n=172; placebo n=168), patients receiving Taltz achieved a mean NAPSI of 25 (SD=18) (a 33% reduction from the mean
Taltz baseline score of 36 (SD=16)) at Week 12. Patients receiving placebo achieved a mean
NAPSI of 40 (SD=17) at Week 12 (a 4% increase from the mean placebo baseline score of 39 (SD=16)). In UNCOVER-2 (Taltz n=131; placebo n=72), patients receiving Taltz achieved a mean
NAPSI of 26 (SD=18) at Week 12 (a 34% reduction from the mean Taltz baseline score of 38 (SD=17)). Patients receiving placebo achieved a mean NAPSI of 37 (SD=20) at Week 12 (a 2% reduction from the mean placebo baseline score of 39 (SD=17)).⁸

MMRM=mixed model of repeated measures; NAPSI=Nail Psoriasis Severity Index; SD=standard deviation.

3:03-3:35

[Taltz SPIRIT-P1 and -P2 trial designs.]

Caption:
SPIRIT-P1 and -P2 trial designs^1,10-12

[Table] SPIRIT-P1, -P2
Participants
SPIRIT-P1 (biologic-naïve N=417), SPIRIT-P2 (TNFi-experienced N=363)^*, Patients ≥18 years of page with active PsA, ≥3 swollen and ≥3 tender joints

Trial design
Phase 3, randomized, double-blind, placebo-controlled trials

Dosing

Taltz 80 mg every 2 weeks† (n=203) (n=123)
Taltz 80 mg every 4 weeks (n=107) (n=122)
Placebo (n=106) (n=118)
SPIRIT-P1 had an active reference arm of Humira® (adalimumab) 40 mg every 2 weeks (n=101)
Patients randomized to Taltz received a 160 mg starting dose

Primary endpoint
Proportion of patients achieving ACR20 response at Week 24

[Body] Patients in all study arms were allowed to continue taking stable background medications during the trial. Inadequate responders (as defined by blinded criteria of <20% improvement in tender and in swollen joint counts) at Week 16 received rescue therapy and were analyzed as nonresponders after week 16 until the primary endpoint. After receiving rescue therapy, inadequate responders in the placebo and Humira arms were re-randomized to Taltz 80 mg every 2 or 4 weeks. NRI methods were used for categorical efficacy analysis during the double-blind treatment period.
^*Inadequate response and/or interolance to 1 or 2 prior TNFis.
^†Taltz 80 mg Q2W is not an approved dose to PsA.

ACR20=American College of Rheumatology 20% response rate; NRI=nonresponder imputation; PsA=psoriatic arthritis; TNF-i= TNFi=tumor necrosis factor inhibitor.

3:36-3:53

[Taltz SPIRIT-P1 and -P2 ACR results at Week 24.]

Caption:
[Graph 1 copy]
SPIRIT-P1: Biologic-Naive Patients^1,11,13
ACR Response Rates at Week 24, NRI
PATIENTS ACHIEVING RESPONSE (%)

Taltz 80 mg every 4 weeks (n=107)
ACR20, 58%^*
ACR50, 40%^*
ACR70, 23%^*

Placebo (n=106)
ACR20, 30%
ACR50, 15%
ACR70, 6%

^*P≤0.001 vs Placebo

[Graph 2 copy]
SPIRIT-P1: TNFi-Experienced Patients^1,11,13
ACR Response Rates at Week 24, NRI
PATIENTS ACHIEVING RESPONSE (%)

Taltz 80 mg every 4 weeks (n=122)
ACR20, 53%^†
ACR50, 35%^†
ACR70, 22%^†

Placebo (n=118)
ACR20, 20%
ACR50, 5%
ACR70, 0%

^†P≤0.001 vs Placebo

[Body]
Primary endpoint=ACR20 response at Week 24.
Inadequate responders (<20% improvement in tender and in swollen joint counts) at Week 16 were analyzed as nonresponders after Week 16 until the primary endpoint.
NRI of intent-to-treat population through Week 24.

ACR20=American College of Rheumatology 20% response rate; ACR50=American College of Rheumatology 50% response rate; ACR70=American College of Rheumatology 70% response rate.

3:54-4:07

[Taltz SPIRIT-P1 mTSS results at Week 16, and radiographic progression results at Week 156]

Caption:
[Header] FOR BIOLOGIC-NAIVE PATIENTS WITH PSORIATIC ARTHRITIS

[Visual, left] 67% of patients had no radiographic progression* at Week 156
74% of patients had minimal radiographic progression‡ at Year 3

[Graph copy, right]
SPIRIT-P1 (Biologic-Naïve): Adjusted mean change from baseline in mTSS at Week 16, MMRM^1,11,13,14
ADJUSTED MEAN CHANGE FROM BASELINE, 0, 0.1, 0.2, 0.3, 0.4, 0.5, 0.6
Taltz 80 mg every 4 weeks (n=107), 0.13^†
Humira 40 mg every 2 weeks (n=101), 0.12^†
Placebo (n=106), 0.36 mTSS
SPIRIT-P1 was no designed to test the noninferiority or superiority of Taltz against Humira^® (adalimumab). Thus, these data should not be used to compare the efficacy between these products.

[Body and footnotes]
^*Defined as a change from baseline in mTSS≤0; measured in biologic-naive patients (analysis is based on patients with evaluable X-rays at baseline and Year 3).^14,15
^†P≤0.05 vs placebo. Mean baseline mTSS=19.2 for Taltz, 15.9 for Humira, and 17.6 for placebo.
^‡Defined as a change from baseline in mTSS≤0.5; measured in biologic-naive patients (analysis is based on patients with evaluable X-rays at baseline and Year 3).
Missing mTSS data were imputed using NRI and linear extrapolation for Week 16 and Year 3 (Week 156), respectively. In the open-label extension period, linear extrapolation was used if patients had a baseline and at least one post-baseline value (i.e., Week 52, 108 or 156). At Week 156, 10.8% (n=28) were imputed using linear extrapolation.
Inhibition of progression of structural damage was assessed radiographically and expressed as the adjusted mean change in mTSS and its components, the joint space narrowing score and bone erosion score, at Week 16 vs baseline. The mTSS score was modified for PsA by addition of hand distal interphalangeal (DIP) joints.
mTSS is a composite measure found by totaling the joint space narrowing score and the bone erosion score.
SPIRIT-P2 (TNFi-experienced) did not include an assessment of radiographic progression.¹¹

Primary endpoint=ACR20 response at Week 24.

Week 156 mean mTSS change from baseline (linear extrapolation) was 1.7 (Nx=72) for patients entering the extension period and initially randomized Taltz 80 mg every 4 weeks (n=81; mean baseline 19.2).^1,14
n=total number of patients entering the open-label extension period population (Week 52-156).¹³
Nx=number of patients with nonmissing change after linear extrapolation.¹³
The Week 156 data were from a post hoc analysis and were not placebo-controlled; therefore, statistical conclusions cannot be drawn.
The open-label extension phase of the study has limitations (e.g., no placebo comparison, patients remaining in the extension phase may be those with better results). Patients in the extension period population were all patients administered Taltz on or after Week 24.

ACR20=American College of Rheumatology 20% response rate; DIP=distal interphalangeal; mTSS=modified total Sharp score; NRI=nonresponder imputation; TNFi=tumor necrosis factor inhibitor.

4:08-4:11

[On-screen patient holding their hand, which appears inflammed. An icon with the Taltz prescription box.]

4:12-4:36

[Taltz adverse reactions and infections through Week 12.]

Caption:
[Title and subheadings] FOR ADULTS WITH MODERATE-TO-SEVERE PLAQUE PSORIASIS
ADVERSE REACTIONS AND INFECTIONS1 through Week 12

Taltz 80 mg every 2 weeks (n=1167)
Placebo (n=791)
The most frequent injection site reactions were erythema and pain. Most injection site reactions were mild to moderate in severity and did not lead to discontinuation of Taltz.

Adverse reactions that occurred in ≥1% of Taltz patients and more frequently than with placebo

ADVERSE REACTIONS
17%, Injection site reactions, PBO = 3%
14%, Upper respiratory tract infections*, PBO = 13%
2%, Nausea, PBO = 1%
2%, Tinea infections, PBO <1%

^*Upper respiratory tract infections include nasopharyngitis and rhinovirus infection.
PBO=placebo.

INFECTIONS
27%, Infections, PBO = 23%
0.4%, Serious infections, PBO = 0.4%

4:37-4:45

[On-screen patient with their arms folded. The Taltz prescription box is pointing to the plaques that are present on the patient’s arms and scalp, as well as their nails.]

4:46-4:57

[Timeline with six dots, representing six months.]

Caption:
[Labels] 6-month delay

4:58-9:34

[Taltz logo with dosage and remainder of the ISI disclaimers appear on screen.]

Caption:
INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR TALTZ (IXEKIZUMAB)

INDICATIONS
Taltz is indicated for adults with active psoriatic arthritis (PsA), for adults with active ankylosing spondylitis (AS), and for adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation. Taltz is also indicated for patients aged 6 years or older with moderate-to-severe plaque psoriasis (PsO) who are candidates for systemic therapy or phototherapy.

CONTRAINDICATIONS
Taltz is contraindicated in patients with a previous serious hypersensitivity reaction, such as anaphylaxis, to ixekizumab or to any of the excipients.

WARNINGS AND PRECAUTIONS
Infections
Taltz may increase the risk of infection. Serious infections have occurred. In clinical trials of adult patients with plaque psoriasis, the Taltz group had a higher rate of infections than the placebo group (27% vs 23%). A similar increase in risk of infection was seen in placebo-controlled trials of adult patients with psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, and pediatric patients with plaque psoriasis. In the post-marketing setting, serious bacterial, viral, and fungal opportunistic infections have been reported in patients receiving IL-17 inhibitors, including Taltz. Instruct patients to seek medical advice if signs or symptoms of clinically important chronic or acute infection occur. If a patient develops a serious infection or is not responding to standard therapy, monitor the patient closely and discontinue Taltz until the infection resolves.

Pre-Treatment Evaluation for Tuberculosis
Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with Taltz. Do not administer to patients with active TB infection. Initiate treatment of latent TB prior to administering Taltz. Consider anti-TB therapy prior to initiating Taltz in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Patients receiving Taltz should be monitored closely for signs and symptoms of active TB during and after treatment.

Hypersensitivity
Serious hypersensitivity reactions, including angioedema and urticaria (each ≤0.1%), occurred in the Taltz group in clinical trials. Anaphylaxis, including cases leading to hospitalization, has been reported in post-marketing use with Taltz. If a serious hypersensitivity reaction occurs, discontinue Taltz immediately and initiate appropriate therapy.

Eczematous Eruptions
In the postmarketing setting, cases of severe eczematous eruptions, including atopic dermatitis-like eruptions, dyshidrotic eczema, and erythroderma were reported in patients receiving Taltz; some cases resulted in hospitalization. The onset of eczematous eruptions was variable, ranging from days to months after the first dose of Taltz. Treatment may need to be discontinued to resolve the eczematous eruption. Some patients with limited psoriasis treatment options were successfully treated for eczema while continuing Taltz.

Inflammatory Bowel Disease
Patients treated with Taltz may be at an increased risk of inflammatory bowel disease. In clinical trials, Crohn’s disease and ulcerative colitis, including exacerbations, occurred at a greater frequency in the Taltz group than the placebo group. During Taltz treatment, monitor patients for onset or exacerbations of inflammatory bowel disease and if IBD occurs, discontinue Taltz and initiate appropriate medical management.

Immunizations
Prior to initiating therapy with Taltz, consider completion of all age-appropriate immunizations according to current immunization guidelines. Avoid use of live vaccines in patients treated with Taltz.

ADVERSE REACTIONS
Most common adverse reactions (≥1%) associated with Taltz treatment are injection site reactions, upper respiratory tract infections, nausea, and tinea infections. Overall, the safety profiles observed in adult patients with psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, and pediatric patients with plaque psoriasis were consistent with the safety profile in adult patients with plaque psoriasis, with the exception of influenza and conjunctivitis in psoriatic arthritis and conjunctivitis, influenza, and urticaria in pediatric psoriasis.
Please see Prescribing Information and Medication Guide. See Instructions for Use included with the device.
Taltz is available as an 80 mg/mL, 40 mg/0.5 mL, 20 mg/0.25 mL injection.

IX HCP ISI 20AUG2024

9:35-9:38

[Reference list progresses on screen]
References

Taltz. Prescribing Information. Lilly USA, LLC.
Wilson FC, Icen M, Crowson CS, McEvoy MT, Gabriel SE, Kremers HM. Incidence and clinical predictors of psoriatic arthritis in patients with psoriasis: a population-based study. Arthritis Rheum. 2009;61(2):233-239.
Prey S, Paul C, Bronsard V, et al. Assessment of risk of psoriatic arthritis in patients with plaque psoriasis: a systematic review of the literature. J Eur Acad Dermatol Venereol. 2010;24(suppl 2):31-35. doi:10.1111/j.1468-3083.2009.03565.x
Gelfand JM, Gladman DD, Mease PJ, et al. Epidemiology of psoriatic arthritis in the population of the United States. J Am Acad Dermatol. 2005;53(4):573-577.
Data on file. Lilly USA, LLC. DOF-IX-US-0183.
Data on file. Lilly USA, LLC. DOF-IX-US-0008.
Reich K, Leonardi C, Lebwohl M, et al. Sustained response with ixekizumab treatment of moderate-to-severe psoriasis with scalp involvement: results from three phase 3 trials (UNCOVER-1, UNCOVER-2, UNCOVER-3). J Dermatolog Treat. 2017;28:282-287.
Data on file. Lilly USA, LLC. TAL20170829A.
Dennehy EB, Zhang L, Amato D, Goldblum O, Rich P. Ixekizumab is effective in subjects with moderate to severe plaque psoriasis with significant nail involvement: results from UNCOVER 3. J Drugs Dermatol. 2016;15:958-961.
Mease PJ, van der Heijde D, Ritchlin CT, et al; on behalf of SPIRIT-P1 Study Group. Ixekizumab, an interleukin-17A specific monoclonal antibody, for the treatment of biologic-naive patients with active psoriatic arthritis: results from the 24-week randomised, double-blind, placebo-controlled and active (adalimumab)-controlled period of the phase 3 trial SPIRIT-P1. Ann Rheum Dis. 2017;76(suppl):^1-30.
Nash P, Kirkham B, Okada M, et al; on behalf of SPIRIT-P2 Study Group. Ixekizumab for the treatment of patients with active psoriatic arthritis and an inadequate response to tumour necrosis factor inhibitors: results from the 24-week randomised, double-blind, placebo-controlled period of the SPIRIT-P2 phase 3 trial. Lancet. 2017;389:2317-2327.
Nash P, Kirkham B, Okada M, et al; on behalf of SPIRIT-P2 Study Group. Ixekizumab for the treatment of patients with active psoriatic arthritis and an inadequate response to tumour necrosis factor inhibitors: results from the 24-week randomised, double-blind, placebo-controlled period of the SPIRIT-P2 phase 3 trial. Lancet. 2017;389:2317-2327. Supplementary appendix.
Mease PJ, van der Heijde D, Ritchlin CT, et al; on behalf of SPIRIT-P1 Study Group. Ixekizumab, an interleukin-17A specific monoclonal antibody, for the treatment of biologic-naive patients with active psoriatic arthritis: results from the 24-week randomised, double-blind, placebo-controlled and active (adalimumab)-controlled period of the phase 3 trial SPIRIT-P1. Ann Rheum Dis. 2017;76:79-87.
Data on file. Lilly USA, LLC. DOF-IX-US-0094.
Chandran V, van der Heijde D, Fleischmann RM, et al. Ixekizumab treatment of biologic-naïve patients with active psoriatic arthritis: 3-year results from a phase III clinical trial (SPIRIT-P1). Rheumatology (Oxford). 2020;59:2774-2784.

9:39-9:43

Caption:
For more information, visit Taltz.com/HCP

9:44-9:46

[Text fades to white. Lilly logo appears.]

Caption:
Lilly
PP-IX-US-6952 09/2024 ©Lilly USA 2024. All rights reserved.

Please see below for full data on challenging body areas.

FOR ADULTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS

Taltz provided consistent, complete clearance data in scalp psoriasis through 5 years^1,2,11

Line graph of UNCOVER-3 post hoc analysis for scalp psoriasis through 5 years with mNRI data

In the post hoc mNRI analysis of UNCOVER-3 study, among patients with scalp psoriasis (Taltz n=349; placebo n=176), patients receiving Taltz at weeks 12 (the induction period), 60, 108, 156, 204, and 264 (the open-label extension period), 78%, 81%, 78%, 74%, 64%, and 69% of patients, respectively, achieved PSSI=0; at week 12, 10% of patients on placebo achieved PSSI=0.

PSSI=0 response rates are for a subset of patients from UNCOVER-3 with baseline scalp psoriasis. The mean baseline PSSI score was 20 for Taltz.

The open-label phase of the study has limitations (eg, no placebo comparison, patients remaining in the extension phase may be those with better results).

mNRI analysis imputes missing data due to study drug (eg, inadequate response, adverse event, lack of efficacy) as nonresponse; whereas missing data due to other reasons (eg, missed visits, lost to follow-up) is included as a predicted value based on statistical modeling of observed data.

Trial design

SELECT IMPORTANT SAFETY INFORMATION: INFECTIONS
Taltz may increase the risk of infection. Serious infections have occurred. In clinical trials of adult patients with plaque psoriasis, the Taltz group had a higher rate of infections than the placebo group (27% vs 23%). A similar increase in risk of infection was seen in placebo-controlled trials of adult patients with psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, and pediatric patients with plaque psoriasis. In the post-marketing setting, serious bacterial, viral, and fungal opportunistic infections have been reported in patients receiving IL-17 inhibitors, including Taltz. Instruct patients to seek medical advice if signs or symptoms of clinically important chronic or acute infection occur. If a serious infection develops, discontinue Taltz until the infection resolves.

FOR ADULTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS

Taltz provided consistent, complete clearance data in nail psoriasis through 5 years^1,2,12

Line graph of UNCOVER-3 post hoc analysis for nail psoriasis through 5 years with mNRI data

In the post hoc mNRI analysis of UNCOVER-3 study, among patients with nail psoriasis (Taltz n=229; placebo n=116), patients receiving Taltz at weeks 12 (the induction period), 60, 108, 156, 204, and 264 (the open-label extension period), 18%, 65%, 65%, 70%, 60%, and 64% of patients, respectively, achieved NAPSI=0; at week 12, 4% of patients on placebo achieved NAPSI=0.

NAPSI=0 response rates were for a subset of patients from UNCOVER-3 with baseline nail psoriasis. For nail psoriasis assessments, only fingernail psoriasis was assessed in UNCOVER-3. The mean baseline NAPSI score was 27 for Taltz.^1,2

The open-label phase of the study has limitations (eg, no placebo comparison, patients remaining in the extension phase may be those with better results).

mNRI analysis imputes missing data due to study drug (eg, inadequate response, adverse event, lack of efficacy) as nonresponse; whereas missing data due to other reasons (eg, missed visits, lost to follow-up) is included as a predicted value based on statistical modeling of observed data.

Trial design

SELECT IMPORTANT SAFETY INFORMATION: PRE-TREATMENT EVALUATION FOR TUBERCULOSIS
Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with Taltz. Do not administer to patients with active TB infection. Initiate treatment of latent TB prior to administering Taltz. Consider anti-TB therapy prior to initiating Taltz in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Patients receiving Taltz should be monitored closely for signs and symptoms of active TB during and after treatment.

FOR ADULTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS

Taltz provided consistent, complete clearance data in palmoplantar psoriasis through 5 years^1,2,14

Line graph of UNCOVER-3 post hoc analysis for palmoplantar psoriasis through 5 years with mNRI data

In the post hoc mNRI analysis of UNCOVER-3 study, among patients with palmoplantar psoriasis (Taltz n=96; placebo n=54), patients receiving Taltz at weeks 12 (the induction period), 60, 108, 156, 204, and 264 (the open-label extension period), 65%, 78%, 79%, 72%, 78%, and 75% of patients, respectively, achieved PPASI 100; at week 12, 30% of patients on placebo achieved PPASI 100.

PPASI 100 response rates are for a subset of patients from UNCOVER-3 with baseline non-pustular palmoplantar psoriasis. The mean baseline PPASI score was 10 for Taltz.

The open-label phase of the study has limitations (eg, no placebo comparison, patients remaining in the extension phase may be those with better results).

mNRI analysis imputes missing data due to study drug (eg, inadequate response, adverse event, lack of efficacy) as nonresponse; whereas missing data due to other reasons (eg, missed visits, lost to follow-up) is included as a predicted value based on statistical modeling of observed data.

Trial design

SELECT IMPORTANT SAFETY INFORMATION: ECZEMATOUS ERUPTIONS
In the postmarketing setting, cases of severe eczematous eruptions, including atopic dermatitis-like eruptions, dyshidrotic eczema, and erythroderma were reported in patients receiving Taltz; some cases resulted in hospitalization. The onset of eczematous eruptions was variable, ranging from days to months after the first dose of Taltz. Treatment may need to be discontinued to resolve the eczematous eruption. Some patients with limited psoriasis treatment options were successfully treated for eczema while continuing Taltz.

References:

Blauvelt A, Lebwohl MG, Mabuchi T, et al. Long-term efficacy and safety of ixekizumab: a 5-year analysis of the UNCOVER-3 randomized controlled trial. J Am Acad Dermatol. 2021;85:360-368.
Blauvelt A, Lebwohl MG, Mabuchi T, et al. Long-term efficacy and safety of ixekizumab: a 5-year analysis of the UNCOVER-3 randomized controlled trial. Supplementary material. J Am Acad Dermatol. 2021;85:360-368.
Guenther L, Potts Bleakman A, Weisman J, et al. Ixekizumab results in persistent clinical improvement in moderate-to-severe genital psoriasis during a 52 week, randomized, placebo-controlled, phase 3 clinical trial. Acta Derm Venereol. 2020;100:adv00006.
Ventura A, Mazzeo M, Gaziano R, Galluzzo M, Bianchi L, Campione E. New insight into the pathogenesis of nail psoriasis and overview of treatment strategies. Drug Des Devel Ther. 2017;11:2527-2535.
Data on file. Lilly USA, LLC. DOF-IX-US-0121.
Data on file. Lilly USA, LLC. DOF-IX-US-0122.
Data on file. Lilly USA, LLC. DOF-IX-US-0123.
Data on file. Lilly USA, LLC. DOF-IX-US-0124.
Data on file. Lilly USA, LLC. DOF-IX-US-0125.
Haroon M, Gallagher P, FitzGerald O. Diagnostic delay of more than 6 months contributes to poor radiographic and functional outcome in psoriatic arthritis. Ann Rheum Dis. 2015;74:1045-1050.
Data on file. Lilly USA, LLC. DOF-IX-US-0264.
Data on file. Lilly USA, LLC. DOF-IX-US-0259.
Data on file. Lilly USA, LLC. DOF-IX-US-0258.
Data on file. Lilly USA, LLC. DOF-IX-US-0263.

5 head-to-head clinical trials testing superiority in 2 disease states^36-40

Adult Plaque Psoriasis

IXORA-R

The primary endpoint was the proportion of patients achieving PASI 100 at week 12.

IXORA-S

The primary endpoint was the proportion of patients achieving PASI 90 at week 12.

UNCOVER-2, -3

The co-primary outcome measures of these trials were the proportion of patients with sPGA 0,1 with ≥2-point improvement from baseline, and proportion of patients achieving PASI 75 at week 12.

Adult Psoriatic Arthritis

SPIRIT-H2H

The primary outcome measure of this trial was the proportion of patients simultaneously achieving both ACR50 and PASI 100 at week 24.

^*US-approved Enbrel.

Please refer to the Prescribing Information of each product for indication, dosage, and administration.

The brands listed are registered trademarks of their respective owners.

SELECT IMPORTANT SAFETY INFORMATION: INFLAMMATORY BOWEL DISEASE
Patients treated with Taltz may be at an increased risk of inflammatory bowel disease. In clinical trials, Crohn's disease and ulcerative colitis, including exacerbations, occurred at a greater frequency in the Taltz group than the placebo group. During Taltz treatment, monitor patients for onset or exacerbation of inflammatory bowel disease and if IBD occurs, discontinue Taltz and initiate appropriate medical management.

PASI=Psoriasis Area Severity Index; PASI 75/90/100=75%/90%/100% improvement from baseline in PASI criteria; sPGA=static Physician’s Global Assessment; ACR50=American College of Rheumatology 50% response.

Taltz showed superiority in complete skin clearance (PASI 100) in head-to-head trials in 2 disease states^6,7

PsO: TALTZ VS TREMFYA
PASI 100 response rates at
week 12, NRI

PsA: TALTZ VS HUMIRA (BIOLOGIC-NAIVE)
PASI 100 response rates at
week 24, NRI

Taltz vs Humira PASI 100 reponse rates at week 24

In a head-to-head trial in patients with PsO, 41%^* of patients receiving Taltz (n=520) achieved PASI 100 vs 25% of patients receiving Tremfya (n=507) at week 12, NRI.

In a head-to-head trial in patients with PsA, 60%^† of patients receiving Taltz (n=283) achieved PASI 100 vs 47% of patients receiving Humira (n=283) at week 24, NRI.

^*P<.001 vs Tremfya.
^†P=.001 vs Humira.

In the Taltz vs Humira study , primary endpoint=simultaneous achievement of ACR50 and PASI 100 at week 24.

All patients had BSA ≥3%; patients with BSA ≥10%, PASI ≥12, and sPGA ≥3 followed the dosing for moderate to severe psoriasis. All other patients followed PsA dosing.

IXORA-R and SPIRIT-H2H trial designs.

SELECT IMPORTANT SAFETY INFORMATION: IMMUNIZATIONS
Prior to initiating Taltz, consider completion of all age-appropriate immunizations according to current immunization guidelines. Avoid use of live vaccines in patients treated with Taltz.

PASI=Psoriasis Area Severity Index; PASI 100=100% improvement from baseline in PASI criteria; PsO=plaque psoriasis; NRI=nonresponder imputation; PsA=psoriatic arthritis; ACR50=American College of Rheumatology 50% response; BSA=body surface area; sPGA=static Physician’s Global Assessment.

FOR ADULTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS

Taltz established superiority to Tremfya across all efficacy endpoints through week 12⁸

IXORA-R: RESPONSE RATES OF KEY EFFICACY ENDPOINTS, NRI

IXORA-R: Taltz vs Tremfya response rates of key efficacy endpoints

In an NRI^* analysis of IXORA-R (Taltz n=520; Tremfya n=507), 41% of patients receiving Taltz achieved PASI 100 at week 12 (primary efficacy endpoint) vs 25% of patients receiving Tremfya (P<.001). For secondary endpoints, 28% of patients receiving Taltz achieved PASI 50 at week 1 vs 9% of patients receiving Tremfya (P<.001); 23% of patients receiving Taltz achieved PASI 75 at week 2 vs 5% of patients receiving Tremfya (P<.001); 21% of patients receiving Taltz achieved PASI 90 at week 4 vs 8% of patients receiving Tremfya (P<.001); 7% of patients receiving Taltz achieved PASI 100 at week 4 vs 1% of patients receiving Tremfya (P<.001); 58% of patients receiving Taltz achieved PASI 90 at week 8 vs 36% of patients receiving Tremfya (P<.001); 30% of patients receiving Taltz achieved PASI 100 at week 8 vs 14% of patients receiving Tremfya (P<.001); 42% of patients receiving Taltz achieved sPGA 0 at week 12 vs 25% of patients receiving Tremfya (P<.001).

Secondary efficacy endpoint, PASI 100 at week 24, was type-I error controlled but did not achieve superiority. Noninferiority analysis of PASI 100 at week 24 was prespecified and achieved with a noninferiority margin of -11.4%, but not type-I error–controlled (Taltz vs Tremfya treatment difference of -2.3% with 95% CI [-8.4, 3.8]). At week 24, 50% of patients taking Taltz and 52% of patients taking Tremfya achieved PASI 100.

^*Primary and secondary endpoints were analyzed according to a prespecified graphical multiplicity adjustment approach.

All patients were ≥18 years of age and had plaque psoriasis with BSA ≥10%, sPGA ≥3, and a PASI score ≥12, and were candidates for phototherapy and/or systemic therapy.

Trial design

Registration trial results

SELECT IMPORTANT SAFETY INFORMATION: ADVERSE REACTIONS
Most common adverse reactions (≥1%) associated with Taltz treatment are injection site reactions, upper respiratory tract infections, nausea, and tinea infections. Overall, the safety profiles observed in adult patients with psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, and pediatric patients with plaque psoriasis were consistent with the safety profile in adult patients with plaque psoriasis, with the exception of influenza and conjunctivitis in psoriatic arthritis, and conjunctivitis, influenza, and urticaria in pediatric psoriasis.

FOR ADULTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS

Taltz was superior to Tremfya in the percentage of patients achieving completely clear skin (PASI 100) at week 12⁸

PASI 100 results at week 12 were consistent with registration trials

IXORA-R: Taltz vs Tremfya percentage of patients achieving PASI 100 at week 12

In an NRI analysis of IXORA-R (Taltz n=520; Tremfya n=507), 41%^* of patients receiving Taltz achieved PASI 100 at week 12 vs 25% of patients receiving Tremfya.

^*P<.001 vs Tremfya.

PASI 100 at week 12 was the primary endpoint.

Trial design

Registration trial results

SELECT IMPORTANT SAFETY INFORMATION: CONTRAINDICATIONS
Taltz is contraindicated in patients with a previous serious hypersensitivity reaction, such as anaphylaxis, to ixekizumab or to any of the excipients.

FOR ADULTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS

Taltz was superior to Tremfya in providing rapid and visible skin clearance (PASI 75) at week 2⁸

IXORA-R: Taltz vs Tremfya percentage of patients achieving PASI 75 at week 2

In an NRI analysis of IXORA-R (Taltz n=520; Tremfya n=507), 23%^* of patients receiving Taltz achieved PASI 75 at week 2 vs 5% of patients receiving Tremfya.

^*P<.001 vs Tremfya at week 2.

PASI 75 response at week 2 was a secondary endpoint.

Prespecified analysis was also conducted for PASI 75 at week 12 (Taltz: 87%, Tremfya: 83%). The data were not type-I error–controlled; therefore, results cannot be regarded as statistically significant.

Trial design

Registration trial results

SELECT IMPORTANT SAFETY INFORMATION: INFECTIONS
Taltz may increase the risk of infection. Serious infections have occurred. In clinical trials of adult patients with plaque psoriasis, the Taltz group had a higher rate of infections than the placebo group (27% vs 23%). A similar increase in risk of infection was seen in placebo-controlled trials of adult patients with psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, and pediatric patients with plaque psoriasis. In the post-marketing setting, serious bacterial, viral, and fungal opportunistic infections have been reported in patients receiving IL-17 inhibitors, including Taltz. Instruct patients to seek medical advice if signs or symptoms of clinically important chronic or acute infection occur. If a serious infection develops, discontinue Taltz until the infection resolves.

FOR BIOLOGIC-NAIVE PATIENTS WITH ACTIVE PSORIATIC ARTHRITIS

Taltz was superior to Humira in the percentage of patients who simultaneously achieved both ACR50 and PASI 100 at week 24, with consistency at week 52^7,12

SPIRIT-H2H: Taltz vs Humira percentage of patients simultaneously achieving ACR50 and PASI 100 at week 24

In an NRI analysis of SPIRIT-H2H (biologic-naive) (Taltz n=283; Humira n=283), at week 24, 36%^* of patients receiving Taltz simultaneously achieved ACR50 and PASI 100 vs 28% of patients receiving Humira. Additionally, at week 52, 39%^† of patients receiving Taltz simultaneously achieved ACR50 and PASI 100 vs 26% of patients receiving Humira.

^*P<.05 vs Humira at week 24.
^†P≤.001 vs Humira at week 52. Nominal P value: Week 52 measure of ACR50 + PASI 100 was not controlled for type-I error; therefore, no statistical comparisons can be made.
All patients had BSA ≥3%; patients with BSA ≥10%, PASI ≥12, sPGA ≥3 followed the dosing for moderate to severe plaque psoriasis.
Primary endpoint=simultaneous achievement of ACR50 and PASI 100 at week 24.

PsA Registration Trials Data

SPIRIT-P1 and -P2: ACR response rates at week 24, NRI^11,13,14
In SPIRIT-P1 (biologic-naive) (Taltz 80 mg every 4 weeks n=107; placebo n=106) and SPIRIT-P2 (TNFi-experienced) (Taltz 80 mg every 4 weeks n=122; placebo n=118), 58% and 53% of Taltz patients, respectively, achieved ACR20 vs 30% and 20% for placebo. Additionally, in Spirit-P1 and -P2, 40% and 35% of patients receiving Taltz achieved ACR50 vs 15% and 5% for placebo respectively.

Primary endpoint=ACR20 response at week 24.
Inadequate responders (<20% improvement in tender and in swollen joint counts) at week 16 were analyzed as nonresponders after week 16 until the primary endpoint.
NRI of intent-to-treat population through week 24.

SPIRIT-P1 and -P2: PASI results at week 12, NRI^11,13-16
In SPIRIT-P1 (biologic-naive) (Taltz 80 mg every 4 weeks n=73; placebo n=67), among PsA patients with plaque psoriasis ≥3% BSA, 75% of patients receiving Taltz achieved PASI 75 at week 12 vs 8% of patients who received placebo. 32% of patients receiving Taltz achieved PASI 100 at week 12 vs 2% of patients who received placebo. In SPIRIT-P2 (TNFi-experienced) (Taltz 80 mg every 4 weeks n=68; placebo n=67), among PsA patients with plaque psoriasis ≥3% BSA, 57% of patients receiving Taltz achieved PASI 75 at week 12 vs 10% for placebo. Additionally, 19% of patients receiving Taltz achieved PASI 100 at week 12 vs 6% for placebo.
Among patients with sPGA ≥3 at baseline, in SPIRIT-P1 (biologic-naive) (Taltz 80 mg every 4 weeks n=52; placebo n=41), 75% of patients receiving Taltz achieved sPGA 0,1 at week 12 vs 7% for placebo. Additionally, in SPIRIT-P2 among patients with sPGA ≥3 at baseline (TNFi-experienced) (Taltz 80 mg every 4 weeks n=60; placebo n=55), 63% of patients receiving Taltz achieved sPGA 0,1 vs 4% for placebo.

NRI of intent-to-treat population through week 12.
PASI=Psoriasis Area Severity Index; ACR20/50=American College of Rheumatology 20%/50% response; NRI=nonresponder imputation; BSA=body surface area; sPGA=static Physician’s Global Assessment.

SPIRIT-H2H trial design

SPIRIT-P1 and -P2 trial design

SELECT IMPORTANT SAFETY INFORMATION: HYPERSENSITIVITY
Serious hypersensitivity reactions, including angioedema and urticaria (each ≤0.1%), occurred in the Taltz group in clinical trials. Anaphylaxis, including cases leading to hospitalization, has been reported in post-marketing use with Taltz. If a serious hypersensitivity reaction occurs, discontinue Taltz immediately and initiate appropriate therapy.

FOR BIOLOGIC-NAIVE PATIENTS WITH ACTIVE PSORIATIC ARTHRITIS

Taltz demonstrated superiority to Humira in the percentage of patients achieving PASI 100 at week 24^7,17

SPIRIT-H2H: Taltz vs Humira PASI response rates at week 24

In an NRI analysis of SPIRIT-H2H (biologic-naive) (Taltz n=283; Humira n=283), at week 24, 60%^* of patients receiving Taltz achieved PASI 100 vs 47% of patients receiving Humira. Additionally, at week 52, 64%^† of patients receiving Taltz achieved PASI 100 vs 41% of patients receiving Humira.

^*P≤.001 vs Humira at week 24 for PASI 100.
^†P≤.001 vs Humira at week 52 for PASI 100. Nominal P value: Week 52 was not controlled for type-I error; therefore, no statistical comparisons can be made.
Primary endpoint=simultaneous achievement of ACR50 and PASI 100 at week 24.
All patients had BSA ≥3%; patients with BSA ≥10%, PASI ≥12, sPGA ≥3 followed the dosing regimen indicated for moderate to severe plaque psoriasis.

SPIRIT-H2H trial design

SELECT IMPORTANT SAFETY INFORMATION: ECZEMATOUS ERUPTIONS
In the postmarketing setting, cases of severe eczematous eruptions, including atopic dermatitis-like eruptions, dyshidrotic eczema, and erythroderma were reported in patients receiving Taltz; some cases resulted in hospitalization. The onset of eczematous eruptions was variable, ranging from days to months after the first dose of Taltz. Treatment may need to be discontinued to resolve the eczematous eruption. Some patients with limited psoriasis treatment options were successfully treated for eczema while continuing Taltz.

FOR BIOLOGIC-NAIVE PATIENTS WITH ACTIVE PSORIATIC ARTHRITIS

Taltz provided comparable improvement in ACR50 to Humira at week 24, NRI^7,18

In SPIRIT-H2H, 51% of patients receiving Taltz (n=283) achieved ACR50 at week 24 vs 47% for Humira (n=283).

Major secondary objective met: demonstrate noninferiority of Taltz vs Humira on ACR50 response at 24 weeks (95% CI [-4.3% , 12.1%]) for noninferiority with -12.0% margin.
ACR50=American College of Rheumatology 50% response; NRI=nonresponder imputation; PASI=Psoriasis Area Severity Index.

SPIRIT-H2H trial design

SELECT IMPORTANT SAFETY INFORMATION: INFLAMMATORY BOWEL DISEASE
Patients treated with Taltz may be at an increased risk of inflammatory bowel disease. In clinical trials, Crohn's disease and ulcerative colitis, including exacerbations, occurred at a greater frequency in the Taltz group than the placebo group. During Taltz treatment, monitor patients for onset or exacerbation of inflammatory bowel disease and if IBD occurs, discontinue Taltz and initiate appropriate medical management.

References:

ClinicalTrials.gov Identifier: NCT03573323.
ClinicalTrials.gov Identifier: NCT02561806.
ClinicalTrials.gov Identifier: NCT01597245.
ClinicalTrials.gov Identifier: NCT01646177.
ClinicalTrials.gov Identifier: NCT03151551.
Blauvelt A, Papp K, Gottlieb A, et al; IXORA-R Study Group. A head-to-head comparison of ixekizumab vs. guselkumab in patients with moderate-to-severe plaque psoriasis: 12-week efficacy, safety and speed of response from a randomized, double-blinded trial. Br J Dermatol. 2020;182:1348-1358.
Mease PJ, Smolen JS, Behrens F, et al; SPIRIT H2H Study Group. A head-to-head comparison of the efficacy and safety of ixekizumab and adalimumab in biological-naïve patients with active psoriatic arthritis: 24-week results of a randomised, open-label, blinded-assessor trial. Ann Rheum Dis. 2020;79:123-131.
Data on file. Lilly USA, LLC. DOF-IX-US-0167.
Paul C, Griffiths CEM, van der Kerkhof PCM, et al. Ixekizumab provides superior efficacy compared with ustekinumab over 52 weeks of treatment: results from IXORA-S, a phase 3 study. J Am Acad Dermatol. 2019;80:70-79.
Data on file. Lilly USA, LLC. DOF-IX-US-0006.
Taltz. Prescribing Information. Lilly USA, LLC.
Data on file. Lilly USA, LLC. DOF-IX-US-0190.
Mease PJ, van der Heijde D, Ritchlin CT, et al; on behalf of SPIRIT-P1 Study Group. Ixekizumab, an interleukin-17A specific monoclonal antibody, for the treatment of biologic-naive patients with active psoriatic arthritis: results from the 24-week randomised, double-blind, placebo-controlled and active (adalimumab)-controlled period of the phase III trial SPIRIT-P1. Ann Rheum Dis. 2017;76:79-87.
Nash P, Kirkham B, Okada M, et al; on behalf of SPIRIT-P2 Study Group. Ixekizumab for the treatment of patients with active psoriatic arthritis and an inadequate response to tumour necrosis factor inhibitors: results from the 24-week randomised, double-blind, placebo-controlled period of the SPIRIT-P2 phase 3 trial. Lancet. 2017;389:2317-2327.
Nash P, Kirkham B, Okada M, et al; on behalf of SPIRIT-P2 Study Group. Ixekizumab for the treatment of patients with active psoriatic arthritis and an inadequate response to tumour necrosis factor inhibitors: results from the 24-week randomised, double-blind, placebo-controlled period of the SPIRIT-P2 phase 3 trial. Lancet. 2017;389:2317-2327. Supplementary appendix.
Data on file. Lilly USA, LLC. TAL20171127A.
Data on file. Lilly USA, LLC. DOF-IX-US-0191.
Data on file. Lilly USA, LLC. DOF-IX-US-0189.

For adults with moderate to severe plaque psoriasis

Trust the Taltz long-term safety data^1-9

Five years of established safety experience with this IL-17A antagonist

Across 17 global PsO clinical trials²

6,800+ PsO patients treated in adult studies³

18,000+ patient-years of exposure to Taltz³

The same active ingredient with significantly less injection site pain^1,4†

No boxed warnings or routine lab monitoring required^4‡

Adjudicated IBD events were low and infrequent (0.4%)^6§

The Taltz label does not contain suicidal ideation and behavior as an adverse reaction or warning⁴

Rate of oral candidiasis was 2.1% and did not lead to treatment discontinuation^7,8

Patients treated with Taltz worldwide since launch now nearly at 393,600⁹

See long-term safety data

Injection site pain trial design

Please see long-term safety data and injection site pain trial design.

^†P<.0001; 3.5 vs 25.2 based on VAS 0-100
^‡During Taltz treatment, monitor patients for signs and symptoms of infection and for onset or exacerbation of inflammatory bowel disease. During and after treatment with Taltz, monitor patients for active tuberculosis (TB) infection.
^§There were 5 additional patients with adjudicated IBD that weren’t considered TEAEs. Total adjudicated IBD, n=31 patients (0.5%).⁶

Long-term safety data was evaluated using an integrated data set comprising 17 phase 1, 2, 3, and 4 studies in adult patients with moderate to severe plaque psoriasis.²

This analysis includes data from the beginning of the studies to the March 2022 cutoff for integrated safety data.^2,3

IL-17A=interleukin-17A; PsO=psoriasis; ISR=injection site reaction; IBD=inflammatory bowel disease; TEAE=treatment-emergent adverse event.

SELECT IMPORTANT SAFETY INFORMATION
Taltz is contraindicated in patients with a previous serious hypersensitivity reaction, such as anaphylaxis, to ixekizumab or to any of the excipients.
Warnings and precautions include infections, pre-treatment evaluation for tuberculosis, hypersensitivity, eczematous eruptions, inflammatory bowel disease, and immunizations. The most common adverse reactions (≥1%) associated with Taltz treatment are injection site reactions, upper respiratory tract infections, nausea, and tinea infections.

FOR ADULTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS

Adverse reactions that occurred in ≥1% of Taltz patients and more frequently than with placebo⁴

INTEGRATED SAFETY: UNCOVER registration trials

ADVERSE REACTIONS THROUGH WEEK 12

	Taltz 80 mg formulation every 2 weeks (n=1167)	Enbrel^® (etanercept)^‖ 50 mg twice weekly (n=287)	Placebo (n=791)
Injection site reactions	Taltz 80 mg original formulation every 2 weeks (n=1167): 17%	Enbrel^® (etanercept)^‖ 50 mg twice weekly (n=287): 11%	Placebo (n=791): 3%
Upper respiratory tract infections^¶	Taltz 80 mg original formulation every 2 weeks (n=1167): 14%	Enbrel^® (etanercept)^‖ 50 mg twice weekly (n=287): 8%	Placebo (n=791): 13%
Nausea	Taltz 80 mg original formulation every 2 weeks (n=1167): 2%	Enbrel^® (etanercept)^‖ 50 mg twice weekly (n=287): <1%	Placebo (n=791): 1%
Tinea infections	Taltz 80 mg original formulation every 2 weeks (n=1167): 2%	Enbrel^® (etanercept)^‖ 50 mg twice weekly (n=287): 0%	Placebo (n=791): <1%

INFECTIONS THROUGH WEEK 12

	Taltz 80 mg formulation every 2 weeks (n=1167)	Enbrel^® (etanercept)^‖ 50 mg twice weekly (n=287)	Placebo (n=791)
Infections	Taltz 80 mg original formulation every 2 weeks (n=1167): 27%	Enbrel^‖ 50 mg twice weekly (n=287): 18%	Placebo (n=791): 23%
Serious infections	Taltz 80 mg original formulation every 2 weeks (n=1167): 0.4%	Enbrel^‖ 50 mg twice weekly (n=287): 0.3%	Placebo (n=791): 0.4%

^‖US-approved Enbrel (etanercept).
^¶Upper respiratory tract infections include nasopharyngitis and rhinovirus infection.

The most frequent injection site reactions were erythema and pain. Most injection site reactions were mild to moderate in severity and did not lead to discontinuation of Taltz.

ADDITIONAL ACTIVE COMPARATOR SAFETY INFORMATION FROM UNCOVER-2 AND -3
In the 2 clinical trials that included US-approved etanercept, an active comparator, the rate of serious adverse events during weeks 0 to 12 was 2% with Taltz and 0.7% with US-approved Enbrel, and the rate of discontinuation from adverse events was 2% with Taltz and 0.7% with US-approved Enbrel.

SAFETY DATA FROM SPIRIT-P1 AND -P2 TRIALS
Overall, patients with psoriatic arthritis had a safety profile consistent with that of patients with plaque psoriasis in UNCOVER-1, -2, and -3 trials, except for frequency of influenza (Taltz 1.3%, placebo 0.4%) and conjunctivitis (Taltz 1.3%, placebo 0%).

TALTZ PSORIASIS CLINICAL TRIALS

Demonstrated long-term safety data for half a decade and counting^2,3

More than 6,800 patients across 15 clinical trials

ADVERSE EVENTS OF SPECIAL INTEREST: INCIDENCE RATES PER 100 PYS

	Total PY=17,599	Year 1 PY=5688	Year 2 PY=3390	Year 3 PY=3108 (n)	Year 4 PY=2882 (n)	Year 5 PY=2375 (n)
Serious infections	Total PY=17,599: 1.3	Year 1 PY=5688: 1.3	Year 2 PY=3390: 1.4	Year 3 PY=3108 (n): 1.7	Year 4 PY=2882 (n): 1.4	Year 5 PY=2375 (n): 1.3
Candida infections	Total PY=17,599: 1.9	Year 1 PY=5688: 3.2	Year 2 PY=3390: 2.2	Year 3 PY=3108 (n): 2.1	Year 4 PY=2882 (n): 2.3	Year 5 PY=2375 (n): 2.0
Hypersensitivity (non-anaphylaxis)	Total PY=17,599: 5.1	Year 1 PY=5688: 9.8	Year 2 PY=3390: 5.0	Year 3 PY=3108 (n): 4.4	Year 4 PY=2882 (n): 4.2	Year 5 PY=2375 (n): 3.5
Hypersensitivity (potential anaphylaxis^**)	Total PY=17,599: 0.1	Year 1 PY=5688: 0.2	Year 2 PY=3390: 0.1	Year 3 PY=3108 (n): 0.0 (0)	Year 4 PY=2882 (n): 0.0 (0)	Year 5 PY=2375 (n): 0.0 (0)
Crohn's disease^††	Total PY=17,599: 0.1	Year 1 PY=5688: 0.1	Year 2 PY=3390: 0.1	Year 3 PY=3108 (n): 0.0 (1)	Year 4 PY=2882 (n): 0.0 (1)	Year 5 PY=2375 (n): 0.1
Ulcerative colitis^††	Total PY=17,599: 0.1	Year 1 PY=5688: 0.2	Year 2 PY=3390: 0.1	Year 3 PY=3108 (n): 0.0 (1)	Year 4 PY=2882 (n): 0.0 (0)	Year 5 PY=2375 (n): 0.1
Malignancy-related (Nonmelanoma skin cancer)	Total PY=17,599: 0.3	Year 1 PY=5688: 0.5	Year 2 PY=3390: 0.2	Year 3 PY=3108 (n): 0.4	Year 4 PY=2882 (n): 0.2	Year 5 PY=2375 (n): 0.2
Malignancy-related (Malignancies excluding NMSCs)	Total PY=17,599: 0.5	Year 1 PY=5688: 0.5	Year 2 PY=3390: 0.6	Year 3 PY=3108 (n): 0.5	Year 4 PY=2882 (n): 0.6	Year 5 PY=2375 (n): 0.6
Injection site reactions	Total PY=17,599: 5.5	Year 1 PY=5688: 16.1	Year 2 PY=3390: 4.2	Year 3 PY=3108 (n): 2.2	Year 4 PY=2882 (n): 2.3	Year 5 PY=2375 (n): 1.7

^**After review of potential cases, no confirmed cases of anaphylaxis in clinical trials.¹⁰
^††Data on all suspected IBD, as identified by events potentially indicative of ulcerative colitis or Crohn’s disease, were adjudicated according to EPIMAD criteria by an external clinical review committee of gastroenterologists with IBD expertise.

When incidence rates equal 0.0, the n value is added; n=number of events.

The average and median Taltz exposure durations were 996.7 days and 718 days, respectively.¹¹

Certain adverse events, such as malignancy, require longer observation periods and larger patient exposure to ascertain risk. In the reported safety population of the psoriasis clinical trials, not all patients received the recommended dosing regimen consistent with the FDA-approved label.

PY=patient-year; NMSC=nonmelanoma skin cancer; IBD=inflammatory bowel disease; EPIMAD=Registre Epidemiologique des Maladies de l’Appareil Digestif.

Identifying Patients with Symptoms of Inflammatory Bowel Disease (IBD)

Current affiliations reflected in video are from the time of recording

00:00-00:18
[First section of caption fades away and is replaced by second section of caption.]

Caption:
How to identify patients with symptoms of inflammatory bowel disease (IBD) and when to make a referral—Insights from a dermatologist, rheumatologist, and gastroenterologist.
PP-LI-US-0795 01/2024 © Lilly USA, LLC 2024. All rights reserved.

Lilly invited speakers to discuss a specific topic based on a series of questions and assisted in developing a script for discussion. Speakers were encouraged to include their own experience where appropriate. Some of the content in this video may therefore reflect the speakers’ personal opinions and may be specific to their own practice. Particular recommendations are those of the individual physicians and not those of Eli Lilly and Company.

00:19-00:32
[The pictures, names, and captions of the three doctors appear on screen.]

Caption:
Prof. Alexander Moschen, Gastroenterologist, Assistant Professor of Internal Medicine, Consultant Gastroenterologist, Medical University Innsbruck, Austria.
Prof. Dennis McGonagle, Rheumatologist, Professor of Investigative Rheumatology, Consultant Rheumatologist, Leeds Teaching Hospitals NHS Trust, UK.
Dr Joseph Merola, Dermatologist, Associate Physician, Brigham and Women’s Hospital, Associate Professor of Dermatology, Harvard Medical School, Boston, MA, USA.

Dr. Moschen: Hi, my name is Dr. Moschen. I'm joined by Professor McGonagle and Dr. Merola to discuss inflammatory bowel disease from our three different perspectives: gastroenterology, rheumatology, and dermatology.

00:33-00:55
[The caption is replaced by Dr. Moschen’s photograph. A diagram of the intestines with the colon highlighted with the label Ulcerative colitis appears. Then a diagram of the whole intestinal tract appears with the large intestines and then the ileum being highlighted with the label Crohn’s disease.]

Caption:
What is IBD?
Prof. Alexander Moschen, Gastroenterologist
IBD – Ulcerative colitis, Crohn’s disease

Dr. Moschen: IBD is a chronic relapsing-remitting, immune-mediated disorder characterized by inflammation in the gastrointestinal tract. Two major forms of IBD include ulcerative colitis, affecting only the colon, and Crohn's disease, which may affect the whole of the intestinal tract, but typically in a discontinuous region.

00:56-01:15
[A DNA icon within a circle appears, joined by circles representing ulcerative colitis and Crohn’s disease. Then a circle with the words immune-mediated diseases e.g. PsO, axSpA, and PsA appears. come onto the screen as he begins talking.]

Caption:
Ulcerative colitis, Crohn’s disease, immune-mediated disease e.g. PsO, axSpA, PsA

Dr. Moschen: Research shows that there is a lot of overlap in terms of genetic susceptibility between Crohn's disease, ulcerative colitis, and other immune-mediated diseases. We need to keep this relationship in mind and ask our patients with immune-mediated diseases about IBD and vice versa.

01:16-01:35
[A series of people icons appears labeled with the captions, joined by a world map with the United States, Canada, and Europe highlighted.]

Caption:
300 in 100,000; 500 in 100,000, Immune-mediated disorders

Dr. Moschen: If we look at the epidemiology of IBD, a comparable prevalence rate is observed in North America and Europe with approximately 300 to 500 cases per 100,000 inhabitants. By comparison, the incidence rate in patients with immune-mediated disorders is marginally higher.

01:36-02:11
[The caption is replaced by Prof. McGonagle’s photograph. Representative icons labeled with the captions appear and slide off screen to the left.]

Caption:
What clinical symptoms do you look for in patients who may be at higher risk of IBD?
Prof. Dennis McGonagle, Rheumatologist
Abdominal symptoms, Family history, Inflammatory markers, Anemia, Fecal calprotectin

Prof. McGonagle: In rheumatology, we will ask the patients who we suspect might have spondyloarthritis about abdominal symptoms and ask about a family history of IBD. Beyond that, we run routine blood investigations, including inflammatory markers, looking for evidence of anemia, and we may also check fecal calprotectin. And based on these findings, we may then refer the patient to our gastroenterologist to further evaluate for IBD.

02:12-02:44
[A photograph of Dr. Merola appears. Representative icons labeled with the captions appear and slide off screen to the left.]

Caption:
Dr Joseph Merola, Dermatologist
Abdominal symptoms, Family history, Blood, Mucus, Fever, Fatigue, >6-10 bowel movements, hypoalbuminemia, anemia, increased WBC, Fecal calprotectin

Dr. Merola: From a dermatologist perspective, I certainly consider it crucial to obtain the patient’s personal history, in terms of symptoms that might be relevant to IBD as well as family history. I look for red flags such as bleeding, mucus in the stool, fever, and I typically will ask about fatigue, maybe number of bowel movements throughout the day. I would also look for signs in their blood work, such as hypoalbuminemia, anemia, elevated white blood count, as well as considering a fecal calprotectin.

02:45-03:05
[The caption is replaced by Dr. Moschen’s photograph. Then later captions and representative icons animate and slide to the left.]

Caption:
What would be the main questions to ask your patient?
Prof. Alexander Moschen, Gastroenterologist
Have you experienced gastrointestinal symptoms?
Diarrhea, Blood, Mucus, Abdominal pain, >4 weeks

Dr. Moschen: I would recommend asking two simple questions. The first one is, “Have you ever experienced any gastrointestinal symptoms, namely diarrhea, blood in stool, mucus, abdominal pain that have lasted longer than four weeks?”

03:06-03:41
[Captions and representative icons animate and slide to the left.]

Caption:
Does anyone in the family suffer from IBD?
Family history, Abdominal symptoms, Fecal calprotectin
-No further testing (likely IBS)
+Further investigation required (refer to a gastroenterologist)

Dr. Moschen: And secondly, does anyone in the family suffer from IBD? If the patient has a positive family history or is reporting persistent GI symptoms, my recommendation would be to run a test for fecal calprotectin. Fecal calprotectin is the most important parameter to distinguish between inflammatory and functional gastrointestinal diseases and the results are similar to a traffic light system. If the test is negative, it might not really be necessary to do any further testing. Then it's likely IBS.

03:42-04:24
[The caption is replaced by Dr. Moschen’s photograph. Captions and representative icons animate and slide to the left.]

Caption:
How do you differentiate idiopathic gastrointestinal symptoms from real IBD?
Prof. Alexander Moschen, Gastroenterologist
How long have you had these symptoms?
Chronic diarrhea is defined as having symptoms for more than 4 weeks
In patients with immune-mediated disease, refer to a gastroenterologist if GI symptoms persist longer than 2 weeks
How rapid was the onset of symptoms?

Dr. Moschen: The first question to ask is how long have you had these symptoms? The duration of symptoms is very important. IBD is a form of chronic diarrhea and is defined as having symptoms for more than four weeks. In a patient with an immune-mediated disease, I would recommend referring to a gastroenterologist if the patient has GI symptoms for longer than two weeks. Secondly, the onset of symptoms occur very rapidly. It's likely that the problem is not IBD, then it's more likely an acute gastroenteritis caused by virus or bacteria or by food poisoning.

04:25-04:55
[A photograph of Prof. McGonagle appears. Representative icons and captions animate and slide to the left.]

Caption:
Prof. Dennis McGonagle
Rheumatologist
Abdominal symptoms
Bloody diarrhea, Mucus, Weight loss, Colitis, IBS

Prof. McGonagle: From a rheumatology perspective, if a patient’s been on an IL-17 inhibitor for psoriatic arthritis or ankylosing spondylitis for several months and they develop abdominal symptoms, but the absence of bloody diarrhea, mucus, and weight loss and clearly overt colitis and they simply have pains, which may be linked to irritable bowel, we wouldn't jump in and stop treatment.

04:56-05:06
[A photograph of Dr. Merola appears. Representative icons and captions animate and slide to the left.]

Caption:
Dr Joseph Merola
Dermatologist
Abdominal symptoms

Dr. Merola: And I agree, I'd say from the dermatology perspective, abdominal complaints, diarrhea, and GI symptoms are pretty common. So, I wouldn't be in a rush to switch treatment, particularly effective treatment, unless I really saw those true red flags.

05:07-05:27
[A photograph of Dr. Moschen appears. Captions and representative icons animate and slide to the left.]

Caption:
Prof. Alexander Moschen
Gastroenterologist
Idiopathic GI symptoms
IBD
Thank you

Dr. Moschen: So, I fully agree. So, simple questions are really useful tools to begin differentiating idiopathic gastrointestinal symptoms from real IBD. I think it's important to understand the signs and symptoms and how to manage your patients and when to refer to a gastroenterologist. Thank you very much.

05:28-05:35
Caption:
Taltz Label Language
Inflammatory Bowel Disease
Patients treated with Taltz may be at increased risk of inflammatory bowel disease. In clinical trials, Crohn's disease and ulcerative colitis, including exacerbations, occurred at a greater frequency in the Taltz group than the placebo control group. During Taltz treatment, monitor for onset or exacerbation of inflammatory bowel disease and if IBD occurs, discontinue Taltz and initiate appropriate medical management.

05:36-05:40
Caption:
References:

David T, Ling SF, Barton A. Clin Exp Immunol. 2018;193(1):3-12.
Egeberg A, Mallbris L, Warren RB, et al. Br J Dermatol. 2016;175(3):487-492.
Graves NS. Prim Care. 2013;40(3):727-741.
Juckett G, Trivedi R. Am Fam Physician. 2011;84(10):1119-1126.
Li WQ, Han JL, Chan AT, Qureshi AA. Ann Rheum Dis. 2013;72(7):1200-1205.
Ng SC, Shi HY, Hamidi N, Underwood FE, et al. Lancet. 2018;390(10114):2769-2778.
Silverberg MS, Satsangi J, Ahmad T, et al. Can J Gastroenterol. 2005;19(Suppl A):5A-36A.
Taltz US PI. Indianapolis, IN, USA: Eli Lilly USA LLC, 2020.
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125521s020lbl.pdf (Accessed October 14, 2020).

05:41-05:45
Caption: Abbreviations:
axSpA=Axial Spondyloarthritis
GI=Gastrointestinal
IBD=Inflammatory Bowel Disease
IBS=Irritable Bowel Syndrome
IL-17=Interleukin-17
PsA=Psoriatic Arthritis
PsO=Psoriasis
WBC=White Blood Count

05:46-05:51
Caption:
Eli Lilly and Company would like to thank Prof McGonagle, Dr Merola and Dr Moschen for kindly providing their time and expertise for this video project. Speakers were encouraged to include their own experience where appropriate. Some of the content in this video may reflect the speakers’ personal opinions and may be specific to their own practice.

References:

Chabra S, Gill BJ, Gallo G, et al. Ixekizumab citrate-free formulation: results from two clinical trials. Adv Ther. 2022;Epub (Incl Suppl Inf):1-11, 1-4. https://doi.org/10.1007/s12325-022-02126-0.
Data on file. Lilly USA, LLC. DOF-IX-US-0251.
Data on file. Lilly USA, LLC. DOF-IX-US-0256.
Taltz. Prescribing Information. Lilly USA, LLC.
Data on file. Lilly USA, LLC. DOF-IX-US-0292.
Data on file. Lilly USA, LLC. DOF-IX-US-0265.
Data on file. Lilly USA, LLC. DOF-IX-US-0288.
Data on file. Lilly USA, LLC. DOF-IX-US-0289.
Data on file. Lilly USA, LLC. DOF-IX-US-0311.
Data on file. Lilly USA, LLC. DOF-IX-US-0255.
Data on file. Lilly USA, LLC. DOF-IX-US-0267.

Adult Psoriasis (PsO)

Dermatology Efficacy

Week 12 results

Complete and consistent clearance across all 3 UNCOVER trials¹

Before & After Results

Week 60 results

Week 264 results

FOR ADULTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS

Challenging Body Areas

Even a 6-month delay in PsA diagnosis can cause irreversible structural damage and worse long-term physical function¹⁰

Head-to-Head Results

5 head-to-head clinical trials testing superiority in 2 disease states^36-40

Adult Plaque Psoriasis

Adult Psoriatic Arthritis

Taltz showed superiority in complete skin clearance (PASI 100) in head-to-head trials in 2 disease states^6,7

Taltz provided comparable improvement in ACR50 to Humira at week 24, NRI^7,18

Safety

Trust the Taltz long-term safety data^1-9

Five years of established safety experience with this IL-17A antagonist

Adverse reactions that occurred in ≥1% of Taltz patients and more frequently than with placebo⁴

Demonstrated long-term safety data for half a decade and counting^2,3

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS:

WARNINGS AND PRECAUTIONS

ADVERSE REACTIONS

INDICATIONS

Adult Psoriasis (PsO)

Dermatology Efficacy

Week 12 results

Expand accordion PASI/sPGA

Complete and consistent clearance across all 3 UNCOVER trials1

Before & After Results

Week 60 results

Week 264 results

FOR ADULTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS

Challenging Body Areas

Even a 6-month delay in PsA diagnosis can cause irreversible structural damage and worse long-term physical function10

Expand accordion Scalp data (PSSI 0)

Expand accordion Nail data (NAPSI 0)

Expand accordion Genital data (sPGA-G 0)

Expand accordion Palmoplantar data (PPASI 100)

Head-to-Head Results

5 head-to-head clinical trials testing superiority in 2 disease states36-40

Adult Plaque Psoriasis

Adult Psoriatic Arthritis

Taltz showed superiority in complete skin clearance (PASI 100) in head-to-head trials in 2 disease states6,7

Expand accordion Head-to-head vs Tremfya

Expand accordion Head-to-head vs Stelara

Expand accordion Head-to-head vs Enbrel

Expand accordion Head-to-head vs Humira in Psoriatic Arthritis

Taltz provided comparable improvement in ACR50 to Humira at week 24, NRI7,18

Safety

Trust the Taltz long-term safety data1-9

Five years of established safety experience with this IL-17A antagonist

Adverse reactions that occurred in ≥1% of Taltz patients and more frequently than with placebo4

Demonstrated long-term safety data for half a decade and counting2,3

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS:

WARNINGS AND PRECAUTIONS

ADVERSE REACTIONS

INDICATIONS

Complete and consistent clearance across all 3 UNCOVER trials¹

Even a 6-month delay in PsA diagnosis can cause irreversible structural damage and worse long-term physical function¹⁰

5 head-to-head clinical trials testing superiority in 2 disease states^36-40

Taltz showed superiority in complete skin clearance (PASI 100) in head-to-head trials in 2 disease states^6,7

Taltz provided comparable improvement in ACR50 to Humira at week 24, NRI^7,18

Trust the Taltz long-term safety data^1-9

Adverse reactions that occurred in ≥1% of Taltz patients and more frequently than with placebo⁴

Demonstrated long-term safety data for half a decade and counting^2,3