Taltz Citrate-Free: The same active ingredient with significantly less injection site pain vs the original formulation^1*
^*P<.0001; 3.5 vs 25.2 based on VAS 0-100

man and woman climbing a spiral of changing seasons in the clouds

Taltz is for Today and Tomorrow^1-18

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.

RAPID

ACR20 response seen as early as Week 2 in some patients with active PsA, regardless of TNFi experience ( See Rapid ACR data )

PASI 75 and PASI 90 responses seen as early as Week 2 in some biologic-naive patients with active PsA ( See Rapid PASI data )

Improvement in back pain, function, and inflammation seen as early as Week 2 in some biologic-naive patients with AS ( See Rapid AS data )

SUSTAINED

Joint symptom results sustained for 3 years, regardless of TNFi experience in patients with PsA ( See Sustained ACR data )

Skin symptom results sustained for 3 years, regardless of TNFi experience in patients with PsA ( See Sustained PASI data )

ASAS40 results sustained through week 52 in patients with AS ( See Sustained AS data )

Data were not controlled for type-1 error; therefore, statistical conclusions cannot be made.

See SPIRIT-P1 and SPIRIT-P2 trial designs

See COAST-V and W 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.

Real Patient Journeys

Letters from Patients to HCPs

00:00-00:08

[Kirk writes a letter in his dining room.]

Caption: Kirk is a real person, diagnosed with Psoriatic Arthritis as an adult. Kirk was compensated for his time.

00:09-00:26

[Kirk is writing a letter in the dining room. He is then seen standing outside in nature.]

Kirk: Dear Dr. Yu, being outdoors for me, it's like meditation.

Caption: Dear Dr. Yu,

00:26-00:35

[Kirk staring into distance wearing bicycle helmet. Flashes of archival photos.]

Kirk: Whether it was skiing, biking, or fishing; you name it, I loved it.

00:36-00:43

[Garage door closes]

Kirk: With the onset of Psoriatic Arthritis and its impact on my joints, my participation in these activities came to a halt.

00:44-00:54

[Kirk continues reading and writing the letter]

Kirk: At my toughest time, you were there for me. You knew I couldn’t wait for fast and lasting relief. So, I'm writing you this letter to say thank you.

00:57-01:10

[Archival footage of Kirk enjoying the outdoors, and joint pain setting in.]

Kirk: Aside from having bothersome skin plaques, I was at the top of my game when I started to feel the onset of pain and stiffness in some of my joints. And then, just like that, things started to go downhill.

01:11-01:27

[Kirk puts on his biking socks and gloves, and grips a cup of coffee outside. He continues to read the letter.]

Kirk: Something as simple as putting my socks on was next to impossible, let alone gripping the handles on my bike. Even cooling a cup of coffee in my hands, the pain was unbelievable. I could feel it just thinking about it.

01:29-01:44

[Kirk looks at photos of his family before his diagnosis.]

Kirk: The hardest part, it was affecting my family. My kids had school, but I could barely get out of bed to drive them there. My wife was mowing the lawn, but I couldn't get off the couch to help her. I was in tears many mornings.

01:45-01:54

[Kirk is on the balcony reflecting and looking at the mountains. Archival footage of Kirk’s friends.]

Kirk: Because I wasn't able to do what I loved, what I’d lived for, I didn't want to be around the circle of my friends.

01:55-02:01

[Kirk is on the balcony reflecting. He looks at photos of himself before his diagnosis.]

Kirk: As I thought of my future, I kept thinking, “I've got to figure this out before joint damage sets in.”

02:02-02:16

[Kirk puts away the photo box and heads outside to work on his bike. He continues reading the letter.]

Kirk: I feared I would never return to my outdoor way of life, which is why I needed an expert on my team to help find a medication I could be on, long-term. And that expert was you.

02:17-02:37

[Alternating shots of Kirk reading his letter and riding his bicycle.]

Kirk: From our first appointment, you understood my treatment goals. I talked about how my priority was to get fast relief. You talked about finding a solution that would last. I've never had anybody listen to me like you did that day, and every day since.

02:38-03:04

[Alternating shots of Kirk reading his letter and close-ups of him riding his bicycle, looking happy and hopeful.]

Caption: Sincerely, Thank You, Kirk.

Kirk: You moved quickly to help get my joint pain and skin plaques under control. I want you to know how lucky I feel to be in your care. While every day on the mountain might not be 100%, you got me back outside. And that's exactly where I belong. Sincerely, thank you, Kirk.

03:05-03:11

[Lilly and Taltz logos appear on screen, along with other text]

Caption: To learn more, visit taltz.com/letters

Caption: Please continue watching for Taltz^® efficacy and safety results and Important Safety Information.

Caption: Please see Prescribing Information and Medication Guide.

Caption: Please see Instructions for Use included with the device.

03:12-04:13

[trial design graphic and text appears on screen]

Narrator: SPIRIT-P1 and SPIRIT-P2 were phase 3, randomized, double-blind, placebo-controlled clinical trials designed to evaluate the efficacy of Taltz vs placebo in adults with active psoriatic arthritis. Patients in SPIRIT-P1 were biologic naive, while patients in SPIRIT-P2 had an inadequate response or were intolerant to 1 or 2 prior TNF inhibitors. Patients were randomized to placebo or Taltz 80 mg Q2W or Q4W following a 160-mg starting dose. In SPIRIT-P1, an active reference arm of Humira 40 mg Q2W was included. Taltz 80 mg every two weeks is not an approved dose for psoriatic arthritis. Only data from the Q4W arm will be shown. In both trials, the primary efficacy endpoint was the proportion of patients achieving ACR20 response at week 24.

Caption: SPIRIT-P1 SPIRIT-P2

Caption: Clinical Trial Designs in PsA^1-4

Caption: SPIRIT-P1 (Biologic-Naïve, N=417) and SPIRIT-P2 (TNFi-Experienced, *N=363)

Caption: Taltz 80 mg Q2W: SPIRIT-P1, n=103; SPIRIT-P2, n=123

Caption: Taltz 80 mg Q4W: SPIRIT-P1, n=107; SPIRIT-P2, n=122

Caption: Placebo: SPIRIT-P1, n=106; SPIRIT-P2, n=118

Caption: Active Reference Arm (SPIRIT-P1 Only): Humira® (adalimumab) 40 mg Q2W (n=101)

Caption: Double-Blind Treatment Period:

Week 0
Week 16: Inadequate responders receive rescue therapy and analyzed as nonresponders after week 16 until week 24
Week 24: Primary endpoint ACR20 response at week 24

Caption: IRs (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, IRs in the PBO and Humira arms were rerandomized to Taltz 80 mg Q2W or Q4W. After week 24, patients knew they were taking active treatment but remained blind to the dose until the last patient completed week 24.

Caption: ^*Inadequate response and/or intolerance to 1 or 2 prior TNFis. ^†Taltz 80 mg Q2W is not an approved dose for PsA.

Caption: ACR20=American College of Rheumatology 20% response rate; IR=inadequate responder; PBO=placebo; PsA-psoriatic arthritis; TNFi =tumor necrosis factor inhibitor; Q2W=every 2 weeks; Q4W=every 4 weeks.

Caption: Phase 3, Randomized, Double-Blind, Placebo-Controlled Trials to Evaluate the Efficacy and Safety of Taltz vs Placebo in Patients With Active PsA

Caption: Patients were ≥18 years of age who had active PsA and ≥3 swollen and ≥3 tender joints.

Caption: Humira was an active reference arm. SPIRIT-P1 was not designed to test the noninferiority or superiority of Taltz vs Humira; no statistical analyses were done comparing Humira with Taltz.

Caption: Please see Important Safety Information at the end of the video and accompanying Prescribing Information and Medication Guide.

Caption: Please see Instructions for Use included with the device.

04:13-04:41

[Two line graphs and associated text appear, showing ACR20 response rates for patients in SPIRIT-P1 and SPIRIT-P2 trials]

Narrator: Both SPIRIT-P1 and -P2 reached their primary efficacy endpoints, where 58% of patients in SPIRIT-P1 and 53% of patients in SPIRIT-P2 achieved ACR20 at week 24 compared to 30% and 20% with placebo. As early as week 2, 39% of patients in SPIRIT-P1 and 38% of patients in SPIRIT-P2 achieved ACR20 with Taltz.

Caption: SPIRIT-P1 SPIRIT-P2

Caption: Rapid ACR20 Responses Seen as Early as Week 2 in Some Patients, Regardless of TNFi Experience^1,3-6

Caption: ^*P≤.001 vs PBO at weeks 12 and 24. tP<.0001 vs PBO at weeks 12 and 24.

Caption: ACR20 at week 2 was not controlled for type-I error; therefore, statistical conclusions cannot be made

Caption: Additional Week 24 Data, NRI: In SPIRIT-P1 and SPIRIT-P2, 40% and 35% of patients receiving Taltz achieved ACR50 vs 15% and 5% for PBO, and 23% and 22% of Taltz patients achieved ACR70 vs 6% and 0% for PBO (P≤.001 vs PBO).

Caption: NRI of ITT population through week 24.

Caption: ACR50/70=American College of Rheumatology criteria for 50%/70% improvement; ITT=intent-to-treat; NRI=nonresponder imputation.

Caption: Please see Important Safety Information at the end of the video and accompanying Prescribing Information and Medication Guide.

Caption: Please see Instructions for Use included with the device.

Descriptive Clue:

There are two graphs on the screen.

The first graph depicts a comparison of response rates (in %) between Biologic-Naive patients with active psoriatic arthritis (PsA) administered with Taltz and Placebo (PBO) from week 0 to week 24. Patients administered with Taltz at week 2, 12, and 24 demonstrated response rates of 39%, 57%, and 58%, respectively while patients given PBO at week 2, 12, and 24 demonstrated response rates of 13%, 31%, and 30%, respectively. The total number of patients administered with Taltz and PBO were 107 and 106, respectively.

The second graph depicts a comparison of response rates (in %) between TNFi-Experienced patients with active PsA who were administered with Taltz and PBO from week 0 to week 24. The patients who were given Taltz at week 2, 12, and 24 demonstrated response rates of 38%, 50%, and 53%, respectively while the patients who were given PBO at week 2, 12, and 24 demonstrated response rates of 12%, 22%, and 20%, respectively. The total number of patients who were given Taltz and PBO were 122 and 118, respectively.

04:42-04:54

Narrator: Patients sustained join symptom response for 3 years, regardless of TNFi experience

Caption: SPIRIT-P1 SPIRIT-P2

Caption: Joint Symptom Results Sustained for 3 Years, Regardless of TNFi Experience^1,7-10

Caption: ACR20/50/70 RESPONSE RATES, OBSERVED

Caption: In SPIRIT-P1, in an mNRI analysis of patients receiving Taltz: at week 52, 76% achieved ACR20, 60% achieved ACR50, and 40% achieved ACR70; at week 108, 71% achieved ACR20, 52% achieved ACR50, and 30%. achieved ACR70; at week 156, 70% achieved ACR20, 52% achieved ACR50, and 33% achieved ACR70. In SPIRIT-P2, in a modified mNRI analysis of patients receiving Taltz at week 52, 70% achieved ACR20, 47% achieved ACR50, and 29% achieved ACR70. At week 108, 60% achieved ACR20, 46% achieved ACR50, and 23% achieved ACR70. At week 156, 55% achieved ACR20, 40% achieved ACR50, and 23% achieved ACR70. The uncontrolled extension period of the study has limitations (eg, no placebo comparisons, patients remaining in the study may be those with better results).

Caption: ^*Nx=observed population at week 156. mNRI of ITT population through week 156.

Caption: ACR50/70=American College of Rheumatology criteria for 50%/70% improvement; mNRI=modified nonresponder imputation.

Caption: Please see Important Safety Information at the end of the video and accompanying Prescribing Information and Medication Guide.

Caption: Please see Instructions for Use included with the device.

Descriptive Clue: There are two graphs on the screen.

The first graph demonstrates a comparison between biologic-naive patients with active PsA who achieved ACR20, ACR50, and ACR70 in SPIRIT-P1 from week 0 to week 156. At week 52, the percentage of patients who achieved ACR20, ACR50, and ACR70 was 88, 71, and 49, respectively. At week 108, the percentage of patients who achieved ACR20, ACR50, and ACR70 was 86, 65, and 39, respectively, and at week 156, the percentage for ACR20, ACR50, and ACR70 was 95, 71, and 49, respectively.

The period from week 24 to 156 was the uncontrolled extension period. This period of the study had limitations (for example, no placebo comparisons; patients who remained in the study were maybe those with better results). The observed population of patients who achieved ACR20, ACR50, and ACR70 in SPIRIT-P1 at week 156 (Nx) was 57, 58, and 59, respectively. The period from week 2 to week 24 was the double-blind treatment period.

The second graph demonstrates a comparison between TNFi-experienced patients with active PsA who achieved ACR20, ACR50, and ACR70 in SPIRIT-P2 from week 0 to week 156. At week 52, the percentage of patients who achieved ACR20, ACR50, and ACR70 was 89, 59, and 37, respectively. The percentage of people who achieved ACR20, ACR50, and ACR70 at week 108 was 82, 64, and 32, respectively and at week 156, the percentage was 84, 60, and 35.

The observed population of people who achieved ACR20, ACR50, and ACR70 at week 156 (Nx) was 67, 65, and 68, respectively.

04:55-05:14

[Two line graphs and text appear showing observed ACR20/50/70 response rates]

Narrator: In biologic-naive patients at week 12, 75% and 52% of Taltz patients achieved PASI 75 and 90, and as early as week 2, 25% of patients achieved PASI 75, and 11% of patients achieved PASI 90 with Taltz.

Caption: SPIRIT-P1 SPIRIT P-2

Caption: Rapid PASI 75 and PASI 90 Responses Seen as Early as Week 2 in Some Patients^1,3-5,11-12

Caption: *P<.001 vs PBO.

Caption: PASI 75 response rates at weeks 2 and 24 and PASI 90 response rates were not controlled for type-l error; therefore, statistical conclusions cannot be made.

Caption: In SPIRIT-P1, among patients with sPGA≥3 at baseline (Taltz n=52; placebo n=41) 75% of patients receiving Taltz achieved sPGA 0,1 at week 12 vs 7% of patients who received placebo and 65% of patients receiving Taltz achieved PGA 0,1 at week 24 vs 17% of patients who received placebo.

Caption: ADDITIONAL WEEK 12 RESULTS FROM SPIRIT-P2 TRIAL: In SPIRIT-P2 (Taltz n=68, placebo n=67), 57% of patients receiving Taltz achieved PASI 75 at week 12 vs 10% for placebo. And, 38% of patients receiving Taltz achieved PASI 90 at week 12 vs 6% for placebo. Among patients with sPGA ≥3 at baseline (Taltz 80 mg every 4 weeks n=60, placebo n=55), 63% of patients receiving Taltz achieved sPGA 0,1 at week 12 vs 4% of patients who received placebo.

Caption: Please see Important Safety Information at the end of the video and accompanying Prescribing Information and Medication Guide.

Caption: Please see Instructions for Use included with the device.

Descriptive Clue: There are two graphs on the screen.

The first graph demonstrates a comparison between the PASI 75 response rates of patients through week 24 in PsA patients with plaque PSO≥3% BSA, NRI when administered with Taltz and PBO, in SPIRIT-P1 from week 0 to week 24. At week 2, 12, and 24, at least 25%, 75%, and 71% of patients who were given Taltz, respectively, achieved PASI 75 compared to 0%, 8%, and 10% of PASI 75 responders at week 2, 12, and 24, respectively, when they were given PBO.

73 patients were given Taltz while 67 patients were given PBO.

The second graph demonstrates a comparison between PASI 90 response rates through week 24 in PsA patients with plaque PSO≥3% BSA, NRI when they were given Taltz and when they were given PBO, in SPIRIT-P1 from week 0 to week 24. At week 2, 12, and 24, at least 11%, 52%, and 56% of the patients who were given Taltz, respectively, achieved PASI 90 compared to 0%, 2%, and 6% of PASI 90 responders at week 2, 12, and 24, respectively, when they were given PBO.

05:15-05:30

Narrator: Patients also reported improvement in physical function as assessed by HAQ-DI at week 16. Results were sustained through the open label extension period at week 156.

Caption: SPIRIT-P1

Caption: Patients Treated With Taltz Showed Improvement In Physical Function, as Assessed by HAQ-DI^1,3-5,13,14

Caption: A ≥0.35 improvement from baseline is considered clinically meaningful in patients with PsA. In SPIRIT-P2 (TNFi-experienced) (Taltz n=122; mean baseline= 1.2; placebo n=118; mean baseline= 1.2), patients receiving Taltz experienced an improvement in HAQ-D1 total scores, with a mean change from baseline at week 16 of -0.5 vs -0.1 for placebo.

Caption: Mean baseline HAQ-D1=1.2. In an LOCF analysis of patients receiving Taltz (n=107): the mean change in HAQ-DI from baseline was -0.49 at Week 52, -0.44 at Week 108, and -0.43 at Week 156. ITT population through Week 156. The uncontrolled extension period of the study has limitations (e.g., no placebo comparisons; patients remaining in the study may be those with better results).

Caption: ^*Nx=observed population at Week 156.

Caption: HAQ-DI: 0=best, 3=worst; measures the patient's ability to perform the following: dress/groom, arise, eat, walk, reach, grip, maintain hygiene, and maintain daily activity. HAQ-DI=Health Assessment Questionnaire-Disability Index; LOCF=last observation carried forward.

Caption: Please see Important Safety Information at the end of the video and accompanying Prescribing Information and Medication Guide.

Caption: Please see Instructions for Use included with the device.

Descriptive Clue: There are two graphs on the screen.

The first graph demonstrates the mean change from baseline in HAQ-DI total score at week 16, MMRM for biologic-naive patients with active PsA.

The patients who were given Taltz demonstrated a mean change from baseline of 0.4 compared to the 0.1 change from baseline demonstrated by those who were given placebo. 107 patients were given Taltz whereas 106 patients were given PBO.

The second graph demonstrates Post-HOC analysis of mean change from baseline as assessed by HAQ-DI of patients who were given Taltz from week 0 to week 156. At week 52, 108, and 156, the patients who were given Taltz demonstrated 0.63, 0.56, and 0.57 mean change from baseline, respectively, in SPIRIT-P1.

05:31-05:47

Narrator: Taltz inhibited progression of structural joint damage in patients as early as week 16, with 74% of patients recording minimal radiographic progression at year 3.

Caption: SPIRIT-P1

Caption: Taltz Inhibited Progression of Structural Joint Damage in Patients as Early as Week 16 and Through 3 Years^1,3,5,7,15

Caption: FOR BIOLOGIC-NAIVE PATIENTS WITH ACTIVE PsA

Caption: 74% of patients had minimal radiographic progression at year 3

Caption: Week 16 data: In SPIRIT-P1 (biologic-naive) (Taltz 80 mg Q4W n=107; PBO=106). Taltz inhibited the progression of structural joint damage, with an adjusted mean change from baseline for mTSS at week 16 of 0.13 (mean baseline=19.2) compared to 0.36 for PBO (mean baseline=17.6). #P≤.05 vs

Caption: 67% of patients had no radiographic progression* at week 156.

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 Q4W (n=81; mean baseline 19.2).

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 ≥1 post-baseline value (ie, week 52, 108, or 156).

At week 156, 10.8% (n=28) were imputed using linear extrapolation.

The week 156 data were from a post hoc analysis and were not PBO controlled; therefore, statistical conclusions cannot be drawn.

The open-label extension phase of the study has limitations (eg, no PBO 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.

Primary endpoint=ACR20 response at week 24.

Please see ACR data. Please see SPIRIT-P1 and -P2 trial design.

Caption: Inhibition of progression of structural damage was assessed radiographically and expressed as the adjusted mean change in mTSS and the 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 DIP joints. SPIRIT-P2 (TNFi-experienced) did not include an assessment of radiographic progression.

Caption: ^*No progression 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). ^†Minimal progression 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).

Caption: DIP=distal interphalangeal.

Caption: Please see Important Safety Information at the end of the video and accompanying Prescribing Information and Medication Guide.

Caption: Please see Instructions for Use included with the device.

05:38-06:05

Narrator: Common adverse events from pooled SPIRT-P1 and -P2 safety data through week 24 included injection site reactions, upper respiratory tract infection, headache, and sinusitis. Serious infections occurred in 0.4% of patients taking Taltz.

Caption: SPIRIT-P1 SPIRIT-P2

Caption: Common AEs That Occurred Through Week 24^1,16

Caption:

IN PSA TRIALS

AEs That Occurred in ≥2% of Taltz Patients and More Frequently Than With Placebo Through Week 24	Taltz 80 mg Q4W (n=229) (%)	Placebo (n=224) (%)
Overall ISRs^*	17.5	4.5
Mild	14.8	2.7
Moderate	2.2	1.3
Severe	0.4	0.4
Upper respiratory tract infections^†	13.5	11.2
Diarrhea	3.1	2.7
Headache	4.4	1.8
Sinusitis	3.9	2.2
Urinary tract infections	3.5	2.2
Cough	2.2	1.8
Back pain	3.1	0.9
Oropharyngeal pain	3.1	0.4
Arthralgia	2.2	0.9
Tonsillitis	2.2	0

Infections Through Week 24	Taltz 80 mg Q4W (n=229) (%)	Placebo (n=224) (%)
Infections	33.6	27.7
Serious Infections	0.4	0

Caption: Overall, the safety profile in patients with PsA treated with Taltz is consistent with the safety profile in patients with plaque PsO.

The exception is the higher frequency of influenza (Taltz=1.3%, placebo=0.4%) and conjunctivitis (Taltz=1.3%, placebo=0%) in the PsA safety population vs the plaque PsO safety population.

Caption: Pooled safety data from SPIRIT-P1 and SPIRIT-P2 clinical trials.

^*The most frequent ISRs were erythema and pain. Most ISRs were mild to moderate in severity. Discontinuation due to ISRs at 24 weeks in the Taltz Q4W arm were 0.4% and 0.4% for placebo. ^†Upper respiratory tract infections cluster includes nasopharyngitis and rhinovirus infection.

AE=adverse event; ISR=injection-site reaction.

Caption: Please see Important Safety Information at the end of the video and accompanying Prescribing Information and Medication Guide.

Caption: Please see Instructions for Use included with the device.

06:06-10:55

Caption:

Indications and Important Safety Information for TALTZ (ixekizumab)

INDICATIONS

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/0.5mL, 20 mg/0.25mL injection.]

IX HCP ISI 20AUG2024

Please see Important Safety Information at the end of the video and accompanying Prescribing Information and Medication Guide. Please see Instructions for Use included with the device.

10:56-11:01

Caption:

References

Taltz. Prescribing Information. Lilly USA, LLC.
Mease PJ, van der Heijde D, Ritchlin CT, et al; on behalf of the SPIRIT-P1 Study Group. Ixekizumab, an interleukin-17A specific monoclonal antibody, for the treatment of biologic-naïve 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(1)(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.
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. DOF-IX-US-0304.
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 Ill clinical trial (SPIRIT-P1). Rheumatology. 2020;59:2774-2784.
Orbai A, Gratacós J, Turkiewicz A, et al. Efficacy and safety of ixekizumab in patients with psoriatic arthritis and inadequate response to TNF inhibitors: 3-year follow-up (SPIRIT-P2). Rheumatol Ther. 2021;8:199-217. https://doi.org/10.1007/s40744-020-00261-0
Data on file. Lilly USA, LLC. DOF-IX-US-0013.
Data on file. Lilly USA, LLC. DOF-IX-US-0247.
Data on file. Lilly USA, LLC. DOF-IX-US-0308.
Data on file. Lilly USA, LLC. DOF-IX-US-0102.
Mease PJ, Wooley JM, Bitman B, et al. Minimally important difference of Health Assessment Questionnaire in psoriatic arthritis: relating thresholds of improvement in functional ability to patient-rated importance and satisfaction. J Rheumatol. 2011;38(11):2461-2465.
Data on file. Lilly USA, LLC. DOF-IX-US-0134.
Data on file. Lilly USA, LLC. DOF-IX-US-0094.
Data on file. Lilly USA, LLC. TAL20171016A.

Caption: Please see Important Safety Information at the end of the video and accompanying Prescribing Information and Medication Guide. Please see Instructions for Use included with the device.

11:02-11:07

Caption:

To learn more, visit taltz.com/letters

Taltz® and its delivery device base are trademarks owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates. Other product/company names mentioned herein are the trademarks of their respective owners. PP-IX-US-6945 09/2024 ©Lilly USA, LLC. All rights reserved

Meet Kirk - A Patient with PsA

"My priority was to get fast relief, and you talked about finding a solution that would last."

00:00-00:06

[Abby walks to the table and opens her journal]

Caption:

Abby is a real person, diagnosed at age 21 with Ankylosing Spondylitis. Abby was compensated for her time.

00:07-00:17

[Abby runs on a trail. Quick cuts lead to Abby taking a deep breath.]

Abby: Dear Dr. Steven, Being active has been my escape and my therapy. Then all of a sudden—my outlet was gone.

00:18-00:34

[She speaks while seated in her room. The following frame transitions to her sitting on the sofa, jotting down in her diary. She then makes tea in the kitchen, drinking it and looking out the window.]

Abby: My life turned upside down when I was first diagnosed with Ankylosing Spondylitis. I'm writing this letter because you typically only see me when I'm in a lot of pain, frustrated by my disease and not when I'm back to living my life and doing what I love.

00:35-00:55

[Abby opens a photo album, with blurred faces inside. In the next scene, she brushes her hair at a mirror.]

Abby: Before my AS diagnosis, I was always go-go-go. I had big dreams; I was on my college dance team; I was studying to be a nurse and then it all fell apart. When the pain in my back started to worsen and become unbearable, simple things became harder and harder. I couldn't move like I used to.

00:56-01:15

[Abby flashes back to a past hike with friends. In the next scene, she is breathing and contemplating while walking outdoors]

Abby: Before my AS diagnosis, my friends and I were always doing active things together. As the pain in my back became worse, those activities became impossible, and I saw my friends less. Everything came to a pause, and I couldn't help but think…Is this going to be the rest of my life?

01:16-01:36

[The scene begins with Abby sitting at a table, with a photo of Abby’s past life visible. The scene changes to Abby stretching outside, and then returns to her writing a letter at a desk in her room.]

Abby: I needed something that would work fast. I needed something that would last so, I could return to my life. I was scared and frustrated about putting my life on hold, but you really listened to me. From the start, you could sense my impatience. I was desperate to find a medication that would work fast and would last.

01:37-02:07

[Abby is seen reading the letter outdoors. She smiles, and begins running on the trail. The scene closes with her signing the letter and smiling at the camera.]

Abby: I didn't want to end up back in your office in search of another treatment. I felt seen by you and even better—when I was at my lowest, I knew you still believed I could get better. Of course, not every day will be perfect, but—because of you—I'm living my life again, back to doing the activities I love. Because of you. I'll be hiking with my friends this weekend. Thank you will never be enough. With ongoing gratitude, Abby.

02:08-02:13

[Taltz logo and text appears on screen]

Caption: To learn more, visit taltz.com/letters

Caption: Please continue watching for Taltz^® efficacy and safety results and important Safety Information.

Caption: Please see Prescribing Information and Medication Guide.

Caption: Please see Instructions for Use included with the device.

02:13-03:02

Narrator: COAST-V and COAST-W were phase 3, multicenter, randomized, double-blind clinical trials designed to evaluate the efficacy and safety of Taltz vs placebo in adults with active ankylosing spondylitis. Patients in COAST-V were biologic naive, while patients in COAST-W had an inadequate response or were intolerant to 1 or 2 prior TNF inhibitors. Each trial included a treatment arm using Taltz 80 mg every 2 weeks or 4 weeks after being randomized to a starting dose of placebo, Taltz 80 mg or Taltz 160 mg. The approved AS dose for Taltz is 160 mg starting dose followed by Taltz 80 mg every 4 weeks. The primary efficacy endpoint for COAST-V and -W was the proportion of patients achieving ASAS40 response at Week 16.

Caption: COAST-V, COAST-W

Caption: COAST-V (Biologic Naive) and COAST-W (TNFi Experienced): Trial Designs^1-4

Caption: All patients were allowed to remain on concomitant NSAID or cDMARD therapy. Patients were given either placebo or Taltz 80 or 160 mg as a starting dose at Week 0. The approved AS dose for Taltz is 160 mg at Week 0 followed by 80 mg Q4W. Taltz 80 mg Q2W is not an approved dose for AS.

Caption: ^aLast Humira dose at Week 14, followed by a 6-week washout period; first Taltz dose administered at Week 20 with an 80-mg starting dose.

Caption: After Week 16, patients knew they were taking active treatment, but both investigators and patients remained blinded to the dose through 52 weeks. The extended treatment period of the study (Weeks 16-52) has limitations (ie, no placebo comparison, patients remaining in the extension phase may be those more responsive to treatment). COAST-V was not designed to test the noninferiority or superiority of Taltz to Humira®. Thus, these data should not be used to compare the efficacy between these products. Only data from the Taltz Q4W arm will be shown in this presentation.

Caption: AS=ankylosing spondylitis; ASAS40=Assessment of Spondyloarthritis International Society response criteria, 240% improvement; cDMARD=conventional disease modifying antirheumatic drug; NSAID= nonsteroidal anti-inflammatory drug; Q2W=every two weeks; Q4W=every four weeks; TNFi= tumor necrosis factor inhibitor.

Caption: Please see Important Safety Information at the end of the video and accompanying Prescribing Information and Medication Guide. Please see Instructions for Use included with the device.

03:03-03:14

Narrator: Both COAST-V and -W reached their primary efficacy endpoints, with 48% of patients in COAST-V and 25% of patients in COAST-W achieving ASAS40 at Week 16.

Caption: COAST-V, COAST-W

Caption: Rapid ASAS40 Response Seen as Early as Week 2 in Some Patients and Maintained Through Week 5^21,5-9

Caption: ASAS40 Responses at Week 16 and Through Week 52, NRI

Caption: COAST-V was not designed to test the noninferiority or superiority of Taltz to Humira. Thus, these data should not be used to compare the efficacy between these products.

Caption: ^*Nominal P-value: Taltz P=.003, Humira P=.001 vs placebo. Not controlled for type-I error; therefore, no statistical conclusions can be made. Results at Week 2: Taltz=20%; Humira=21%; placebo=5%.

Caption: ^†P<.0001 vs placebo at Week 16; ^‡P=.0053 vs placebo at Week 16. ^**P<.05 vs placebo at Week 16. NRI of intent-to-treat population through Weeks 16 and 52.

Caption: The extended treatment period of the study (Weeks 16-52) has limitations (ie, no placebo comparison, patients remaining in the extension phase may be those more responsive to treatment).

Caption: NRI= nonresponder imputation.

Caption: Please see Important Safety Information at the end of the video and accompanying Prescribing Information and Medication Guide. Please see Instructions for Use included with the device.

Descriptive clues:

Two graphs are shown on the screen: One showing the response rates for biologic-naïve patients with AS, and one for TNFi-experienced patients with AS. For biologic-naïve patients with AS, 48% of Taltz patients (n=81), achieved \ response at week 16 and 53% at week 52. For Humira patients (n=90), 36% achieved response at week 16. For placebo patients (n=87), 18% achieved response at week 16. For TNFi-experienced patients with AS, 25% of Taltz patients (n=114) achieved response at week 16, and 34% achieved response at week 52. For placebo patients (n=104), 13% achieved response at week 16.

03:15-03:30

Narrator: Improvements in spinal pain, function as measured by mean change in BASFI score, and inflammation as measured by mean of BASDAI questions 5 and 6 were seen at week 16 with some patients experiencing improvements as early as week 2.

Caption: COAST-V

Caption: Rapid Improvement in Back Pain, Function, and Inflammation Seen as Early as Week 2 in Some Patients^1,10

Caption: For Biologic-Naive Patients With AS

Caption: Improvement in ASAS Component Scores Through Week 16, MMRM^11,12

Caption: ^*P<.005 vs placebo. Nominal P-value: not controlled for type-I error; therefore, no statistical comparisons can be made. ^†P<.001 vs placebo. ^‡Mean of BASDAI questions 5 and 6 (morning stiffness duration and morning stiffness severity).

Caption: ADDITIONAL COAST-V WEEK 16 ASAS COMPONENT RESULTS, MMRM

For PGA score, change from baseline in PGA score at Week 16 was -2.5 (baseline 6.9) for patients receiving Taltz, -2.6 (baseline 7.1) for those receiving Humira, and -1.4 (baseline 7.1) for placebo.

For Spinal Pain Assessment score, Function score, and Inflammation score, mean baseline was 7.2, 6.1, and 6.5 for patients receiving Taltz; 7.0, 6.1, and 6.6 for those receiving Humira; and 7.4, 6.4, and 6.8 for placebo, respectively. PGA score range 0-10.

Caption: ADDITIONAL WEEK 16 RESULTS FROM COAST-W TRIAL, MMRM¹

Among TNFi-experienced patients, change from baseline in inflammation at Week 16 was -2.42 (baseline 7.21) for patients receiving Taltz and -0.70 (baseline 7.20) for placebo, and change from baseline in BASFI at Week 16 was -1.69 (baseline 7.35) for patients receiving Taltz and -0.64 (baseline 7.01) for placebo, and change from baseline in Spinal Pain at Week 16 was -2.4 (baseline 7.9) for patients receiving Taltz and -1.0 (baseline 7.8) for placebo, and change from baseline in PGA score at Week 16 was -2.4 (baseline 8.0) for patients receiving Taltz and -0.7 (baseline 7,8) for placebo.

Caption: COAST-V was not designed to test the noninferiority or superiority of Taltz against Humira. Thus, these data should not be used to compare the efficacy between these products.

Caption: BASDAI= Bath Ankylosing Spondylitis Disease Activity Index; BASFI= Bath Ankylosing Spondylitis Functional Index; LSM=least squares mean; MMRM=mixed-effect model for repeated measures; PGA=Patient's Global Assessment.

Caption: Please see Important Safety Information at the end of the video and accompanying Prescribing Information and Medication Guide. Please see Instructions for Use included with the device.

Descriptive clues:

Three line graphs showing the LSM change from baseline in spinal pain, function (BASFI) and inflammation for COAST-V patients on Taltz (n=81), Humira (n=90) and placebo (n=87). For spinal pain, Taltz patients saw a -1.9 change at week 2 and -3.2 change at week 16; Humira patients saw a -2.0 change at week 2 and -2.7 change at week 16, and placebo patients saw a -0.8 change at week 2 and -1.7 change at week 16. For function (BASFI), Taltz patients saw a -1.16 change at week 2 and -2.39 change at week 16; Humira patients saw a -1.29 change at week 2 and -2.14 change at week 16, and placebo patients saw a -0.42 change at week 2 and -1.16 change at week 16. For inflammation, Taltz patients saw a -1.88 change at week 2 and -3.18 change at week 16; Humira patients saw a -1.88 change at week 2 and -2.67 change at week 16, and placebo patients saw a -0.60 change at week 2 and -1.27 change at week 16.

03:31-03:40

Narrator: On the SF-36 Physical Component Score, both biologic-naïve and TNFi-experienced patients treated with Taltz showed greater improvement from baseline.

Caption: COAST-V, COAST-W

Caption: Quality of Life: SF-36 Physical Component Scores Through Week 16, MMRM^13,14

Caption: SF-36 PCS Through Week 16, MMRM

Caption: COAST-V was not designed to test the noninferiority or superiority of Taltz to Humira. Thus, these data should not be used to compare the efficacy between these products. Compared to placebo, patients treated with Taltz showed greater improvement from baseline in the SF-36 physical component summary (PCS) score and the physical functioning, role physical, bodily pain, vitality, and general health domains, with no consistent improvements in the mental component summary (MCS), social functioning, role emotional, and mental health domains.

Caption: ^*P<.001 vs placebo, ^†P=.002 vs placebo at Week 16

Caption: COAST-V Baseline mean scores: Taltz=33.99, Humira=33.49, placebo=31.95, COAST-W Baseline mean scores: Taltz=27.47, placebo=30.56.

SF-36 PCS scale=0-100%. Assessments were performed at Weeks 4, 8, and 16.

Caption: MCS=mental component summary; SF-36 PCS=Short Form (36) Health Survey Physical Component Score

Caption: Please see accompanying Prescribing Information and Medication Guide. Please see Instructions for Use included with the device.

Descriptive clues:

Graph showing trajectory of SF-36 PCS improvement through Week 16 for COAST-V and COAST-W patients on Taltz, Humira and placebo

03:41-03:55

Narrator: Common adverse events from both COAST-V and –W through week 16 included upper respiratory tract infection, injection site reactions, arthralgia, and diarrhea. Back pain and bronchitis were also reported during the extended treatment period.

Caption: COAST-V, COAST-W

Caption: Common Adverse Events That Occurred Through Week 16 and From Weeks 16 Through 5^21,15,16

Caption: For Biologic-Naive and TNFi-Experienced Patients With AS

Caption: Most Common TEAEs Through Week 16 and From Weeks 16-52

Through Week 16	Taltz N=195 n(%)	Placebo N=190 n(%)
Upper respiratory tract infection^‡	25 (12.8)	13 (6.8)
Injection site reactions	12 (6.2)	10 (5.3)
Mild	9 (4.6)	10 (5.3)
Moderate	3 (1.5)	0
Severe	0	0
Arthralgia	9 (4.6)	3 (1.6)
Diarrhea	6 (3.1)	2 (1.1)
Alanine aminotransferase increased	5 (2.6)	1 (0.5)
Oropharyngeal pain	5 (2.6)	0
Musculoskeletal pain	4 (2.1)	2 (1.1)

Caption: Through Week 16, overall, the safety profile observed in patients with AS treated with Taltz Q4W was consistent with the safety profile in patients with plaque PsO.¹⁴

Caption:

Extended treatment group Week 16 to Week 52^t	Taltz N=176 n (%)
Upper respiratory tract infection	19 (10.8)
Back pain	9 (5.1)
Injection site reactions	8 (4.5)
Mild	8 (4.5)
Moderate	0
Severe	0
Bronchitis	5 (2.8)
Arthralgia	4 (2.3)
Aspartate aminotransferase increased	4 (2.3)
Hypertension	4 (2.3)
Insomnia	4 (2.3)
Iridocyclitis	4 (2.3)
Musculoskeletal pain	4 (2.3)
Pharyngitis	4 (2.3)

Caption: Week 16-52 data includes patients who were in the placebo or adalimumab arm prior to week 16 and were re-randomized to the Q4W extended treatment period.

Caption: Taltz has no boxed warning

Caption: Pooled safety data from COAST-V and COAST-W clinical trials.

Caption: ^*Adverse events ≥2% and more frequently than placebo. ^†Adverse events that occurred in ≥2% of Taltz patients. ^‡Upper respiratory tract infections cluster includes nasopharyngitis.

Caption: PsO=psoriasis; TEAE=treatment-emergent adverse event.

Caption: Please see accompanying Prescribing Information and Medication Guide. Please see Instructions for Use included with the device.

03:56-08:44

[Taltz logo appears on screen and Important Safety Information scrolls on screen]

Narrator: 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

Hypersensitivity

Eczematous Eruptions

Inflammatory Bowel Disease

Immunizations

ADVERSE REACTIONS

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/0.5mL, 20 mg/0.25mL injection.

Caption:

Indications and Important Safety Information [for TALTZ (ixekizumab)]

INDICATIONS

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/0.5mL, 20 mg/0.25mL injection.

IX HCP ISI 20AUG2024

Please see accompanying Prescribing Information and Medication Guide. Please see Instructions for Use included with the device.

08:45-08:47

Caption:

References

Taltz. Prescribing Information. Lilly USA, LLC.
Data on file. Lilly USA, LLC. DOF-IX-US-0159.
Dougados M, Wei JC, Landewé R, et al. Efficacy and safety of ixekizumab through 52 weeks in two phase 3, randomised, controlled clinical trials in patients with active radiographic axial spondyloarthritis (COAST-V and COAST-W). Ann Rheum Dis. 2020;79:176-185.
Data on file. Lilly USA, LLC. DOF-IX-US-0160.
van der Heijde D, Cheng-Chung Wei J, Dougados M, et al. Ixekizumab, an interleukin-17A antagonist in the treatment of ankylosing spondylitis or radiographic axial spondyloarthritis in patients previously untreated with biological disease-modifying anti-rheumatic drugs (COAST-V): 16 week results of a phase 3 randomized, double-blind, active-controlled and placebo-controlled trial. Lancet. 2018;392:2441-2451.
Data on fille. Lilly USA, LLC. DOF-IX-US-0155.
Deodhar A, Poddubnyy D, Pacheco-Tena C, et al. Efficacy and safety of ixekizumab in the treatment of radiographic axial spondyloarthritis: sixteen-week results from a phase Ill randomized, double-blind, placebo-controlled trial in patients with prior inadequate response to or intolerance of tumor necrosis factor inhibitors. Arthritis Rheumatol. 2019;71:599-611.
Data on file. Lilly USA, LLC. DOF-IX-US-0157.
Data on file. Lilly USA, LLC. DOF-IX-US-0162.
Data on file. Lilly USA, LLC. DOF-IX-US-0309.
Data on file. Lilly USA, LLC. DOF-IX-US-0158.
Data on file. Lilly USA, LLC. DOF-IX-US-0163.
Data on file. Lilly USA, LLC. DOF-IS-US-0176.
Data on file. Lilly USA, LLC. DOF-IX-US-0177.
Data on file. Lilly USA, LLC. DOF-IX-US-0165.
Data on file. Lilly USA, LLC. DOF-IX-US-0204.

Caption:

Please see Important Safety Information at the end of the video and accompanying Prescribing Information and Medication Guide. Please see Instructions for Use included with the device.

Lilly logo

08:48-08:52

[Taltz logo and Lilly logo appear on screen]

Caption: To learn more, visit taltz.com/letters

Caption: Taltz^® and its delivery device base are trademarks owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates. Other product/company names mentioned here in are the trademarks of their respective owners. PP-IX-US-6944 09/2024 © Lilly USA, LLC. All rights reserved.

Meet Abby - A Patient with AS

"When I was at my lowest, I knew you still believed I could get better."

FOR ADULT PATIENTS WITH PsA and axSpA (nr-axSpA, AS)

Consider Taltz as your preferred IL-17A antagonist

Michelle^* has psoriatic arthritis

Presenting with joint pain and bothersome skin plaques

Full body image of woman with psoriatic arthritis

Full body image of man with ankylosing spondylitis

Daniel^* has ankylosing spondylitis

Experiencing spinal pain and morning stiffness

^* Hypothetical Patient Profiles

Michelle and Daniel are frustrated their current treatment is not working and need a treatment that provides powerful and consistent efficacy.

Taltz offers rapid results for Today and sustained efficacy for Tomorrow so that Michelle and Daniel can participate in everyday moments that matter.

View PsA efficacy data View AS efficacy data

IL-17A=Interleukin-17A.

Explore

Abbreviations:
ACR=American College of Rheumatology; ACR20=American College of Rheumatology 20% response; ACR50=American College of Rheumatology 50% response; ACR 20/50=American College of Rheumatology 20%/50% response; ACR20/50/70=American College of Rheumatology 20%/50%/70% response; AE=adverse event; AS=ankylosing spondylitis; ASAS40=Assessment of Spondyloarthritis International Society response criteria, ≥40% improvement; axSpA=axial spondyloarthritis; BASDAI=Bath Ankylosing Spondylitis Disease Activity Index; BASFI=Bath Ankylosing Spondylitis Functional Index; BSA=body surface area; CD=Crohn’s disease; cDMARD=conventional disease-modifying antirheumatic drug; CI=confidence interval; HAQ-DI=Health Assessment Questionnaire Disability Index; H2H=head-to-head; IBD=inflammatory bowel disease; IL-17A=interleukin-17A; IR=inadequate responder; ITT=intent-to-treat; LSM=least squares mean; MACE=major adverse cardiovascular event; MDA=minimal disease activity; MMRM=mixed-effect model of repeated measure; mNRI=modified nonresponder imputation; n=total number of patients entering the study or extension period; mSASSS=modified Stroke Ankylosing Spondylitis Spinal Score; mTSS=modified Total Sharp Score; nr-axSpA=nonradiographic axial spondyloarthritis; NRI=nonresponder imputation; NSAID=non-steroidal anti-inflammatory drug; Nx=observed population; PA=prior authorization; PASI=Psoriasis Area and Severity Index; PASI 75/90/100=75%/90%/100% improvement from baseline in PASI criteria; PASI 100=100% improvement from baseline in PASI criteria; PsA=psoriatic arthritis; PBO=Placebo; PsO=psoriasis; Q4W=every 4 weeks; r-axSpA=radiographic axial spondyloarthritis; Rx=prescription; sPGA=Static Physician Global Assessment; TEAE=treatment-emergent adverse event; TNFi=tumor necrosis factor inhibitor; UC=ulcerative colitis; VAS=visual analogue scale.

References:

Data on file. Lilly USA, LLC. DOF-IX-US-0304.
Mease P, van der Heidje 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 III trial. Lancet. 2017;389:2317-2327.
Taltz. Prescribing Information. Lilly USA, LLC.
Data on file. Lilly USA, LLC. DOF-IX-US-0013.
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. 2020;59:2774-2784.
Data on file. Lilly USA, LLC. DOF-IX-US-0247.
Data on file. Lilly USA, LLC. DOF-IX-US-0308.
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 III trial. Lancet. 2017;389:2317-2327. Supplementary appendix.
Data on file. Lilly USA, LLC. DOF-IX-US-0102.
Data on file. Lilly USA, LLC. DOF-IX-US-0012.
Data on file. Lilly USA, LLC. DOF-IX-US-0278.
Orbai A, Gratacós J, Turkiewicz A, et al. Efficacy and Safety of Ixekizumab in Patients with Psoriatic Arthritis and Inadequate Response to TNF Inhibitors: 3-Year Follow-Up (SPIRIT-P2). Rheumatol Ther. 2021;8:199-217. https://doi.org/10.1007/s40744-020-00261-0.
van der Heijde D, Gladman DD, Kishimoto M, et al. Efficacy and safety of ixekizumab in patients with active psoriatic arthritis: 52-week results from a phase II study (SPIRIT-P1) J Rheumatol. 2018;45:367-377.
Data on file. Lilly USA, LLC. DOF-IX-US-0155.
Data on file. Lilly USA, LLC. DOF-IX-US-0157.
Deodhar A, Poddubnyy D, Pacheco-Tena C, et al; COAST-W Study Group. Efficacy and safety of ixekizumab in the treatment of radiographic axial spondyloarthritis: sixteen-week results from a phase III randomized, double-blind, placebo-controlled trial in patients with prior inadequate response to or intolerance of tumor necrosis factor inhibitors. Arthritis Rheumatol. 2019;71:599-611.
Data on file. Lilly USA, LLC. DOF-IX-US-0162.

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.

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 placebocontrolled 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.

ADVERSE REACTIONS

Please see Prescribing Information and Medication Guide. Please see Instructions for Use included with the device.

Taltz is available as an 80 mg/mL, 40 mg/0.5mL, 20 mg/0.25mL injection.

IX HCP ISI 20AUG2024

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 moderateto-severe plaque psoriasis (PsO) who are candidates for systemic therapy or phototherapy.

Taltz is for Today and Tomorrow1-18

RAPID

SUSTAINED

Consider Taltz as your preferred IL-17A antagonist

Explore

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS:

WARNINGS AND PRECAUTIONS

ADVERSE REACTIONS

INDICATIONS

Taltz is for Today and Tomorrow^1-18