person jumping into pool while others watch

Hypothetical Patient

Dermatology Efficacy

Week 12 results

Efficacy you can see

FOR ADULTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS

See the difference Taltz can make in 12 weeks2-5

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)

Dermatology efficacy after PASI 75
Dermatology efficacy before PASI 75

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)

Dermatology efficacy after PASI 90
Dermatology efficacy before PASI 90

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)

Dermatology efficacy after PASI 100
Dermatology efficacy before PASI 100

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)

Dermatology efficacy after PASI SPGA
Dermatology efficacy before PASI SPGA

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 601,6

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 years7-9

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

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 26411-13

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: 1. Taltz. Prescribing Information. Lilly USA, LLC. 2. Data on file. Lilly USA, LLC. TAL20160222D. 3. Data on file. Lilly USA, LLC. TAL20160222A. 4. Data on file. Lilly USA, LLC. TAL20160222E. 5. Data on file. Lilly USA, LLC. TAL20160222B. 6. Data on file. Lilly USA, LLC. DOF-IX-US-0274. 7. 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. 8. 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. 9. Data on file. Lilly USA, LLC. DOF-IX-US-0197. 10. Data on file. Lilly USA, LLC. DOF-IX-US-0209. 11. Data on file. Lilly USA, LLC. DOF-IX-US-0232. 12. Data on file. Lilly USA, LLC. DOF-IX-US-0051. 13. Data on file. Lilly USA, LLC. DOF-IX-US-0272.

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.

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. 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 patients aged 6 years or older with moderate-to-severe plaque psoriasis (PsO) who are candidates for systemic therapy or phototherapy. Taltz is also 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.