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

Chart Description

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

Please see below for full data on challenging body areas.

Scalp data (PSSI 0)

FOR ADULTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS

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

Chart description

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. 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. Serious infections have occurred. 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.

Nail data (NAPSI 0)

FOR ADULTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS

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

Chart description

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. Closely monitor patients receiving Taltz for signs and symptoms of active TB during and after treatment.

Genital data (sPGA-G 0)

FOR ADULTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS

More than half of patients achieved sPGA-G 0 by week 12, which was maintained through week 52¹³

56% of Taltz-treated patients achieved sPGA-G 0 (completely clear genital skin) at week 12

Chart description

NRI of intent-to-treat population through week 52.

In NRI analysis, 73% of Taltz patients achieved sPGA-G 0,1 at week 12 compared to 8% of placebo (primary endpoint).

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).

Data were from a pre-specified, exploratory endpoint and not controlled for type-I error.

sPGA-G=static Physician’s Global Assessment of Genitalia.

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.

Palmoplantar data (PPASI 100)

FOR ADULTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS

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

Chart description

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: 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: 1. 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. 2. 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. 3. 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. 4. 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. 5. Data on file. Lilly USA, LLC. DOF-IX-US-0121. 6. Data on file. Lilly USA, LLC. DOF-IX-US-0122. 7. Data on file. Lilly USA, LLC. DOF-IX-US-0123. 8. Data on file. Lilly USA, LLC. DOF-IX-US-0124. 9. Data on file. Lilly USA, LLC. DOF-IX-US-0125. 10. 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. 11. Data on file. Lilly USA, LLC. DOF-IX-US-0264. 12. Data on file. Lilly USA, LLC. DOF-IX-US-0259. 13. Data on file. Lilly USA, LLC. DOF-IX-US-0258. 14. Data on file. Lilly USA, LLC. DOF-IX-US-0263.