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FOR ADULTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS

Complete clearance data from head-to-toe1-9

COMPLETE CLEARANCE IN SCALP PSORIASIS

PSSI=0 by year 5,
observed Nx=173
Mean baseline PSSI=20


COMPLETE CLEARANCE IN NAIL PSORIASIS

NAPSI=0 by year 5,
observed Nx=127
Mean baseline NAPSI=27


Scalp and nail psoriasis often are predictors of a patient developing PsA4

COMPLETE CLEARANCE IN GENITAL PSORIASIS

sPGA-G 0 by year 1,
NRI* n=75
Mean baseline sPGA-G=3.4


COMPLETE CLEARANCE IN PALMOPLANTAR PSORIASIS

PPASI 100 by year 5,
observed Nx=41
Mean baseline PPASI=10


*At week 12, 73% of patients taking Taltz vs 8% of patients taking placebo achieved the IXORA-Q primary endpoint of sPGA-G 0,1, n=75.
Nx=observed population.

Data on complete clearance in challenging body areas, mNRI1,3

Complete clearance in scalp psoriasis

69% of patients with psoriasis achieved
PSSI 0 by year 5 (n=349)


Complete clearance in nail psoriasis

64% of patients with psoriasis achieved
NAPSI 0 by year 5 (n=229)


Complete clearance in palmoplantar psoriasis

75% of patients with psoriasis achieved
PPASI 100 by year 5 (n=96)

Nail, scalp, and palmoplantar data are from an open-label extension of 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 an open-label extension of IXORA-Q.

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

The first IL-17A antagonist to demonstrate superiority on the primary endpoint in a head-to-head trial against Humira® (adalimumab) in psoriatic arthritis.5-9

See head-to-head data vs Humira

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.

PSSI=Psoriasis Scalp Severity Index; NAPSI=Nail Psoriasis Severity Index; 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.

Please see below for full data on challenging body areas.

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. Data on file. Lilly USA, LLC. DOF-IX-US-0264. 11. 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. 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.

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. 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.

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.

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.

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.

IX HCP ISI 07MAY2020

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.