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EFFICACY

Week 12 Results

Taltz Icon

Taltz can provide high levels of clearance—even complete resolution of plaques (PASI 100) is possible1

Trial 2 Week 12 Efficacy Trial 2 Week 12 Efficacy

In Trial 2, 83% of patients taking Taltz 80 mg every 2 weeks achieved clear or almost clear skin (sPGA 0,1) vs 2% who received placebo.

  • In the 3 pivotal trials, examination of age, gender, race, body weight, and previous treatment with a biologic did not identify differences in response to Taltz among these subgroups at week 12
Additional Results

In Trials 1 and 3, Taltz patients achieved similar results: 89% and 87% of Taltz patients achieved PASI 75 vs 4% and 7% for placebo. Additionally, 71% and 68% of Taltz patients achieved PASI 90 vs 1% and 3% for placebo, and 35% and 38% achieved PASI 100 vs 0% and 0% for placebo. Also, 82% and 81% achieved sPGA 0,1 vs 3% and 7% for placebo.

Select Important Safety Information

Infections

Taltz may increase the risk of infection. In trials, the rate of infection in the Taltz group was 27% vs 23% in the placebo group. 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.

AVERAGE % CHANGE IN PASI

In Trial 2, the average change in PASI was 91% at week 122

Course of Onset

In Trial 1, the mean percentage improvement in PASI at week 12 was 85% in the Taltz group compared to 0% in the placebo group. In Trial 3, the mean percentage improvement in PASI at week 12 was 91% in the Taltz group compared to 14% in the placebo group.

The comparison of mean percent change in PASI using LOCF (last observation carried forward) at each study week between treatments is based on an analysis of a covariance model.

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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.

HEAD TO HEAD VS ETANERCEPT

Taltz showed superiority in 2 head-to-head trials vs US-approved etanercept1

Head to Head vs Etanercept Chart

In integrated Trials 2 and 3, 73% of patients taking Taltz achieved clear or almost clear skin (sPGA 0,1) vs 27% who received etanercept.

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adverse events and discontinuation rates for taltz compared to us-approved etanercept

The rate of serious adverse events during the controlled induction period (weeks 0-12) was 0.7% for US-approved etanercept and 2% for Taltz and the rate of discontinuation from adverse events was 0.7% for US-approved etanercept and 2% for Taltz. The incidence of infections was 18% for US-approved etanercept and 26% for Taltz. The rate of serious infections was 0.3% for both US-approved etanercept and Taltz.

In Trial 2, the average change in PASI was 91% at week 122

Trial 2 Average % Change In PASI

In Trial 1, the mean percentage improvement in PASI at week 12 was 85% in the Taltz group compared to 0% in the placebo group. In Trial 3, the mean percentage improvement in PASI at week 12 was 91% in the Taltz group compared to 14% in the placebo group.

The comparison of mean percent change in PASI using LOCF (last observation carried forward) at each study week between treatments is based on an analysis of a covariance model.

Trial Design Trial Design Arrow
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.

Taltz showed superiority in 2 head-to-head trials vs US-approved etanercept1

Trial 2 and 3 Head-to-Head Results

In integrated Trials 2 and 3, 73% of patients taking Taltz achieved clear or almost clear skin (sPGA 0,1) vs 27% who received etanercept.

Trial Design Trial Design Arrow
Select Important Safety Information

adverse events and discontinuation rates for taltz compared to us-approved etanercept

The rate of serious adverse events during the controlled induction period (weeks 0-12) was 0.7% for US-approved etanercept and 2% for Taltz and the rate of discontinuation from adverse events was 0.7% for US-approved etanercept and 2% for Taltz. The incidence of infections was 18% for US-approved etanercept and 26% for Taltz. The rate of serious infections was 0.3% for both US-approved etanercept and Taltz.

Efficacy You Can See

See the difference Taltz can make in 12 weeks3-6

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. The results at baseline and week 12 can be viewed below by dragging the slider right or left.

Taltz Patient PASI 75
Taltz Patient Baseline

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PATIENT AT BASELINE
(PASI SCORE=19.2)

DRAG Drag To View TO VIEW
PATIENT AT WEEK 12
(PASI SCORE=2.8)

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

Trial B was a phase 3b, double-arm, open-label study examining disease severity of Taltz-treated patients with moderate to severe plaque psoriasis through patient- and physician-reported clinical measures. The trial used sequential photographic images to support clinical measurements with visual representations of improvements in disease severity. All patients received a starting dose of 160 mg of Taltz, and then received 80 mg of Taltz every 2 weeks through week 12 (n=6).

Week 60 Results

Reassure your patients* that consistent results can be maintained with Taltz at week 601

Efficacy Week 60 Efficacy Week 60

Of the patients who completed 60 weeks of treatment without relapse (sPGA ≥3) or discontinuation (n=147), 92% maintained clear or almost clear skin (sPGA 0,1) at week 60 based on an observed analysis.

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).

*Patient responders at week 12.
NRI=Nonresponder imputation analysis.

Trial Design

The Taltz clinical program included 3 randomized, double-blind, placebo-controlled trials to evaluate the efficacy and safety of Taltz. All patients were ≥18 years of age and had plaque psoriasis with a body surface area involvement of ≥10%, a static Physician’s Global Assessment (sPGA) score ≥3, and a Psoriasis Area Severity Index (PASI) score ≥12, and were candidates for phototherapy or systemic therapy. Participants were randomized to receive placebo or Taltz 80 mg every 2 weeks following a 160 mg starting dose. In Trials 2 and 3, an additional arm of US-approved etanercept (50 mg twice weekly) was included. Co-primary efficacy endpoints were proportion of patients with an sPGA 0,1 and at least a 2-point improvement from baseline and proportion of patients achieving PASI 75 (at least a 75% reduction in the PASI composite score) at week 12. Nonresponder imputation (NRI) methods were used for categorical efficacy analyses.

Patients originally randomized to Taltz who were responders at week 12 (ie, sPGA 0,1) in Trials 1 and 2 were re-randomized to either Taltz 80 mg every 4 weeks or placebo for an additional 48 weeks. Patients who relapsed (sPGA ≥3) at any time during the maintenance period were classified as nonresponders at week 60.

References

  1. Taltz [package insert]. Indianapolis, IN: Eli Lilly and Company; 2016.
  2. Data on file. Lilly USA, LLC. TAL20160328B.
  3. Data on file. Lilly USA, LLC. TAL20160222D.
  4. Data on file. Lilly USA, LLC. TAL20160222A.
  5. Data on file. Lilly USA, LLC. TAL20160222E.
  6. Data on file. Lilly USA, LLC. TAL20160222B.
Indication and Important Safety Information

Taltz is indicated for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

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. The Taltz group had a higher rate of infections than the placebo group (27% vs 23%). 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. 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. If a serious hypersensitivity reaction occurs, discontinue Taltz immediately and initiate appropriate therapy.

Inflammatory Bowel Disease

Crohn’s disease and ulcerative colitis, including exacerbations, occurred at a greater frequency in the Taltz group (Crohn’s disease 0.1%, ulcerative colitis 0.2%) than in the placebo group (0%) during clinical trials. During Taltz treatment, monitor patients for onset or exacerbations of inflammatory bowel disease.

Immunizations

Prior to initiating therapy with Taltz, consider completion of all age-appropriate immunizations according to current immunization guidelines. Live vaccines should not be given 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.

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

IX HCP ISI 22MAR2016