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EFFICACY

Week 12 Results

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 achieved clear or almost clear skin (sPGA 0,1) vs 2% who received placebo.

Additional Results

In Trial 1 (Taltz n=433, placebo n=431) and Trial 3 (Taltz n=385, placebo n=193), 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% of Taltz patients achieved sPGA 0,1 vs 3% and 7% for 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
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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 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.

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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.

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BIOLOGIC-NAIVE AND BIOLOGIC-EXPERIENCED

Taltz provided high levels of efficacy compared to placebo at week 12 regardless of previous treatment with a biologic3

TRIALS 1, 2, 3: WEEK 12 EFFICACY IN BIOLOGIC-NAIVE VS BIOLOGIC-EXPERIENCED* PATIENTS (NRI†)

In these trials, 83% of biologic-naive and 80% of biologic-experienced patients receiving Taltz achieved sPGA 0,1 vs 5% and 2%, respectively, for patients receiving placebo. In the placebo group, biologic-naive (n=535) and biologic-experienced (n=257) patients achieved PASI 75 rates of 5% and 3%, PASI 90 rates of 2% and 0%, and PASI 100 rates of 0% and 0%, respectively.

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HYPERSENSITIVITY

Serious hypersensitivity reactions, including anaphylaxis, angioedema and urticaria, have been reported with Taltz. If a serious hypersensitivity reaction occurs, discontinue Taltz immediately and initiate appropriate therapy.

Couple Holding

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 covariance model.

Trial Design Trial Design Arrow
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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.

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.

Taltz provided high levels of efficacy compared to placebo at week 12 regardless of previous treatment with a biologic3

TRIALS 1, 2, 3: WEEK 12 EFFICACY IN BIOLOGIC-NAIVE VS BIOLOGIC-EXPERIENCED* PATIENTS (NRI†)

In these trials, 83% of biologic-naive and 80% of biologic-experienced patients receiving Taltz achieved sPGA 0,1 vs 5% and 2%, respectively, for patients receiving placebo. In the placebo group, biologic-naive (n=535) and biologic-experienced (n=257) patients achieved PASI 75 rates of 5% and 3%, PASI 90 rates of 2% and 0%, and PASI 100 rates of 0% and 0%, respectively.

Trial Design Trial Design Arrow
Select Important Safety Information

HYPERSENSITIVITY

Serious hypersensitivity reactions, including anaphylaxis, angioedema and urticaria, have been reported with Taltz. If a serious hypersensitivity reaction occurs, discontinue Taltz immediately and initiate appropriate therapy.

Efficacy You Can See

90% PASI 75 vs 2%
71% PASI 90 vs 1%
40% PASI 100 vs 1%
83% sPGA 0,1 vs 2%
Taltz 80 mg every 2 weeks (n=351) Placebo (n=168) Results from Trial 2 at week 12.1

Additional Results

In Trial 1 (Taltz n=433; placebo n=431) and Trial 3 (Taltz n=385; placebo n=193), 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% of Taltz patients achieved sPGA 0,1 vs 3% and 7% for placebo.

Trial Design Trial Design Arrow

See the difference Taltz can make in 12 weeks4-7

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 photos 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)

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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.

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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%). Monitor patients for onset or exacerbations of inflammatory bowel disease.

Week 108 Results

PASI 75, PASI 90, and PASI 100 results at weeks 60 and 1088*

Induction Period and Open-Label Extension

Trial 3

In an NRI analysis of patients receiving Taltz at week 60, 83% of patients achieved PASI 75, 73% of patients achieved PASI 90, and 55% of patients achieved PASI 100. In an NRI analysis of patients receiving Taltz at week 108, 75% of patients achieved PASI 75, 64% of patients achieved PASI 90, and 46% of patients achieved PASI 100.

*Post hoc analysis from Trial 3; outcomes through week 108, NRI and observed.
A subset of patients from Trial 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 are shown.
Nx=observed population at week 108.

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; 2017.
  2. Data on file. Lilly USA, LLC. TAL20160223C.
  3. Data on file. Lilly USA, LLC. TAL20160328C.
  4. Data on file. Lilly USA, LLC. TAL20160222D.
  5. Data on file. Lilly USA, LLC. TAL20160222A.
  6. Data on file. Lilly USA, LLC. TAL20160222E.
  7. Data on file. Lilly USA, LLC. TAL20160222B.
  8. Data on file. Lilly USA, LLC. TAL20160215B.
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 for Taltz (ixekizumab)

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 anaphylaxis, angioedema and urticaria, have been reported with Taltz. 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.

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

IX HCP ISI 18JAN2017