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SAFETY

Week 12 Data

Adverse reactions that occurred in ≥1% of Taltz patients and more frequently than with placebo1

Adverse Reactions Through Week 12 Adverse Reactions Through Week 12

*US-approved etanercept.

Upper respiratory tract infections include nasopharyngitis and rhinovirus infection.

Infections Through Week 12 Infections Through Week 12

*US-approved etanercept.

ADDITIONAL ACTIVE COMPARATOR SAFETY INFORMATION

In the 2 clinical trials that included an active comparator, the rate of serious adverse events during weeks 0 to 12 was 2% with Taltz and 0.7% with US-approved etanercept, and the rate of discontinuation from adverse events was 2% with Taltz and 0.7% with US-approved etanercept.

Week 60 Data

Adverse events during weeks 0 to 60 with Taltz vs placebo1

Adverse Events Weeks 0-60 Adverse Events Weeks 0-60

*Safety population includes all patients who received Taltz every 2 weeks in the induction phase and every 4 weeks in the maintenance phase. The placebo group received placebo for the duration of the trial. Data based on 541 total person-years for the Taltz group and 190 total person-years for the placebo group.

Exposure-adjusted rates.

Long-term Data

Safety in Taltz clinical trial participants studied for up to 6 years2

In the psoriasis safety population, 5689 patients across 11 clinical trials* received Taltz, with a total exposure of 12,062 patient-years (PY).

Certain adverse events, such as MACE and malignancy, require longer observation periods and larger patient exposure to ascertain risk. Lilly is conducting continued long-term safety studies, including post-marketing studies, to continue to evaluate the safety of Taltz.

*Phase 1-3 clinical trials.

No confirmed cases of anaphylaxis in clinical trials; events reported here are based on potential identifiers using Sampson criteria.

n=5515 in 9 trials.

Reference

  1. Taltz [package insert]. Indianapolis, IN: Eli Lilly and Company; 2017.
  2. Data on file. Lilly USA, LLC. TAL20170310A.
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