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now approved for psoriatic arthritis

Lilly is excited to announce a new indication for Taltz.

Taltz is approved to treat adult patients with:

  • Active psoriatic arthritis (PsA)
  • Moderate to severe plaque psoriasis (PsO) who are candidates for systemic therapy or phototherapy
SCROLL FOR PLAQUE PSORIASIS INFORMATION
Taltz Couple

Embrace the Opportunity to GiveCompletely Clear Skin

For adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

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 UNCOVER-1 (Taltz n=433; placebo n=431) and UNCOVER-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 Green Right Arrow

Reference

  1. Taltz [package insert]. Indianapolis, IN: Eli Lilly and Company; 2017.

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Indication and Important Safety Information

Psoriatic Arthritis:

Taltz is indicated for the treatment of adult patients with active psoriatic arthritis.

Plaque Psoriasis:

Taltz is indicated for the treatment of adult patients 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. In clinical trials of 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 patients with psoriatic arthritis. 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

During Taltz treatment, monitor patients for onset or exacerbations of 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 in patients with plaque psoriasis.

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 profile observed in patients with psoriatic arthritis was consistent with the safety profile in patients with plaque psoriasis, with the exception of influenza and conjunctivitis.

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IX HCP ISI 01DEC2017