copaydosingefficacyresourcesafety

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NOW ALSO APPROVED FOR ORAL ULCERS
ASSOCIATED WITH BEHÇET'S DISEASE +
Results the way They Want Them
Otezla® (apremilast) has a proven efficacy and safety profile, oral dosing, and no label-required lab monitoring—making it a treatment experience patients can respond to.*

Indications

  • Otezla is indicated for the treatment of patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy
  • Otezla is indicated for the treatment of adult patients with active psoriatic arthritis
Otezla: the ONLY ORAL treatment indicated for
psoriatic arthritis and plaque psoriasis1

MODERATE TO SEVERE Plaque Psoriasis

Significant skin improvement1,2

In ESTEEM® 1
33% PASI-75 response with Otezla 30 mg
twice daily (n = 562)
vs 5% with placebo (n = 282) at week 16
(primary endpoint; P < 0.0001)

*
The efficacy and safety of Otezla in plaque psoriasis was evaluated in 2 multicenter, double-blind, placebo-controlled trials of similar design. Patients with moderate to severe plaque psoriasis (N = 1257) were randomized 2:1 to Otezla 30 mg twice daily or placebo for 16 weeks after a 5-day titration.1-3
In ESTEEM 1, Otezla significantly increased PASI-75 response (n = 562) at week 16 (primary endpoint) vs placebo (n = 282) (33% vs 5%; P < 0.0001).1,2
Safety profile: The most common adverse reactions (≥5%) were diarrhea, nausea, upper respiratory tract infection, tension headache, and headache.1
Study Design

Psoriatic Arthritis

Significant joint improvement1,4,5

In PALACE™ 1
38% ACR20 response with Otezla 30 mg
twice daily (n = 168)
vs 19% with placebo (n = 168) at week 16
(primary endpoint; P = 0.0001)

The efficacy and safety of Otezla in psoriatic arthritis was evaluated in 3 multicenter, randomized, double-blind, placebo-controlled phase 3 trials in adult patients with active psoriatic arthritis (N = 1493). Patients were randomized 1:1:1 to either Otezla 30 mg twice daily, Otezla 20 mg twice daily, or placebo for 24 weeks, after a 5-day titration period.1,4,5
In PALACE 1, Otezla significantly increased ACR20 response (n = 168) at week 16 (primary endpoint) vs placebo (n = 168) (38% vs 19%; P = 0.0001).1,4,5
Safety profile: The most common adverse reactions (≥5%) were diarrhea, nausea, and headache.1
Study Design

ACR, American College of Rheumatology; ESTEEM, Efficacy and Safety Trial Evaluating the Effects of Apremilast in Psoriasis; PALACE, Psoriatic Arthritis Long-Term Assessment of Clinical Efficacy; PASI, Psoriasis Area and Severity Index.

References: 1. Otezla [package insert]. Summit, NJ: Celgene Corporation. 2. Papp K, Reich K, Leonardi CL, et al. J Am Acad Dermatol. 2015;73(1):37-49. 3. Paul C, Cather J, Gooderham M, et al. Br J Dermatol. 2015;173(6):1387-1399. 4. Data on file, Celgene Corporation. 5. Kavanaugh A, Mease PJ, Gomez-Reino JJ, et al. J Rheumatol. 2015;42(3):479-488.

Indications & Important Safety Information

Please click here for Full Prescribing Information.

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