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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 is indicated for the treatment of adult patients with oral ulcers associated with Behçet's Disease
Otezla: the ONLY ORAL treatment indicated for
psoriatic arthritis and plaque psoriasis1

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

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
The FIRST & ONLY treatment for
oral ulcers associated with Behçet's Disease1

ORAL ULCERS IN
BEHÇET'S DISEASE

Improvements in measures of oral ulcers1,6

In RELIEF, reduced pain and number of oral ulcers were seen with Otezla 30 mg twice daily (n = 104) vs placebo (n = 103) at week 12.
In RELIEF, the endpoints were:

  • Change from baseline in the pain of oral ulcers as measured by VAS at week 12 (-42.7, -18.7)
  • Proportion of subjects achieving oral ulcer complete response (oral ulcer–free) at week 12 (53%, 22%)
  • Proportion of subjects achieving oral ulcer complete response (oral ulcer–free) by week 6 and who remained oral ulcer–free for at least 6 additional weeks during the 12-week, placebo-controlled treatment phase (30%, 5%)
  • The daily average number of oral ulcers during the 12-week placebo-controlled treatment phase (1.5, 2.6)

The efficacy and safety of Otezla were evaluated in a multicenter, randomized, placebo-controlled phase 3 trial. Adult patients with Behçet's Disease (BD) with active oral ulcers who were previously treated with at least 1 non-biologic BD medication (N = 207) were randomized 1:1 to Otezla 30 mg twice daily or placebo for 12 weeks after a 5-day titration period. After 12 weeks, all patients received Otezla 30 mg twice daily.1,4

Safety profile: The most common adverse reactions (≥10%) were diarrhea, nausea, headache, and upper respiratory tract infection.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; VAS, visual analog scale.

References: 1. Otezla [package insert]. Thousand Oaks, CA: Amgen Inc. 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, Amgen Inc. 5. Kavanaugh A, Mease PJ, Gomez-Reino JJ, et al. J Rheumatol. 2015;42(3):479-488. 6. Hatemi G, Mahr A, Ishigatsubo Y, et al. Trial of Apremilast for oral ulcers in Behçet’s Syndrome. N Engl J Med. 2019; 381:1918-1928.

Indications & Important Safety Information

Please click here for Full Prescribing Information.

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