Oral Ulcers in Behçet's Disease

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Oral Ulcers Associated
with Behçets Disease*

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* 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.1-3

In the RELIEF™ trial, the efficacy of Otezla was demonstrated using the following endpoints (Otezla, placebo): 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%) and the daily average number of oral ulcers during the 12-week placebo-controlled treatment phase (1.5, 2.6).1,3

The most common adverse reactions (≥10%) were diarrhea, nausea, headache, and upper respiratory tract infection.1,3

Certain restrictions apply; eligibility not based on income, must be 18 years of age or older. This offer is not valid for persons eligible for reimbursement of this product, in whole or in part under Medicaid, Medicare, or similar state or federal programs. Offer not valid for cash-paying patients. People who are not eligible can call 1-844-4OTEZLA to discuss other financial assistance opportunities.

VAS, visual analog scale.

RELIEF, Researching Oral Apremilast Safety and Efficacy in Behcet's Disease.

References: 1. Otezla [package insert]. Thousand Oaks, CA: Amgen Inc. 2. Data on file, Amgen Inc. 3. 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

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The FDA approves a new indication for Otezla® (apremilast) Learn more about this treatment option for your patients