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FDA Approves Apremilast for Behcet's Oral Ulcers

Jul 22, 2019 3:00 am

The US Food and Drug Administration (FDA) has approved apremilast (Otezla) for the treatment of oral ulcers associated with Behçet’s Disease, a rare chronic multisystem inflammatory disease that affects about 5 in 100,000 persons in the USA.

Apremilast, an oral phosphodiesterase 4 inhibitor was previously FDA approved for use in psoriasis and psoriatic arthritis where it has been used in over 250,000 patients in the U.S., since its FDA approval in 2014.

The approved dose for Behcet's disease will be 30 mg twice-daily.

FDA approval on Friday, July 19th, was based on efficacy and safety seen in a Phase 3 study that included 207 Behçet’s disease patients with active oral ulcers who were randomized to apremilast (APR) or placebo (PBO). This 12 week study showed significant benefits of APR compared with PBO:

  • Less oral ulcer pain (-42.7 vs -18.7 points respectively)
  • More were oral ulcer-free at week 12 (52.9% vs. 22.3%)
  • Lower daily average number of oral ulcers (1.5 vs. 2.6)

Common adverse events observed with APR in this trial were diarrhea (41%), nausea (19%), headache (14%) and upper respiratory tract infection (11%).






The author has no conflicts of interest to disclose related to this subject

Rheumatologists’ Comments

Mahdi vojdanian

| Jul 22, 2019 5:28 pm

Did apremilast compare with colchicine? How about its price , side effects in comparison to colchicine
Read the study - no colchicine comparison. Look up the price

howard offenberg

| Jul 24, 2019 10:19 am

Expensive treatment for mouth ulcers
Chronic intermittent steroid therapy may be ultimately more expensive and harmful. THe point being that treatment has to be tailored to the needs of each patient.

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