First Oral Ulcer Treatment for Rare Inflammatory Disease

Otezla Approved for Behçet’s Syndrome

Patients with Behçet’s disease, a rare, inflammatory disorder, now have a new treatment option with apremilast (Otezla, Celgene). The plaque psoriasis drug was approved by the FDA for the treatment of adults with oral ulcers caused by Behçet’s. Apremilast is an oral, selective inhibitor of phosphodiesterase 4 (PDE4).

Also known as Behçet’s syndrome, the chronic inflammatory disease affects approximately five of every 100,000 people in the United States. Oral ulcers are present in the majority of people with Behçet’s; they can be painful and negatively affect patients’ quality of life. In addition to oral ulcers, Behçet’s disease is characterized by recurrent genital ulcers, skin lesions, uveitis, arthritis, and vascular, central nervous system, and gastrointestinal involvement. 

Approval was granted based on positive phase 3 data from the RELIEF study. Results at 12 weeks showed that 30-mg doses of apremilast resulted in a 42.7-point reduction from baseline in oral ulcer pain compared to an 18.7-point reduction with placebo.

Trial data also showed that at 12 weeks, 52.9% of Otezla patients achieved an ulcer-free complete response, compared to 22.3% of placebo patients. Responses were seen as early as six weeks.

The most common adverse event was diarrhea, which occurred in 41.3% of apremilast patients and 20.4% of placebo patients.

Source: BioSpace, July 22, 2019