Phase II data for apremilast in Behçet’s disease published

Results from a multicentre, randomized, placebo-controlled phase II trial (BCT-001) of apremilast in patients with Behçet’s disease have been published.

Behçet’s disease is a rare, chronic inflammatory disorder characterised by recurrent oral and genital ulcers, which are considered a hallmark of the disease. Joint inflammation and recurrent skin and eye lesions may also occur.

“Painful oral ulcers due to Behçet’s disease are the hallmark of the condition and can have a significant impact on the lives of many patients. Currently used drugs for this condition may not control oral or genital ulcers in some patients or have potential adverse events that may limit their use,” said Gulen Hatemi, M.D., Associate Professor, Cerrahpasa Medical School, Istanbul, Turkey.

The BCT-001 study followed 111 subjects with active Behçet’s disease. After a screening period of up to 90 days, patients were randomized 1:1 to receive apremilast 30 mg twice daily or placebo for 12 weeks after an initial seven-day titration period, followed by a 12-week blinded extension, where the placebo group was switched to apremilast, and a 28-day post-treatment observational follow-up. For those treated with apremilast for the full 24 weeks, the decrease in the mean number of oral ulcers was evident by week two and this decrease was sustained through week 24. In the placebo arm, the mean number of oral ulcers was 2.9 at baseline and 1.7 at week two. At week 24, following 12 weeks of apremilast treatment, the mean number of oral ulcers in the placebo group was 0.4.

Patients treated with apremilast also experienced a decrease in pain associated with oral ulcers

A decrease in pain associated with oral ulcers paralleled this decrease in ulcers over time. Mean pain scores, measured using a visual analogue scale, decreased from 54.3 at baseline to 12.0 at week 2 and 9.7 at week 24. In the placebo arm, pain scores were 51.7 at baseline and 29.8 at week 2. At week 24, mean pain score in this group was 9.7.

Apremilast also significantly improved several measures of disease activity and quality of life at week 12.

“Celgene is dedicated to investigating and delivering to patients new treatment options for rare, chronic inflammatory disorders such as Behçet’s disease,” said Scott Smith, President, Celgene Inflammation & Immunology. “Based on these phase II results, Celgene has filed with regulatory authorities in Turkey and has initiated a global phase III trial of OTEZLA in this debilitating disease.”

The results from the study are published in the April 16 issue of The New England Journal of Medicine.

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