Apremilast (Celgene) success in Phase II for Behçet's disease.
Celgene International Sàrl, presented Phase II trial (BCT-001) results of apremilast, the Company's first-in-class, oral, targeted inhibitor of phosphodiesterase 4 (PDE4), in patients with Behçet's disease. The findings were presented at the 2013 American College of Rheumatology (ACR)/Association of Rheumatology Health Professionals (ARHP) annual meeting in San Diego.
The data, showed that significantly more patients on apremilast achieved a complete response (were free from active oral ulcers) at week 12 compared with those on placebo (apremilast, 71%; placebo, 29%; p<0.0001). Among patients with genital ulcers at baseline (n=16), 100% of those receiving apremilast had a complete response at week 12 compared with 50% of those receiving placebo (p=0.036).
The beneficial effect of apremilast on oral ulcers reached a stable effect within two weeks and was sustained while patients remained on treatment.
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