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Oral Apremilast Demonstrated Rapid, Clinically Significant Improvements In Oral Ulcers In Patients With Behçet’s Disease In A Phase II Trial

Celgene International Sàrl, a wholly-owned subsidiary of Celgene Corporation (NASDAQ:CELG), today 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. These results have been featured as part of the official ACR press program, which highlights data considered representative of the highest quality and most meaningful research presented at the ACR annual meeting.

Behçet’s disease is a rare and chronic inflammatory disorder characterized by recurrent oral and genital ulcers, skin and eye lesions (which may cause blindness) and joint inflammation. Inflammation may also affect the brain and gastrointestinal tract.

These data, which were also presented at the European League Against Rheumatism (EULAR) annual meeting this year in June, 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).

“Behçet’s disease can have a severe negative impact on patients’ quality of life, and there are limited therapies available, so there is a clear need for a new therapy to help this patient population,” said Gulen Hatemi, M.D., Associate Professor, Cerrahpasa Medical School, Istanbul, Turkey. “We are encouraged by the rapid response seen in this important phase II study and by apremilast’s potential to treat oral ulcers in this orphan disease.”

The beneficial effect of apremilast on oral ulcers reached a stable effect within two weeks and was sustained while patients remained on treatment.

At week 12, apremilast also improved several patient-reported outcome scores, including the Behçet’s disease current activity form (BDCAF), Behçet’s syndrome activity score (BSAS) and Behçet’s disease quality of life (QoL) instrument. Improvement in oral ulcer pain was also significantly higher with apremilast than with placebo (apremilast, -44.7 ± 24.30; placebo, -16.0 ± 32.54; p<0.0001).

The type and severity of adverse events (AEs) were comparable to the known apremilast safety profile. In BCT-001, treatment-emergent adverse events (TEAE), including severe and serious adverse events (SAEs) and withdrawal due to adverse events, were comparable between 30 mg twice daily (BID) and placebo. None of the SAEs in the apremilast group were reported more than once. Out of the five most common TEAEs in the 30 mg BID group, two (headache and Behçet’s syndrome/flare) were comparable to placebo, while nausea, diarrhea and vomiting were reported more frequently with APR 30 mg BID.

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