Celgene Corporation asserted OTEZLA’s Phase II Clinical Trial data

Celgene Corporation asserted that data from a randomized, placebo-controlled, multi-center, phase II clinical trial of apremilast in patients with active ulcerative colitis who had failed at least one conventional therapy but were naïve to biologic therapy were presented in an oral session .

Results exhibited that a higher proportion of patients taking apremilast 30 mg twice daily (BID) achieved clinical remission versus placebo (nominally significant, P<0.05). OTEZLA (apremilast) is Celgene’s oral selective inhibitor of phosphodiesterase 4 (PDE4).

170 patients were randomized to placebo, apremilast 40 mg BID or apremilast 30 mg BID. The primary endpoint of the study was Total Mayo Score (TMS) clinical remission at week 12 for the 40 mg BID arm. At week 12, TMS clinical remission was achieved by 21.8 percent of patients in the apremilast 40 mg BID arm (n=55) versus 13.8 percent in the placebo group (n=58; P=non-significant (NS)). In the apremilast 30 mg BID arm, 31.6 percent of patients (n=57) achieved clinical remission as measured by TMS at week 12 versus 13.8 percent in the placebo group (n=58; nominally significant, P<0.05).

Silvio Danese, M.D., Ph.D., Head of the Inflammatory Bowel Disease Clinical and Research Center, Humanitas Research Hospital said “These findings suggest apremilast, which improved the likelihood of achieving remission in this 12-week study, merits further study in a larger trial.”

Treatment-emergent adverse events reported in at least 5 percent of patients treated with apremilast included headache (23 percent with apremilast 30 mg BID, 26 percent with apremilast 40 mg BID and 7 percent with placebo); viral upper respiratory tract infection (9 percent, 4 percent and 2 percent, respectively); nausea (5 percent, 11 percent and 9 percent); abdominal pain (5 percent, 2 percent and 2 percent); back pain (0 percent, 6 percent and 2 percent); and asthenia (5 percent, 2 percent and 3 percent).