Placebo-controlled, four-arm study met its primary endpoint at 16 weeks
Study demonstrates PASI-75 of 41% for apremilast 30mg twice daily compared to 6% for placebo (p<0.001) at 16 weeks; apremilast was also generally well-tolerated
Pivotal phase III studies evaluating apremilast in inflammatory conditions to begin in 2010
SUMMIT, N.J.--(BUSINESS WIRE)--Celgene Corporation (NASDAQ:CELG - News) announced clinical data from an investigational Phase IIb, double-blind, placebo-controlled study of apremilast (CC-10004) in patients with moderate-to-severe plaque-type psoriasis (PSOR-005). This was a 352-patient, multi-center study in which patients received either 10mg, 20mg or 30mg of apremilast twice per day (BID), or placebo.
Forty-one percent of patients treated with 30mg of oral apremilast BID achieved a PASI-75 after 16 weeks (p<0.001), compared to a 6% of patients receiving placebo. In addition, a dose-dependent effect was observed between the active therapy arms of the study. Specifically, 29% of patients receiving 20mg BID of apremilast achieved a PASI-75 (p<0.001), while 11% of patients receiving 10mg BID of apremilast achieved a PASI-75.
“These results are extremely important,” said Kim Papp, M.D., Ph.D. of Probity Medical Research, Canada. “The results suggest apremilast is active and may meet a significant unmet medical need: a new oral treatment for patients with moderate-to-severe psoriasis.”
In general, common treatment-emergent adverse events were self-limited and manageable and included headache (32% of patients in the 30mg BID apremilast arm vs. 14% in the placebo arm), nausea (18% vs. 8%, respectively), upper respiratory tract infection (16% vs. 6%, respectively) and diarrhea (14% vs. 5%, respectively). Overall infections were 48% with 30mg BID compared to 33% in the placebo group, with 1% of patients in both the 30mg BID apremilast and placebo arms discontinuing treatment due to infection. In total, discontinuations due to adverse events were 14% for the 30mg BID apremilast arm and 6% for placebo. Most treatment emergent adverse events were mild to moderate (>96%), with no serious adverse events related to apremilast reported in this study.
“The 30mg bid dose of apremilast achieving a PASI-75 rate of 41%, coupled with data from the earlier psoriatic arthritis trial, supports our move to pivotal programs in moderate-to-severe psoriasis and psoriatic arthritis,” said Randall Stevens, MD, Vice President and Clinical Head, Inflammation and Immunology at Celgene. “Importantly, the results of this study suggest that apremilast may become a new oral therapy for psoriasis with a unique balance of safety, tolerability and efficacy in the range of biologic therapies.”
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