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Shaky mid-stage data won’t halt Celgene’s plans for Otezla

The US biotech will continue to test the drug in patients with UC and Behçet’s disease

CelgeneDespite less than stellar phase II results, Celgene has said it intends to press on with registration trials for its PDE4 inhibitor Otezla in ulcerative colitis due to start later this year.

Otezla (apremilast) is already approved to treat moderate-to-severe plaque psoriasis and has become a blockbuster in that indication, bringing in $1.28bn in sales last year. Celgene intends to expand its use into a series of other inflammatory diseases with ulcerative colitis at the head of its list along with Behçet’s disease.

Now, phase II results reported at the European Crohn’s and Colitis Organisation (ECCO) congress in Vienna show that the drug provides ‘clinically meaningful’ improvements as a second-line treatment for ulcerative colitis patients who had failed at least on conventional systemic therapy, but had not been treated with biologic drugs such as TNF inhibitors.

A higher proportion of patients taking Otezla at a dose of 30mg twice daily achieved clinical remission versus placebo, which just squeaked past the threshold of statistical significance.

The 170-patient trial’s primary endpoint - Total Mayo Score (TMS) clinical remission at week 12 for a 40mg twice-daily dose - was numerically higher for Celgene’s drug (21.8% versus 13.8%) but couldn’t achieve a statistically significant improvement over placebo.

Strangely, a higher proportion of patients went into remission at 12 weeks on the lower 30mg dose (31.6%), but despite the quirks principal investigator Silvio Danese of Humanitas Research Hospital in Italy said the data “merits further study in a larger trial”.

Celgene reported stronger data with Otezla in reducing oral ulcers in patients with Behçet’s disease, a rare inflammatory disease, at the American Academy of Dermatology (AAD) in San Diego this week. The company says it remains on track to file for approval of the drug in this indication in the US and Japan later this year with a European submission following in 2019.

The RELIEF study in 207 patients with active Behçet's Disease who were previously treated with at least one topical or systemic medication met its primary objective of reducing the number of oral ulcers suffered by patients over a 12-week period compared to placebo.

Article by
Phil Taylor

20th February 2018

From: Research



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