Otezla Elicits Improvements Among Biologic-Naive Patients with Ulcerative Colitis

Celgene recently announced positive findings from a phase 2 clinical trial of apremilast (Otezla) in patients with ulcerative colitis who have failed at least 1 therapy but who never received treatment with a biologic, according to a press release.

The study showed that a higher number of patients treated with apremilast 30-mg twice per day (BID) achieved remission compared with placebo.

Included in the trial were 170 patients with active ulcerative colitis who were randomized to receive apremilast 40-mg BID, apremilast 30-mg BID, or placebo. The primary endpoint of the study was clinical remission at week 12 for the 40-mg cohort measured by Total Mayo Score (TMS).

At 12 weeks, 21.8% of patients treated with apremilast 40-mg achieved TMS clinical remission compared with 13.8% of placebo-treated patients, according to the release. Additionally, 31.6% of patients treated with apremilast 30-mg BID achieved remission by week 12.

"The achievement of clinical remission, which requires endoscopic improvement of the mucosa, is a meaningful goal in the treatment of ulcerative colitis," said study author Silvio Danese, MD, PhD. "These findings suggest apremilast, which improved the likelihood of achieving remission in this 12-week study, merits further study in a larger trial."

A secondary endpoint of clinical remission measured by Partial Mayo Score (PMS) was reached by 59.6% of patients in the 30-mg arm and 52.7% of those in the 40-mg arm, according to the release. Comparatively, only 32.6% of patients in the placebo arm achieved PMS clinical remission.

Other secondary endpoints of the trial included endoscopic remission, TMS clinical response, serum biomarkers, and mucosal healing, which all showed clinically meaningful improvements in ulcerative colitis disease activity, according to the release.

Celgene reported that treatment-emergent adverse events included headache, viral upper respiratory tract infection, nausea, abdominal pain, back pain, and asthenia.

Currently, apremilast is indicated to treat moderate-to-severe plaque psoriasis and active psoriatic arthritis. It is not approved to treat ulcerative colitis in any country, according to the release.

"The strength of these data advances our plans to initiate a phase III program for Otezla (apremilast) 30-mg in ulcerative colitis," said Terrie Curran, president, Celgene Inflammation and Immunology. "We remain committed to bringing forth innovative, oral, immunomodulatory treatment options for patients with inflammatory bowel disease."