Patients with ulcerative colitis treated with Otezla showed significantly higher rates of clinical remission than those who received placebo, according to research presented at the Congress of the European Crohn’s and Colitis Organisation.
Otezla (apremilast, Celgene) is an oral small-molecule inhibitor of phosphodiesterase 4 (PDE4) specific for cyclic adenosine monophosphate (cAMP). The drug is currently approved for psoriasis and psoriatic arthritis, and the FDA issued it orphan drug status in January for the potential treatment of pediatric patients with ulcerative colitis, according to a press release.
Silvio Danese, MD, PhD, head of the Inflammatory Bowel Disease Clinical and Research Center at Humanitas Research Hospital in Italy, and colleagues conducted a randomized, placebo-controlled, multi-center, phase 2 clinical trial of apremilast in patients with ulcerative colitis (UC) who failed at least one conventional therapy but were naive to biologic therapy.
“The strength of these data advances our plans to initiate a phase 3 program for Otezla 30 mg in ulcerative colitis,” Terrie Curran, president of Celgene Inflammation and Immunology said in a press release. “We remain committed to bringing forth innovative, oral, immunomodulatory treatment options for patients with inflammatory bowel disease.”
The researchers randomly assigned the patients (n = 170) into three groups: apremilast 40 mg (APR40; n = 55), apremilast 30 mg (APR30; n = 57) and a placebo group (n = 58). The primary endpoint was Total Mayo Score (TMS) remission at week 12 of the study.
At the end of the study, 21.8% of the patients in the APR40 group achieved TMS clinical remission compared with 31.6% in the APR30 group and 13.8% in the control group.
When measuring clinical remission by Partial Mayo Score, 59.6% of patients in the APR30 group and 52.5% in the APR40 group achieved clinical remission vs. 36.2% in the placebo group.
Danese and colleagues also measured several secondary endpoints, including endoscopic remission, TMS clinical response, serum biomarkers and mucosal healing and found clinically meaningful improvements in the APR30 group compared with the placebo group.
“The achievement of clinical remission, which requires endoscopic improvement of the mucosa, is a meaningful goal in the treatment of ulcerative colitis,” Danese said in a press release. “These findings suggest apremilast, which improved the likelihood of achieving remission in this 12-week study, merits further study in a larger trial.” – by Alex Young
Danese S, et al. Abstract OP006; Presented at: Congress of the European Crohn’s and Colitis Organisation; Feb. 14-17; Vienna, Austria.
Disclosures: Curran is employed by Celgene. Danese reports receiving consulting fees from Celgene.