Participants in the randomized study included ulcerative colitis patients who had failed at least one conventional treatment but had not received any biological therapy.
Otezla is an oral inhibitor of phosphodiesterase 4 (PDE4), an enzyme associated with ulcerative colitis. The therapy is thought to control the production of inflammatory agents, but the company has not determined how yet.
Otezla is currently approved in the United States as a treatment for moderate-to-severe plaque psoriasis as well as for the treatment of adults with active psoriatic arthritis, but has not yet been approved for the treatment of ulcerative colitis in any country.
In January 2018, the U.S. Food and Drug Administration (FDA) granted Otezla orphan drug status for the potential treatment of children with ulcerative colitis.
Results from the Phase 2 trial (NCT02289417) suggest that a higher percentage of patients taking 30 mg of Otezla twice daily achieved clinical remission versus placebo in active ulcerative colitis. The company presented the data at the 13th Congress of the European Crohn’s and Colitis Organization (ECCO) in Vienna, Austria.
“The achievement of clinical remission, which requires endoscopic improvement of the mucosa, is a meaningful goal in the treatment of ulcerative colitis,” Silvio Danese, MD, PhD, presenting author of the study, 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.” Danese is the head of the Inflammatory Bowel Disease Clinical and Research Center at Humanitas Research Hospital in Italy.
In the study, 170 patients were randomized to receive placebo, Otezla at 40 mg, or Otezla at 30 mg, all administered twice daily. The primary goal was clinical remission, assessed by total mayo score (TMS), at 12 weeks for the 40 mg group. At week 12, TMS clinical remission was achieved by 21.8 percent of the patients in the 40 mg group versus 13.8 percent in the placebo group. In the 30 mg arm, 31.6 percent achieved clinical remission at week 12.
When measured by partial mayo score (PMS), clinical remission was achieved by 59.6 percent of patients in the 30 mg group versus 36.2 percent in the placebo group and 52.7 percent in the 40 mg group at week 12.
Researchers also found clinically meaningful improvements for the 30 mg group, compared with placebo. Based on these results, Celgene is now planning a Phase 3 clinical trial of Otezla in UC, expected to begin this year.
“The strength of these data advances our plans to initiate a phase 3 program for Otezla (apremilast) 30 mg in ulcerative colitis,” said Terrie Curran, president of Celgene Inflammation and Immunology. “We remain committed to bringing forth innovative, oral, immunomodulatory treatment options for patients with inflammatory bowel disease.”
Adverse effects were reported in at least 5 percent of patients treated with Otezla, including headaches, viral upper respiratory tract infection, nausea and abdominal pain, among others. Headaches were most reported, affecting 23 percent of patients in the 30 mg group and 26 percent in the 40 mg group, compared with 7 percent in the placebo group.
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