Celgene says OTEZLA data shows 'clinically meaningful improvements' in patients
Celgene Corporation announced that data from a randomized, placebo-controlled, multi-center, phase II clinical trial of apremilast in patients with active ulcerative colitis who had failed at least one conventional therapy but were naive to biologic therapy were presented in an oral session today at the 13th Congress of ECCO in Vienna. The results showed that a higher proportion of patients taking apremilast 30 mg twice daily achieved clinical remission versus placebo. OTEZLA is Celgene's oral selective inhibitor of phosphodiesterase 4. In the study, a total of 170 patients were randomized to placebo, apremilast 40 mg BID or apremilast 30 mg BID. The primary endpoint of the study was Total Mayo Score clinical remission at week 12 for the 40 mg BID arm. At week 12, TMS clinical remission was achieved by 21.8% of patients in the apremilast 40 mg BID arm versus 13.8% in the placebo group. In the apremilast 30 mg BID arm, 31.6% of patients achieved clinical remission as measured by TMS at week 12 versus 13.8% in the placebo group. Clinical remission as measured by Partial Mayo Score, a secondary endpoint, was achieved by 59.6% of patients in the apremilast 30 mg BID arm versus 36.2% in the placebo arm at week 12. PMS clinical remission was also achieved by 52.7% of patients in the apremilast 40 mg BID arm. Additional secondary endpoints examined in the trial, including endoscopic remission, TMS clinical response, serum biomarkers and mucosal healing, showed clinically meaningful improvements for apremilast 30 mg BID versus placebo. Treatment-emergent adverse events reported in at least 5% of patients treated with apremilast included headache; viral upper respiratory tract infection; nausea; abdominal pain; back pain; and asthenia. Apremilast is not approved for the treatment of ulcerative colitis in any country. In January 2018, the U.S. Food and Drug Administration designated apremilast an Orphan Drug for the potential treatment of pediatric patients with ulcerative colitis.