A new drug improved management of ulcerative colitis, according to a study published in the New England Journal of Medicine.
Patients treated with ozanimod, a sphongosine 1 phosphate receptor modulator that prevents inflammation, experienced a higher rate of remission compared to patients who received a placebo.
"This is a safe and effective oral option for patients with moderate-severe disease," said Stephen Hanauer, MD, the Clifford Joseph Barborka Professor of Medicine in the Division of Gastroenterology and Hepatology and a co-author of the study.
Ulcerative colitis is an inflammatory bowel disease, characterized by inflammation and sores in the innermost lining of the colon and rectum. There is no cure and while current pharmacological therapies are effective in mild or moderate disease, options for severe disease are lacking, according to Hanauer.
There are several biologic and small molecules now available for moderate-severe ulcerative colitis, but none as effective as we would like."
Stephen Hanauer, MD, the Clifford Joseph Barborka Professor of Medicine
Ozanimod is a sphingosine-1-phosphate (S1P) receptor modulator, causing S1P1 receptors to internalize in lymphocytes, preventing those immune cells from mobilizing to inflammatory sites.
"It 'traps' lymphocytes in lymph nodes so they are unable to get into the colon to cause tissue damage," Hanauer said.
Investigators enrolled more than 1,000 patients in the trial, randomly assigning them to receive once-daily oral ozanimod or a placebo. Incidence of clinical remission was significantly higher among patients who received ozanimod than among those who received placebo. Furthermore, incidence of infection — a concern with any immune-suppressing drug — was similar among the treatment and placebo groups.
Ozanimod has been approved by the Food and Drug Administration (FDA) for use in multiple sclerosis and now moderate-severe ulcerative colitis, and is also being tested for use in Crohn's disease, Hanauer said.
Hanauer has consulted for Bristol Myers Squibb, who provided funding for this study.
Sandborn, W.J., et al. (2021) Ozanimod as Induction and Maintenance Therapy for Ulcerative Colitis. New England Journal of Medicine. doi.org/10.1056/NEJMoa2033617.