Infections in patients with ulcerative colitis treated with ozanimod were mostly characterized as non-serious.
A new look at ozanimod shows the treatment does not result in serious infections for patients with ulcerative colitis.
In data presented at the 2021 Digestive Disease Week (DDW) Virtual Meeting, a team led by Florian Rieder, MD, Gastroenterology, Hepatology, and Nutrition, The Cleveland Clinic, assessed the link between absolute lymphocyte count (ALC) reduction and incidence of serious or opportunistic infections in patients with moderately to severely active ulcerative colitis.
The researchers identified adverse events including infections and ALC levels from pooled analysis of multiple ozanimod studies.
Ozanimod was temporarily discontinued if ALC was confirmed as <0.2 x 109/L, and weekly testing was performed until ALC reached >0.5 x 109/L, when reinitiation of study drug was allowed.
Of the 1158 patients treated with ozanimod, there was a mean ALC reduction to 47% of baseline values in ozanimod-treated patients, which were identified at week 5.
Overall, infections in patients with ulcerative colitis treated with ozanimod were mostly characterized by non-serious infections of the upper respiratory tract, with no clear connection between ALC <0.2 x 109/L and the onset of serious or opportunistic infections.
In an interview with HCPLive®, Rieder explained the results and how ozanimod fits in with the current lineup of treatments for ulcerative colitis.