Researchers have found that low and high doses of the experimental immunotherapy drug ozanimod achieve better results than placebo for patients with ulcerative colitis.
A poster presentation at the 2015 Advances in Inflammatory Bowel Disease conference suggested that low and high doses of the experimental immunotherapy drug ozanimod achieve better results than placebo for patients with ulcerative colitis (UC).
The study, a post-hoc analysis of the long-term TOUCHSTONE trial that was awarded a top abstract prize at the earlier United European Gastroenterology (UEG) Week in Barcelona, Spain, showed that patients with moderate to severe UC who continued treatment with ozanimod were more likely to both achieve and maintain clinical remission, clinical response, and mucosal improvement than those receiving placebo.
The poster presented a different definition of clinical remission than was used in TOUCHSTONE; the researchers considered clinical remission using the Mayo scoring system without physician global assessments. Clinical remission is notoriously difficult to define for UC patients, due to a lack of standardization.
Ozanimod is an oral, selective sphingosine 1-phosphate (S1P) 1 and 5 receptor modulator in clinical development for the treatment of UC and relapsing multiple sclerosis. TOUCHSTONE was a randomized, double-blind, placebo-controlled trial that assessed the efficacy, safety and tolerability of two orally administered doses of ozanimod vs. placebo in patients with moderate to severe UC. A total of 197 patients were randomized (1:1:1) and treated once daily with placebo, low-dose ozanimod, LD (n=65) or high dose ozanimod.
The current study found that using the different definition of clinical remission led to a greater difference between the drug and placebo in those given high doses of the drug. “Further, the analysis confirms that patients with moderate to severe UC treated with ozanimod HD were more likely to both achieve and maintain clinical remission,” the authors noted. “The increase in the proportion of patients in clinical remission at Week 32 when compared to week 8 in the ozanimod groups suggests that longer treatment is associated with improving and sustained remission rates.”
Ozanimod was well-tolerated by the majority of patients. The most common treatment emergent adverse events were UC flare, anemia, headache, and nausea.