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ORLANDO -- Treatment with the investigational drug ozanimod led to clinical, endoscopic, and histologic remission at the end of a 32-week trial in patients with moderate to severe ulcerative colitis, researchers reported here.
In a cohort of 197 colitis patients, endoscopic (87.1%) and clinical remission (82.6%,) were highly concordant with histological remission at week 32, according to , of the University of California San Diego, and colleagues.
Action Points
- Note that this study was published as an abstract and presented at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.
However, histological remission was less concordant with Patient Global Assessment (PGA, 75.8%), absence of diarrhea (73.5%), and rectal bleeding (65.2%), he explained during a poster session at the Advances in Inflammatory Bowel Diseases meeting.
Ozanimod is an oral, selective, sphingosine 1-phosphate 1 (S1PR1) and 5 (S1PR5) receptor modulator.
The current study is part of the , a randomized, double-blind, placebo-controlled phase II trial to assess the efficacy and safety of at 0.5 mg and 1.0 mg versus placebo in patients with moderate to severe ulcerative colitis. TOUCHSTONE concluded that a significantly greater proportion of patients taking the 1.0 mg dose achieved clinical remission, response, and endoscopic mucosal healing at weeks 8 and 32.
The randomized 197 patients received treatment with ozanimod 1.0 mg (n=67), ozanimod 0.5 mg (n=65), or placebo (n=65). Each patient received their assigned dose for 1 week, followed by 8 weeks of treatment.
Of the 197 patients in the induction period, 103 (52.3%) continued taking their dose during a maintenance period and 91 (88.3%) patients fully completed their dose for 32 weeks.
The biopsies at baseline, week 8, and week 32 were scored by a blinded central pathologist, and concordance between histological remission and other assessments was determined by comparing the number of patients with assessments that agreed to the total number of patients assessed. The researchers measured histologic improvement by assessing the change from baseline in Geboes score (range 0-22), with remission defined as a Geboes grade <2.
The researchers concluded that histological remission at week 32 following treatment with ozanimod was highly concordant with endoscopic and clinical remission, but less concordant with PGA, absence of diarrhea, and rectal bleeding.
At baseline, histologic remission based on baseline Geboes mean score was similar among all three groups: 1.0 mg (12.92), 0.5 mg (14.36), and placebo (13.94).
Compared with the placebo cohort, patients who received 1.0 mg ozanimod showed greater histologic improvement at both week 8 (-2.20 versus -4.37, P=0.0345) and week 32 (-2.24 versus -5.50, P=0.0033).
Histologic remission at week 8 occurred in 22.4% of the 1.0 mg cohort (P=0.0705 vs placebo), 13.8% of the 0.5 mg cohort (P=0.6294 versus placebo), and 10.8% of the placebo cohort. By week 32, histologic remission rates were 31.3% (P=0.0006 versus placebo), 23.1% (P=0.0164 versus placebo), and 7.7%, respectively.
"Ozanimod was effective in the induction of clinical, endoscopic, and histologic remission at week 32 in patients with moderate to severe UC," the authors concluded.
Disclosures
The study was supported by Celegne.
Primary Source
Advances in Inflammatory Bowel Diseases
Sandborn W, et al "Histological remission induced by ozanimod is associated with clinical remission and endoscopic mucosal healing: results from the TOUCHSTONE Study" AIBD 2016; Abstract P-010.