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Alternative definition for clinical remission in UC shows potential for future clinical trials
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ORLANDO — An alternative definition for clinical remission in ulcerative colitis shows promise as a potential endpoint for use in future clinical trials, according to a poster presentation at the 2015 Advances in IBD Meeting.
The FDA has scrutinized the current definition of clinical remission in UC used for approval of biologic agents — a Mayo score of two or lower with no subscore greater than 1 — because of its “lack of formal validation and inclusion of the poorly-defined physician global assessment subscore (PGA),” William Sandborn, MD, from University of California San Diego, and colleagues wrote. Therefore, they performed a post hoc analysis of data from the TOUCHSTONE trial to evaluate a proposed alternative definition of clinical remission that uses the Mayo score without the PGA.
William Sandborn
The proposed alternative requires a rectal bleeding subscore (RBS) of zero, an endoscopy subscore (ES) of 1 or less, a stool frequency subscore (SFS) of 1 or less and improvement in one or more of these measures. Sandborn and colleagues calculated clinical remission rates of the 197 patients (high-dose group, n = 65; low-dose group, n = 65; placebo group, n = 67) who completed the induction phase at week 8 and the 103 who completed the maintenance phase at week 32 using this alternative definition.
Using the original definition, the week 8 clinical remission rate was 16.4% for the high-dose group (P = .0482 vs. placebo), 13.8% for the low-dose group (P = .1422 vs. placebo) and 6.2% for the placebo group. Using the alternative definition, the week 8 clinical remission rates were 23.9% (P = .0154), 16.9% (P = .2099) and 9.2%, respectively.
Week 32 clinical remission rates using the original definition were 20.9% (P = .0108), 26.2% (P = .0021) and 6.2%, respectively, and using the alternate definition were 26.9% (P = .0025), 26.2% (P = .0053) and 7.7%, respectively.
A greater difference between the high-dose group and the placebo group was demonstrated using the alternative definition.
“An endpoint that excludes the PGA but maintains the other components of the Mayo score … is able to demonstrate a treatment effect and could be one of the endpoints in clinical trials of UC,” the researchers wrote, adding that the analysis also confirms that patients in the high-dose group had greater odds of achieving and maintaining clinical remission. – by Adam Leitenberger
Reference: Sandborn W, et al. Abstract P-106. Presented at Advances in Inflammatory Bowel Diseases; Dec. 10-12, 2015; Orlando, Fla.
Disclosures: Sandborn reports he is a consultant for AbbVie, Arena Pharmaceuticals, Celgene, Pfizer, Prometheus and Receptos.