Clinical Edge

Summaries of Must-Read Clinical Literature, Guidelines, and FDA Actions

Efficacy Outcomes in RCTs of Crohn’s Disease

Clin Gastroenterol Hepatol; ePub 2018 Mar 26; Ma, et al

Establishing a core outcome set to standardize efficacy and safety endpoint definitions in clinical trials of Crohn’s disease should be a priority, according to a recent review that looked at efficacy and safety outcomes reported in placebo-controlled randomized controlled trials (RCTs) of patients with Crohn’s disease. The systematic review to March 1, 2017 included 116 RCTs and 27,263 patients. Researchers found:

  • 38 unique definitions of clinical response or remission and 32 definitions of loss of response were identified.
  • Definitions of endoscopic response, remission, and endoscopic healing were also heterogeneous.
  • Histologic outcomes were reported in 11.1%, 2.3%, and 14.3% of induction, maintenance, and postoperative prevention trials, respectively.
  • Biomarker outcomes were reported in 81.5%, 68.2%, and 42.9% of induction, maintenance, and postoperative prevention trials, respectively.
  • Safety outcomes were reported in 93.8%, 97.7%, and 85.7% of induction, maintenance, and postoperative prevention trials, respectively.

Citation:

Ma C, Hussein IM, Al-Abbar YJ, et al. Heterogeneity in definitions of efficacy and safety endpoints for clinical trials of Crohn’s disease: A systematic review for development of a core outcome set. [Published online ahead of print March 26, 2018]. Clin Gastroenterol Hepatol. doi:10.1016/j.cgh.2018.02.051.