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.
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.
This Week's Must Reads
Must Reads in Crohn’s Disease
Ustekinumab & Health-Related Quality of Life in CD, J Crohns Colitis; ePub 2018 May 3; Sands, et al
Increased Risk of Acute MI and HF with IBD, Clin Gastroenterol Hepatol; ePub 2018 Apr 24; Aniwan, et al
Opioid Use Disorder & IBD Hospitalizations, J Crohns Colitis; ePub 2018 May 7; Cohen-Mekelburg, et al
Clinical Course of IBD with Celiac Disease, J Crohns Colitis; ePub 2018 May 7; Tse, et al
Incidence of Intestinal Infections in IBD, Inflamm Bowel Dis; ePub 2018 May 2; Barber, et al