Corticosteroid-Free Remission vs Overall Remission in Clinical Trials of Moderate–Severe Ulcerative Colitis and Crohn's Disease. Issue 4 (30th August 2019)

• Record Type: Journal Article
• Authors: George, John; Singh, Siddharth; Dulai, Parambir S; Ma, Christopher; Nguyen, Tran; Feagan, Brian G; Sandborn, William J; Jairath, Vipul
• Is Part Of: Inflammatory bowel diseases. Volume 26:Issue 4(2020)
• Page Start: 515
• Page End: 523
• Publication Date: 2019-08-30
• Subjects: end points -- clinical trials -- ulcerative colitis -- Crohn's disease -- maintenance therapy; Inflammatory bowel diseases -- Periodicals; Colitis, Ulcerative -- Periodicals; Crohn Disease -- Periodicals; Inflammatory Bowel Diseases -- Periodicals; 616.344
• DOI: 10.1093/ibd/izz193
• Languages: English
• ISSNs: 1078-0998

Abstract

Abstract: Background: We summarized the protocol-specified corticosteroid tapering regimens in clinical trials of moderate–severe ulcerative colitis (UC) and Crohn's disease (CD) and calculated differences in rates of clinical remission vs corticosteroid-free clinical remission (CSF-CR). Methods: Through a systematic literature review through February 28, 2019, we identified 16 randomized controlled trials (RCTs) of biologics or small molecules in patients with moderate–severe UC or CD who reported CSF-CR as an outcome. We estimated the relative risk and 95% confidence interval of achieving CSF-CR vs overall clinical remission in patients treated with active intervention or placebo through random-effects meta-analysis. Results: Across trials of UC (11 trials) and CD (5 trials), a median of 53% and 49% of participants were on corticosteroids at the time of trial entry, respectively. Participants were allowed to enter trials at a median corticosteroid dose (range) of 35 (20–40) mg/d. Doses were kept stable for a median (range) of 8 (5–10) weeks during induction therapy, after which a mandatory and structured taper was implemented, albeit with the investigators' discretion depending on clinical status. Pooled rates of CSF-CR in patients with UC and CD treated with placebo were 9.7% and 19.1%, respectively. In UC and CD trials, the rate of CSF-CR was 24% and 18% lower than the rate of overall clinical remission, respectively. Conclusions: Protocol-specified corticosteroid tapering regimens vary across trials. These findings will help to inform the design and interpretation of future clinical trials and highlight the need for standardization. Abstract : Protocol-specified corticosteroid tapering regimens vary across trials. Most trials keep the dose of corticosteroids stable during induction therapy, after which a mandatory and structured taper is implemented, albeit with the investigators' discretion depending on clinical status. Rates of corticosteroid-free clinical remission are 18%–24% lower than overall rates clinical remission.