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Meta-Analysis
. 2020 Mar 4;26(4):515-523.
doi: 10.1093/ibd/izz193.

Corticosteroid-Free Remission vs Overall Remission in Clinical Trials of Moderate-Severe Ulcerative Colitis and Crohn's Disease

John George  1 , Siddharth Singh  2   3 , Parambir S Dulai  2 , Christopher Ma  4   5 , Tran Nguyen  4 , Brian G Feagan  4   6   7 , William J Sandborn  2 , Vipul Jairath  4   6   7
Affiliations
Meta-Analysis

Corticosteroid-Free Remission vs Overall Remission in Clinical Trials of Moderate-Severe Ulcerative Colitis and Crohn's Disease

John George et al. Inflamm Bowel Dis. .

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.

Keywords: Crohn’s disease; clinical trials; end points; maintenance therapy; ulcerative colitis.

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Figures

FIGURE 1.
FIGURE 1.
Study selection flowsheet.
FIGURE 2.
FIGURE 2.
Risk of achieving corticosteroid-free remission vs overall clinical remission in patients with moderate to severe ulcerative colitis.
FIGURE 3.
FIGURE 3.
Risk of achieving corticosteroid-free remission vs overall clinical remission in patients with moderate to severe Crohn’s disease.
See this image and copyright information in PMC

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