Abstract

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

George J1, Singh S2,3, Dulai PS2, Ma C4,5, Nguyen T4, Feagan BG4,6,7, Sandborn WJ2, Jairath V4,6,7. Inflamm Bowel Dis. 2019 Aug 30. pii: izz193. doi: 10.1093/ibd/izz193. [Epub ahead of print]

 
     

Author information

Department of Internal Medicine, Bridgeport Hospital-Yale New Haven Health, Bridgeport, Connecticut, USA.

Division of Gastroenterology and, La Jolla, California, USA.

Division of Biomedical Informatics, University of California San Diego, La Jolla, California, USA.

Division of Robarts Clinical Trials Inc., London, Ontario, Canada.

Division of Gastroenterology and Hepatology, University of Calgary, Calgary, Alberta, Canada.

Department of Epidemiology and Biostatistics, Western University, London, Ontario, Canada.

Division of Gastroenterology, Department of Medicine, University Hospital London, Ontario, Canada.

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.

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