Journal
INFLAMMATORY BOWEL DISEASES
Volume 26, Issue 4, Pages 515-523Publisher
OXFORD UNIV PRESS INC
DOI: 10.1093/ibd/izz193
Keywords
end points; clinical trials; ulcerative colitis; Crohn's disease; maintenance therapy
Categories
Funding
- NIDDK [K23DK117058]
- American College of Gastroenterology Junior Faculty Development Award
- Crohn's and Colitis Foundation Career Development Award [404614]
- Pfizer
- AbbVie
- AMAG Pharmaceuticals
- Takeda
- Prometheus, Polymedco
- Abbvie
- Robarts Clinical Trials, Inc.
- Robarts Clinical Trials Inc.
- Millennium Pharmaceuticals
- Tillotts Pharma
- Novartis Pharmaceuticals
- Elan/Biogen
- UCB Pharma
- Bristol-Myers Squibb
- Genentech
- ActoGenix
- Wyeth Pharmaceuticals
- Unity Pharmaceuticals, Albireo Pharma
- GiCare Pharma
- Sigmoid Pharma
- UCB
- JJ/Janssen
- Atlantic Healthcare Limited
- Celgene/Receptos
- Allergan
- Arena Pharmaceuticals
- BeiGene
- Conatus
- Kyowa Kirin Pharmaceutical Research
- Lilly
- Otsuka
- Prizer, Precision IBD, Progenity
- Shire
- Sigmoid Biotechnologies, Sterna Biologicals
- Progenity
- John and Susan McDonald Endowed IBD Chair at Western University
- Eli Lilly
- Pendopharm
- Robarts Clinical Trials, Topivert
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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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