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

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.