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Consistent efficacy outcomes between phase 2 and phase 3 trials in Crohn's disease or ulcerative colitis in adults: a

Ziqi Wan1,2, Qingwei Jiang1, Runing Zhou1

  • 1Department of Gastroenterology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China.

Inflammation Research : Official Journal of the European Histamine Research Society ... [Et Al.]
|April 8, 2024
PubMed
Abstract

Insights

Efficacy outcomes in Crohn's disease (CD) and ulcerative colitis (UC) trials are generally consistent between phase 2 and phase 3. Phase 2 data for CD and UC are reliable for designing phase 3 studies, with an exception for UC response rates.

Area of Science:

  • Gastroenterology
  • Clinical Pharmacology
  • Biostatistics

Background:

  • Biologic agents and small molecules for Crohn's disease (CD) and ulcerative colitis (UC) require phase 3 randomized controlled trials (RCTs) for approval.
  • Phase 3 RCTs sometimes yield different efficacy outcomes than observed in earlier phase 2 trials.

Purpose of the Study:

  • To systematically review and compare efficacy outcomes between phase 2 and phase 3 randomized controlled trials (RCTs) for biologic agents and small molecules in CD and UC.
  • To assess the reliability of phase 2 efficacy data for informing phase 3 trial design.

Main Methods:

  • Systematic review of RCTs evaluating paired phase 2 and phase 3 regimens for CD and UC.
  • Searched Medline, EMBASE, and Cochrane databases up to February 13, 2024.
  • Utilized the revised Cochrane tool for risk of bias assessment and a generalized linear mixed-effects model (GLMM) to compare phase 2 and phase 3 efficacy outcomes.

Main Results:

  • For CD, phase 2 trials showed numerically higher efficacy (9-13%) across CDAI measures but lacked statistical significance.
  • For UC, clinical remission and endoscopic improvement were similar between phase 2 and 3 (ORs ~1.00).
  • UC clinical response rates were underestimated in phase 2 trials (OR 0.81, p=0.03), with significant interaction noted with Mayo score inclusion criteria.

Conclusions:

  • Efficacy outcomes for CD and UC are largely consistent between phase 2 and phase 3 trials.
  • Phase 2 efficacy data is generally reliable for phase 3 trial design, with the exception of UC response rates.
  • The findings support the continued use of phase 2 data in planning subsequent clinical trials for IBD therapeutics.
Keywords:
BiologicsCrohn’s diseaseSmall moleculesUlcerative colitis

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