An international panel of 45 experts in inflammatory bowel disease clinical trials established consensus recommendations on corticosteroid use and presented recommendations during United European Gastroenterology (UEG) Week 2025. The group determined that inconsistent tapering, prolonged exposure, and poorly defined maintenance protocols compromise trial validity, inflate placebo response rates, and increase steroid-related risks.

Using a structured Delphi process with two survey rounds, the researchers reviewed trial evidence and standardized approaches to corticosteroid management. Notably, the panel did not reach consensus on the required duration of corticosteroid withdrawal before the final study visit to define corticosteroid-free remission. The panel recommended harmonizing tapering schedules, limiting exposure during induction, and imposing strict definitions for screening and maintenance phases. Short, fixed-duration or reduced-duration regimens were favored over open-ended tapering, with explicit documentation of steroid initiation and withdrawal required in trial protocols. The recommendations also specify operational details often missed in coverage—e.g., require at least 2 weeks of stable dosing before screening, begin tapering within 2 weeks of induction with a protocol-mandated 5 mg/week prednisone-equivalent taper, do not taper enteric/colonic-release budesonide, and exclude participants who received intravenous steroids during screening.

The final guidance called for standardized definitions of steroid-related endpoints to improve comparability across randomized controlled trials; however, the required duration of steroid withdrawal for defining corticosteroid-free remission remained unresolved. Recommendations included minimizing steroid dependence in induction, accounting for prior use during screening, and avoiding prolonged treatment in maintenance to reduce bias in efficacy outcomes.

The consensus statements are intended to serve as a framework for corticosteroid management in trials enrolling patients with moderate-to-severe disease. The researchers noted that consistent application of these standards may improve the reliability of trial outcomes while reducing unnecessary steroid-related harm to participants.

Source: United European Gastroenterology (UEG) Week 2025