Presentation (CTI)

OBJECTIVES: Chronic conditions in various therapeutic areas necessitate the evaluation of treatment outcomes in both the induction and maintenance phases of treatment. Clinical trials have evolved over time to enable this sequential evaluation of efficacy, resulting in important heterogeneity in the designs of trials that include a maintenance phase. The objective of this study is to summarize methodological approaches reported in network meta-analyses (NMAs) to address study design variations, using a case study of inflammatory bowel diseases.
METHODS: A targeted review was conducted in PubMed, from database inception until December 2025, to identify full-text publications of NMAs focused on the maintenance phase of treatment for ulcerative colitis (UC) and Crohn’s disease (CD). Notably, studies which did not analyze efficacy outcomes, focused on post-operative patients, or rescue therapy were excluded, as well as studies published prior to 2005. Methods of included studies were critically analyzed to understand various maintenance phase trial designs, and how heterogeneity in designs and design limitations were addressed in the statistical approach for ITCs.
RESULTS: Of 395 records identified, 64 reported NMAs meeting eligibility criteria and were included in the targeted review. Variations in trial designs were frequently noted, including treat-through trials, response-based trials, and re-randomized trials (where patients were re-randomized after induction to a new treatment for the duration of the maintenance phase). Identified methods for accounting for such differences included subgroup and sensitivity analysis based on study design, and re-calculation to standardize reported estimates to a common study design prior to conducting NMA. Several NMAs did not account for cross-trial differences in maintenance phase study design.
CONCLUSIONS: This study supports the importance of addressing variations in maintenance study design when planning and conducting ITCs for chronic immunological diseases. Careful planning and detailed feasibility assessment can ensure more robust ITCs are available for clinical decision making.