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Meta-Analysis
17 March 2025

Efficacy and safety of advanced therapies for moderately to severely active ulcerative colitis in induction and maintenance: systematic literature review and Bayesian network meta-analysis

Authors: Vipul Jairath https://orcid.org/0000-0002-1092-0033 [email protected], Tim Raine https://orcid.org/0000-0002-5855-9873, Thomas P Leahy https://orcid.org/0000-0003-3958-6224, Ravi Potluri https://orcid.org/0000-0002-0509-2659, Karolina Wosik https://orcid.org/0009-0002-7233-0933, David Gruben, Joseph C Cappelleri https://orcid.org/0000-0001-9586-0748, Peter Hur, and Lauren BartolomeAuthor Info & Affiliations
Volume 14, Number 5
https://doi.org/10.57264/cer-2024-0225
PDFFormats

Abstract

Aim: Several therapies have recently been licensed for the treatment of patients with moderately to severely active ulcerative colitis (UC). To provide comparative evidence of newly available treatments, Bayesian network meta-analyses were conducted to compare their relative efficacy and safety profiles in both the induction and maintenance phases. Materials & methods: A systematic literature review was conducted to identify the available literature on randomized controlled trials for advanced treatments (AT) of moderately to severely active UC. Bayesian network meta-analyses were used to synthesize evidence on prespecified efficacy and safety outcomes. Primary efficacy end points clinical response and clinical remission were measured at the end of induction and clinical response and clinical remission among induction phase responders were assessed at the end of the maintenance period. Efficacy outcomes were analyzed separately for AT-naive and -experienced populations. Safety outcomes included serious infections over the induction period, and serious infections among others over the maintenance period. Treat-through trial outcomes were adjusted to align with responder rerandomized trial outcomes. Results: The systematic review identified 58 relevant trials of which 28 met criteria for inclusion in the main analysis networks. At the end of the induction period, all treatments were efficacious against placebo for both AT-naive and AT-experienced populations. Upadacitinib 45 mg demonstrated a higher likelihood of clinical response and remission compared with other treatments. Adalimumab had less favorable performance over the induction period. Among induction phase responders, most treatments demonstrated similar efficacy at the end of the maintenance period. Tofacitinib 10 mg was more likely to achieve clinical response and remission than several other treatments in the AT-naive population. In the AT-experienced population, upadacitinib 30 mg demonstrated a higher likelihood of clinical response and remission compared with other treatments. The safety outcomes among treatments were similar. Conclusion: This study provides an updated comparison of treatments for moderately to severely active UC. Most treatments demonstrated comparable efficacy at the end of maintenance. The findings from this study can inform decision making in treatment choice for patients with moderately to severely active UC.

Plain language summary

What is the article about?

Ulcerative colitis (UC) is a chronic inflammatory condition of the colon that can significantly impact daily life. For individuals with moderately to severely active UC, several new treatments have recently been approved. This study compared the effectiveness and safety of these therapies using data from clinical trials using advanced statistical methods.

What were the results?

A systematic review identified 28 trials that met the criteria for inclusion in our analysis. Treatments were assessed in two key phases: the induction phase and the maintenance phase. Analyses were conducted separately for patients who were new to advanced therapies (AT-naive) and those who had previous exposure (AT-experienced). During the induction phase, all treatments outperformed placebo in both AT-naive and AT-experienced groups. Upadacitinib 45 mg demonstrated the highest likelihood of achieving clinical response and remission, while adalimumab showed less favorable outcomes compared with other treatments. By the end of the maintenance phase, most treatments showed similar effectiveness. Tofacitinib 10 mg was most effective for maintaining response and remission in AT-naive patients. For AT-experienced patients, upadacitinib 30 mg had the greatest likelihood of clinical response and remission among induction phases responders at the end of maintenance. Safety outcomes were broadly comparable across treatments.

Why is this important?

The findings of this study offers valuable insights to support informed treatment decisions, helping clinicians navigate the growing range of therapeutic options.

Supplementary Material

File (supplementary material.doc)

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