Philippe Pinton

doi:10.5217/ir.2025.00234

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Letter to the Editor Comments on “Week 2 remission with vedolizumab as a predictor of long-term remission in patients with ulcerative colitis: a multicenter, retrospective, observational study”: Philippe Pinton; DOI: https://doi.org/10.5217/ir.2025.00234
Published online: January 15, 2026

Ferring Pharmaceuticals, Ferring International PharmaScience Centre, Kastrup, Denmark

Correspondence to Philippe Pinton, Ferring Pharmaceuticals, Ferring International PharmaScience Centre, Amager Strandvej 405, Kastrup 2770, Denmark. E-mail: phpi@ferring.com

• Received: September 22, 2025 • Accepted: October 26, 2025

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

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We read with strong interest the study by Kobayashi et al. [1] evaluating week 2 remission as a predictor of long-term outcomes with vedolizumab in ulcerative colitis (UC). The authors demonstrate a statistically significant association between early clinical remission and week 54 outcomes. However, we believe that the clinical utility of week 2 remission as a decision-making tool requires more rigorous quantitative assessment and clearer integration into clinical practice. First, the absence of quantitative predictive metrics such as sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) limits the translation of these findings into practice. In the present cohort, nearly half of patients who failed to achieve week 2 remission ultimately achieved remission at week 54. This observation, while acknowledged by the authors, is not quantified in terms of NPV or likelihood ratios, which are essential for clinicians to assess the risk of premature therapy modification. Without these metrics, the practical value of week 2 remission as a rule-out or rule-in criterion remains uncertain. Second, clinical decision-making frameworks in UC increasingly rely on validated, quantitative thresholds to guide therapy optimization and escalation. The landmark VARSITY trial [2], the first head-to-head randomized controlled trial of biologics in UC, and its post hoc analyses [3] provide critical context: while early clinical remission (week 4/6) with vedolizumab is associated with higher rates of week 52 remission, a substantial proportion of delayed responders (remission at week 14) also achieve favorable long-term outcomes. These findings, echoed in real-world studies, caution against premature discontinuation of vedolizumab based solely on early non-response, given the agent’s delayed onset of action and the existence of late responders.

To further inform clinical decision-making, we calculated the predictive metrics for week 2 remission as a predictor of week 54 remission using the data presented in Fig. 2A of the article. The sensitivity was 58%, specificity 60%, PPV 70%, and NPV 47%. These findings indicate that while week 2 remission is associated with favorable long-term outcomes, the absence of early remission does not reliably exclude the possibility of later clinical benefit. This is consistent with our previous findings [4], which demonstrated that early symptomatic improvement at week 2 predicted clinical response, remission, and mucosal healing at week 10, but that some patients without early response still achieved favorable outcomes. We therefore recommend that future studies report these metrics and consider decision-analytic approaches to better guide therapy optimization.

In summary, while week 2 remission is a statistically significant prognostic marker, its clinical application as a decision point should be supported by robust quantitative predictive metrics and integrated into evidence-based decision frameworks. We encourage the authors and future investigators to report these metrics and to contextualize early response within a structured, patient-centered treatment algorithm, as exemplified by the VARSITY trial and its subsequent analyses [3].

NOTES

Funding Source

The author received no financial support for the research, authorship, and/or publication of this article.

Conflict of Interest

Pinton P is an employee of Ferring Pharmaceuticals, belongs to the board of directors of PharmaBiome, and owns stocks in Takeda Pharmaceutical Company Ltd.

Data Availability Statement

Not applicable.

Author Contributions

Writing and approval of the final manuscript: Pinton P.

REFERENCES

1. Kobayashi T, Hisamatsu T, Motoya S, et al. Week 2 remission with vedolizumab as a predictor of long-term remission in patients with ulcerative colitis: a multicenter, retrospective, observational study. Intest Res 2025;Jul 14 [Epub]. https://doi.org/10.5217/ir.2025.00047.Article
2. Sands BE, Peyrin-Biroulet L, Loftus EV Jr, et al. Vedolizumab versus adalimumab for moderate-to-severe ulcerative colitis. N Engl J Med 2019;381:1215–1226.Article PubMed
3. Narula N, Wong ECL, Marshall JK, Jairath V, Dulai PS, Reinisch W. Long-term outcomes of early vs delayed responders to vedolizumab and adalimumab: a post hoc analysis of the VARSITY Study. Am J Gastroenterol 2023;118:121–128.Article PubMed
4. Nagahori M, Watanabe K, Motoya S, et al. Week 2 symptomatic response with vedolizumab as a predictive factor in Japanese anti-TNFα-naive patients with ulcerative colitis: a post hoc analysis of a randomized, placebo-controlled phase 3 trial. Digestion 2021;102:742–752.Article PubMed PDF

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Comments on “Week 2 remission with vedolizumab as a predictor of long-term remission in patients with ulcerative colitis: a multicenter, retrospective, observational study”

DOI: https://doi.org/10.5217/ir.2025.00234

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