Ustekinumab combined with upadacitinib promotes endoscopic healing in moderate-to-severe Crohn's disease with anti-TNF-α failure.

Authors

Changqin Liu, Qi Geng, Lu Lu, Ping An, Xiaolei Wang, Yanhong Shi, Cui Zhang, Zhanju Liu, Ping Liu, Xiaomin Sun

Published in

Revista espanola de enfermedades digestivas. Sep 09, 2026. Epub Sep 09, 2026.

Abstract

Anti-tumor necrosis factor-α (TNF-α) therapy failure in moderate-to-severe Crohn's disease (CD) represents a major clinical challenge. However, the exploration of advanced combination therapy offers a promising direction. This study compared the efficacy of ustekinumab (UST) plus upadacitinib (UPA) with either agent as monotherapy in these patients.
In this multicenter, retrospective study, 110 moderate-to-severe CD patients with anti-TNF-α failure were categorized into three groups according to the treatment they received: UST + UPA 30 mg (n = 41), UST monotherapy (n = 40), or UPA 45 mg monotherapy (n = 29). The primary outcome was endoscopic remission at 12-24 weeks, with secondary outcomes including clinical remission, clinical and endoscopic response, and safety.
Following 12-24 weeks of treatment, UST + UPA 30 mg demonstrated superior efficacy. The combination group achieved significantly higher rates of endoscopic remission (51.2% vs. 17.5% UST, 24.1% UPA; p = 0.0029). The clinical remission rate in the combination group (85.4%) was significantly higher than that in the UST group (37.5%, p < 0.0001) but not significantly different from that in the UPA group (75.9%, p = 0.3138). All groups exhibited improvements in disease activity scores and inflammatory bowel disease questionnaire from baseline. Treatment-related adverse events occurred in 19.5%, 2.5%, and 13.8% of patients in the combination, UST, and UPA groups, respectively, with no serious events reported.
For moderate-to-severe CD patients with anti-TNF-α therapy failure, the UST combined with UPA 30 mg regimen showed superior endoscopic healing to either monotherapy, with a tolerable safety profile. These findings suggest that this combination strategy may represent an effective treatment option for such CD patients.

PMID:
42714117
Bibliographic data and abstract were imported from PubMed on 09 Sep 2026.

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