Advanced Combination Therapy with Biologics and Upadacitinib in Refractory Inflammatory Bowel Disease: A Retrospective Study from Taiwan.

Background: Refractory inflammatory bowel disease (IBD) remains challenging despite the availability of various biologics. Advanced combination therapy (ACT) with biologics and Upadacitinib (UPA), a rapid-onset oral selective Janus kinase inhibitor, has shown promise in managing refractory IBD. However, its use in Asia has not been explored. This study aims to fill that gap by providing data from Taiwan. Materials and Methods: This retrospective study included refractory IBD patients who received ACT with biologics and UPA, followed up at the Chang Gung Inflammatory Bowel Disease Center from July 2020 to August 2024. Patients were assessed for clinical response and remission at weeks 4, 12, and 24. Safety profiles were monitored throughout the follow-up period to evaluate the risk of adverse events. Results: Sixteen refractory IBD patients were enrolled. The median disease duration was 4.5 years [IQR 2.25-9.50]. The most common regimen was Ustekinumab plus UPA (63%). Clinical response rates at weeks 4, 12, and 24 were 88%, 83%, and 100%, respectively, while remission rates were 31%, 50%, and 80%. One patient (6.25%) experienced a minor adverse event (acne), with no major events like herpes zoster reactivation or major cardiac complications. Conclusion: This is the first study in Asia to demonstrate that UPA-based ACT is both effective and safe in treating refractory IBD. However, the limitations of this retrospective, single-center study with a relatively small sample size highlight the need for future larger-scale, multi-center prospective studies to confirm these findings, identify predictors of treatment response, and evaluate long-term outcomes.