Journal of clinical gastroenterology · 2025
Real-World Comparative Effectiveness of Vedolizumab Versus Upadacitinib for Crohn's Disease Through 52 Weeks.
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Dalal Rahul S, Carlin Alex, Cabral Heidy, Hardwick Grace B, Clarke Lindsay M, Allegretti Jessica R
Аннотация
GOALS: To compare the effectiveness, durability, and safety of vedolizumab and upadacitinib for CD through 52 weeks.
BACKGROUND: Comparative real-world data for vedolizumab versus upadacitinib in Crohn's disease (CD) are limited.
STUDY: This retrospective cohort study included 139 adults with active CD who began vedolizumab (n=72) or upadacitinib (n=67) during 2023 at a large academic health system. Co-primary outcomes were steroid-free clinical remission (SFCR) at 12 and 52 weeks and treatment discontinuation within 52 weeks; secondary outcomes included clinical response at 12 and 52 weeks. Inverse probability of treatment weighting balanced relevant confounders. Logistic regression was used for binary outcomes and Cox proportional hazards and competing risks regression were used for treatment discontinuation. Adverse events were ascertained by manual chart review.
RESULTS: After weighting, all covariates were balanced (standardized mean differences <0.10). At 12 weeks, vedolizumab was associated with lower odds of clinical response versus upadacitinib (OR: 0.36; 95% CI: 0.16-0.85). There were no significant differences for SFCR, treatment discontinuation, or other outcomes through 52 weeks. Competing risks regression, accounting for adverse events as competing events, showed a higher incidence of treatment discontinuation due to nonresponse for vedolizumab, but this did not reach statistical significance. Adverse events within 52 weeks were comparable (vedolizumab 33% vs. upadacitinib 39%; P=0.45), and discontinuations due to adverse events were infrequent (3% vs. 6%).
CONCLUSIONS: In this tertiary-center cohort, upadacitinib produced faster clinical response at 12 weeks, but SFCR, durability, and safety profiles were similar through 52 weeks.
BACKGROUND: Comparative real-world data for vedolizumab versus upadacitinib in Crohn's disease (CD) are limited.
STUDY: This retrospective cohort study included 139 adults with active CD who began vedolizumab (n=72) or upadacitinib (n=67) during 2023 at a large academic health system. Co-primary outcomes were steroid-free clinical remission (SFCR) at 12 and 52 weeks and treatment discontinuation within 52 weeks; secondary outcomes included clinical response at 12 and 52 weeks. Inverse probability of treatment weighting balanced relevant confounders. Logistic regression was used for binary outcomes and Cox proportional hazards and competing risks regression were used for treatment discontinuation. Adverse events were ascertained by manual chart review.
RESULTS: After weighting, all covariates were balanced (standardized mean differences <0.10). At 12 weeks, vedolizumab was associated with lower odds of clinical response versus upadacitinib (OR: 0.36; 95% CI: 0.16-0.85). There were no significant differences for SFCR, treatment discontinuation, or other outcomes through 52 weeks. Competing risks regression, accounting for adverse events as competing events, showed a higher incidence of treatment discontinuation due to nonresponse for vedolizumab, but this did not reach statistical significance. Adverse events within 52 weeks were comparable (vedolizumab 33% vs. upadacitinib 39%; P=0.45), and discontinuations due to adverse events were infrequent (3% vs. 6%).
CONCLUSIONS: In this tertiary-center cohort, upadacitinib produced faster clinical response at 12 weeks, but SFCR, durability, and safety profiles were similar through 52 weeks.