Efficacy and Safety of Second-Line Advanced Therapy After Vedolizumab in Ulcerative Colitis: A Multicenter Cohort Study From the GETAID.
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Calméjane Louis, Reenaers Catherine, Gay Claire, Amiot Aurélien, Nuzzo Alexandre, Vuitton Lucine, Atanasiu Calina, Stefanescu Carmen, Altwegg Romain, Guillo Lucas, Serrero Mélanie, Bouguen Guillaume, Nachury Maria, Le Cosquer Guillaume, Roblin Xavier, Abitbol Vered, Hammoudi Nassim, Simon Marion, Fumery Mathurin, Savoye Guillaume, Benezech Alban, Cavicchi Maryan, Charkaoui Maeva, Buisson Anthony, Caron Bénédicte, Coffin Benoît, Geyl Sophie, Goutorbe Félix, Hupé Marianne, Vidon Mathias, Laharie David, Kirchgesner Julien, Uzzan Mathieu, GETAID‐AFTER‐VEDO Study Group
Аннотация
METHODS: We conducted a multicenter retrospective study including UC patients from 31 centers who received infliximab (IFX), subcutaneous (SC) anti-TNFs, or ustekinumab after vedolizumab failure. The primary endpoint was steroid-free clinical remission (SFCR) at week 14. Predictors of remission were identified using multivariate logistic regression.
RESULTS: Among 196 patients, 99 received IFX, 27 anti-TNF SC, and 70 ustekinumab. At week 14, SFCR was achieved in 78 patients (39.8%): 38 (38.4%) with IFX, 8 (29.6%) with anti-TNF SC, and 32 (45.7%) with ustekinumab, with no significant difference between groups (p = 0.32). Median treatment persistence ranged from 8 to 9.2 months. Baseline corticosteroid use was associated with lower odds of SFCR (OR = 0.37, 95% CI [0.18-0.73]). Adverse events occurred in 15.8% of patients, including 12.2% serious events. Overall adverse events were less frequent with ustekinumab than with IFX (10.0% vs. 24.2%, p = 0.02), while serious events were comparable (5.7% vs. 16.1%, p = 0.08). Discontinuation due to adverse events was more frequent with IFX (12.1%) and anti-TNF SC (14.8%) than with ustekinumab (2.9%, p = 0.045 and 0.049).
CONCLUSION: In UC patients failing vedolizumab, second-line IFX, anti-TNF SC, and ustekinumab showed similar effectiveness and persistence. Infliximab remains a robust option for rapid control in high inflammatory burden, whereas ustekinumab may be preferred for its superior safety profile in high-risk patients.