Digestive and liver disease : official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver · 2025
Real-life effectiveness and safety of tofacitinib and vedolizumab as 2nd-line for ulcerative colitis after anti-TNFs: A multicenter cohort IGIBD study (VE2TO-UC).
СтатьяМногоцентровое исследованиеНаблюдательное исследованиеСравнительное исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Noviello D, Fries W, Orlando A, Conforti F S, Bezzio C, Castiglione F, Fantini M C, Savarino E V, Festa S, Ribaldone D G, Mocci G, Grossi L, Viganò C, Imperatore N, Ceccarelli L, Gabrielli A M Carvalhas, Scardino G, Saibeni S, Balestrieri P, Principi M, Campigotto M, Gravina A G, Spagnuolo R, Scaldaferri F, Neri B, Sario A Di, Baldoni M, Mitri R Di, Tettoni E, Calderone S, Armuzzi A, Macaluso F S, Vecchi M, Ventimiglia M, Caprioli F, VE2TO-UC study group
Аннотация
BACKGROUND AND AIMS: Drug positioning in ulcerative colitis (UC) patients refractory to anti-tumor necrosis factor (TNF) is still debated. In a nationwide multicentre observational cohort, we aimed to compare the real-life effectiveness and safety of tofacitinib and vedolizumab as second-line for UC after anti-TNFs.
METHODS: Disease activity was evaluated at weeks 8, 26, and 52 ± 4. The primary outcome was to compare clinical remission (partial Mayo score (PMS) ≤2 with no subscore >1) at week 26. Secondary outcomes included comparative effectiveness for corticosteroid-free clinical remission (CFCR); biochemical, endoscopic, and histologic remission; combined corticosteroid-free clinical-objective remission; and treatment persistence. Inverse probability of treatment weighting was used for all comparisons.
RESULTS: Overall, 134 tofacitinib- and 277 vedolizumab-treated UC patients were included. At week 26, no difference was observed between tofacitinib and vedolizumab for clinical remission (adjusted odds ratio [aOR]: 0.9; 95 % confidence interval [CI]: 0.6 - 1.6). At week 8, tofacitinib was more effective in achieving CFCR (aOR: 1.7; 95 % CI: 1.0 - 2.7). Clinical, biochemical, endoscopic, and histologic outcomes showed no difference between tofacitinib and vedolizumab at weeks 26 and 52. In patients with baseline PMS ≥ 2, steroid use, or anti-TNF non-response no difference was found for clinical remission at week 26. Tofacitinib-treated patients were more likely to discontinue treatment (adjusted Hazard Ratio: 1.8; 95 % CI: 1.2 - 2.8). Safety was consistent with treatment profiles in UC.
CONCLUSIONS: Tofacitinib and vedolizumab were equally effective and safe as second-line therapy in anti-TNFs experienced UC patients. Tofacitinib showed greater efficacy in inducing CFCR at week 8, but carried higher discontinuation risk.
METHODS: Disease activity was evaluated at weeks 8, 26, and 52 ± 4. The primary outcome was to compare clinical remission (partial Mayo score (PMS) ≤2 with no subscore >1) at week 26. Secondary outcomes included comparative effectiveness for corticosteroid-free clinical remission (CFCR); biochemical, endoscopic, and histologic remission; combined corticosteroid-free clinical-objective remission; and treatment persistence. Inverse probability of treatment weighting was used for all comparisons.
RESULTS: Overall, 134 tofacitinib- and 277 vedolizumab-treated UC patients were included. At week 26, no difference was observed between tofacitinib and vedolizumab for clinical remission (adjusted odds ratio [aOR]: 0.9; 95 % confidence interval [CI]: 0.6 - 1.6). At week 8, tofacitinib was more effective in achieving CFCR (aOR: 1.7; 95 % CI: 1.0 - 2.7). Clinical, biochemical, endoscopic, and histologic outcomes showed no difference between tofacitinib and vedolizumab at weeks 26 and 52. In patients with baseline PMS ≥ 2, steroid use, or anti-TNF non-response no difference was found for clinical remission at week 26. Tofacitinib-treated patients were more likely to discontinue treatment (adjusted Hazard Ratio: 1.8; 95 % CI: 1.2 - 2.8). Safety was consistent with treatment profiles in UC.
CONCLUSIONS: Tofacitinib and vedolizumab were equally effective and safe as second-line therapy in anti-TNFs experienced UC patients. Tofacitinib showed greater efficacy in inducing CFCR at week 8, but carried higher discontinuation risk.