Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association · 2025
Upadacitinib Is Associated With Better Clinical and Biochemical Outcomes Than Tofacitinib in Refractory, Moderate-to-Severe Ulcerative Colitis.
СтатьяМногоцентровое исследованиеСравнительное исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Farkas Bernadett, Resál Tamás, Lakatos Peter L, Bessissow Talat, Limdi Jimmy K, Armuzzi Alessandro, Bezzio Cristina, Savarino Edoardo V, Saibeni Simone, Michalopoulos George, Attauabi Mohamed, Seidelin Jakob Benedict, Fousekis Fotios S, Katsanos Kostas, Bacsur Péter, Bálint Anita, Ivány Emese, Szepes Zoltán, Farkas Klaudia, Molnár Tamás
Аннотация
BACKGROUND & AIMS: Comparative data on the effectiveness of tofacitinib (TOFA) and upadacitinib (UPA) in ulcerative colitis (UC) remain limited. We conducted a multicenter, retrospective cohort study to evaluate and compare the short- and mid-term effectiveness of TOFA and UPA in bio-experienced, moderate-to-severe UC.
METHODS: Inverse probability weighting analysis was performed for demographics, baseline Mayo score, and baseline C-reactive protein [CRP] and fecal calprotectin [FCal], as well as concomitant corticosteroid use between the 2 treatment groups. The coprimary outcome was week 12 and 24 corticosteroid-free remission (CSFR) defined as clinical remission (CR) and CRP ≤5 mg/L, as well as not receiving steroids ≥30 days. We also assessed the rate of CR and biochemical remission (defined as CRP ≤5 mg/L and FCal ≤ 250 μg/g) during the first 6 months of therapy.
RESULTS: A total of 350 patients with UC (246 TOFA, 104 UPA; mean age, 38.6 ±13.8 years; median follow-up, 11 months) were enrolled in the study. The likelihood of achieving CSFR at both week 12 (adjusted odds ratio [aOR], 2.2; 95% confidence interval [CI], 1.2-4.1) and week 24 (aOR, 2.2; 95% CI, 1.2-3.9) was found to be significantly higher in patients treated with UPA than in patients receiving TOFA. UPA was also associated with around 2-fold higher odds of reaching both CR (95% CI, 1.3-4.3; 95% CI, 1.0-3.4) and biochemical remission (95% CI, 1.3-4.4; 95% CI, 1.2-4.0) at the same timepoints compared with TOFA. No significant differences were seen in IBD-related hospitalization and early colectomy rates between the 2 treatment groups. No new safety signal was noted.
CONCLUSIONS: UPA might be associated with better short- and mid-term clinical and biochemical outcomes compared with TOFA in refractory, moderate-to-severe UC.
METHODS: Inverse probability weighting analysis was performed for demographics, baseline Mayo score, and baseline C-reactive protein [CRP] and fecal calprotectin [FCal], as well as concomitant corticosteroid use between the 2 treatment groups. The coprimary outcome was week 12 and 24 corticosteroid-free remission (CSFR) defined as clinical remission (CR) and CRP ≤5 mg/L, as well as not receiving steroids ≥30 days. We also assessed the rate of CR and biochemical remission (defined as CRP ≤5 mg/L and FCal ≤ 250 μg/g) during the first 6 months of therapy.
RESULTS: A total of 350 patients with UC (246 TOFA, 104 UPA; mean age, 38.6 ±13.8 years; median follow-up, 11 months) were enrolled in the study. The likelihood of achieving CSFR at both week 12 (adjusted odds ratio [aOR], 2.2; 95% confidence interval [CI], 1.2-4.1) and week 24 (aOR, 2.2; 95% CI, 1.2-3.9) was found to be significantly higher in patients treated with UPA than in patients receiving TOFA. UPA was also associated with around 2-fold higher odds of reaching both CR (95% CI, 1.3-4.3; 95% CI, 1.0-3.4) and biochemical remission (95% CI, 1.3-4.4; 95% CI, 1.2-4.0) at the same timepoints compared with TOFA. No significant differences were seen in IBD-related hospitalization and early colectomy rates between the 2 treatment groups. No new safety signal was noted.
CONCLUSIONS: UPA might be associated with better short- and mid-term clinical and biochemical outcomes compared with TOFA in refractory, moderate-to-severe UC.