Real-world multicenter study shows vedolizumab and ustekinumab have comparable efficacy in ulcerative colitis, suggesting personalized treatment may be beneficial.
Background Data comparing the efficacy and safety of vedolizumab and ustekinumab for ulcerative colitis remained limited. This multicenter real-world study was designed to compare the clinical efficacy and safety of vedolizumab and ustekinumab in biologic-experienced ulcerative colitis patients Methods Retrospective data of patients who were treated with vedolizumab or ustekinumab from 2020 to 2024 was collected from 14 centers. The outcomes included steroid-free clinical remission, clinical remission, treatment persistence and adverse events at week 14-16, 52 and 104. Propensity score adjustment with inverse probability treatment weighting was applied. Results A total of 420 patients were included (vedolizumab: 260, ustekinumab: 160). At week 14-16 and week 52, in the weighted cohort, two drugs were comparable for steroid-free clinical remission and clinical remission (p > 0.05). Although steroid-free clinical remission rates were similar, clinical remission rate was more favorable with vedolizumab, compared to ustekinumab at week 104 (aOR = 0.66; 95%CI 0.45-0.91) (Tabe 1). Among patients with one biologic history, clinical remission (aOR = 0.51; 95%CI 0.35-0.74) and steroid-free clinical remission (aOR = 0.57; 95%CI 0.38-0.85) rates for vedolizumab were better than ustekinumab at week 104. For patients with history of ≥ 2 biologic agent, ustekinumab performed better for clinical remission (aOR = 1.86; 95%CI 1.10-3.16) and steroid-free clinical remission (aOR = 1.79; 95%CI 1.05-3.09) at week 52 (Figure 1). Treatment persistence throughout the treatment was significantly better for ustekinumab (aOR = 1.82; 95%CI 1.36-2.44). Severe adverse event rate was similar for both groups. Conclusion Both drugs have acceptable and similar clinical response rates and safety profile with few exceptions. Conflict of interest: Dr. Araz, Filiz: No conflict of interest Sezgin, Orhan: No conflict of interest Barutcu, Sezgin: Unal, Nalan Gulsen: No conflict of interest Bengi, Goksel: no conflicts Ozseker, Burak: No conflict of interest Karaogullarindan, Umit: No conflict of interest Hakim, Gozde: No conflict of interest Özer, Birol: No conflict of interest Akpinar, Hale: No conflict of interest Oruç, Nevin: No conflict of interest Gişi, Kadir: No conflict of interest Atay, Kadri: No conflict of interest Kara, Banu: No conflict of interest Kasap, Elmas: No conflict of interest Cekin, Ayhan Hilmi: No conflict of interest Yilmaz, Nimet: No conflict of interest Altintas, Engin: No conflict of interest Ates, Fehmi: No conflict of interest Ucbilek, Enver: No conflict of interest Harput, Zekiye Nur: none Şahan, Mehmet Ali: No conflict of interest Dolu, Süleyman: No conflict of interest Mamadov, Etibar: No conflict of interest Odabaş, Emre: No conflict of interest Tuncel, Elif Tuğba: No conflict of interest Kuş, Mesut: No conflict of interest Tasdogan, Burcak Evren: No conflict of interest Akbay Harmandar, Ferda: No conflict of interest Seydaoğlu, Gülşah: No conflict of interest Aykut, Mert Burak: No conflict of interest Kara, Taner: No conflict of interest Çapar, Halil: No conflict of interest Çetin, Duran Deha: No conflict of interest Atar, Galip Egemen: No conflict of interest Yücel, Sevinç Püren: No conflict of interest
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