Comparative Effectiveness of Vedolizumab and Ustekinumab in Biologic-Experienced Ulcerative Colitis: A Real-World Multicenter Study from the Güntürk Group.
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Araz Filiz, Sezgin Orhan, Barutçu Sezgin, Ünal Nalan Gülşen, Bengi Göksel, Özşeker Burak, Karaoğullarindan Ümit, Derviş Hakim Gözde, Özer Birol, Akpinar Hale, Oruç Nevin, Gişi Kadir, Atay Kadri, Kara Banu, Kasap Elmas, Çekin Ayhan Hilmi, Yilmaz Nimet, Altintaş Engin, Ateş Fehmi, Üçbilek Enver, Harput Zekiye Nur, Şahan Mehmet Ali, Dolu Süleyman, Mammadov Etibar, Odabaş Emre, Tuncel Elif Tuğba, Kuş Mesut, Taşdoğan Burçak Evren, Akbay Harmandar Ferda, Seydaoğlu Gülşah, Aykut Burak Mert, Kara Taner, Çapar Halil, Çetin Duran Deha, Atar Galip Egemen, Püren Yücel Sevinç
Аннотация
MATERIALS AND METHODS: In this multicenter retrospective study, data from 420 patients treated at 14 centers with VDZ (n = 260) or UST (n = 160) between 2020 and 2024 were analyzed. Outcomes included steroid-free clinical remission (SFCR), clinical remission (CR), treatment persistence, and adverse events at weeks 14-16, 52, and 104. Inverse probability of treatment weighting was used to adjust for baseline differences between treatment groups.
RESULTS: In the weighted cohort, rates of SFCR and CR were comparable between treatments at weeks 14-16 and 52 (P > .05). At week 104, SFCR rates did not differ significantly between treatment groups, whereas VDZ was associated with higher CR rates (adjusted odds ratio [aOR] = 0.66; 95% CI = 0.45-0.91). In subgroup analyses, VDZ was associated with higher CR and SFCR rates among patients with 1 prior biologic exposure, whereas UST was associated with higher CR (aOR = 1.86; 95% CI = 1.10-3.16) and SFCR (aOR = 1.79; 95% CI = 1.05-3.09) rates at week 52 among patients with 2 or more prior biologic exposures. Treatment persistence was significantly higher with UST (aOR = 1.82; 95% CI = 1.36-2.44). Safety profiles were comparable between treatment groups.
CONCLUSION: VDZ and UST demonstrated broadly comparable effectiveness in biologic-experienced UC. The higher CR rate favoring VDZ at week 104 should be interpreted cautiously given the lack of a significant difference in SFCR rate and limitations of long-term followup assessment. Exploratory subgroup findings suggest that UST may have a potential role in patients who were heavily pretreated. These findings may inform hypotheses regarding individualized treatment sequencing.