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Poster presentations: Clinical: Therapy and Observation 2020

P690 A propensity score weighted comparison of vedolizumab, adalimumab, and golimumab in patients with ulcerative colitis: Real-life data from the Sicilian Network for Inflammatory Bowel Disease (SN-IBD)

F.S. Macaluso1, M. Ventimiglia1, W. Fries2, A. Viola2, M. Cappello3, B. Scrivo3, A. Magnano4, D. Pluchino4, S. Camilleri5, S. Garufi5, R. Di Mitri6, F. Mocciaro6, G. Magrì7, C. Ferracane7, M. Citrano8, F. Graziano8, C. Bertolami9, S. Renna1, R. Orlando1, G. Rizzuto1, M. Cottone1, A. Orlando1, Sicilian Network for Inflammatory Bowel Disease (SN-IBD)

1A.O.O.R. ‘Villa Sofia-Cervello’, IBD Unit, Department of Medicine, Palermo, Italy, 2A.O.U. Policlinico ‘G. Martino’, Inflammatory bowel disease Unit, Messina, Italy, 3A.O.U. Policlinico ‘G. Giaccone’, Gastroenterology and Hepatology Unit, Palermo, Italy, 4A.O.U. Policlinico ‘Vittorio Emanuele’, Gastroenterology Unit, Catania, Italy, 5A.O.O.R. ‘S. Elia- M. Raimondi’, Gastroenterology Unit, Caltanissetta, Italy, 6A.R.N.A.S. ‘Civico Di Cristina Benfratelli’, Gastroenterology and endoscopy Unit, Palermo, Italy, 7A.O. ‘Santa Marta e S. Venera’, Gastroenterology Unit, Acireale, Italy, 8A.O.O.R. ‘Villa Sofia-Cervello’, Pediatrics Unit, Palermo, Italy, 9A.O.O.R. ‘Papardo Piemonte’, Gastroenterology Unit-, Messina, Italy

Background

No real-life study aiming at comparing at the same time the effectiveness of vedolizumab (VDZ), adalimumab (ADA), and golimumab (GOL) in Ulcerative colitis (UC) is currently available.

Methods

Data of consecutive patients with UC treated with VDZ, ADA, and GOL from June 2015 to December 2018 were extracted from the cohort of the Sicilian Network for Inflammatory Bowel Disease (SN-IBD). A three-arms propensity score-adjusted analysis was performed to reduce bias caused by imbalanced covariates at baseline, including the proportion of TNF-α inhibitor naïve and non-naïve patients, using the Inverse Probability of Treatment Weighting (IPTW) method. The effectiveness was evaluated at 8 weeks, 52 weeks, and as treatment persistence at the end of follow-up. The clinical endpoints were steroid-free clinical remission (partial Mayo score <2 without steroid use) and clinical response (reduction of the partial Mayo score ≥2 points with a concomitant decrease of steroid dosage compared with baseline). The sum of the two outcomes was defined as a clinical benefit. The achievement of mucosal healing (endoscopic Mayo score 0–1) was assessed after at least 6 months of biological treatment.

Results

A total of 463 treatments (VDZ: n = 187; ADA: n = 168; GOL: n = 108) were included, with a median follow-up of 47.6 weeks (IQR 20.0–85.9). At 8 weeks, a clinical benefit was achieved in 70.6% patients treated with VDZ, in 68.5% patients treated with ADA, and in 67.6% patients treated with GOL (p = n.s. for all comparisons). After 52 weeks, VDZ showed better rates of clinical benefit compared with both ADA (71.6% vs. 47.5; OR: 2.79, 95% CI 1.63–4.79, p < 0.001) and GOL (71.6% vs. 40.2%; OR: 3.77, 95% CI 2.08–6.80, p < 0.001), while the difference between ADA and GOL was not significant. Cox survival analysis demonstrated that patients treated with VDZ had a reduced probability of treatment discontinuation compared with those treated with ADA (HR: 0.42, 95% CI 0.28–0.64, p < 0.001) and GOL (HR: 0.30, 95% CI 0.19–0.46, p < 0.001), while patients treated with ADA had a reduced risk of treatment discontinuation compared with those treated with GOL (HR: 0.71, 95% CI 0.50–1.00, p = 0.048). Post-treatment mucosal healing rates showed a numerical but non-significant difference in favour of VDZ (48.1%) compared with ADA and GOL (38.0% and 34.6%, respectively).

Conclusion

In the first study comparing at the same time the clinical effectiveness of VDZ, ADA, and GOL in UC patients via propensity score-adjusted analysis, VDZ was superior to both subcutaneous agents at 52 weeks and as treatment persistence, while ADA showed a superior treatment persistence compared with GOL.