Comparative Efficacy of Vedolizumab and Adalimumab in Ulcerative Colitis Patients Previously Treated With Infliximab

Author:

Favale Agnese1,Onali Sara2,Caprioli Flavio3,Pugliese Daniela4,Armuzzi Alessandro4,Macaluso Fabio Salvatore5,Orlando Ambrogio5,Viola Anna6,Fries Walter6,Rispo Antonio7,Castiglione Fabiana7,Mocci Giammarco8,Chicco Fabio9,Usai Paolo9,Calabrese Emma1,Biancone Livia1,Monteleone Giovanni1,Fantini Massimo Claudio1,

Affiliation:

1. Dep. of Systems Medicine, University of Rome “Tor Vergata”, Rome, Italy

2. Dep. of Biomedicine and Prevention, University of Rome “Tor Vergata”, Rome, Italy

3. IRCCS “Cà Grada” Foundation, “Ospedale Maggiore” hospital, University of Milan, Milan, Italy

4. “IRCCS Policlinico Agostino Gemelli”, Holy Heart Catholic University, Rome, Italy

5. United Hospitals “Villa Sofia-Cervello”, Palermo, Italy

6. Dep. of Clinical Medicine, University of Messina, Messina, Italy

7. Dep. of Clinical Medicine and Surgery, University of Naples “Federico II”, Naples, Italy

8. “Brotzu” Hospital, Cagliari, Italy

9. University of Cagliari, Cagliari, Italy

Abstract

Abstract Background Adalimumab (ADA) and vedolizumab (VDZ) have shown efficacy in moderate to severe ulcerative colitis (UC) patients who failed infliximab (IFX). Although, a comparative efficacy evaluation of ADA and VDZ in this clinical setting is currently missing. Aim The aim of this study is to compare the efficacy of ADA and VDZ in patients affected by UC who failed IFX. Methods Clinical records of UC patients from 8 Italian IBD referral centers who failed IFX and were candidates to receive either ADA or VDZ were retrospectively reviewed. The primary end point was therapeutic failure at week 52. Secondary end points included therapy discontinuation at weeks 8, 24 and 52, the discontinuation-free survival, and safety. Results One hundred sixty-one UC patients, 15 (9.2%) primary, 83 (51.6%) secondary IFX failures, and 63 (39.2%) IFX intolerants were included. Sixty-four (40%) patients received ADA and 97 (60%) VDZ as second line therapy. At week 52, 37.5% and 28.9% of patients on ADA and VDZ, respectively, had therapeutic failure (P = 0.302). However, the failure rate was significantly higher in the ADA group as compared with VDZ group among IFX secondary failures (48.0% ADA vs 22.4%VDZ, P = 0.035). The therapy discontinuation-free survival was significantly higher in the group of IFX secondary failures who received VDZ as compared with ADA at both the univariate (P = 0.007) and multivariate survival analysis (OR 2.79; 95% CI, 1.23–6.34; P = 0.014). No difference in the failure and biologic discontinuation-free survival was observed in the IFX primary failure and intolerant subgroups. Conclusion Vedolizumab might be the therapy of choice in those UC patients who showed secondary failure to IFX.

Publisher

Oxford University Press (OUP)

Subject

Gastroenterology,Immunology and Allergy

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