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P690 Comparative efficacy of vedolizumab and adalimumab as second-line therapy in ulcerative colitis patients previously treated with infliximab

A. Favale1, S. Onali*1, F. Caprioli2, D. Pugliese3, A. Armuzzi3, F. S. Macaluso4, A. Orlando4, A. Viola5, W. Fries5, G. Mocci6, F. Chicco7, P. Usai7, A. Rispo8, F. Castiglione8, E. Calabrese1, L. Biancone1, G. Monteleone1, M. C. Fantini1

1Università degli studi di Roma, Tor Vergata, Roma, Italy, 2Fondazione IRCCS Cà Granda, Ospedale Maggiore Policlinico, Università degli studi di Milano, Milano, Italy, 3Fondazione Policlinico Universitario Gemelli IRCCS, Università Cattolica del Sacro Cuore, Roma, Italy, 4Ospedali Riuniti Villa Sofia-Cervello, Palermo, Italy, 5Università degli studi di Messina, Messina, Italy, 6Azienda Ospedaliera Brotzu, Cagliari, Italy, 7Università degli studi di Cagliari, Cagliari, Italy, 8Università Federico II di Napoli, Napoli, Italy

Background

Adalimumab (ADA) and Vedolizumab (VDZ) have shown efficacy in moderate to severe ulcerative colitis (UC) patients who failed Infliximab (IFX). Though, a comparative efficacy evaluation of ADA and VDZ in this clinical setting is currently missing.

Aim:

to compare the efficacy of ADA and VDZ in patients affected by UC who failed the first-line therapy with IFX.

Methods

Clinical records of UC patients from 8 Italian IBD referral centres, who failed IFX given for active luminal disease and candidate to receive a second-line biologic with either ADA or VDZ were retrospectively reviewed. Clinical variables, including reason for IFX discontinuation, clinical activity and therapy duration were recorded. The proportion of patients still on therapy at Week 52 was evaluated as primary endpoint. The failure-free survival was analysed by univariate and multi-variate analysis. Secondary endpoints included therapy discontinuation at Week 8, 24 and 52, discontinuation-free survival and safety.

Results

Of 161 UC patients (15 [9%] primary, 87 [52%] secondary failures to IFX and 63 [39%] IFX intolerants), 64 (40%) 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, showed therapeutic failure (p = 0.302). However, the failure rate was significantly higher in the ADA- when 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 when compared with ADA at both the univariate (p = 0.007) and multi-variate survival analysis (OR 2.6; 95% CI 1.11–5.98; p = 0.028). No differences in the failure and biologic discontinuation-free survival was observed in the IFX primary failure and intolerant subgroups.

Conclusion

VDZ might be the therapy of choice in those UC patients who showed secondary failure to IFX.