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* = Presenting author

P624 Effectiveness and safety of vedolizumab for the induction of remission in inflammatory bowel disease

M. Chaparro*1, M. Sierra-Ausin2, F. Mesonero3, N. Maroto4, C. Fernandez de Castro5, V. García-Sánchez6, A.J. Lucendo7, D. Busquets8, M. Barreiro-de Acosta9, I. Marín-Jiménez10, B. Beltrán11, L. Ruiz Belmonte12, F. Bermejo13, M. Mínguez14, R. Pajares15, J. R. Pineda16, B. Sicilia17, D. Martín-Rodríguez18, A. Gutiérrez19, S. Rubio20, I. García Tercero21, M. Piqueras22, D. Ginard23, B. Jucha24, C. Muñoz Villafranca25, M. D. Martín-Arranz26, L. Marti Romero27, E. M. Fernández Bonilla28, A. Echarri29, J. F. Forcelledo30, M. G. Donday1, M. Ramas1, J. P. Gisbert1

1Hospital Universitario de La Princesa, IIS-IP and CIBERehd, Gastroenterology Unit, Madrid, Spain, 2Hospital Universitario de León, Gastroenterology Unit, León, Spain, 3Hospital Universitario Ramón y Cajal, Gastroenterology Unit, Madrid, Spain, 4Hospital de Manises, Gastroenterology Unit, Valencia, Spain, 5Hospital Universitario Central de Asturias, Gastroenterology Unit, Oviedo, Spain, 6Hospital Universitario Reina Sofía, Gastroenterology Unit, Córdoba, Spain, 7Hospital General de Tomelloso, Gastroenterology Unit, Tomelloso, Spain, 8Hospital universitari de Girona Dr Josep Trueta, Gastroenterology Unit, Girona, Spain, 9Hospital Clínico Universitario de Santiago, Gastroenterology Unit, Santiago de Compostela, Spain, 10Hospital Gregorio Marañón and IiSGM, Gastroenterology Unit, Madrid, Spain, 11Hospital Universitario La Fe and CIBERehd, Gastroenterology Unit, Valencia, Spain, 12Hospital Universitario Miguel Servet, Gastroenterology Unit, Zaragoza, Spain, 13Hospital Universitario de Fuenlabrada, Gastroenterology Unit, Madrid, Spain, 14Hospital Clínico Universitario de Valencia, Gastroenterology Unit, Valencia, Spain, 15Hospital Infanta Sofía, Gastroenterology Unit, Madrid, Spain, 16Hospital Álvaro Cunqueiro, Gastroenterology Unit, Vigo, Spain, 17Hospital Universitario de Burgos, Gastroenterology unit, Burgos, Spain, 18Hospital Universitario Infanta Cristina, Gastroenterology Unit, Madrid, Spain, 19Hospital General Universitario de Alicante and CIBERehd, Gastroenterology Unit, Alicante, Spain, 20Complejo Hospitalario de Navarra, Gastroenterology Unit, Pamplona, Spain, 21Hospital Universitario Santa Lucía, Gastroenterology Unit, Cartagena, Spain, 22Consorcio Sanitario de Terrassa, Gastroenterology Unit, Barcelona, Spain, 23Hospital Universitario Son Espases, Gastroenterology Unit, Palma de Mallorca, Spain, 24Hospital Comarcal de Melilla, Gastroenterology Unit, Melilla, Spain, 25Hospital de Basurto, Gastroenterology Unit, Bilbao, Spain, 26Hospital Universitario La Paz, Gastroenterology Unit, Madrid, Spain, 27Hospital Francisco de Borja, Gastroenterology Unit, Gandía, Spain, 28Hospital de Alcañiz, Gastroenterology Unit, Teruel, Spain, 29Complejo Hospitalario Universitario de Ferrol, Gastroenterology Unit, Coruña, Spain, 30Hospital Sierrallana, Gastroenterology Unit, Torrelavega, Spain

Background

Data of the effectiveness and safety of vedolizumab in Crohn’s disease (CD) and ulcerative colitis (UC) patients in clinical practice are scarce.

Aims: to assess the effectiveness of vedolizumab in IBD patients, to identify factors associated with the response to the treatment, and to evaluate the safety of this drug in clinical practice.

Methods

Observational, multicentre, nationwide study. Patients treated with vedolizumab because of active IBD were retrospectively included (Partial Mayo Score ≥ 2 or Harvey–Bradshaw > 4). Short-term response was evaluated at week 14. The variables associated with the short-term effectiveness were identified by logistic regression model. Adverse events during the treatment with vedolizumab were recorded.

Results

In total, 71 patients were included. Mean age was 43 years (standard deviation [SD] = 14 years), and mean time of evolution of the disease was 10.7 years (SD = 7 years). Further, 36 patients (51%) were female, and 21 (30%) were current smokers. Forty-two patients (59%) were diagnosed with CD. Amongst them, 23 (56%) had ileocolonic involvement, and 42 (29%) ileal location; 22 patients (52.4%) had inflammatory behaviour; 12 (28.6%) fistulising disease; and 33% perianal disease. Amongst UC patients, 16 (57%) had left-sided colitis, and 11 (39%) extensive colitis. In addition, 24 patients (34%) had been operated on because of IBD: 18 patients (25.4%) had undergone intestinal resection, and 6 patients (8.5%) had undergone surgery because of perianal disease. With respect to previous treatments, 68 (96%) patients had received azathioprine; 20 (28%) mercaptopurine; 27 (38%) methotrexate; and 4 (5.6%) cyclosporine. Further, 66 patients (93%) had been refractory to biologic agents before starting vedolizumab: 3 patients (4%) had previously failed to 4 biologic agents (22 [31%] to 3; 35 [49.3%] to 2; and 5 [7%] to 1 biologic agent). Overall, 28 patients were under concomitant immunosuppressants when they were started on vedolizumab. After the induction doses (week 14th), 66% (95%CI, 54%–78%) of patients responded to the treatment (18% achieved remission, and 48% partial response). The percentages of remission and response were similar between CD and UC patients: 14.3 vs 25% (p = 0.2) for remission, and 62 vs 71.4% (p = 0.4) for response. We could not identify any factor associated with the probability of response (including the type of IBD and concomitant immunomodulators). Finally, 9 patients (12%) presented adverse events during the treatment, all of them being mild: 4 had respiratory infection; 2 headache; 1 herpes infection; 1 arthralgia; and 1 infusion reaction.

Conclusion

In the short-term, vedolizumab seems to be effective and safe for the treatment of IBD, even in refractory patients.