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* = Presenting author

P449 Efficacy and safety of switching between originator and biosimilar infliximab in patients with inflammatory bowel disease in practical clinic: results to 6 months

L. Díaz Hernández*1, G. E. Rodríguez González1, M. Vela González1, C. A. Tardillo Marín1, C. Y. Rodríguez Díaz1, L. Arranz Hernández1, J. A. Montero Delgado2, M. San Juan Acosta1, F. Pérez Hernández1

1Hospital Universitario Ntra. Sra. Candelaria, Gastroenterology, Santa Cruz de Tenerife, Spain, 2Hospital Universitario Ntra. Sra. Candelaria, Pharmacology, Santa Cruz de Tenerife, Spain

Background

In 2015, the biosimilar of infliximab has been approved. The indications were obtained from extrapolating the results of researches accomplished in rheumatic diseases. We do not have data of efficacy and safety in patients with inflammatory bowel diseases (IBD).The aim of this study was to investigate the clinical efficacy and safety of switching to the biosimilar (BS) of infliximab in patients in treatment of maintenance with originator infliximab in clinical practice, and evaluating the cost savings of the treatment with the introduction of BS.

Methods

We conducted observational, retrospective study of our data base of IBD. Analysis was carried out of 72 patients with IBD in treatment of maintenance with infliximab with complete phase of induction before switch. The clinical activity was analysed at 6 months of treatment, it was assessed using the Harvey–Bradshaw index and for Crohn’s disease (CD) and of partial May index for ulcerative colitis (UC), comparing with punctuation before the switch.

Results

Of patients included in the study, 46 % were male; average age was of 45 years (SD+/ - 13.97 years); CD 62 and UC 10. Most of CD was ileocolic (58%), diseases penetrating 21%, and perianal fistulising disease associate 43%; 9 of 10 patients with UC have had extensive affectation. The time average of treatment with infliximab before switching to BS was 4 years (SD +/ - 38.84 months). There were 62 of 72 patients that were in clinical remission at the time of switch. During the follow-up, 5 patients had flares that needed corticoids, and 2 urgent surgery of perianal fistulising disease. The treatment was withdrawn in 3 patients: 1 primary non-response and 2 with secondary loss of response. Adverse effects: 2 infections, 1 cutaneous injuries, 1 cephalea, 1 fever allergic reaction but none needed withdraw of BS. At 6 months, 86% of the patients (62/72) were in clinical remission. The introduction of the BS supposed a cost savings of a 26% (117 178 euros in 6 months) as compared with the biological 1 belonging to the reference.

Conclusion

Switching to the BS of infliximab was effective in the maintenance clinical remission at 6 months of treatment. No relevant adverse effects were observed during the analysed period. The use of the biosimilar supposed a cost savings in the treatment.