P310. Safety profile of anti‑TNF therapy in Brazilian IBD patients: Are there differences between infliximab and adalimumab?
P.G. Kotze1, M.J. Luvizotto1, F.K. Akiyoshi1, R. Nisihara2, L.M.d.S. Kotze3
1Pontificial Catholic University Of Paraná, Department of Colorectal Surgery, Curitiba, Brazil; 2Federal University of Parana, Immunology, Curitiba, Brazil; 3Pontificial Catholic University Of Paraná, Department of Gastroenterology, Curitiba, Brazil
Background: Two biological agents are currently used in Brazil for the management of inflammatory bowel diseases (IBD), infliximab (IFX) and adalimumab (ADA). Only IFX is currently approved for ulcerative colitis (UC) patients. There are few studies regarding the safety of these agents in Brazilian Crohn's disease (CD) and UC patients, most of the information in our country is based on the rheumathology field. The purpose of this study was to analyze the incidence and safety profile of both IFX and ADA in a Brazilian case series of IBD patients.
Methods: A retrospective longitudinal analysis of a Brazilian single center case series of IBD patients exposed to biological agents was performed. Data were collected from electronic chart review. The patients were divided in two groups (IFX and ADA). Demographics, baseline characteristics, disease phenotype, concomitant immunosupressors, number and type of adverse events (AE) and the need for treatment interruption were analyzed and compared within the two groups. Local pain on the injection and infusion sites was excluded from the analysis. The hypothesis of the study was that no difference on the incidence and profile of adverse events would be observed. Statistical analysis was performed with Fischer method for most variables, and Mann-Whitney test for mean age, with p < 0.05 considered significant.
Results: This sample included 27 patients (3 with UC) on the IFX group and 25 CD patients on the ADA group. The mean age of the IFX group was 41.3 (±14.6) years and 37.4 (±14.6) years for the ADA (p = 0.38). Mean follow-up period was 20.81 months (IFX) and 19.32 months (ADA) (p = 0.65). Adverse events: 14 were observed in 13 patients from the IFX group (51.8%) and 14 in 11 cases (56%) exposed to ADA (p = 0.49). The most common AE on the IFX group was cutaneous reaction (n = 5) and on the ADA group was sinusitis (n = 3). There was no significant difference regarding infectious events (p = 0.15), cutaneous reactions (p = 0.24), arthralgia (p = 66) and the need for treatment interruption (p = 0.08) between the two groups.
Conclusions: In this Brazilian single-center case series, there were no significant differences regarding the incidence of adverse events and the safety profile between IFX and ADA on IBD patients.