P437 Risk of immunomediated adverse events or secondary loss of response to infliximab in elderly patients with inflammatory bowel disease: a cohort study of the ENEIDA registry. (25th January 2019)

• Record Type: Journal Article
• Authors: Calafat, M; Mañosa, M; Panes, J; Nos, P; Iglesias, E; Vera, I; López-Sanromán, A; Guardiola, J; Taxonera, C; Mínguez, M; Martín, M D; de Castro, L; Riestra, S; Rivero, M; García-Planella, E; Calvet, X; García-López, S; Andreu, M; Gomollón, F; Barrio, J; Esteve, M; Rodríguez, A; Gisbert, J P; Gutierrez, A; Hinojosa, J; Argüelles, F; Busquets, D; Bujanda, L; Lázaro, J; Sicilia, B; Merino, O; Martínez, P; Bermejo, F; Lorente, R; Barreiro-de-Acosta, M; Rodríguez, C; Fe, M; Piqueras, M; Romero, P; Rodríguez, E; Roncero, Ó; Llaó, J; Alcaín, G; Riera, J; Sierra, M; Fdez. Salazar, L I; Jair, V; Navarro, M; Montoro, M A; Muñoz, C; Lucendo, A J; Van Domselaar, M; Moraleja, I; Huguet, J M; Ramos, L; Ramírez, P; Almeda, P; Pajares, R; Khorrami, S; Madrigal, R E; Sesé, E; Trapero, A M; Legido, J; Abad, Á; Cañete, F; Cabré, E; Domènech, E;
• Is Part Of: Journal of Crohn's and colitis. Volume 13(2019)Supplement 1
• Page Start: S328
• Page End: S329
• Publication Date: 2019-01-25
• Subjects: Inflammatory bowel diseases -- Periodicals; 616.344005
• DOI: 10.1093/ecco-jcc/jjy222.561
• Languages: English
• ISSNs: 1873-9946

Abstract

Abstract: Background: Infliximab is one of the most used biological drugs in inflammatory bowel disease (IBD). Immunomediated adverse events (IAE) are of the most frequent reported infliximab-related adverse events. Elderly patients have differential pharmacodynamic and pharmacokinetic characteristics. We recently reported an increased risk of thiopurine-related AEs in this population; hence, it would be relevant to ascertain if combined treatment is adequate in this population. Our aim was to evaluate the rate of infliximab-related IAE in elderly IBD patients. Methods: All adult patients in the ENEIDA registry (a large, prospectively maintained database of the Spanish Working Group in IBD–GETECCU) who received a first course of infliximab treatment were identified. Patients were selected in two cohorts regarding the age at the beginning of infliximab treatment: over 60 years, and between 18 and 50 years of age. The rates of IAE recorded in the ENEIDA database (infusion reactions, delayed hypersensitivity, oedema, allergy, anaphylaxis, psoriasis, lupus-like syndrome) were compared, as well as the rate of secondary loss of response (SLR). Results: We included 939 (12%) patients who started infliximab over 60 years and 6844 (88%) patients below 50 years. The rate of IAE (15% vs. 15%, ns) and treatment withdrawal due to IAE (13% vs. 12%, ns) was similar in both groups. Neither differences were observed according to IAE: infusion reactions (8.3% vs. 8.2%), late hypersensitivity (1.4% vs. 1.2%), paradoxical psoriasis (0.9% vs. 1.4%) and drug-induced lupus erythematosus (0.7% vs. 0.6%). Patients below 50 years were significantly more often treated with concomitant immunosuppressants (57% vs. 48.1% >60 years, p < 0.05). In the multi-variate analysis, combination with immunosuppressants (OR 0.741; 95% CI 0.64–8.5, p < 0.05) and female sex (OR 1.8; 95% CI 1.6–2.1, p < 0.05) were the only independent predictors to develop IAE. The rate of SLR was also similar in both study groups (20% vs. 21%). Combination therapy with immunosuppressants was the unique risk factor to develop SLR (OR 0.85; CI 95% 0.73 to 0.98, p = 0.021). Conclusions: Elderly IBD patients who start treatment with infliximab have a similar risk of developing IAE and SLR than younger patients. From this point of view, elderly would benefit from combination therapy.