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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

M. Calafat*1, M. Mañosa1,2, J. Panes2,3, P. Nos2,4, E. Iglesias5, I. Vera6, A. López-Sanromán7, J. Guardiola8, C. Taxonera9, M. Mínguez10, M. D. Martín11, L. de Castro12, S. Riestra13, M. Rivero14, E. García-Planella15, X. Calvet2,16, S. García-López17, M. Andreu18, F. Gomollón19, J. Barrio20, M. Esteve2,21, A. Rodríguez22, J. P. Gisbert2,23, A. Gutierrez24, J. Hinojosa25, F. Argüelles26, D. Busquets27, L. Bujanda28, J. Lázaro29, B. Sicilia30, O. Merino31, P. Martínez32, F. Bermejo33, R. Lorente34, M. Barreiro-de-Acosta35, C. Rodríguez36, M. Fe37, M. Piqueras38, P. Romero39, E. Rodríguez40, Ó. Roncero41, J. Llaó42, G. Alcaín43, J. Riera44, M. Sierra45, L. I. Fdez. Salazar46, V. Jair47, M. Navarro48, M. A. Montoro49, C. Muñoz, A. J. Lucendo, M. Van Domselaar, I. Moraleja, J. M. Huguet, L. Ramos, P. Ramírez, P. Almeda, R. Pajares, S. Khorrami, R. E. Madrigal, E. Sesé, A. M. Trapero, J. Legido, Á. Abad, F. Cañete1,2, E. Cabré1,2, E. Domènech1,2

1Hospital Universitari Germans Trias i Pujol, Gastroenterology Department, Badalona, Spain, 2CIBERehd, Madrid, Spain, 3Hospital Clínic, Barcelona, Spain, 4Hospital La Fe de Valencia, Valencia, Spain, 5Hospital Reina Sofía, Córdoba, Spain, 6Hospital Puerta de Hierro, Majadahonda, Spain, 7Hospital Ramón y Cajal, Madrid, Spain, 8Hospital de Bellvitge, L'Hospitalet del Llobregat, Spain, 9Hospital Clínico San Carlos, Madrid, Spain, 10Hospital Clínico de Valencia, Valencia, Spain, 11Hospital La Paz, Madrid, Spain, 12Complexo H. Universitario de Vigo, Vigo, Spain, 13H.U. Central de Asturias, Oviedo, Spain, 14H.U. Marqués de Valdecilla, Santander, Spain, 15H. Santa Creu i Sant Pau, Barcelona, Spain, 16H. Parc Taulí, Sabadell, Spain, 17H.U. Miguel Servet, Zaragoza, Spain, 18Hospital del Mar, Barcelona, Spain, 19H. Clínico Lozano Blesa, Zaragoza, Spain, 20H. Río Hortega, Valladolid, Spain, 21H. Mútua de Terrassa, Terrassa, Spain, 22H.U. Salamanca, Salamanca, Spain, 23Hospital Universitario de La Princesa, Madrid, Spain, 24H.G.U. Alicante, Alicante, Spain, 25H. Manises, Manises, Valencia, Spain, 26H. Virgen de la Macarena, Sevilla, Spain, 27H. Dr. Josep Trueta, Girona, Spain, 28H. Donostia, Donostia, Spain, 29H.U. Fundación de Alcorcón, Alcorcón, Spain, 30Complejo Hosp. Burgos, Burgos, Spain, 31H. de Cruces, Cruces-Barakaldo, Spain, 32H. 12 de Octubre, Madrid, Spain, 33H.U. Fuenlabrada, Fuenlabrada, Spain, 34H. General de Ciudad Real, Ciudad Real, Spain, 35H. Clínico Santiago, Santiago, Spain, 36Complejo Hospitalario de Navarra, Pamplona, Spain, 37H.G.U. Elche, Elche, Spain, 38Consorci Sanitari de Terrassa, Terrassa, Spain, 39H. Santa Lucía Cartagena, Cartagena, Spain, 40H. Nuestra Sra. de la Candelaria, Santa Cruz de Tenerife, Spain, 41H. Mancha Centro, Alcázar de San Juan, Spain, 42H. Sant Joan de Déu – Althaia, Manresa, Spain, 43H. Clínico de Málaga, Virgen de la Victoria, Spain, 44Hospital Son Llàtzer, Palma De Mallorca, Spain, 45Complejo Hospitalario de León, León, Spain, 46H. Clínico Univ. Valladolid, Valladolid, Spain, 47H. General de Granollers, Granollers, Spain, 48H. Moisès Broggi, St Joan Despí, Spain, 49H. San Jorge, Huesca, Spain, H. Basurto, Bilbao, Spain, H. General de Tomelloso, Ciudad Real, Spain, H. Torrejón, Madrid, Spain, H. de Galdakao, Vizcaya, Spain, H.G.U. de Valencia, Valencia, Spain, H.U. Canarias, La Laguna, Spain, H.U. Áraba, Vitoria, Spain, H. General de Castelló, Castelló, Spain, H. Infanta Sofía, San Sebastián de los Reyes, Spain, H. Son Espases, Mallorca, Spain, Complejo Hospitalario de Palencia, Palencia, Spain, H.U. Arnau de Vilanova, LLeida, Spain, Complejo Hospitalario de Jaén, Jaén, Spain, H. General de Segovia, Segovia, Spain, H. Viladecans, Viladecans, Spain

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).

Conclusion

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.