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OP034 The initiation of thiopurines in elderly patients with inflammatory bowel disease is associated with an increased risk of adverse effects: a case–control study of the ENEIDA registry

M. Calafat1,2*, M. Mañosa3,4, F. Cañete3, J. Panés4,5, V. García Sánchez4,6, M. Calvo7, F. Rodríguez-Moranta8, C. Taxonera9, P. Nos4,10, A. López Sanromán11, M.D. Martín Arranz12, M. Mínguez13, J.P. Gisbert4,14, S. García-López15, R. de Francisco16, F. Gomollón4,17, X. Calvet4,18, E. Garcia-Planella19, M. Rivero20, J. Martínez-Cadilla21, F. Argüelles22, L. Arias García23, M. Cimavilla24, Y. Zabana4,25, L. Márquez26, A. Gutiérrez4,27, G. Alcaín28, P. Martínez Montiel29, J. Lázaro30, D. Busquets31, M.F. García Sepulcre32, C. Verdejo33, F. Bermejo34, M. Mora35, D. Monfort36, P. Romero37, B. Velayos38, C. Rodríguez39, A. Rodríguez40, O. Merino41, A. Rodríguez-Pescador42, L. Bujanda4,43, Y. Ber44, M. Vela45, O. Roncero46, J.M. Huguet47, O. García-Bosch48, M. Barreiro-de-Acosta49, R.E. Madrigal50, L. Ramos51, M. Van Domselaar52, P. Almela53, J. Llaó54, A.J. Lucendo4,55, C. Muñoz Vilafranca56, À. Abad57, M. Charro58, J. Legido59, J. Riera1, S. Khorrami60, E. Sesé61, A.M. Trapero62, E. Domènech3,4

1Hospital Son Llàtzer, Palma, Spain, 2Universitat Autònoma de Barcelona, Barcelona, Spain, 3Hospital Universitari Germans Trias i Pujol, Badalona, Spain, 4CIBERehd Instituto de Salud Carlos III, Madrid, Spain, 5Hospital Clínic, Barcelona, Spain, 6Hospital Reina Sofia, Córdoba, Spain, 7Hospital Puerta de Hierro, Majadahonda, Spain, 8Hospital Bellvitge, L’Hospitalet de Llobregat, Spain, 9Hospital Clínico San Carlos, Madrid, Spain, 10Hospital La Fe, Valencia, Spain, 11Hospital Ramón y Cajal, Madrid, Spain, 12Hospital La Paz, Madrid, Spain, 13Hospital Clínico de Valencia, Valencia, Spain, 14Hospital La Princesa, Madrid, Spain, 15Hospital Universitario Miguel Servet, Zaragoza, Spain, 16Hospital Universitario Central de Asturias, Oviedo, Spain, 17Hospital Clínico Lozano Blesa, Zaragoza, Spain, 18Hospital Parc Taulí, Sabadell, Spain, 19Hospital Santa Creu i Sant Pau, Barcelona, Spain, 20Hospital Universitario Marqués de Valdecilla, Santander, Spain, 21Complexo Hospital Universitario de Vigo, Vigo, Spain, 22Hospital Virgen de la Macarena, Sevilla, Spain, 23Hospital Universitario Burgos, Burgos, Spain, 24Hospital Río Hortega, Valladolid, Spain, 25Hospital Mutua de Terrassa, Terrassa, Spain, 26Hospital del mar, Barcelona, Spain, 27Hospital General Universitario de Alicante, Alicante, Spain, 28Hospital Clínico de Málaga, Málaga, Spain, 29Hospital 12 de octubre, Madrid, Spain, 30Hospital Universitario Fundación Alcorcón, Alcorcón, Spain, 31Hospital Dr Josep Trueta, Girona, Spain, 32Hospital General Universitario de Elche, Elche, Spain, 33Hospital General de Ciudad Real, Ciudad Real, Spain, 34Hospital Universitario Fuenlabrada, Fuenlabrada, Spain, 35Hospital Manises, Manises, Spain, 36Consorci sanitari de Terrassa, Terrassa, Spain, 37Hospital Santa Lucía, Cartagena, Spain, 38Hospital Clínico Universitario Valladolid, Valladolid, Spain, 39CH de Navarra, Pamplona, Spain, 40Hospital Universitario de Salamanca, Salamanca, Spain, 41Hospital de Cruces, Barakaldo, Spain, 42Hospital Galdakao, Galdakao, Spain, 43Instituto Biodonostia UPV/EHU, (Donostia, Spain, 44Hospital San Jorge, Huesca, Spain, 45Hospital Nuestra Sra Candelaria, Sta Cruz Tenerife, Spain, 46Hospital Mancha Centro, Alcazar de San Juan, Spain, 47Hospital General Universitario Valencia, Valencia, Spain, 48Hospital Moisès Broggi, St Joan Despí, Spain, 49CH Santiago, Santiago de Compostela, Spain, 50CH de Palencia, Palencia, Spain, 51Hospital Universitario de Canarias, La Laguna, Spain, 52Hospital Torrejón, Torrejón, Spain, 53HG de Castelló, Castelló, Spain, 54Hospital Sant Joan de Déu-Althaia, Manresa, Spain, 55Hospital General de Tomelloso, Tomelloso, Spain, 56Hospital Basurto, Bilbao, Spain, 57Hospital Viladecans, Viladecans, Spain, 58Hospital Royo Vilanova, Zaragoza, Spain, 59Hospital General, Segovia, Spain, 60Hospital Son Espases, Palma, Spain, 61Hospital Arnau de Vilanova, Lleida, Spain, 62Complejo Hospitalario de Jaén, Jaén, Spain

Background

Thiopurines are the most widely used immunosuppressants in inflammatory bowel disease (IBD). However, patients using these drugs present drug-related adverse effects (AE) in 20–30% of cases. In a previous study, we observed a different profile of thiopurine-related AE in elderly-onset IBD. On the other hand, the use of biological agents in elderly patients could be associated with an increased risk of infections, so they are not a clear alternative. Our aim was to evaluate safety of thiopurines in IBD patients according to the age of initiation of treatment.

Table. Changes from BL in liqid levels, MACE events and risk factors for MACE in the tofacitinib clinical programme

Methods

Case–control study including all adult patients of the ENEIDA registry (a large, prospectively maintained database of the Spanish Working Group in IBD –GETECCU) who had received treatment with thiopurines. Patients were grouped regarding the age at the beginning of thiopurine treatment: over 60 years, and between 18 and 50 years of age. Thiopurine-related AE registered in the ENEIDA database were compared between both groups.

Results

Out of 48.752 IBD patients included in the ENEIDA database, 17 371 (35.6%) had been treated with thiopurines. Of these, 1892 (11%) patients started therapy over the age of 60 years and 15 479 (89%) under 50 years of age. Time from IBD diagnosis to the beginning of thiopurines was significantly longer in those who started >60 years (33 months [IQR 7–117] vs. 24 months [IQR 5–85]; p < 0.001). The median treatment duration was significantly shorter in those who started thiopurines >60 years (20.5 [IQR 2–64] vs. 39 [IQR 6–93] months; p < 0.001). Regarding thiopurine-related AE, patients starting >60 years had a significantly higher rate of myelotoxicity (anaemia, leukopoenia, lymphopenia, thrombocytopenia and aplasia), digestive intolerance (nausea and vomiting), infections, hepatotoxicity and neoplasms (p < 0.05). Thiopurines were discontinued due to AE in a significantly higher proportion of patients starting >60 years (35.8% vs. 23.6%, p < 0.001) and also more frequently within the first 3 months of treatment (37.1% vs. 28.2%, p <0.001).

Conclusion

The use of thiopurines in elderly IBD patients is associated with an increased risk of AE. Starting thiopurines over 60 years of age should be followed by a closer monitoring, paticularly during the first 3 months, due to the increased risk of developing AE.