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Real‐world outcomes of switching from adalimumab originator to adalimumab biosimilar in patients with inflammatory bowel disease: The ADA‐SWITCH study

2023; Wiley; Volume: 58; Issue: 1 Linguagem: Inglês

10.1111/apt.17525

1365-2036

María José Casanova, Óscar Nantes, Pilar Varela, M Vela-González, Montserrat Rivero, Olivia Sierra‐Gabarda, Sabino Riestra, Manuel Barreiro–de Acosta, M D M Martín-Rodríguez, Carla J. Gargallo-Puyuelo, Cristina Reygosa, Roser Muñoz, Irene García de la Filia‐Molina, Andrea Núñez‐Ortiz, Lilyan Kolle, Margalida Calafat, José María Huguet, E Iglesias-Flores, Teresa Martínez-Pérez, Orencio Bosch, José María Duque‐Alcorta, Santiago Frago‐Larramona, Manuel Van Domselaar, Víctor Manuel González‐Cosano, Luís Bujanda, S Rubio, Alejo Mancebo Mata, Beatriz Castro, Santiago García‐López, Ruth de Francisco, Laura Nieto‐García, Viviana Laredo, Ana Gutiérrez, Francisco Mesonero, Eduardo Leo‐Carnerero, Fiorella Cañete, Lucía Ruiz, Beatriz Gros, María del Moral‐Martínez, Cristina Rodríguez, María Chaparro, Javier P. Gisbert,

Microscopic Colitis

Summary Background and Aims Data on the outcomes after switching from adalimumab (ADA) originator to ADA biosimilar are limited. The aim was to compare the treatment persistence, clinical efficacy, and safety outcomes in inflammatory bowel disease patients who maintained ADA originator vs. those who switched to ADA biosimilar. Methods Patients receiving ADA originator who were in clinical remission at standard dose of ADA originator were included. Patients who maintained ADA originator formed the non‐switch cohort (NSC), and those who switched to different ADA biosimilars constituted the switch cohort (SC). Clinical remission was defined as a Harvey–Bradshaw index ≤4 in Crohn's disease and a partial Mayo score ≤2 in ulcerative colitis. To control possible confounding effects on treatment discontinuation, an inverse probability treatment weighted proportional hazard Cox regression was performed. Results Five hundred and twenty‐four patients were included: 211 in the SC and 313 in the NSC. The median follow‐up was 13 months in the SC and 24 months in the NSC ( p < 0.001). The incidence rate of ADA discontinuation was 8% and 7% per patient‐year in the SC and in the NSC, respectively ( p > 0.05). In the multivariate analysis, switching from ADA originator to ADA biosimilar was not associated with therapy discontinuation. The incidence rate of relapse was 8% per patient‐year in the SC and 6% per patient‐year in the NSC ( p > 0.05). Six percent of the patients had adverse events in the SC vs. 5% in the NSC ( p > 0.05). Conclusion Switching to ADA biosimilar did not impair patients' outcomes in comparison with maintaining on the originator.