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

• DOI: 10.1111/apt.17525
• Publication Date: 2023-04-24T06:38:00Z
• Authors: María José Casanova; Óscar Nantes; Pilar Varela; Milagros Vela‐Gon...; Montserrat Rivero; Olivia Sierra‐Gab...; Sabino Riestra; Manuel Barreiro‐d...; María del Mar Mar...; Carla Jerusalén G...; Cristina Reygosa; Roser Muñoz; Irene García de l...; Andrea Núñez‐Ortiz; Lilyan Kolle; Margalida Calafat; José María Huguet; Eva Iglesias‐Flores; Teresa de Jesús M...; Orencio Bosch; José María Duque‐...; Santiago Frago‐La...; Manuel Van Domselaar; Víctor Manuel Gon...; Luis Bujanda; Saioa Rubio; Alejo Mancebo; Beatriz Castro; Santiago García‐L...; Ruth de Francisco; Laura Nieto‐García; Viviana Laredo; Ana Gutiérrez‐Casbas; Francisco Mesonero; Eduardo Leo‐Carne...; Fiorella Cañete; Lucía Ruiz; Beatriz Gros; María del Moral‐M...; Cristina Rodríguez; María Chaparro; Javier P. Gisbert
• Keywords: Treatment Outcome; Gastrointestinal Agents; inflammatory bowel disease; Drug Substitution; adalimumab; Adalimumab; Humans; Antibodies, Monoclonal; biosimilar; Inflammatory Bowel Diseases; Biosimilar Pharmaceuticals; Infliximab; 3. Good health

SummaryBackground and AimsData 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.MethodsPatients 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.ResultsFive 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).ConclusionSwitching to ADA biosimilar did not impair patients' outcomes in comparison with maintaining on the originator.