학술논문
Real-world outcomes of switching from adalimumab originator to adalimumab biosimilar in patients with inflammatory bowel disease: The ADA-SWITCH study.
Document Type
Academic Journal
Author
Casanova MJ; Gastroenterology Department, Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa (IIS-Princesa), Universidad Autónoma de Madrid (UAM), Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain.; Nantes Ó; Gastroenterology Department, Hospital Universitario de Navarra, Instituto de Investigación Sanitaria de Navarra (IdiSNA), Pamplona, Spain.; Varela P; Gastroenterology Department, Hospital Universitario de Cabueñes, Gijón, Spain.; Vela-González M; Gastroenterology Department, Hospital Universitario Nuestra Señora de la Candelaria, Santa Cruz de Tenerife, Spain.; Rivero M; Gastroenterology Department, Hospital Universitario Marqués de Valdecilla, Instituto de Investigación Sanitaria Valdecilla (IDIVAL), Santander, Spain.; Sierra-Gabarda O; Gastroenterology Department, Hospital Universitario Miguel Servet, Zaragoza, Spain.; Riestra S; Gastroenterology Department, Hospital Universitario Central de Asturias, Instituto de Investigación Sanitaria del Principado de Asturias (ISPA), Oviedo, Spain.; Barreiro-de Acosta M; Gastroenterology Department, Hospital Clínico Universitario de Santiago de Compostela, Santiago de Compostela, Spain.; Martín-Rodríguez MDM; Gastroenterology Department, Hospital Universitario Virgen de las Nieves, Granada, Spain.; Gargallo-Puyuelo CJ; Gastroenterology Department, Hospital Clínico Lozano Blesa, Instituto de Investigación Sanitaria Aragón (IIS Aragón), y CIBEREHD, Zaragoza, Spain.; Reygosa C; Gastroenterology Department, Hospital Universitario de Canarias, La Laguna, Spain.; Muñoz R; Gastroenterology Department, Hospital General Universitario Dr. Balmis, Instituto de Investigación Sanitaria y Biomédica de Alicante (ISABIAL), y CIBEREHD, Alicante, Spain.; de la Filia-Molina IG; Gastroenterology Department, Hospital Universitario Ramón y Cajal, Madrid, Spain.; Núñez-Ortiz A; Gastroenterology Department, Hospital Universitario Virgen del Rocío, Sevilla, Spain.; Kolle L; Gastroenterology Department, Hospital General de La Palma, Santa Cruz de Tenerife, Spain.; Calafat M; Gastroenterology Department, Hospital Universitario Germans Trias i Pujol, y CIBEREHD, Badalona, Spain.; Huguet JM; Gastroenterology Department, Consorcio Hospital General Universitario de Valencia, Valencia, Spain.; Iglesias-Flores E; Gastroenterology Department, Hospital Universitario Reina Sofía, Instituto Maimónides de Investigación Biomédica de Córdoba (IMIBIC), Córdoba, Spain.; Martínez-Pérez TJ; Gastroenterology Department, Hospital Virgen de La Luz, Cuenca, Spain.; Bosch O; Gastroenterology Department, Fundación Jiménez Díaz, Madrid, Spain.; Duque-Alcorta JM; Gastroenterology Department, Hospital Universitario San Agustín, Avilés, Spain.; Frago-Larramona S; Gastroenterology Department, Hospital Santa Bárbara, Soria, Spain.; Van Domselaar M; Gastroenterology Department, Hospital Universitario de Torrejón, Madrid, Spain.; González-Cosano VM; Gastroenterology Department, Hospital de Montilla, Córdoba, Spain.; Bujanda L; Gastroenterology Department, Hospital Universitario de Donostia, Instituto Biodonostia, Universidad del País Vasco (UPV/EHU), y CIBEREHD, Donostia, Spain.; Rubio S; Gastroenterology Department, Hospital Universitario de Navarra, Instituto de Investigación Sanitaria de Navarra (IdiSNA), Pamplona, Spain.; Mancebo A; Gastroenterology Department, Hospital Universitario de Cabueñes, Gijón, Spain.; Castro B; Gastroenterology Department, Hospital Universitario Marqués de Valdecilla, Instituto de Investigación Sanitaria Valdecilla (IDIVAL), Santander, Spain.; García-López S; Gastroenterology Department, Hospital Universitario Miguel Servet, Zaragoza, Spain.; de Francisco R; Gastroenterology Department, Hospital Universitario Central de Asturias, Instituto de Investigación Sanitaria del Principado de Asturias (ISPA), Oviedo, Spain.; Nieto-García L; Gastroenterology Department, Hospital Clínico Universitario de Santiago de Compostela, Santiago de Compostela, Spain.; Laredo V; Gastroenterology Department, Hospital Clínico Lozano Blesa, Instituto de Investigación Sanitaria Aragón (IIS Aragón), y CIBEREHD, Zaragoza, Spain.; Gutiérrez-Casbas A; Gastroenterology Department, Hospital General Universitario Dr. Balmis, Instituto de Investigación Sanitaria y Biomédica de Alicante (ISABIAL), y CIBEREHD, Alicante, Spain.; Mesonero F; Gastroenterology Department, Hospital Universitario Ramón y Cajal, Madrid, Spain.; Leo-Carnerero E; Gastroenterology Department, Hospital Universitario Virgen del Rocío, Sevilla, Spain.; Cañete F; Gastroenterology Department, Hospital Universitario Germans Trias i Pujol, y CIBEREHD, Badalona, Spain.; Ruiz L; Gastroenterology Department, Consorcio Hospital General Universitario de Valencia, Valencia, Spain.; Gros B; Gastroenterology Department, Hospital Universitario Reina Sofía, Instituto Maimónides de Investigación Biomédica de Córdoba (IMIBIC), Córdoba, Spain.; Del Moral-Martínez M; Gastroenterology Department, Hospital Virgen de La Luz, Cuenca, Spain.; Rodríguez C; Gastroenterology Department, Hospital Universitario de Navarra, Instituto de Investigación Sanitaria de Navarra (IdiSNA), Pamplona, Spain.; Chaparro M; Gastroenterology Department, Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa (IIS-Princesa), Universidad Autónoma de Madrid (UAM), Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain.; Gisbert JP; Gastroenterology Department, Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa (IIS-Princesa), Universidad Autónoma de Madrid (UAM), Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain.
Source
Publisher: Wiley-Blackwell Country of Publication: England NLM ID: 8707234 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1365-2036 (Electronic) Linking ISSN: 02692813 NLM ISO Abbreviation: Aliment Pharmacol Ther Subsets: MEDLINE
Subject
Language
English
Abstract
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.
(© 2023 John Wiley & Sons Ltd.)
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.
(© 2023 John Wiley & Sons Ltd.)