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

April 25, 2023

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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

Publicated to:ALIMENTARY PHARMACOLOGY & THERAPEUTICS. 58 (1): 60-70 - 2023-04-23 58(1), DOI: 10.1111/apt.17525

Authors: Jose Casanova, Maria; Nantes, Oscar; Varela, Pilar; Vela-Gonzalez, Milagros; Rivero, Montserrat; Sierra-Gabarda, Olivia; Riestra, Sabino; Barreiro-de Acosta, Manuel; del Mar Martin-Rodriguez, Maria; Jerusalen Gargallo-Puyuelo, Carla; Reygosa, Cristina; Munoz, Roser; Garcia de la Filia-Molina, Irene; Nunez-Ortiz, Andrea; Kolle, Lilyan; Calafat, Margalida; Maria Huguet, Jose; Iglesias-Flores, Eva; de Jesus Martinez-Perez, Teresa; Bosch, Orencio; Maria Duque-Alcorta, Jose; Frago-Larramona, Santiago; Van Domselaar, Manuel; Manuel Gonzalez-Cosano, Victor; Bujanda, Luis; Garcia-Lopez, Santiago; de Francisco, Ruth; Nieto-Garcia, Laura; Laredo, Viviana; Gutierrez-Casbas, Ana; Mesonero, Francisco; Canete, Fiorella; Rodriguez, Cristina; Chaparro, Maria; Gisbert, Javier P

Affiliations

CIBERehd, Alicante, Spain - Author

CIBERehd, Badalona, Spain - Author

CIBEREHD, Donostia San Sebastian, Spain - Author

CIBERehd, Zaragoza, Spain - Author

Complejo Hospitalario Universitario de Granada - Author

Consorcio Hosp Gen Univ Valencia, Gastroenterol Dept, Valencia, Spain - Author

Fdn Jimenez Diaz, Gastroenterol Dept, Madrid, Spain - Author

Fundación Jiménez Díaz - Author

Hosp Clin Lozano Blesa, Inst Invest Sanitaria Aragon, Gastroenterol Dept, Zaragoza, Spain - Author

Hosp Clin Univ Santiago Compostela, Gastroenterol Dept, Santiago De Compostela, Spain - Author

Hosp Gen La Palma, Gastroenterol Dept, Santa Cruz De Tenerife, Spain - Author

Hosp Gen Univ Dr Balmis, Gastroenterol Dept, Inst Invest Sanitaria Biomed de Alicante, Alicante, Spain - Author

Hosp Santa Barbara, Gastroenterol Dept, Soria, Spain - Author

Hosp Univ Cabuenes, Gastroenterol Dept, Gijon, Spain - Author

Hosp Univ Canarias, Gastroenterol Dept, San Cristobal la Laguna, Spain - Author

Hosp Univ Cent Asturias, Inst Invest Sanitaria Principado Asturias, Gastroenterol Dept, Oviedo, Spain - Author

Hosp Univ Germans Trias I Pujol, Gastroenterol Dept, Badalona, Spain - Author

Hosp Univ Marques Valdecilla, Inst Invest Sanitaria Valdecilla, Gastroenterol Dept, Santander, Spain - Author

Hosp Univ Miguel Servet, Gastroenterol Dept, Zaragoza, Spain - Author

Hosp Univ Navarra, Inst Invest Sanitaria Navarra IdiSNA, Gastroenterol Dept, Pamplona, Spain - Author

Hosp Univ Nuestra Senora Candelaria, Gastroenterol Dept, Santa Cruz De Tenerife, CA, Spain - Author

Hosp Univ Ramon & Cajal, Gastroenterol Dept, Madrid, Spain - Author

Hosp Univ Reina Sofia, Inst Maimonides Invest Biomed Cordoba, Gastroenterol Dept, Cordoba, Spain - Author

Hosp Univ San Agustin, Gastroenterol Dept, Aviles, Spain - Author

Hosp Univ Torrejon, Gastroenterol Dept, Madrid, Spain - Author

Hosp Univ Virgen de Ias Nieves, Gastroenterol Dept, Granada, Spain - Author

Hosp Univ Virgen Rocio, Gastroenterol Dept, Seville, Spain - Author

Hosp Virgen La Luz, Gastroenterol Dept, Cuenca, Spain - Author

Hospital Clínico Universitario de Santiago - Author

Hospital Clínico Universitario Lozano Blesa - Author

Hospital de Montilla - Author

Hospital de Santa Bárbara de Soria - Author

Hospital General de La Palma - Author

Hospital General Universitario de Alicante - Author

Hospital General Universitario de Valencia - Author

Hospital Miguel Servet - Author

Hospital Universitari Germans Trias i Pujol - Author

Hospital Universitario Central de Asturias - Author

Hospital Universitario de Cabueñes - Author

Hospital Universitario de Canarias - Author

Hospital Universitario de Torrejón - Author

Hospital Universitario Marqués de Valdecilla - Author

Hospital Universitario Nuestra Senora de Candelaria - Author

Hospital Universitario Ramón y Cajal - Author

Hospital Universitario Reina Sofía - Author

Hospital Universitario San Agustín - Author

HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO - Author

Hospital Virgen de La Luz de Cuenca - Author

Instituto de Investigación Sanitaria Hospital Universitario de La Princesa - Author

Osakidetza, Donostia University Hospital - Author

Univ Autonoma Madrid, Hosp Univ La Princesa, Inst Invest Sanitaria Princesa, CIBEREHD,Gastroenterol Dept, Madrid, Spain - Author

Univ Pais Vasco UPV EHU, Hosp Univ Donostia, Inst Biodonostia, Gastroenterol Dept, Donostia San Sebastian, Spain - Author

Universidad de Navarra - Author

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.

Keywords

biosimilarinflammatory bowel diseaseinfliximabmaintenancesafetyAdalimumabAntibodies, monoclonalBiosimilarBiosimilar pharmaceuticalsDrug substitutionGastrointestinal agentsHumansInflammatory bowel diseaseInflammatory bowel diseasesInfliximabSb5Treatment outcome

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Bibliometric impact. Analysis of the contribution and dissemination channel

The work has been published in the journal ALIMENTARY PHARMACOLOGY & THERAPEUTICS due to its progression and the good impact it has achieved in recent years, according to the agency WoS (JCR), it has become a reference in its field. In the year of publication of the work, 2023, it was in position 21/354, thus managing to position itself as a Q1 (Primer Cuartil), in the category Pharmacology & Pharmacy. Notably, the journal is positioned above the 90th percentile.

From a relative perspective, and based on the normalized impact indicator calculated from the Field Citation Ratio (FCR) of the Dimensions source, it yields a value of: 9.51, which indicates that, compared to works in the same discipline and in the same year of publication, it ranks as a work cited above average. (source consulted: Dimensions Jul 2025)

Specifically, and according to different indexing agencies, this work has accumulated citations as of 2025-07-18, the following number of citations:

WoS: 5
Scopus: 6
Europe PMC: 2

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This work has been carried out with international collaboration, specifically with researchers from: Granada.

There is a significant leadership presence as some of the institution’s authors appear as the first or last signer, detailed as follows: First Author (Casanova MJ) .

the author responsible for correspondence tasks has been Casanova MJ.

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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

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Abstract

Keywords

Quality index

Bibliometric impact. Analysis of the contribution and dissemination channel

Impact and social visibility

Leadership analysis of institutional authors