Switching from biosimilar to biosimilar adalimumab, including multiple switching, in crohn’s disease: A prospective study

Davide Giuseppe Ribaldone, Elisa Tribocco, Chiara Rosso, Angelo Armandi, Marta Vernero, Elisabetta Bugianesi, Marco Astegiano, Giorgio Maria Saracco, Gian Paolo Caviglia

Research output: Contribution to journalArticlepeer-review

Abstract

No data are available regarding the safety and effectiveness of the biosimilar-to-biosimilar switch of adalimumab in any disease, and in particular in Crohn’s disease (CD). The aim of our study was to provide real world data on switching from biosimilar adalimumab to another biosimilar, including multiple switching. We conducted a prospective, single-centre observational study in which we consecutively recruited all CD patients who switched from adalimumab biosimilar ABP 501 to biosimilar SB5 from January to July 2021. Sixty-one patients were included in the final analysis, of whom 43/61 (70.5%) were multiple switches (Humira® → ABP 501 → SB5). After 6 months of follow up, 88.5% (54/61) of patients maintained SB5 on therapy. The success of the switch (defined as no systemic corticosteroids within 6 months, non-discontinuation of SB5, no dose escalation) was achieved by 82.0% (50/61) of patients. At multivariate analysis, C-reactive protein > 5 mg/L predicted switch failure (p = 0.03). Seven patients (11.5%) experienced side effects, compared to one patient (1.6%) in the 6 pre-switch months (p = 0.03). In conclusion, switching from biosimilar to biosimilar of adalimumab did not lead to signs of safety or loss of efficacy other than those already known in the literature for the class of drugs.

Original languageEnglish
Article number3387
JournalJournal of Clinical Medicine
Volume10
Issue number15
DOIs
Publication statusPublished - Aug 1 2021
Externally publishedYes

Keywords

  • Amgevita
  • Amjevita
  • Imraldi
  • Originator

ASJC Scopus subject areas

  • Medicine(all)

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