Switching between reference adalimumab and biosimilars in chronic immune‐mediated inflammatory diseases: A systematic literature review

Abstract

Adalimumab is a biological therapy used to treat different chronic inflammatory diseases. At present, there is an increasing number of adalimumab biosimilars. To assume the acceptability of interchangeability between reference adalimumab and biosimilars, there should be evidence about efficacy and safety of this switching. Regulation of this practice falls under the authority of individual European UnionMember States. The aim of this study is to systematically review the evidence on the efficacy, safety and immunogenicity of switching between reference adalimumab and biosimilars in different chronic immune-mediated inflammatory diseases.Methods: Studies presenting data about switching between reference adalimumab and biosimilars were identified by sensitive search strategies in Medline and EMBASE from 1 January 2004 to 30 June 2021.Results: A total of 471 references were obtained and 21 finally included in the analysis (total number of patients switching: 2802). Eight different adalimumab biosimilars were tested after receiving reference adalimumab. Eight articles included rheumatoid arthritis (RA), one miscellaneous rheumatic disease, six psoriasis (PSO) and six inflammatory bowel disease (IBD) patients. Overall, the efficacy results in the switching groups were comparable to those obtained in the arms of continuous biosimilar and continuous reference adalimumab. There were no significant differences in treatment emergent adverse events, anti-drug or neutralising antibodies among the three groups.Conclusions: Switching between reference adalimumab and biosimilars has no impact on efficacy, safety and immunogenicity in patients with RA, PSO and IBD. This finding was consistent for the different adalimumab biosimilars analysed. These conclusions could probably be extended to other rheumatic diseases such as psoriatic arthritis and ankylosing spondylitis.

Patient perspectives of successful adalimumab biosimilar transitioning in Crohn’s disease: an interview study

“…Nine adalimumab biosimilar products are currently authorised for use by the European Medicines Agency (table 1). Various groups have now reported the clinical outcome of switching to adalimumab biosimilars, including in patients with CD, with no differences in efficacy, safety or immunogenicity 4…”

Anti-Drug Antibody Formation Against Biologic Agents in Inflammatory Bowel Disease: A Systematic Review and Meta-Analysis

“…We also did not assess risk of immunogenicity when switching from originator to biosimilar biologics since this was not within the scope of this review. Nevertheless, is has been shown in previous studies that switching to a biosimilar is safe, effective and not associated with increased immunogenicity [66,67]. Lastly, there is also some evidence that genetic factors play a role in immunogenicity [68].…”

Secukinumab Loss of Efficacy Is Perfectly Counteracted by the Introduction of Combination Therapy (Rescue Therapy): Data from a Multicenter Real-Life Study in a Cohort of Italian Psoriatic Patients That Avoided Secukinumab Switching

“…Thus, interclass switching is a limited option and intraclass switching increases the failure rate configure the actual scenario of progressive implementation of multifailure patients [42,43]. Furthermore, biosimilars are different drugs from the originator but a failure with the originator may implies a potential failure also with the related biosimilar [44,45].…”