SWITCHING BETWEEN REFERENCE ADALIMUMAB AND BIOSIMILARS IN CHRONIC IMMUNE-MEDIATED INFLAMMATORY DISEASES: A SYSTEMATIC LITERATURE REVIEW.

INTRODUCTION adalimumab is a biological therapy used to treat different chronic inflammatory diseases. At present, there are an increasing number of adalimumab biosimilars. To assume interchangeability between reference adalimumab and biosimilars as acceptable, there should be evidence about efficacy and safety of this switching. Regulation of this practice falls under the authority of individual European Union member states. OBJECTIVES 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 the studies presenting data about switching between reference adalimumab and biosimilars were identified by sensitive search strategies in Medline and EMBASE from 1st January 2004 until 30th June 2021. RESULTS 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), 1 miscellaneous rheumatic disease, 6 psoriasis (PSO) and 6 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 as psoriatic arthritis and ankylosing spondylitis.