Biosimilars for Rheumatic Diseases: Safety, Efficacy of Switching Assessed
WASHINGTON, DC—Switching from an original biologic therapeutic to a biosimilar for rheumatic diseases results in similar efficacy and safety data, a study summarizing the current literature presented at the 2016 ACR/ARHP Annual Meeting has concluded.
With biosimilars entering the market, clinical and real-world data on the effects of switching are limited to transition studies of approved biosimilars. To address this gap in understanding the switching process—both originator to biosimilar and between different biosimilars—Robert J. Moots, MB BS (hons), PhD, department of musculoskeletal biology, University of Liverpool, Liverpool, UK, and colleagues searched MEDLINE/Web of Science to identify studies where healthy volunteers or patients receiving infliximab, etanercept, adalimumab, or rituximab switched between originator biologics and biosimilars.
The investigators found switching data for 12 studies in rheumatic diseases: four for infliximab to CT-P13 (indications were rheumatoid arthritis [RA], ankylosing spondylitis AS], spondyloarthritis [SpA], psoriatic arthritis [PsA], juvenile idiopathic arthritis [JIA], chronic reactive arthritis, and other; n=611); one for infliximab to SB2 (RA; n=396); two for infliximab to an unidentified biosimilar (inflammatory arthritis, AS, PsA, SpA, enteropathic arthritis; n=65); two for etanercept to SB4 (RA; n=383); one for etanercept to GP2015 (not specified; n=54); one for adalimumab to SB5 (RA; n=508); and one for rituximab to CT-P10 (RA; n=87).
Follow-up after the switch ranged from 20 days to 56 weeks.
“The infliximab/CT-P13 studies showed efficacy and safety of infliximab and CT-P13 to be similar in switch and maintenance groups, and similar pre- and post-switch. Immunogenicity was assessed in three studies and did not change post-switch,” they noted. Two were open-label extension studies of a double-blind randomized controlled trial (RCT); one, an observational single-center study, and one, an observational registry study.
In the 24-week double-blind RCT infliximab/SB2 study, similar safety, efficacy, and immunogenicity profiles were shown for the switch and maintenance groups; however, comparisons before and after the switch were not assessed. The other two infliximab/biosimilar switch studies showed no difference in efficacy or safety 6 months after the switch.
The phase 1 etanercept/SB4 single-blind crossover study and the etanercept/GP2015 open-label extension of a double-blind RCT showed similar pharmacokinetic parameters for etanercept and the two biosimilars. In patients with RA, similar safety, efficacy, and immunogenicity profiles were seen between etanercept/SB4 (switch) and SB4/SB4 (maintenance) groups.
The 28-week, double-blind RCT of adalimumab/SB5 showed clinical measures of efficacy, safety, and immunogenicity to be similar in the switch and maintenance groups but comparisons pre- and post-switch were not made.
The rituximab/CT-P10 study, an open-label extension of an RCT, showed clinical measures of efficacy and safety to be similar in the switch and maintenance groups but efficacy pre- and post-switch could not be compared.
“While initial transition data confirm maintenance of efficacy and safety, additional data from clinical and real-world switching studies, especially of switching between biosimilars, are required, as is continuing pharmacovigilance,” Dr. Moots concluded. “Any switching should remain a clinical decision made jointly by the treating physician and patient on an individual patient basis supported by scientific evidence.”