FKB327, an adalimumab biosimilar, vs the reference product: Results of a randomized, Phase III, double-blind study, and its open-label extension
Arthritis Research & Therapy Dec 19, 2019
Genovese MC, Glover J, Greenwald M, et al. - In patients with moderate-to-severe, active rheumatoid arthritis (RA), researchers compared the effectiveness, serum drug concentrations, immunogenicity, and safety of FKB327 with the adalimumab reference product (RP) in combination with methotrexate. Participants in the study were randomized 1:1 in a double-blind study, received 40 mg of FKB327 or RP by subcutaneous injection every other week for 24 weeks (Period I), then re-randomized 2:1, remaining on the same study drug or switching to the other up to week 54 in an open-label extension (Period II). In total, 730 individuals were randomized in Period I (n = 367 FKB327, n = 363 RP), and 645 transitioned to Period II (n = 216 FKB327–FKB327, n = 108 FKB327–RP, n = 108 RP–FKB327, n = 213 RP–RP). In patients with moderate-to-severe RA, FKB327 was equivalent to RP in clinical effectiveness and showed similar safety and immunogenicity. There was no observed effect of switching between FKB327 and RP.
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