A proposed tocilizumab biosimilar—BAT1806/BIIB800—showed comparable safety and efficacy to reference tocilizumab in patients with moderate-to-severe rheumatoid arthritis, according to a report published by Leng et al in The Lancet Rheumatology. In a phase III equivalence study, researchers randomly assigned 621 patients with moderate-to-severe rheumatoid arthritis who did not adequately respond to treatment with methotrexate to receive either 8 mg/kg of intravenous BAT1806/BIIB800 administered every 4 weeks (n = 312) or reference tocilizumab (n = 309) between December 2018 and January 2021. The trial consisted of a 24-week initial treatment period and a 24-week secondary treatment period. The researchers found that 69.0% of the patients who received BAT1806/BIIB800 vs 64.8% of those who received reference tocilizumab experienced a 20% improvement in the American College of Rheumatology criteria after a follow-up of 12 weeks, and a respective 69.9% vs 67.9% experienced improvements after a follow-up of 24 weeks. The researchers reported similar pharmacokinetic and immunogenicity profiles between the two agents. Further, safety was also comparable—with 206 patients in the BAT1806/BIIB800 group and 201 patients in the reference tocilizumab group experiencing adverse events. The researchers concluded that the tocilizumab biosimilar demonstrated equivalent safety, efficacy, immunogenicity, and pharmacokinetic profiles to reference tocilizumab.
January 04, 2024