A phase 3, randomized, double-blind, active-controlled clinical trial to compare BAT1806/BIIB800, a tocilizumab biosimilar, with tocilizumab reference product in participants with moderate-to-severe rheumatoid arthritis with inadequate response to methotrexate: treatment period 2 analysis (week 24 to week 48)
Authors' conclusion
In TP2, efficacy, safety, immunogenicity, and pharmacokinetic profiles were comparable between the TCZ, TCZ to BAT1806/BIIB800, and BAT1806/BIIB800 groups.
Study context
- Population
- Participants with active moderate-to-severe rheumatoid arthritis (RA) despite MTX577 entered TP2
- Participants
- 621 participants
- Comparison
- BAT1806/BIIB800 (tocilizumab biosimilar) vs reference tocilizumab (TCZ), including switch from TCZ to BAT1806/BIIB800 at week 24
- TCZn = 145reference
- TCZ to BAT1806/BIIB800n = 142
- BAT1806/BIIB800n = 290
Methodological detailsphase 3, multicentre, multiregional, double-blind, active-controlled, equivalence, treatment period 2 analysis (week 24 to week 48)
- Phase 3
- Multicentre
- Multiregional
- Double-blind
- Active-controlled
- Equivalence
- Treatment period 2 analysis (week 24 to week 48)
Primary result
As reported in the abstract
ACR20 response · week 48
Further findings
ACR50 and ACR70 response, reduction in DAS28 · TP2
- Similar between treatment groups
Drug trough levels and antidrug antibody incidence · TP2
- Comparable between the treatment groups
Safety
Adverse events · TP2
- Balanced across the treatment groups
Fatal events · TP2
- None reported
- 0
Original publication
A phase 3, randomized, double-blind, active-controlled clinical trial to compare BAT1806/BIIB800, a tocilizumab biosimilar, with tocilizumab reference product in participants with moderate-to-severe rheumatoid arthritis with inadequate response to methotrexate: treatment period 2 analysis (week 24 to week 48). Arthritis Res Ther. Published 7 September 2024. doi:10.
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