Comparing tocilizumab biosimilar BAT1806/BIIB800 with reference tocilizumab in patients with moderate-to-severe rheumatoid arthritis with an inadequate response to methotrexate: a phase 3, randomised, multicentre, double-blind, active-controlled clinical trial
An erratum to this article was published (Lancet Rheumatol, Mar 2024 ↗)
Primary result · ACR20 response (primary estimand)Result — go to the resultTreatment difference 4.1% 95% CI −3.6 to 11.9Authors' conclusion
BAT1806/BIIB800 showed equivalent efficacy, and comparable safety, immunogenicity, and pharmacokinetic profiles as reference tocilizumab.
Study context
- Population
- Patients with active RA with an inadequate response to MTX, 54 centres in China, Ukraine, Poland, Georgia and Bulgaria534 (86%) women
- Participants
- 621 patients
- Comparison
- Biosimilar BAT1806/BIIB800 vs reference tocilizumab, IV every 4 weeks, starting dose 8 mg/kg
- BAT1806/BIIB800n = 312
- Reference tocilizumabn = 309reference
- Primary endpoint
- Proportion with ACR20 at week 12 (EMA) or week 24 (FDA, NMPA), prespecified equivalence margins
- Follow-up
- Week 12 or week 24
Methodological detailsphase 3, multicentre, double-blind, active-controlled, equivalence, ICH E9(R1) estimand framework, 24-week initial treatment period reported; 24-week secondary treatment period
- Phase 3
- Multicentre
- Double-blind
- Active-controlled
- Equivalence
- ICH E9(R1) estimand framework
- 24-week initial treatment period reported; 24-week secondary treatment period
Primary result
ACR20 response (primary estimand) · week 12
Treatment difference
4.1%
95% CI −3.6 to 11.9
By group
BAT1806/BIIB800vs Reference tocilizumab
treatment difference 4.1% (95% CI −3.6 to 11.9)
As reported in the abstract
Further findings
| Outcome | Reference tocilizumab | BAT1806/BIIB800 | Treatment difference (90% CI) | |
|---|---|---|---|---|
| ACR20 response (primary estimand, FDA/NMPA time point) · up to week 24 | 67.9% | 69.9% | 1.9% (−4.0 to 7.9) | |
| −50510Difference (linear scale) |
- ACR20 response (primary estimand, FDA/NMPA time point): 95% CI −5.2 to 9.1; within equivalence margins (FDA 90% CI −12.0 to +15.0; NMPA 95% CI −13.6 to +13.6)
Pharmacokinetic and immunogenicity profiles
- Comparable pharmacokinetic and immunogenicity profiles were observed for the reference tocilizumab and BAT1806/BIIB800 groups
Safety
Adverse events
Treatment-emergent adverse events
Events
| Outcome | Reference tocilizumab | BAT1806/BIIB800 |
|---|---|---|
| Fatal eventsFive participants had a fatal event | 1 | 4 |
Original publication
Comparing tocilizumab biosimilar BAT1806/BIIB800 with reference tocilizumab in patients with moderate-to-severe rheumatoid arthritis with an inadequate response to methotrexate: a phase 3, randomised, multicentre, double-blind, active-controlled clinical trial. Lancet Rheumatol. Published January 2024. doi:10.
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