Establishing Biosimilarity
Phase III Clinical Study:
TOFlDENCE biosimilarity was supported by comparing the efficacy and safety profile to reference Actemra in RA patients1,2
Study Design
N=621*
Baseline to
Week 48
Week 48
Phase lll, randomized, double-blind equivalence study. Patients with active RA and an inadequate response to methotrexate were randomized 2:1:1 to receive TOFIDENCE up to Week 48, Actemra up to Week 48, or Actemra up to Week 24 followed by TOFIDENCE from Week 24 to Week 48, administered intravenously every 4 weeks at a dose of 8 mg/kg through to the last dose at 44 weeks.
Primary endpoint was the proportion of patients with RA and an inadequate response to methotrexate achieving an ACR20 response at Week 24. Efficacy outcomes were measured up to Week 48, while safety and immunogenicity were measured up to Week 52.
*N=number of randomized patients entering treatment period 1.
Primary endpoint: ACR20 Response at Week 242
Percentage of Patients Who Achieved ACR20 at Week 242
The estimated difference between ACR response rates which fell within the predefined equivalence margins was 1.94% at Week 24 (90% CI: -4.0 and 7.9)2
The 90% CI of the difference in ACR20 at Week 24 were contained within predefined equivalence margins2*
*ACR20 response rates for regulatory-agency-preferred predefined timepoints (primary estimand).
The proportion of patients achieving ACR20 response rates at Week 24 were similar between patients receiving Actemra and TOFIDENCE1
Secondary endpoint: ACR20 Response at Week 483
Percentage of Patients Who Achieved ACR20 at Week 483
TOFIDENCE demonstrated similar ACR20 scores vs Actemra3
Secondary endpoint: TOFIDENCE demonstrated similar reductions from baseline in disease activity scores vs Actemra up to Week 242
Mean changes (95% CI) in DAS28 were comparable to Actemra up to Week 242
Secondary endpoint: TOFIDENCE demonstrated similar ACR50/70 scores vs Actemra up to Week 483*
*ACR rates based on the evaluable number of patients at each time point.
ACR50/70 at Week 48 were comparable between the three treatment groups3
Secondary endpoint: DAS28 scores were similar for TOFIDENCE vs Actemra in treatment period 2 (weeks 24-48)3
Mean change in DAS28 from baseline up to Week 48 was similar among the three treatment groups3
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ACR20=American College of Rheumatology ≥20% improvement criteria; ACR50=American College of Rheumatology ≥50% improvement criteria; ACR70=American College of Rheumatology ≥70% improvement criteria; CRP=C-reactive protein; DAS28=Disease Activity Score on 28 joints; ESR=erythrocyte sedimentation rate; MTX=methotrexate; RA=rheumatoid arthritis.
Reference
- TOFIDENCE Prescribing Information, Cambridge, MA: Biogen.
- Leng X, Leszczynski P, Jeka S, et al. Fifty-Two-Week Results From a Phase 3, Randomized, Double-Blind, Active- Controlled Clinical Trial to Compare BAT1806/BIIB800, a Proposed Tocilizumab Biosimilar, With a Tocilizumab Reference Product in Subjects With Moderate to Severe RA With an Inadequate Response to Methotrexate. Poster P0917. Presented at the American College of Rheumatology (ACR). 10-14 November 2022, Philadelphia, PA, USA.
- Leng X, Leszczynski P, Jeka S, et al. 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. 2024;6(1):e40-e50.