Establishing Biosimilarity

Phase III Clinical Study:

TOFlDENCE biosimilarity was supported by comparing the efficacy and safety profile to Actemra* in RA patients1,2

Study Design

Adult woman icon
N=621
Calendar icon
Baseline to
Week 48
Gear icon
Phase lll, randomized, double-blind equivalence study. Patients with moderately to severely 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.
Target icon
Primary endpoint was the proportion of patients with RA and an inadequate response to methotrexate achieving an ACR20 response at Week 24 (Treatment Period 1). Efficacy outcomes were measured up to Week 48, while pharmacokinetics, safety, and immunogenicity were measured up to Week 52 (Treatment Period 2, Weeks 24-48).


TOFIDENCE showed similar efficacy and comparable safety, immunogenicity, and pharmacokinetic profiles to Actemra.

*Actemra is represented by EU-approved tocilizumab in the study. Actemra is a registered trademark of Chugai Seiyaku Kabushiki Kaisha Corp., a member of the Roche Group.

N=number of randomized patients entering Treatment Period 1.

 

Adapted from: Leng, et al. 2024

Actemra is represented by EU-approved tocilizumab in the study.

Primary endpoint achieved: TOFIDENCE demonstrated similar ACR20 scores vs Actemra* (Treatment Period 1)1

Percentage of Patients Who Achieved ACR20 at Week 241

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)1

The 90% CI of the difference in ACR20 at Week 24 were contained within predefined equivalence margins1†

 

Adapted from: Leng, et al. 2024

*Actemra is represented by EU-approved tocilizumab in the study.

Phase III data results shown were conducted in the Full Analysis Set.

The proportion of patients achieving ACR20 response rates at Week 24 were similar between patients receiving Actemra and TOFIDENCE1

TOFIDENCE demonstrated similar ACR20 scores to Actemra* at Week 48 (Treatment Period 2)2

Percentage of Patients Who Achieved ACR20 at Week 482

 

*Actemra is represented by EU-approved tocilizumab in the study.

TOFIDENCE demonstrated similar ACR20/50/70 scores vs Actemra* at Week 48 (Treatment Period 2)2†

*Actemra is represented by EU-approved tocilizumab in the study.

ACR rates based on the evaluable number of patients at each time point.

 

 

Secondary endpoint: Similar reductions in Disease Activity Score (DAS28) were demonstrated with TOFIDENCE vs Actemra* up to Week 24 (Treatment Period 1)1

*Actemra is represented by EU-approved tocilizumab in the study.

Secondary endpoint: DAS28 scores were similar for TOFIDENCE vs Actemra* in Treatment Period 2 (Weeks 24‑48)2

 

At week 48, mean SD changes were seen in the Actemra, Actemra/TOFIDENCE, and TOFIDENCE groups:

  • DAS28-ESR: −3.7 (1.5), −4.1 (1.4), and −4.2 (1.5)
  • DAS28-CRP: −3.1 (1.1), −3.4 (1.2), and −3.4 (1.2)

*Actemra is represented by EU-approved tocilizumab in the study.

Help start a movement for more patients

You also might be interested in:

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.

References
  1. 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.
  2. Leng X, Leszczyński P, Jeka S, et al. 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. 2024;26(1):157. doi: https://doi.org/10.1186/s13075-024-03375-w