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.
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
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
*Actemra is represented by EU-approved tocilizumab in the study.
*Actemra is represented by EU-approved tocilizumab in the study.
†ACR rates based on the evaluable number of patients at each time point.
*Actemra is represented by EU-approved tocilizumab in the study.
At week 48, mean SD changes were seen in the Actemra, Actemra/TOFIDENCE, and TOFIDENCE groups:
*Actemra is represented by EU-approved tocilizumab in the study.
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.