Establishing clinical equivalence
Phase lll Clinical Study:
A randomized study comparing the efficacy and safety profile of reference tocilizumab to TOFIDENCE1,2
TOFIDENCE demonstrated equivalent efficacy to reference TCZ1
The proportion of patients achieving ACR20 response rates at week 12 and week 24 were comparable between patients receiving reference tocilizumab and TOFIDENCE1
*ACR20 response rates for regulatory-agency-preferred predefined timepoints (primary estimand).
Adapted from: Leng X, et al. 20241
TOFIDENCE demonstrated comparable reductions from baseline disease
activity scores vs rTCZ up to Week 241
Mean changes in DAS28 were comparable to rTCZ up to Week 241
Adapted from: Leng X, et al. 20241
TOFIDENCE demonstrated similar responses in ACR20/50/70 to rTCZ at Week 482
ACR20/50/70 scores at Week 48 were comparable between the three treatment groups2
Adapted from: Leng X, et al. 2022
TOFIDENCE demonstrated comparable DAS28-CRP scores vs rTCZ in TP22
Mean changes in DAS28 were similar between Week 28 and Week 48 among the three treatment groups2
Adapted from: Leng X, et al. 2022
TOFIDENCE demonstrated comparable safety profile vs rTCZ across multiple parameters up to Week 241
Treatment emergent adverse events reported of patients in either treatment group at up to Week 241
TEAE type
Total reports of any adverse event were comparable between TOFIDENCE 66% (n=206) and rTCZ 65% (n=201)1
The occurrence of all TEAEs was 64% (n=201) for TOFIDENCE and 63% (n=196) for rTCZ1
Treatment-related TEAE type
*All events occurred in <0.5% of subjects.
Adapted from: Leng X, et al. 20241
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Abbreviations: ACR20, American College of Rheumatology ≥20% improvement criteria; ACR50, American College of Rheumatology ≥50% improvement criteria; ACR70, American College of Rheumatology ≥70% improvement criteria; CI, confidence interval; DAS28, Disease Activity Score 28; DAS28-CRP, Disease Activity score 28 using C-reactive protein; DAS28-ESR, Disease Activity Score using erythrocyte sedimentation rate; EMA, European Medicines Agency; FDA, Food and Drug Administration; NMPA, National Medical Products Administration; rTCZ, reference tocilizumab; SD, standard deviation; TEAE, treatment emergent adverse event; TCZ, tocilizumab; TP2, treatment period 2.
