Efficacy and safety of CT-P47 versus reference tocilizumab: 32-week results of a randomised, active-controlled, double-blind, phase III study in patients with rheumatoid arthritis, including 8 weeks of switching data from reference tocilizumab to CT-P47
Authors' conclusion
Efficacy equivalence, alongside comparable PK, safety and immunogenicity profiles, was determined between CT-P47 and r-TCZ in adults with RA, including after switching from r-TCZ to CT-P47.
Study context
- Population
- Patients with rheumatoid arthritis (RA)randomised in TP1
- Participants
- 471 patients
- Comparison
- CT-P47 vs EU-approved reference tocilizumab, 8 mg/kg every 4 weeks
- CT-P47n = 234
- Reference tocilizumab (r-TCZ)n = 237reference
- Primary endpoint
- Dual primary: mean change from baseline in DAS28-ESR at week 12 and week 24
- Follow-up
- Week 12 and week 24
Methodological detailsdouble-blind, active-controlled, phase III, equivalence, switching (TP2)
- Double-blind
- Active-controlled
- Phase III
- Equivalence
- Switching (TP2)
Primary result
As reported in the abstract
Mean change from baseline in DAS28-ESR (dual primary endpoint), estimated treatment difference · week 12
Estimated difference in DAS28-ESR at week 12 (analysis of covariance (ANCOVA)); within predefined equivalence margin 95% CI −0.6, 0.6
−0.01
95% CI −0.26, 0.24
Secondary outcomes
Dual primary endpoint: mean change from baseline in DAS28-ESR, estimated treatment difference · week 24
- Estimated difference in DAS28-ESR at week 24 (ANCOVA with multiple imputation); within predefined equivalence margin 90% CI −0.6, 0.5
- −0.10 (90% CI −0.30, 0.10)
- Verdict: 90% CI contained within the predefined equivalence margins
Secondary efficacy endpoints and pharmacokinetic (PK) · up to week 32
- Comparable between groups up to week 32
Safety
Overall safety · up to week 32
- Comparable between groups
Original publication
Efficacy and safety of CT-P47 versus reference tocilizumab: 32-week results of a randomised, active-controlled, double-blind, phase III study in patients with rheumatoid arthritis, including 8 weeks of switching data from reference tocilizumab to CT-P47. RMD Open. Published 18 October 2024. doi:10.
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