Comparison of the efficacy and safety of a proposed biosimilar MSB11456 with tocilizumab reference product in subjects with moderate-to-severe rheumatoid arthritis: results of a randomised double-blind study
Authors' conclusion
Therapeutic equivalence was demonstrated for efficacy endpoints, and safety and immunogenicity analyses support the similarity of the two treatments.
Study context
- Population
- Adults with moderate-to-severe active rheumatoid arthritis (RA) and inadequate response to ≥1 DMARD (synthetic or biologic) receiving MTXrandomised
- Participants
- 604 adults
- Comparison
- MSB11456 vs European Union (EU)-approved tocilizumab, 162 mg SC weekly
- Primary endpoint
- Mean change from baseline in DAS28-ESR; equivalence if 95% CI (EMA)/90% CI (FDA) of the difference entirely within −0.6 to 0.6 and −0.6 to 0.5, respectively
- Follow-up
- Week 24
Methodological detailsmulticentre, double-blind, multinational, parallel-group, equivalence, At week 24, patients were rerandomised to continued treatment or MSB11456
- Multicentre
- Double-blind
- Multinational
- Parallel-group
- Equivalence
- At week 24, patients were rerandomised to continued treatment or MSB11456
Primary result
As reported in the abstract
Change from baseline in DAS28-ESR
- Therapeutic equivalence was demonstrated for efficacy endpoints
- Equivalence margins: 95% CI (European Medicines Agency) −0.6 to 0.6; 90% CI (US Food and Drug Administration) −0.6 to 0.5
- 604 randomised patients
Secondary outcomes
All other efficacy and immunogenicity endpoints, incl. patients switched from EU-approved tocilizumab to MSB11456 · to week 52 (efficacy); to week 55 (immunogenicity)
- Similarity between treatments was shown
Parts of this Brief are withheld: the automatic checks could not confirm them against the abstract.
Original publication
Comparison of the efficacy and safety of a proposed biosimilar MSB11456 with tocilizumab reference product in subjects with moderate-to-severe rheumatoid arthritis: results of a randomised double-blind study. RMD Open. Published 5 February 2024. doi:10.
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