Comparing immunogenicity and safety following transition from reference rituximab to biosimilar rituximab (DRL_RI) in patients with rheumatoid arthritis: a randomized, double-blind, phase 3 study
Authors' conclusion
Immunogenicity was low and comparable in RA patients transitioning to DRL_RI or continuing on RP/RMP. The overall safety profile in patients transitioning to DRL_RI did not appear to differ in frequency, severity, or quality from patients continuing on RP/RMP and was in line with the known safety profile of rituximab.
Study context
- Population
- Patients with active rheumatoid arthritis (RA) with prior exposure to reference rituximab (Reference Product (RP)/Reference Medicinal Product (RMP)); mean age 59.8 years
- Participants
- 140 patients
- Comparison
- Transition to DRL_RI vs continuing reference rituximab
- DRL_RIn = 70
- RP/RMPn = 70reference
- Primary endpoint
- Immunogenicity: incidence of anti-drug antibodies (ADAs) after dosing (with neutralizing antibodies (NAbs), ADA titre and TMRC)
- Follow-up
- 12 weeks
Methodological detailsdouble-blind, phase 3, transition (switching) study
- Double-blind
- Phase 3
- Transition (switching) study
Primary result
As reported in the abstract
Incidence of ADA after dosing · Day 15, Week 8 and Week 12 (DRL_RI); Week 12 (RP/RMP)
Further findings
- NAb positivity · Week 8 — DRL_RI
- 1 events
ADA titre
- ADA titre values did not significantly differ between the two groups
Time-matched Rituximab Concentration (TMRC)
- Comparable between groups, indicating no interference for immunogenicity assessment
Safety
TEAEs · follow-up till 26 weeks
Treatment-emergent adverse events (TEAEs) · follow-up till 26 weeks
- Drug-related, discontinuation-leading, grade ≥ 3 and serious TEAEs also comparable
Original publication
Comparing immunogenicity and safety following transition from reference rituximab to biosimilar rituximab (DRL_RI) in patients with rheumatoid arthritis: a randomized, double-blind, phase 3 study. Arthritis Res Ther. Published 21 December 2024. doi:10.
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