Poster Session A
Rheumatoid arthritis (RA)
Narendra Maharaj, MD
Dr Reddys Laboratories Ltd
Hyderabad, Andhra Pradesh, India
No financial relationships with ineligible companies to disclose
To assess immunogenicity and safety in patients with active rheumatoid arthritis (RA) transitioning from US-Rituximab (RP) or EU-Rituximab (RMP) to DRL_RI (proposed rituximab biosimilar), in comparison to those continuing RP/RMP.
Methods:
This double-blind, Phase 3 study included 140 RA patients having prior exposure to RP/RMP; transitioned to DRL_RI (n=70) or continued with RP/RMP (n=70) for two 1000 mg infusions on Days 1 and 15. Anti-drug antibodies (ADA), neutralizing antibodies (NAb), and ADA titre were assessed over a 12-week period, with a safety follow-up till 26 weeks.
Results:
Incidence of ADA after dosing was low in both groups: 1.4% in DRL_RI group on Day 15, Week 8, and Week 12; and 2.9% in RP/RMP group at Week 12. Only 1 patient in DRL_RI group was positive for NAb at Week 8. ADA titre values did not significantly differ between the two groups. The time-matched rituximab concentration was comparable between groups, indicating no interference for immunogenicity assessment.
Treatment-emergent adverse events (TEAEs) were reported by 34.3% and 38.6% patients, respectively, in DRL_RI and RP/RMP groups. Incidences of TEAEs that were drug-related, leading to treatment discontinuation, grade ≥ 3, or serious, were also comparable.
Conclusion:
Immunogenicity was low and comparable in RA patients transitioning to DRL_RI or continuing RP/RMP. The overall safety profile in patients transitioning to DRL_RI did not differ in frequency, severity from patients continuing RP/RMP and was consistent with the known safety profile of rituximab. ClinicalTrials.gov identifier: NCT0426877; EudraCT: 2019‐002810‐37
N. Maharaj: Dr.Reddys Laboratories, 3; D. Uppada: Dr.Reddys Laboratories, 3; N. MAREDDY: Dr.Reddys Laboratories, 3; P. Pundra: Dr.Reddys Laboratories, 3; A. Batalov: None; D. Ivanova: None; n. staykova: None; A. Baranauskaite: None; L. Hassan: None.