Shanghai Henlius Reports P-III Placebo-Controlled Trial Results of HLX01 (biosimilar, rituximab) for Active Rheumatoid Arthritis
Shots:
- The P-III placebo-controlled trial evaluates rituximab biosimilar HLX01 (1000mg, IV) + methotrexate vs PBO in a ratio (2:1) in 275 biologic-naïve patients with active RA across 40 centers in China
- The combination therapy was superior to PBO in clinical outcomes with a comparable safety profile, ~40% with RA may not respond to methotrexate, ACR20 response rate @24wk. (61% vs 36%), patients were switched from PBO to HLX01 @24wk., the response rate increased with greater decreases in measures of disease activity while pain, physical function & mental health indicators also improved
- ADAs (6.0% vs 3.3%) before 24wk.; 3.8% vs 8.8% who continued with biosimilar & switched to the biosimilar from PBO after 24wk., TEAE (83% vs 80%), treatment discontinuation due to TEAEs (7.1% vs 4.3%)
Ref: Biosimilar | Image: Henlius
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