Shanghai Biomabs Pharmaceutical Reports P-III Study Results of CMAB008 (biosimilar, infliximab) for Rheumatoid Arthritis
Shots:
- The P-III study evaluating CMAB008 (3mg/kg, IV) vs infliximab (3mg/kg) at 0, 2, 6, 14, 22 and 30wks. across 31 centers in China
- The results showed non-inferior efficacy of CMAB008 vs infliximab with similar early and lasting therapeutic effects, and the equivalence is further demonstrated. The therapy was well tolerated & the results were published in Rheumatology and Therapy.
- 57.6% vs 62.2% achieved ACR20 at 30wk. while the 2EPs incl. safety, efficacy, immunogenicity, and PK were also highly similar, 82.4% had 1 TEAE with comparable frequencies b/w CMAB008 cohort (83.3%) and the infliximab cohort (81.5%), frequency of TEAEs leading to discontinuation or dose reduction, severe AEs and infusion reaction were similar across treatment groups
Ref: HCP Live | Image: Shanghai Biomabs
Related News:- Mabpharm's Biobetter (CMAB008) for Infliximab Receives NMPA's Approval in China
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