CMAB008 With MTX Therapy in Adult Patients With Moderately to Severely Active Rheumatoid Arthritis

Summary

CMAB008 is an infliximab biosimilar candidate. The host cell of Remicade is mouse myeloma SP2/0 cell, however, the host cell of CMAB008 is CHO (Chinese hamster ovary cell). It seems that CMAB008 has lower immunogenicity and higher safety, because Remicade comprises more complex-type and hybrid-type glycans than CMAB008. However, it is not yet known whether CMAB008 is not inferior to Remicade. This randomized, double-blind trial investigates the efficacy and safety of CMAB008 for moderately to severely active rheumatoid arthritis, compared to Remicade.

Timeline

Start

2018-03-30

Primary completion

2019-06-23

Completion

2019-08-27

Publications

• Ye H, Liu S, Xu J, Chai K, He D, Fang Y, Xie Q, Liu H, Liu Y, Hua B, Hu J, Zhang Z, Zhou M, Zhao D, Li Y, Jiang Z, Wang M, Li J, Zhang Z, Li X, Li Y, Sun E, Bi L, Wei W, Tie N, He L, Huang X, Zhang Y, Huang Q, Wang X, Liu X, Li J, Su Y. Efficacy and Safety of CMAB008 Compared with Innovator Infliximab in Patients with Moderate-to-Severe Rheumatoid Arthritis Receiving Concomitant Methotrexate: A Randomized, Double-blind, Multi-center, Phase III Non-inferiority Study. Rheumatol Ther. 2023 Jun;10(3):757-773. doi: 10.1007/s40744-023-00544-2. Epub 2023 Mar 25.
• Su Y, Li J, Wang C, Zhang X, Hou S, Guo H, Deng C, Ou L, Wang J. Population Pharmacokinetics of CMAB008 (an Infliximab Biosimilar) and Remicade(R) in Healthy Subjects and Patients with Moderately to Severely Active Rheumatoid Arthritis. Adv Ther. 2023 Mar;40(3):1005-1018. doi: 10.1007/s12325-022-02396-8. Epub 2023 Jan 6.

Drugs

Indications