In a Phase III clinical trial, the investigational biosimilar drug CT-P13 was as safe and effective as Remicade® (infliximab) among rheumatoid arthritis (RA) patients with active disease in spite of treatment with methotrexate. These results were published in Annals of the Rheumatic Diseases.
Biological therapies are treatments that are made from human and/or animal materials rather than from chemical processes. Biological therapies play an important role in the treatment of many diseases, including RA.
A biosimilar is a product that is very similar to an already-approved biological therapy. Biosimilars must show similar efficacy and safety to the original product in order to be approved, and have the potential advantage of being less expensive.
CT-P13 is an investigational biosimilar drug that is intended to be similar to Remicade. To compare CT-P13 with Remicade, researchers conducted a Phase 3 clinical trial among 606 RA patients with active disease in spite of treatment with methotrexate. In addition to continuing treatment with methotrexate, patients were treated with either Remicade or CT-P13.
- At week 30, an ACR20 response (at least a 20% reduction in symptoms) was achieved by 61% of patients treated with CT-P13 and 59% of patients treated with Remicade. A good or moderate response based on European criteria was achieved by 86% of patients treated with CT-P13 and 87% of patients treated with Remicade.
- The two drugs also had similar rates of adverse effects.
This study suggests that for the treatment of RA, CT-P13 has similar efficacy and safety to Remicade.
Reference: Yoo DH, Hrycaj P, Miranda P et al. A randomised, double-blind, parallel-group study to demonstrate equivalence in efficacy and safety of CT-P13 compared with innovator infliximab when coadministered with methotrexate in patients with active rheumatoid arthritis: the PLANETRA study. Annals of the Rheumatic Diseases. 2013;72:1613-1620.