Safety and efficacy of biosimilar CT-P17 and adalimumab in RA

Key clinical point: Citrate-free adalimumab biosimilar (CT-P17) and European Union-approved adalimumab (EU-adalimumab) demonstrated equivalent efficacy and comparable safety in patients with rheumatoid arthritis (RA).

Major finding: At week 24, CT-P17 and EU-adalimumab groups showed similar 20% improvement by the American College of Rheumatology criteria response rate (82.7%). The 95% confidence interval (CI; −5.94 to 5.94) and 90% CI (−4.98 to 4.98) for estimated treatment difference were within predefined equivalence margin, demonstrating therapeutic equivalence. Overall, safety was similar between both treatment groups.

Study details: This was a randomized, double-blind phase 3 study of 648 patients with RA who were randomly allocated to receive 40 mg of either CT-P17 (n=324) or EU-adalimumab (n=324), every 2 weeks until week 48.

Disclosures: This study was funded by Celltrion, Inc. (Incheon, Republic of Korea). The authors reported receiving support, investigator fees, speaking fees, and/or consulting for various pharmaceutical companies including Celltrion, Inc. SJ Lee, YJ Bae, GE Yang, and JK Yoo reported being employees of Celltrion, Inc.

Source: Kay J et al. Arthritis Res Ther. 2021 Feb 5. doi: 10.1186/s13075-020-02394-7.

Key clinical point: Citrate-free adalimumab biosimilar (CT-P17) and European Union-approved adalimumab (EU-adalimumab) demonstrated equivalent efficacy and comparable safety in patients with rheumatoid arthritis (RA).

Major finding: At week 24, CT-P17 and EU-adalimumab groups showed similar 20% improvement by the American College of Rheumatology criteria response rate (82.7%). The 95% confidence interval (CI; −5.94 to 5.94) and 90% CI (−4.98 to 4.98) for estimated treatment difference were within predefined equivalence margin, demonstrating therapeutic equivalence. Overall, safety was similar between both treatment groups.

Study details: This was a randomized, double-blind phase 3 study of 648 patients with RA who were randomly allocated to receive 40 mg of either CT-P17 (n=324) or EU-adalimumab (n=324), every 2 weeks until week 48.

Disclosures: This study was funded by Celltrion, Inc. (Incheon, Republic of Korea). The authors reported receiving support, investigator fees, speaking fees, and/or consulting for various pharmaceutical companies including Celltrion, Inc. SJ Lee, YJ Bae, GE Yang, and JK Yoo reported being employees of Celltrion, Inc.

Source: Kay J et al. Arthritis Res Ther. 2021 Feb 5. doi: 10.1186/s13075-020-02394-7.

Key clinical point: Citrate-free adalimumab biosimilar (CT-P17) and European Union-approved adalimumab (EU-adalimumab) demonstrated equivalent efficacy and comparable safety in patients with rheumatoid arthritis (RA).

Major finding: At week 24, CT-P17 and EU-adalimumab groups showed similar 20% improvement by the American College of Rheumatology criteria response rate (82.7%). The 95% confidence interval (CI; −5.94 to 5.94) and 90% CI (−4.98 to 4.98) for estimated treatment difference were within predefined equivalence margin, demonstrating therapeutic equivalence. Overall, safety was similar between both treatment groups.

Study details: This was a randomized, double-blind phase 3 study of 648 patients with RA who were randomly allocated to receive 40 mg of either CT-P17 (n=324) or EU-adalimumab (n=324), every 2 weeks until week 48.

Disclosures: This study was funded by Celltrion, Inc. (Incheon, Republic of Korea). The authors reported receiving support, investigator fees, speaking fees, and/or consulting for various pharmaceutical companies including Celltrion, Inc. SJ Lee, YJ Bae, GE Yang, and JK Yoo reported being employees of Celltrion, Inc.

Source: Kay J et al. Arthritis Res Ther. 2021 Feb 5. doi: 10.1186/s13075-020-02394-7.