Assessment of effectiveness and safety of biosimilar infliximab (CT-P13) in a real-life setting for treatment of patients with active rheumatoid arthritis or ankylosing spondylitis

Abstract

Objective: To assess the effectiveness and safety of infliximab biosimilar, CT-P13, administered in a real-life setting to adult patients with active rheumatoid arthritis (RA) or ankylosing spondylitis (AS).

Methods: This multi-center, non-interventional, observational study was conducted in Bulgaria, the Czech Republic, and Romania. A total of 151 patients with severe active RA (n = 81) or AS (n = 70) were enrolled and treated with CT-P13 for 24 weeks, according to current medical recommendations. Effectiveness was assessed using the 4-item Disease Activity Score 28 with C-reactive protein (DAS28-CRP) for RA patients, and the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) for AS patients. Safety was assessed by withdrawals and adverse events (AEs).

Results: A total of 129 patients (RA: 67; AS: 62) were included in the effectiveness analysis. CT-P13 treatment significantly improved DAS28-CRP scores at 12 and 24 weeks (p = .0001 vs baseline for both timepoints) in patients with RA and BASDAI scores at 12 and 24 weeks (p = .0001 vs baseline for both timepoints) in patients with AS. CRP levels were significantly reduced at 12 and 24 weeks (p = .0001 vs baseline for both timepoints). Among 713 infusions, 34 AEs were reported (4.8% of infusions), of which 11 were considered related to CT-P13 treatment. Two of seven serious AEs were considered possibly (hepatocellular injury) or definitely (dyspnoea due to allergic infusion reaction) treatment-related. Eight patients discontinued CT-P13 due to AEs and four patients were withdrawn due to therapeutic failure.

Conclusions: CT-P13 was effective and safe in a real-life setting in patients with active RA or AS.

Keywords:

• Infliximab biosimilar
• CT-P13
• Rheumatoid arthritis
• Ankylosing spondylitis

Transparency

Declaration of funding

This manuscript was not funded.

Declaration of financial/other interests

The authors have disclosed that they have no significant relationships with or financial interests in any commercial companies related to this study or article. A CMRO peer reviewer on this manuscript declared that s(he) is a scientific consultant of Celltrion. All other CMRO peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Acknowledgments

Medical writing assistance was provided by Content Ed Net (Budapest, Hungary), with funding from Egis Pharmaceuticals PLC (Budapest, Hungary).

Previous presentation

This article was presented at an abstract at the Annual Meeting of the American College of Rheumatology (ACR), November 11–16, 2016, in Washington, DC.