Cookies on this website

We use cookies to ensure that we give you the best experience on our website. If you click 'Accept all cookies' we'll assume that you are happy to receive all cookies and you won't see this message again. If you click 'Reject all non-essential cookies' only necessary cookies providing core functionality such as security, network management, and accessibility will be enabled. Click 'Find out more' for information on how to change your cookie settings.

Abstract Objective Report results from PERSIST, a real-life, observational, prospective cohort study of CT-P13, an infliximab (IFX) biosimilar, for treatment of patients with rheumatoid arthritis (RA), ankylosing spondylitis (AS) or psoriatic arthritis (PsA) who were biologic-naïve or switched from IFX reference product (IFX-RP; Remicade®). Methods Adult patients were recruited during usual care at 38 sites in Europe and Canada, and enrolled by their physicians after meeting eligibility according to the country-approved label for CT-P13. Primary outcomes were to determine drug utilization, treatment persistence and assess safety. Patients were followed for up to 2 years. Data were analysed and reported descriptively. Results Of 351 patients enrolled, 334 were included in the analysis (RA, 40.4%; AS, 34.7%; PsA, 24.9%). The safety analysis set comprised all 328 patients treated with CT-P13. The majority (58.2%) of patients received CT-P13 monotherapy, most (72.6%) by dosing every 6 or 8 weeks. Mean treatment persistence was 449.2 days; 62.3% of patients completed 2-years treatment. In all, 214 treatment-emergent adverse events (TEAEs) were reported in 38.4% of patients. Most TEAEs were of mild or moderate intensity; 13 were severe. Most commonly reported TEAEs were drug ineffective (9.5%) and infusion-related reactions (5.2%). Most frequently reported infection-related TEAEs were upper respiratory tract infections (3.0%), nasopharyngitis (2.1%) and bronchitis (1.5%). No patients experienced tuberculosis. Conclusion : Drug utilization and treatment persistence with CT-P13 were consistent with historical reports of IFX-RP in this patient population. Safety findings did not identify new concerns for CT-P13 in the treatment of patients with RA, AS or PsA.

Original publication

DOI

10.1093/rap/rkab026

Type

Journal article

Journal

Rheumatology advances in practice

Publisher

Oxford University Press (OUP)

Publication Date

22/04/2021