Real-world safety data from patients with rheumatic diseases treated with CT-P13, an infliximab biosimilar: an interim analysis from an observational study

Background CT-P13, an infliximab biosimilar, has been available in Europe and Canada since 2015, and real-world experience with CT-P13 is important to support the safety of this medication. PERSIST is an ongoing, observational cohort study evaluating CT-P13 as treatment for rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis (PsA) in a real-world setting. Objectives This interim analysis reports safety outcomes for patients who received CT-P13 as their first biologic (Biologic-naïve) or who switched from infliximab reference product (IFX-RP) to CT-P13 (Switched) based on data collected from September 2015 to December 2017. Methods Patients were recruited during usual care at 38 academic and community sites in 6 European countries and Canada. Adult RA, AS or PsA patients prescribed CT-P13 or locally-sourced IFX-RP at the investigator’s discretion and according to the approved label were eligible. Data were analysed descriptively. Results This analysis included 329 patients (RA, n=134; AS, n=110; PsA, n=85). Of these, 6 (1.8%) were not treated, 3 (0.9%) completed study treatment, 244 (74.2%) were ongoing and 76 (23.1%) discontinued study treatment, most commonly due to lack of response (30 [9.1%]). Demographics and baseline characteristics were generally similar between groups (Table 1). Most treatment-emergent adverse events (TEAEs; Table 2) were of mild or moderate intensity; 7/129 events were severe. Most commonly reported adverse events were related to infection (n=33; 10.2%); most frequently reported infection-related TEAEs were nasopharyngitis (n=6; 1.9%), respiratory tract infection (n=5; 1.5%) and pneumonia (n=4; 1.2%). No case of tuberculosis was reported. Eight (2.5%) patients reported infusion related reactions.