FRI0122 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-naive) 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. Conclusion Incidences of TEAEs were similar and there was no discernible pattern across the most common TEAEs between groups. These interim analysis results from the PERSIST study conducted in a real-world setting are consistent with the known safety profile of infliximab and do not demonstrate new safety information to change the benefit−risk profile of CT-P13. Disclosure of Interests Peter C. Taylor Grant/research support from: Celgene, Galapagos, Eli Lilly, UCB, Consultant for: AbbVie, Galapagos, Gilead, Eli Lilly, Pfizer Inc, Robin Christensen Grant/research support from: AbbVie Inc, and the Oak Foundation, Speakers bureau: Roche, Shahrzad Moosavi Shareholder of: Pfizer Inc, Employee of: Pfizer Inc, Pamela Selema Shareholder of: Pfizer Inc, Employee of: Pfizer Inc, Ruffy Guilatco Employee of: Pfizer Inc, Heather Fowler Consultant for: Pfizer UK Limited & Pfizer Inc, Claire Bombardier Grant/research support from: Abbvie, Amgen, Bristol-Myers Squibb, Celgene, Eli Lilly, Hospira, Janssen, Merck, Novartis, Pfizer Inc, Roche, Sanofi, UCB, Consultant for: AbbVie, Hospira, Janssen, Merck, Novartis, Pfizer Inc, Sanofi, Speakers bureau: Roche, Boulos Haraoui Grant/research support from: AbbVie Inc, Merck, and Novartis, Consultant for: AbbVie Inc, Amgen Inc, Eli Lilly, Novartis, Pfizer Inc, and UCB