FRI0104 A LARGE REAL WORLD, LONG TERM SAFETY STUDY OF PATIENTS WITH INFLAMMATORY RHEUMATIC DISEASES TREATED WITH INFLIXIMAB BIOSIMILAR (CT-P13): POOLED ANALYSIS OF FOUR GLOBAL POST-MARKETING STUDIES
Authors: Kyungmin Baek, Yoon Jee Lee, Sujin Lee, Houng Kim, Seulgi Lee, Jeong Eun Park, SangJoon Lee
Journal: Annals of the Rheumatic Diseases (2019)

<h3>Background:</h3> CT-P13 was the first approved biosimilar monoclonal antibody globally and is currently marketed in 88 countries, including the European Union (EU) and the United States (US). Since approval, 4 observational prospective cohort studies have been conducted in the EU, Canada and Korea to assess long term safety of CT-P13 in patients with Rheumatoid arthritis (RA), ankylosing spondylitis (AS), psoriatic arthritis (PsA) and psoriasis (PSO). Safety data from the 4 studies were pooled and analysed. <h3>Objectives:</h3> To evaluate the long-term safety of CT-P13 in patients with RA, AS, PsA and PSO in global real world, post-marketing studies <h3>Methods:</h3> Safety data from patients registered in the 4 observational studies (KOREA PMS, CT-P13 4.2, CT-P13 4.4, and PERSIST) have been collected after marketing authorisation was granted. The incidence of Adverse Events of Special Interests (AESIs) from subjects with RA, AS, PsA and PsO who were treated at least 1 dose of CT-P13 with the data cut point of Dec27, 2017 were analysed. <h3>Results:</h3> A total of 1579 patients were treated with at least 1 dose of CT-P13 across the 4 studies (RA = 670; AS = 819; PsA/PsO = 90). Mean age (years) of patients per RA, AS and PsA/PSO indication was 54.5, 40.3 and 52.9, respectively. Average exposure duration (days) to CT-P13 in patients with RA, AS and PsA/PSO was 280.3, 254.0 and 322.1, respectively, and the mean maximum dose of CT-P13 (mg/kg) with RA, AS and PsA/PSO patients was 3.77, 4.51 and 4.31, respectively. Treatment emergent adverse events (TEAEs) were reported in 50.15%, 37.73% and 26.67% for RA, AS and PsA/PSO, respectively. Incidence of TEAEs in RA indication is consistent with the historical rate in this population. Treatment emergent serious adverse events (TESAEs) were reported for 12.39%, 4.52% and 3.33% for RA, AS and PsA/PSO patients, respectively. Incidence of TEAEs leading to discontinuation were 8.81%, 3.42% and 7.78% for RA, AS and PsA/PSO. Two deaths and 1 death were reported among RA and AS patients, respectively. The causes of death in RA patients were acute respiratory distress syndrome (ARDS) and bronchopneumonia; the cause of death in the AS patient was unknown. AESIs of CT-P13 were analysed in safety population who were treated with CT-P13 at least once by the data cut point. No events of serum sickness, haematologic malignancy, demyelinating disorder, sarcoidosis/sarcoidosis-like reaction were reported. <sup>[1]</sup>6 patients of PSO were analysed with PsA patients <h3>Conclusion:</h3> The results of this analysis show that treatment with CT-P13 is well tolerated in patients with RA, AS, PsA and PSO in the real world setting. Incidence of all AESIs including serious infection and TB are comparable to historical data in literatures<sup>[1][2]</sup> and originator Infliximab EU product information. <h3>References:</h3> [1] Vander Cruyssen, et al. (2010), Seven-year follow-up of infliximab therapy in rheumatoid arthritis patients with severe long-standing refractory disease: attrition rate and evolution of disease activity. [2] Delabaye, et al. (2010), 74-week follow-up of safety of infliximab in patients with refractory rheumatoid arthritis. Originator Infliximab EU product information https://www.ema.europa.eu/documents/product-information/remicade-epar-product-information_en.pdf <h3>Disclosure of Interests:</h3> Kyungmin Baek Shareholder of: Celltrion, Inc., Employee of: Celltrion, Inc., Yoon Jee Lee Employee of: Celltrion, Inc., Sujin LEE Employee of: CELLTRION, INC, HoUng Kim Shareholder of: Celltrion Healthcare.Co.,Ltd, Employee of: Celltrion Healthcare.Co.,Ltd, SeulGi Lee Employee of: Celltrion, Inc., Jeong Eun Park Employee of: Celltrion, Inc., SangJoon Lee Shareholder of: Celltrion, Inc., Employee of: Celltrion, Inc.