A NATIONAL, MULTICENTER, SECONDARY DATA USE STUDY EVALUATING EFFICACY AND RETENTION OF FIRST-LINE BIOLOGIC TREATMENT WITH TOCILIZUMAB IN PATIENTS WITH RHEUMATOID ARTHRITIS IN REAL-LIFE SETTING FROM TURKBIO REGISTRY

Background: Tocilizumab (TCZ) is a human anti-interleukin (IL)-6 receptor antibody approved in Turkey for the treatment of rheumatoid arthritis (RA). Objectives: In this study our purpose was to describe the disease activity, quality of life (QoL), and retention rate in RA patients who were prescribed TCZ as first-line biologic treatment in a real-world setting. Methods: Anonymized patient registry of TURKBIO was used based in a national, multicenter, and retrospective context. We conducted a search in the registry between years 2013 and 2020 and included adult RA patients who were prescribed with TCZ as their first-line biologic treatment with a post-TCZ follow-up of at least 6 months. CDAI, DAS28-(ESR), and HAQ-DI scores in 6, 12, and 24 months were obtained. Pairwise comparison was carried out for survey scores across baseline and timepoints. Subgroup analysis for route of TCZ administration was performed. EULAR response criteria were used for response evaluation. Retention of TCZ was evaluated by Kaplan-Meier analysis. Results: Overall,130 patients with a mean RA duration of14 years were included in the study. 87.7% of the patients were female and mean age was53 (SD; 15.0). Median duration of follow-up was 18.5 months. Majority (90.8%) of patients were given tocilizumab via intravenous route at baseline. Number of patients with ongoing TCZ treatment and follow-up at 6, 12, and 24 months were 121 (93%), 85 (65%), and 46 (35%), respectively. Remission rates at 6, 12, and 24 months per CDAI (<2.8) and DAS28-(ESR) (<2.6) scores were 61.5%, 44.6%, 30%, and 54.6%, 40.8%, 27.7%, respectively. CDAI, DAS28-(ESR) and HAQ-DI survey scores significantly improved at 6, 12 and 26 months, respectively (p<0.001) ( Table 1 ) in both IV and SC TCZ subgroups. At 6, 12 and 24months 74.8%, 82.5% and 86.4% of patients achieved a EULAR good response respectively. Twenty-three patients (17.6%) discontinued TCZ at 24 months. Of these, 19 patients discontinued due to unsatisfactory response. Retention rates of TCZ at 6, 12, and 24 months were 93%, 84.3%, and 72.2%, respectively ( Figure 1 ). Conclusion: TCZ as a first-line biologic treatment was found to be clinically effective in this real-world study with a high retention rate. These results are in line with the results gathered from previous TCZ controlled and real-life studies in which TCZ was found clinically safe and effective. REFERENCES: [1]Haraoui B, Casado G, Czirjak L, Taylor A, Dong L, Button P, Luder Y, Caporali R. Tocilizumab Patterns of Use, Effectiveness, and Safety in Patients with Rheumatoid Arthritis: Final Results from a Set of Multi-National Non-Interventional Studies. Rheumatol Ther. 2019 Jun;6(2):231-243. [2]Favalli EG, Raimondo MG, Becciolini A, Crotti C, Biggioggero M, Caporali R. The management of first-line biologic therapy failures in rheumatoid arthritis: Current practice and future perspectives. Autoimmun Rev. 2017 Dec;16(12):1185-1195. [3]Haraoui B, Jamal S, Ahluwalia V, Fung D, Manchanda T, Khraishi M. Real-World Tocilizumab Use in Patients with Rheumatoid Arthritis in Canada: 12-Month Results from an Observational, Noninterventional Study. Rheumatol Ther. 2018 Dec; 5(2): 551–565. Disclosure of Interests: Ayten Yazici Speakers bureau: PFIZER, AbbVie, NOVARTIS, Özlem Özdemir Işik: None declared, Ediz Dalkiliç Speakers bureau: AbbVie, UCB Pharma, PFIZER, Roche, MSD, NOVARTIS, Süleyman Serdar Koca Speakers bureau: MSD, NOVARTIS, GILEAD, PFIZER, ABDI IBRAHIM, UCB Pharma, AMGEN, SANOFİ, Yavuz Pehlivan Speakers bureau: PFIZER, NOVARTIS, MSD, CELLTRION, Consultant of: PFIZER, Soner Şenel: None declared, Nevsun Inanc Speakers bureau: NOVARTIS, PFIZER, ABDI IBRAHIM, JANNSEN, Paid instructor for: NOVARTIS, PFIZER, ABDI IBRAHIM, JANNSEN, Consultant of: NOVARTIS, PFIZER, ABDI IBRAHIM, JANNSEN, Grant/research support from: NOVARTIS, PFIZER, ABDI IBRAHIM, JANNSEN, Servet Akar Speakers bureau: LILLY, MSD, NOVARTIS, GILEAD, PFIZER, ABDI IBRAHIM, JANNSEN, UCB Pharma, AMGEN, Paid instructor for: LILLY, NOVARTIS, GILEAD, PFIZER, ABDI IBRAHIM, UCB, AMGEN, Grant/research support from: PFIZER, Sema Yilmaz: None declared, Özgül Soysal Gündüz: None declared, Ayse Cefle Speakers bureau: UCB Pharma, PFIZER, MSD, AbbVie, AMGEN, NOVARTIS, Fatos Onen Speakers bureau: AbbVie, LILLY, MSD, NOVARTIS, GILEAD, PFIZER, ABDI IBRAHIM, JANNSEN, UCB Pharma, AMGEN, İbrahim Etem-MENARINI, Paid instructor for: AbbVie, LILLY, NOVARTIS, GILEAD, PFIZER, ABDI IBRAHIM, UCB Pharma, AMGEN, İbrahim Etem-MENARINI, Grant/research support from: PFIZER Citation: Ann Rheum Dis, volume 80, supplement 1, year 2021, page 1140Session: Rheumatoid arthritis - biological DMARDs (Publication Only)