AB0306 EXPERIENCE WITH RITUXIMAB BIOSIMILAR BCD-020 IN PATIENTS WITH RHEUMATOID ARTHRITIS IN REAL-WORLD CLINICAL PRACTICE ACCORDING TO DATA FROM MOSCOW UNIFIED ARTHRITIS REGISTRY (MUAR)
Authors: G. Lukina, E. Koltsova, E. Shmidt, K. Lytkina, E. Zhilyaev
Journal: Annals of the Rheumatic Diseases (2020)

Background: The introduction of perspective anti-rheumatic biologic agents into clinical practice has not only increased therapy efficacy and improved medical prognosis in patients with rheumatoid arthritis (RA), but also resulted in a dramatic increase in treatment cost and, therefore, in a reduced accessibility of the innovative treatment for patients. For this reason, over the last years, there has been a huge interest towards developing biosimilars [1,2]. Objectives: To assess the effectiveness and safety of switching from reference rituximab (RTX ref ) to rituximab biosimilar (RTX bs ) BCD-020 in patients with RA in real clinical practice according to the data from MUAR. Methods: Patients with RA who treated by RTX ref at the onset and then switched to RTX bs (BCD-020) were enrolled in the study. For all patients were performed: swollen and tender joints count, ESR, CRP, biochemistry and immunologic blood analyses. Assessment of dynamic of DAS28, RAPID3, HAQ-DI was performed. The great attention was given to the therapy safety assessment. RTX ref effectiveness and safety profile was assessed at the moment of switching; data for RTX bs (BCD-020) were collected not earlier than 6 months after switching. Results: 46 patients with RA were enrolled, 80.5% were women; the mean age was 59.5±12.2 years; 91.3% were RF-positive, 63% - ACCPA-positive, the disease activity at the moment of switching was moderate, the mean DAS28 was 3.5. The duration of RTX ref therapy until switching was 36.8 ± 26.8 months; the duration of the follow-up period for BCD-020 biosimilar was 12.1 ± 6.18 months. In 43.5% of patients, previously inefficiency or intolerance of other biologics was discovered. The proportion of patients who received concomitant therapy with glucocorticoids or methotrexate (MTX) was 45.7% and 43.5%, respectively. The mean MTX dose was 13.6 mg/wk. The mean dose of RTX ref /BCD-020 was 1000 mg. The stability dynamic of clinical parameters was retained after switching to biosimilar (Tab.1) without significant difference between the rituximab products (р&gt;0.05). Table 1. Comparison of Efficiency Parameters for the Reference Rituximab and Biosimilar BCD-020 Parameter Reference rituximab Biosimilar BCD-020 DAS28 (ESR) 3.39 3.34 HAQ-DI 1.48 1.44 RAPID3 12.9 12.6 The safety profile of RTX ref and RTX bs (BCD-020) was also similar. None of the patients discontinued BCD-020 therapy for reasons related to safety or inefficiency. Conclusion: Within the framework of routine clinical practice, switching from reference rituximab to BCD-020 biosimilar is not accompanied by a change in efficiency and safety profile of the therapy and does not pose a risk of discontinuation, which is coherent with the results of the registration clinical trial for BCD-020. [3] References: [1]Edwards CJ, et al. Switching to biosimilars: current perspectives in immune-mediated inflammatory diseases. Expert Opin Biol Ther. 2019 Oct;19(10):1001-1014. doi: 10.1080/14712598.2019.1610381. Epub 2019 May 6. [2]Dörner T, et al. The changing landscape of biosimilars in rheumatology. Ann Rheum Dis 2016;75:974–982. doi:10.1136/annrheumdis-2016-209166 [3]Nasonov EL, et al. The results of a phase III comparative clinical trial of rituximab (Acellbia and MabThera) in rheumatoid arthritis (the BIORA study). Nauchno-Prakticheskaya Revmatologiya = Rheumatology Science and Practice. 2016;54(5):510-519 (In Russ.). doi: http://dx.doi.org/10.14412/1995-4484-2016-510-519 Disclosure of Interests: Galina Lukina Speakers bureau: Novartis, Pfizer, UCB, Abbvie, Biocad, MSD, Roche, Ekaterina Koltsova: None declared, Evgeniya Shmidt Speakers bureau: MSD, Novartis, Pfizer, Karine Lytkina Speakers bureau: Novartis, Eli Lilly, Pfizer, UCB, Abbvie, Biocad, MSD, Jonson&amp;Jonson, Evgeniy Zhilyaev Speakers bureau: Novartis, UCB, Pfizer, Biocad, Abbvie, MSD, Roche