New IL-6 inhibitor olokizumab (Artlegia) in routine clinical practice in patients with moderate and severe rheumatoid arthritis

Davidyan S.Y., Kiryukhina N.A., Rybakova D.V.

Rationale: Rheumatoid arthritis is a prevalent severe immunoinflammatory disease which defines its medical and socioeconomical significance. In 2020 olokizumab — biological product developed and produced in Russia — was registered by Ministry of Health of the Russian Federation for treatment of rheumatoid arthritis. Olokizumab is a humanized monoclonal antibody (IgG4-cappa type) specifically inhibiting interleukin-6 (IL-6). Product efficacy and safety were confirmed in recent international phase 3 clinical trials which included 2444 patients over 18 years old with moderate and severe rheumatoid arthritis (CREDO 1, CREDO 2, CREDO 3). There is limited data on use of olokizumab in rheumatoid arthritis in Russian Federation in routine practice.

Objective: To describe the first experience with olokizumab use in the Department of rheumatology of Pirogov National Medical and Surgical center in patients with rheumatoid arthritis.

Materials and methods: The product was given to 17 patients with RA — 14 women and 3 men aged 20 to 75 years old, with typical clinical features they had polyarthritis with morning stiffness, joint tenderness and swelling on examination, increased ESR and CRB according to test results. Most patients had severe or moderate rheumatoid arthritis and functional disorders, 7 out of 17 patients had extraarticular manifestations. The patients were followed-up for 12 weeks. The response evaluation was based on pain assessment by the patient, tender joint count, swollen joint count (based on evaluation of 28 joints), patient global assessment of disease activity, CRP, ESR and DAS28-CRP index.

Results: Olokizumab use resulted in reduction of pain intensity in 88% of patients. There was a trend to reduction and normalization of CRP, especially in patients with initially high RA activity. After 12 weeks the DAS-CRP and the percentage of patients with severe and moderate disease activity reduced. After 12 weeks the percentage of patients with low activity was 58.8%, and with moderate activity was 41.2%.

Conclusion: The olokizumab therapy led to positive results both in naïve patients and in those previously treated with biologics. The rapid reduction of acute-phase reactants was accompanied by positive changes in articular syndrome. Longer observation is required for more detailed description of olokizumab efficacy and safety.

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