The drug Complarate© produced by GENERIUM is a biosimilar of the drug Actemra© from a Swiss manufacturer. The comparability of the two medications has been demonstrated in preclinical and clinical studies conducted at 38 centers across 14 cities in Russia.
"Rheumatoid arthritis and juvenile arthritis are chronic conditions that significantly reduce the quality of life for patients. Effective therapy for these diseases holds great medical and socio-economic importance. The development of domestically produced medications for the treatment of severe and socially significant diseases is a priority for GENERIUM," noted Daniil Talyansky, CEO of GENERIUM. Among the main indications for the use of tocilizumab are rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis, and cytokine release syndrome.
Juvenile idiopathic (rheumatoid) arthritis is one of the most common and debilitating rheumatic diseases found in children. The incidence ranges from 2 to 16 cases per 100,000 children under the age of 16. Approximately 5.5% of patients have systemic juvenile idiopathic arthritis, a multifactorial disease with unknown etiology and immune-aggressive pathogenesis, which, if left untreated, can lead to the development of a serious fatal complication known as macrophage activation syndrome1.
Rheumatoid arthritis is one of the most severe immune-inflammatory diseases in adults, affecting not only the joints but also various organs and systems. The peak incidence occurs between the ages of 40 and 55. Within 8 to 10 years after manifestation, the disease leads to disability in 37–60% of cases2.
The prevalence of rheumatoid arthritis among the adult population in different geographical areas of the world ranges from 0.5% to 2%. According to official statistics, over 320,000 patients suffering from this systemic disease were registered in Russia in 2019. According to the Russian epidemiological study, approximately 0.6% of the total population is affected by rheumatoid arthritis, which amounts to around 850,000 patients3 4.
The pathogenesis of rheumatoid arthritis is based on the activation of immune system cells and excessive production of cytokines that trigger inflammatory processes. One of the key cytokines is interleukin-6. Its hyperproduction in rheumatoid arthritis leads to systemic inflammatory reactions, dissolution of the mineral component of bones, destruction of collagen, and degradation of bone tissue.
Tocilizumab is the first interleukin-6 inhibitor registered for the treatment of rheumatoid arthritis and systemic juvenile idiopathic arthritis. It suppresses and delays the progression of pathological processes, can slow disease progression, and improve the physical condition of patients5.
1 Clinical guidelines "Juvenile Arthritis with Systemic Onset," Ministry of Health of the Russian Federation 2021, https://cr.minzdrav.gov.ru/schema/26_2
2 Lila A.M., Dreval R.O., Shipitsyn V.V. Assessment of organization of medical care and drug provision for patients with rheumatic diseases, and the socioeconomic burden of these diseases in the Russian Federation. Sovremennaya Revmatologiya=Modern Rheumatology Journal. 2018;12(3):112-119. (In Russ.) https://doi.org/10.14412/1996-7012-2018-3-112-119
3 Folomeeva O.M., Galushko E.A., Erdes S.F. Prevalence of rheumatic diseases in adult populations of Russian Federation and USA. Rheumatology Science and Practice. 2008;46(4):4-13. (In Russ.) https://doi.org/10.14412/1995-4484-2008-529
4 General morbidity of the adult population in Russia in 2017. Statistical materials. Part IV Moscow. 2018