The Ministry of Health of the Russian Federation has issued the 12th version of the Temporary guidelines for the prevention, diagnosis and treatment of COVID-19. The new document includes, inter alia, a revision of the «Pathogenetic treatment» section, where it clarifies the criteria and terms of prescribing genetically engineered biological drugs and elaborates on the possible medicines combinations.
While preparing each version of the Temporary guidelines, a working group of more than 100 experts of various specialties scrutinizes research results and real-world evidence. This time the expert analysis resulted in a significant expansion of olokizumab usage in clinical practice.
In the new document, olokizumab is additionally included in treatment regimens for mild and critical COVID-19 patients in hospital setting. To compare, the drug was previously recommended to treat patients with moderate severity only. Secondly, the maximum dosage has been expanded: it is now possible to use up to 256 mg in a single injection. Moreover, clinicians have been provided with a possibility to administer the drug repeatedly, should the effect prove insufficient.
Olokizumab, the IL-6 cytokine inhibitor, can be additionally prescribed if therapy with IL-6 receptor inhibitors such as tocilizumab, sarilumab or levilimab deemed ineffective. This procedure also works in reverse.
Kira Ivanova, VP of Original Brands & Markets Strategy, R-Pharm Group:
As the coronavirus pandemic still presents an ongoing global challenge, it became our mission to promptly come up with a solution. Working alongside care providers, we were able to provide COVID-19 patients with much needed medicine, which offered a glimpse of hope in combatting this disease. We trust the updated guidelines will allow to unleash the full potential of olokizumab in COVID-19 and save even more lives.
IL-6 is one of the key cytokines that mediate hyperinflammation in patients with COVID-19. It induces the synthesis of C-reactive protein and ferritin. High level of these proteins is associated with macrophage activation syndrome and hemophagocytic lymphohistiocytosis, leading to a surge in the number of deaths. Inhibition of this cytokine plays an important role in blocking the cytokine storm.
Olokizumab is a humanized monoclonal antibody of Ig G4/ϰ isotype developed as an IL-6 inhibitor. Therefore, in February 2020, due to an increasing number of cytokine storm cases among COVID-19 patients in Russia, R-Pharm started the evaluation efficacy and safety of olokizumab in patients with the new coronavirus infection.
Based on successful research results in rheumatoid arthritis, olokizumab received market authorization in the Russian Federation in May 2020. Since June 2020, the drug has been included in the Temporary guidelines for the prevention, diagnosis and treatment of COVID-19 in Russia and became one of the first treatments of moderate coronavirus infection. On October 14, 2020, olokizumab was included in the Essential Drug List by the Russian Ministry of Health.
Taking into account the variability of SARs-CoV-2 virus strains and clinical profiles of patients, R-Pharm team continues to study efficacy and safety of olokizumab: in May 2021 Phase 3 clinical trials were rolled out to evaluate high dose IV administration in COVID-19 patients with hyperinflammation.