R-Pharm Group of Companies successfully registered Artlegia (olokizumab), a novel drug for treatment of rheumatoid arthritis in the first country - Russia. The drug is manufactured at the R-Pharm Yaroslavl Plant of Finished Dosage Forms, and has already been sent to a number of Russian health centers.
R-Pharm acquired the worldwide rights for development, manufacturing, and commercialization of olokizumab from UCB, a Belgian based global biopharma company at the Phase II stage of the drug development in 2013. After that, it initiated a large-scale international clinical program of Phase III studies, CREDO. The first study has been completed in 2019. It included 428 patients from 42 study sites in Russia, Belorussia, and Bulgaria and demonstrated the efficacy and safety of olokizumab in combination with methotrexate in patients with moderate to severe rheumatoid arthritis. A single subcutaneous injection once a month proved to be an effective treatment alternative for these patients. The results of CREDO-2 and CREDO-3 international studies, which recruited over 2,000 patients in 18 countries, including the USA, Latin America, and Europe, are expected to follow this summer. Most patients who participated in the Phase III trials decided to continue treatment in the long-term safety and efficacy study CREDO-4 that will continue until 2022.
In 2020, a new clinical study began. It is aimed at investigation of the efficacy and safety of Artlegia in patients with severe COVID-19.
“The appearance of the first original domestic biotechnology drug for the treatment of rheumatoid arthritis in our country is a big step forward in the fight against this severe disabling disease. Olokizumab has a great potential in treatment of patients with autoimmune diseases, and now we are evaluating its efficacy in the treatment of cytokine storm in patients with severe coronavirus infection. We will be ready to present the results very soon,” said Vasily Ignatiev, the General Director of R-Pharm.
About Artlegia (olokizumab)
Olokizumab is a humanized monoclonal antibody directly blocking IL-6. The phase II clinical studies, which included 340 patients with rheumatoid arthritis (Genovese M., 2014; Takeuchi Y., 2016), were successfully completed in past. The Phase III research program in a total of 2444 patients from 19 countries is nearing its completion. The program consists of the 4 international studies:
- CREDO 1, which proved the efficacy and safety of 2 dosing regimens, 64 mg every 2 or 4 weeks, in 428 patients with rheumatoid arthritis (Nasonov E., 2019). The convenience of administering 64 mg once every 4 weeks can positively affect patients’ compliance to treatment.
- CREDO 2 and CREDO 3, studies that investigated the efficacy of olokizumab in different groups of patients with rheumatoid arthritis, have been successfully completed. Their results will be available in the summer of 2020.
- CREDO 4, a long-term study of the safety of this product, which enrolled patients who wished to continue the therapy after completing the first three studies, is ongoing.
About CREDO Program
Clinical Rheumatoid Arthritis Development for olokizumab/CREDO is a clinical phase 3 trials program for olokizumab that consist of the following studies:
- CREDO 1 (NCT02760368) is a regional multicenter study evaluating olokizumab versus placebo efficacy and safety in RA patients from Russia / Belarus / Bulgaria with inadequate response to methotrexate.
- CREDO 2 (NCT02760407) is a global multicenter comparative study evaluating olokizumab versus adalimumab and placebo efficacy and safety in RA patients with inadequate response to methotrexate.
- CREDO 3 (NCT02760433) is a global study evaluating olokizumab versus placebo efficacy and safety in RA patients with inadequate response to TNF-α therapies.
- CREDO 4 is a common open-label extension study for patients who have completed CREDO 1, CREDO 2, or CREDO 3.
About rheumatoid arthritis
Rheumatoid arthritis is a widespread disease worldwide. According to the clinical guidelines of the Ministry of Health of the Russian Federation (2018), the prevalence rate of rheumatoid arthritis is about 0.61% of the Russian population or nearly 900,000 people. This is a systemic connective tissue disease that typically affects small joints, which suffer from erosive and destructive polyarthritis with a complex autoimmune pathogenesis, potentially leading to early disability and shorter life expectancy of RA patients. In the recent years, a number of innovative genetically engineered biological products have been developed to treat this disease. Olokizumab, an inhibitor of an important pro-inflammatory cytokine (IL-6), is one of these products.