R-Pharm confirmed Efficacy and Safety of Olokizumab in treatment of Rheumatoid Arthritis

September 14
  • Olokizumab is the first Russian original biologic for treatment of rheumatoid arthritis and also the first global direct inhibitor of interleukin-6 (IL-6)  authorized for commercial use;
  • Global trial program CREDO design was developed in cooperation with FDA and EMA for providing registration of drug in the largest markets;
  • Up to date CREDO is the only one such large-scale trial program in Russian pharma: R-Pharm invested in clinical trials more than 9 billion rubles over 7 years. This project was supported by financial aid from VEB.RF;
  • In 2020 R-Pharm Group started to prepare for Olokizumab registration in EU, US and other countries and organized a tender among leading international pharmaceutical companies to select an additional site for drug production;
  • CREDO-3 (global, phase 3 clinical trial, NCT02760433) confirmed efficacy and safety of olokizumab in the treatment of rheumatoid arthritis, inadequately controlled by TNF-alpha inhibitors.

R-Pharm Group announces the positive results of the global CREDO 3 trial is the final one in a large series of phase 3 programs with 2,444 patients enrolled from 19 countries. The study evaluated efficacy and safety of olokizumab in combination with methotrexate in a patient population that is particularly difficult to treat - the patients with rheumatoid arthritis, who have failed TNF-alpha inhibitors.

In both tested dosing regimens - once a month and twice a month - olokizumab outperformed placebo in patients who had not responded to TNF-alpha blockers (such as adalimumab, infliximab, etanercept and others). The results will be presented to an international audience of specialists at the Annual Congress of American College of Rheumatology 2020, European Congress of Rheumatology 2021  and will become the basis for marketing authorization application of the biologic in the US, Europe, Asia and Latin America.

“Olokizumab was proved to be superior to placebo both in achieving the primary endpoint (20% improvement in ACR index) and in the proportion of patients who achieved low disease activity according to DAS28 (CRP),” notes CREDO-3 coordinating investigator Dr. Michael Luggen. “This is convincing evidence of the efficacy of this new biologic agent with a novel mechanism of action.”

The majority of patients (95%) who completed the CREDO 3 study decided to continue olokizumab treatment as part of the long-term (until 2022), open-label CREDO 4 study the main goal of which is to confirm the long-term safety of the drug.

 “Confirming the safety and efficacy of olokizumab has been a key goal for R-Pharm as a product developer. That is why CREDO's research program is so extensive”, - says Alexey Repik, Chairman of the Board of R-Pharm Group. “The research is managed with maximum compliance and care to the details and we are completely satisfied with the results. We continue our study of olokizumab to ensure the confidence of rheumatologists in the long-term safety of this therapy.”

CREDO is a large-scale international program for phase III clinical trials of olokizumab, initiated by R-Pharm Group. The CREDO 1 study included 428 patients from 42 sites in Russia, Belarus and Bulgaria, proved the efficacy and safety of olokizumab in combination with methotrexate in patients with moderate to severe rheumatoid arthritis and was completed in 2019. СREDO 2 confirmed superiority to placebo and non-inferiority to adalimumab in a large scale trial-based data based on 1648 patients from 18 countries.

About Artlegia (olokizumab)

It’s a humanized monoclonal antibody that directly blocks the inflammatory cytokine - interleukin-6. The phase II clinical trials, including 340 patients with rheumatoid arthritis (Genovese M., 2014; Takeuchi Y., 2016), and a phase III (CREDO 1, CREDO 2 and CREDO 3) trials, including 2444 patients from 19 countries has been completed successfully. CREDO 4, a long-term study of the drug safety, is currently ongoing. It enrolled patients who were willing to continue therapy after the completion of one of the double-blind studies.

In May 2020, olokizumab received a market authorization from the Ministry of Health of the Russian Federation under the trade name "Artlegia".  It is produced at the Yaroslavl plant of R-Pharm Group.

About rheumatoid arthritis

Rheumatoid arthritis is widespread throughout the world. According to systematic analysis results published in the Annals of the Rheumatic Diseases, the global prevalence of rheumatoid arthritis increased by 7.4% in 1990-2017, and was estimated up to about 20 million cases in 2017. This is a systemic disease of the connective tissue with a predominant lesion of small joints, leading to early disability and a reduction in patient life expectancy. The treatment base for rheumatoid arthritis is drug therapy, which includes the use of a wide range of drugs. In recent years, several innovative genetically engineered biological drugs have been developed to treat this disease. Olokizumab is one of them.

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