R-Pharm: Artlegia (olokizumab)

Main article: Rheumatoid arthritis

About olokizumab

The reason for the development of olokizumab and large-scale studies was the tendency to increase the number of patients diagnosed with rheumatoid arthritis in the world and the insufficient effectiveness of treatment with existing drugs in some categories of patients. According to R-Pharm, olokizumab is the first Russian innovative genetically engineered biological drug and the world's first registered monoclonal antibody for the treatment of rheumatoid arthritis, directly inhibiting interleukin-6 (IL-6) (data as of November 2020). Olokizumab has been shown to be effective in combination with methotrexate even in cases where conventional therapy or treatment with TNF-a inhibitors shows no improvement in clinical presentation.

2024: Obtaining a certificate "Made in Russia "

The drug for the therapy of rheumatoid arthritis "Artlegia" received a certificate "Made in Russia" for export promotion under the national brand, which is sold by the Russian Export Center (REC, part of the ВЭБ.РФ). The developer of the drug is the R-Pharm group of companies, which announced this on July 12, 2024.

source = P-Pharm

REC implements a promotion program under the "Made in Russia" brand. You can join it through a free and quick voluntary certification procedure. There is a basic condition for obtaining a "Made in Russia" certificate: a company must produce products that have improved qualities or improved characteristics. Successful verification of compliance with the program allows you to guarantee the reliability of the manufacturer and the safety of products.

Rheumatoid arthritis is a severe disabling disease that reduces the quality and life expectancy of patients. The basis of treatment is drug-induced anti-inflammatory therapy. Clinical studies of olokizumab were conducted as part of the ambitious R-Pharm program for the development of innovative drugs.

In 2020, Artlegia was approved in Russia for the treatment of patients with moderate/severe rheumatoid arthritis. The production of the drug is organized at the Yaroslavl R-Pharm plant. As of July 2024, Artlegia is included in the Rheumatoid Arthritis clinical guidelines and therapy recommendations, COVID-19 Ministry of Health Russia as well as in the list of vital and essential drugs. The drug is registered in,, and Azerbaijan Kazakhstan Kyrgyzstan the Republic, Belarus it is planned to register in other friendly. countries

2023

Initiation of the study in patients with advanced pulmonary fibrosis

A clinical study of the original drug of the R-Pharm group of companies in patients with progressive pulmonary fibrosis has started. R-Pharm announced this on December 25, 2023.

Progressive pulmonary fibrosis presents a significant medical and social problem, leading to disability and death of patients. The methods of treatment existing for December 2023 may slow down, but not stop the development of the disease. At the same time, in a number of patients, rapid progression is observed even despite the treatment. In this situation, it is extremely important to find new therapeutics for stabilizing lung function and reducing the risk of exacerbations and suppressing the autoimmune process of inflammation. We hope that the clinical study will confirm the early data obtained by Russian doctors on the effectiveness of direct blocking of the proinflammatory cytokine IL-6, and doctors will have at their disposal a new tool that can contain the development of the disease and prolong patients' active lives, "said Mikhail Samsonov, medical director of R-Pharm.

Registration in Belarus

The original Russian drug against rheumatoid arthritis Artlegia (olokizumab), developed by the R-Pharm group of companies, was registered in the Republic of Belarus. The developer announced this on September 14, 2023.

Rheumatoid arthritis occurs in about 1% of the adult population, more often in women. The average age of clinical manifestation is 30-45 years. According to the Ministry of Health of the Republic of Belarus, in 2022, more than 22 thousand patients with rheumatoid arthritis were registered in the country, including 1,622 patients diagnosed for the first time. Early diagnosis and properly selected therapy can reduce the risk of disability and disability.

Artlegia is a monoclonal antibody for rheumatoid arthritis therapy that blocks the cytokine IL-6, not its receptor. The efficacy and safety of Artlegia in the treatment of rheumatoid arthritis is confirmed in a large-scale program of international clinical studies, which included 2,444 patients from 19 countries around the world. In Russia, olokizumab is included in the list of vital and essential drugs for human use, as well as included in the clinical recommendations "Rheumatoid Arthritis" and temporary guidelines for the treatment, prevention and diagnosis of COVID-19.

In addition to the Republic of Belarus, Artlegia is already registered in Russia, Kazakhstan, Kyrgyzstan and Azerbaijan, registration is planned in a number of other countries.

R-Pharm Group continues to work actively to bring the original Artlegia drug product to international markets. Our mission is to expand access to modern and highly effective therapies, as well as improve the quality of medical care for patients, including those with a socially significant autoimmune disease such as rheumatoid arthritis, "said Kira Ivanova, R-Pharm vice president for in-house brand development.

Initiation of olokizumab clinical trial program in adolescents with juvenile idiopathic arthritis

On June 9, 2023, R-Pharm Group announced the initiation of a study of the efficacy and safety of olokizumab (Artlegia) in adolescents 12-17 years old with juvenile idiopathic arthritis manifesting polyarthritis.

Juvenile idiopathic arthritis (JIA) is the most common chronic rheumatological disease in children and adolescents, characterized by progressive joint damage and a high percentage of disability. About 50% of children who develop JIA retain active disease in adulthood, which leads to a further decrease in quality of life and an increase in the number of complications.

If methotrexate is not effective enough, many patients need genetically engineered biologics (GEBDs) for successful treatment. A quarter of patients who initiated GEBD subsequently need a change of drug. At the same time, the average time to switch to a second biological drug significantly decreased from 55.2 months in 2008 to only 7.2 months in 2016. Thus, the search for new drugs for the treatment of JIA in children and adolescents is an urgent task in the development of the health care system.

Olokizumab is a monoclonal antibody registered for the treatment of rheumatoid arthritis that blocks directly interleukin-6, a molecule involved in inflammatory, including rheumatic, processes. It has already proven its effectiveness in the therapy of rheumatoid arthritis in adults and since 2021 has been included in the clinical recommendations of the Russian Ministry of Health on this nosology. An innovative biological drug is produced at the Yaroslavl R-Pharm plant, which guarantees uninterrupted provision of patients with rheumatoid arthritis in the Russian Federation.

The study will evaluate the pharmacokinetics, pharmacodynamics, efficacy, safety, and immunogenicity of olokizumab. For adolescents with JIA, the drug will be administered according to a regimen registered for the treatment of rheumatoid arthritis in adults. The study is open-label, with no active or placebo control - all patients will receive the same therapy. It is planned to include 15 patients with polyarticular, advanced oligoartricular and systemic JIA without systemic manifestations.

The first participant was enrolled in the study in March 2023 and is continuing treatment to date. This study is very important for our patients, since the larger the choice of drugs with different mechanisms of action, the higher the chance of long-term remission, absence of pain and complications, "explained Mikhail Kostik, professor at the Department of Hospital Pediatrics, St. Petersburg State Medical University, Ministry of Health of Russia.

Juvenile idiopathic arthritis is a rapidly progressive disease that, in the absence of proper treatment, can lead not only to loss of mobility, but also to growth and development delay, visual impairment up to blindness, damage to internal organs. "R-Pharm" initiated a clinical study in order to provide Russian patients of childhood and adolescence with effective and modern biological therapy, "said Mikhail Samsonov, medical director of R-Pharm.

The study takes place in a number of centers, including the FSAU National Medical Research Center of Children's Health V.A. Nasonova Clinical Institute of Children's Health named after N.F. Filatov UDKB, First Moscow State Medical University named after I.M. Sechenov FSBEI HE "Bashkir State Medical University" Ministry of Health of the Russian Federation GBUZ Yaroslavl Region "Regional Children's Clinical Hospital," GBUZ. "Morozovskaya DGKB DZM

Registration in Kyrgyzstan

On March 14, 2023, the R-Pharm Group of Companies announced the registration in the Kyrgyz Republic of an original proprietary drug Artlegia (olokizumab) intended for the treatment of rheumatoid arthritis and coronavirus infection. The drug is included in the Clinical Recommendations "Rheumatoid Arthritis" from 2021, as well as in the temporary guidelines of the Ministry of Health of Russia for the treatment of patients with COVID-19 from 2020.

Artlegia is a registered monoclonal antibody that directly blocks the IL-6, not its receptor, which distinguishes it from other existing drugs of the interleukin-6 inhibitor class.

The efficacy and safety of Artlegia has been confirmed as part of the multi-year CREDO international research program, in which more than 2,400 patients from 19 countries took part. For March 2023, a study of the long-term safety and effectiveness of Artlegia CREDO4 has also been completed, the results of which are presented in June 2022.

The launch of olokizumab on the Kyrgyz market continues a series of registrations of this promising development outside Russia. Thanks to the close interaction of R-Pharm and the healthcare system of the Kyrgyz Republic, thousands of patients with autoimmune disorders will receive effective therapy, "said Vasily Ignatiev, General Director of R-Pharm.

Olokizumab was registered by the Ministry of Health of Russia under the trade name Artlegia in the spring of 2020. In the winter of the same year, the drug was registered in the Republic of Azerbaijan, which was its first registration outside Russia, and in August 2022, the development of R-Pharm received a registration certificate in Kazakhstan.

2022: Obtaining permission from the Ministry of Health to conduct a clinical trial

The R-Pharm Group of Companies received permission from the Ministry of Health of the Russian Federation to conduct a clinical study of its own original drug Artlegia (olokizumab) for the latest indication - idiopathic pulmonary fibrosis. The study of the drug will take place in 11 centers in Russia, the start is scheduled for 2023. The company announced this on December 2, 2022.

Idiopathic pulmonary fibrosis (ILF) is a life-threatening and, as of December 2022, poorly treatable lung disease, which is expressed in inflammation, compaction and scarring of the lung tissue, which leads to a significant decrease in oxygen supply to the blood.

Olokizumab is a registered monoclonal antibody that directly blocks interleukin-6, not its receptor, which distinguishes it from other existing drugs of the IL-6 inhibitor class. Its efficacy and safety in the main indication, rheumatoid arthritis, has been confirmed through the multi-year CREDO International Clinical Research Program, which involved more than 2,400 patients from 19 countries worldwide.

Due to the ability to prevent a "cytokine storm," Artlegia was registered and also included in the guidelines of the Ministry of Health of the Russian Federation for the therapy of coronavirus infection.

Interest in this disease has increased significantly in the medical community amid the COVID-19 epidemic and the study of lung damage. We expect that the clinical trial of olokizumab will confirm the recently published early clinical data on the effectiveness of therapy with a direct inhibitor of interleukin-6, which will significantly extend the active period of life of patients, stopping the progression of the disease, - emphasized the medical director of R-Pharm Mikhail Samsonov.

2020

Recognition as a vital and essential drug

In October 2020, in Russia, olokizumab was recognized as a vital and most important drug, which can make innovative methods of treating rheumatoid arthritis for patients in need of therapy more affordable.

Artlegia ( olokizumab) study results

On September 14, 2020, R-Pharm announced the positive results of the CREDO 3 global study, completing a series of phase 3 double-blind studies involving 2444 patients from 19 countries around the world. The study examined the efficacy and safety of the R-Pharm drug olokizumab (TN: Artlegia) in combination with methotrexate in a difficult-to-treat population - among patients with rheumatoid arthritis, poorly controlled therapy with TNF-alpha inhibitors.

R-Pharm biotechnological development has proven effective in the treatment of rheumatoid arthritis

According to the company, olokizumab in both studied dosing regimens - once a month and twice a month - surpassed placebo in the treatment of patients in whom therapy with TNF-alpha inhibitors (such as adalimumab, infliximab, etanercept, etc.) was not effective enough. The results of the studies will be presented to a wide audience of medical professionals and will serve as the basis for the application for registration of the drug in the USA, Europe, Asia and Latin America.

Olokizumab demonstrated superiority over placebo both at the primary endpoint (20% ACR improvement) and in the proportion of patients achieving low disease activity according to DAS28 (CRP). noted Dr. Mikael Laggen, coordinating researcher on CREDO-3

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

Proof of safety and efficacy of olokizumab are key objectives for R-Pharm as a developer. That's why CREDO's research program is so extensive. For September 2020, we are continuing the study of olokizumab. told the chairman of the board of directors of the R-Pharm group of companies

Registration of Artlegia (olokizumab) for rheumatoid arthritis

On May 29, 2020, the R-Pharm group announced that it had completed the registration process for the treatment of rheumatoid arthritis Artlegia (olokizumab). The production of the drug is carried out at the R-Pharm enterprise in Yaroslavl, the drug has already been sent to Russian medical institutions.

Artlegia (olokizumab) is a humanized monoclonal antibody that directly blocks the mediator of inflammation Interleukin-6. Phase II clinical trials involving 340 patients with rheumatoid arthritis have been successfully completed (Genovese M., 2014; Takeuchi Y., 2016), and a phase III research program comprising 2,444 patients from 19 countries.