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
CREDO is a large-scale international program for phase III clinical trials of olokizumab, initiated by
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
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.