R-Pharm’s Olokizumab Meets Endpoints in Pivotal Global Phase III Study in Rheumatoid Arthritis

July 2

R-Pharm Group announces positive results of CREDO 2, a pivotal global (1648 patients in 18 countries) Phase III clinical study of IL-6 inhibitor olokizumab (OKZ) in patients with rheumatoid arthritis (RA) inadequately controlled by methotrexate therapy. The topline results of CREDO 2 demonstrate that both evaluated OKZ dosing regimens (once per month and twice per month) are superior to placebo and non-inferior to adalimumab.  All primary and secondary endpoints have been achieved.  96% of the patients who completed CREDO 2 study decided to continue the treatment with OKZ in the open-label extension study CREDO 4.

The results of CREDO 2 study are going to be submitted for publication at ACR 2020 as well as marketing authorization abroad Russia (in the USA, Europe, Asia, Latin America).

“Despite the number of biotech pharmaceuticals that are currently available for RA treatment being solid, new medicines are still in high demand. Olokizumab has already received its first marketing authorization in Russia. The data accumulated during CREDO 2 study suggest that olokizumab may become potentially advantageous for patients with moderate-to-severe rheumatoid arthritis inadequately responding to methotrexate therapy”, said Mikhail Samsonov, Chief Medical Officer of R-Pharm Group.

About CREDO 2 Study

The primary objective of this study was to evaluate the efficacy of olokizumab versus placebo and adalimumab in patients with moderately to severely active rheumatoid arthritis inadequately controlled by methotrexate therapy. 1648 patients from 18 countries were randomized into treatment arms in a 2:2:2:1 ratio: olokizumab 64 mg administered subcutaneously once every 2 weeks or once every 4 weeks, adalimumab 40 mg administered subcutaneously once every 2 weeks or placebo. The double-blind 24-week treatment period was followed by a safety follow-up for another 20 weeks. The monitoring of safety events and the overall safety assessment were conducted by independent bodies: the data safety monitoring board and the cardiovascular adjudication committee. After the treatment period completion the eligible subjects had an option to be enrolled in CREDO 4 study (an open long-term extension study evaluating tolerability and safety of olokizumab).

About CREDO Program

Clinical Rheumatoid Arthritis Development for olokizumab/CREDO is a clinical Phase III OKZ trials program that consists of the following studies:

•          CREDO 1 (NCT02760368) is a regional multicenter study evaluating the efficacy and safety of olokizumab versus placebo in RA patients with inadequate response to methotrexate therapy conducted in Russia, Belarus and Bulgaria.

•          CREDO 2 (NCT02760407) is a global multicenter comparative study evaluating the efficacy and safety of olokizumab versus adalimumab and placebo in RA patients with inadequate response to methotrexate therapy.

•          CREDO 3 (NCT02760433) is a global multicenter study evaluating the efficacy and safety of olokizumab versus placebo in RA patients with inadequate response to TNF-α therapies.

•          CREDO 4 is an open-label extension study for patients who have completed CREDO 1, CREDO 2, or CREDO 3.

About Rheumatoid Arthritis

Rheumatoid arthritis (RA) is a systemic connective tissue disease that typically affects small joints that leads to erosive and destructive polyarthritis with a complex autoimmune pathogenesis and may result in early disability and falling life expectancy of RA patients when untreated. This disease is spread worldwide: according to the results of a systematic analysis published in the Annals of the Rheumatic Diseases the prevalence of RA increased by 7.4% between 1990 and 2017 and was estimated up to 19,965,115 cases globally in 2017[1].

Recently a number of innovative genetically engineered biological products have been developed for RA treatment. Olokizumab, the inhibitor of an important pro-inflammatory cytokine (IL-6), is one of these products.


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