OPTION (TOcilizumab Pivotal Trial in Methotrexate Inadequate respONders) trial is the first international Phase III study of Roche’s ACTEMRA™ outside of Japan.
Results of which as announced by Roche, has shown that the study has successfully met its primary endpoint in patients with moderate to severe rheumatoid arthritis (RA) who had an inadequate response to methotrexate (a current standard of care).
The study showed that a greater proportion of RA patients treated with ACTEMRA™ (either 4mg/kg or 8mg/kg) plus methotrexate achieved a significant improvement in disease signs and symptoms (ACR20) at week 24, compared with placebo plus methotrexate.
The study confirmed the safety profile of ACTEMRA™ as demonstrated in previous studies.
Not currently approved in the United States, ACTEMRA™ is the first humanized interleukin-6 (IL-6) receptor-blocking monoclonal antibody with a novel mechanism of action: reduce inflammation of the joints, prevent long-term damage and relieve certain systemic effects of RA such as anemia, fatigue and osteoporosis.
Find more details from the press release.
[Photo Credit: Chugai-Pharm]
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