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Rheumatologists are Now Exploring the Earth
Dr. Shahin Jamal
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June 12 2015 5:00 AM ET — via RheumReports 
In an oral abstract presentation today at EULAR 2015, Dr. Burmester reviewed primary results of the EARTH EXPLORER 1 STUDY, a Phase IIb study evaluating the efficacy and safety of mavrilimumab in patients with moderate to severe rheumatoid arthritis (RA). Mavrilimumab is a monoclonal antibody against Granulocyte-macrophage colony-stimulating factor (GM-CSF) receptor α. This agent has already demonstrated sustained efficacy in a small Phase IIa study.
326 RA patients from Europe, South America and South Africa were included after failing one or more DMARDs. At baseline, average DAS28-CRP was 5.8 and 81% of patients had seropositive (RF or CCP) disease. They were randomized to receive one of three doses of mavrilimumab (150mg, 100mg, or 30mg every other week) or placebo. The co-primary outcomes were change in DAS28-CRP between Day 1 and Week 12, and ACR20 at Week 24.
All doses of mavrilimumab separated from placebo quickly, starting at week 1. At week 12, a statistically significant difference in DAS28-CRP change from baseline was observed for all doses of mavrilimumab compared to placebo with p<0.001. At week 24, ACR 20/50/70 rates were 73.4/40.5/13.9 and 50.6/28.4/12.4 in the 150mg and 30mg mavrilimumab groups, respectively, and 24.7/12.4/3.7 in the placebo group, all of which were statistically significant. Mavrilimumab was well tolerated with headache, nasopharyngitis and bronchitis being the most commonly reported adverse events. There were no serious infections in the higher dose mavrilimumab groups and no adverse pulmonary outcomes. Apparently, more than 90% of patients entered the long-term, open-label extension study.
Based on this phase II data, mavrilimumab seems to be a promising new therapy in patients with RA... I do think exploring the earth would be fun, which is how this study caught my eye!! I have no idea how the name relates to the drug, or even how any of us will be able to keep track of all these new products!! Mavrilimumab works with a novel mechanism of action, which I suspect may be useful in many of our diseases... this gives us something else to watch out for!
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About the Author
Dr. Shahin Jamal
Dr. Jamal is a Clinical Associate Professor at the University of British Columbia and an active staff physician at Vancouver Coastal Health. Her interests include diagnosis and prognosis of early inflammatory arthritis, and timely assessment and access to care for patients with rheumatoid arthritis.
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