Regeneron and Sanofi have announced promising results of a mid-stage clinical trial of their drug sarilumab as a treatment for rheumatoid arthritis.
Pharmaceutical companies Regeneron and Sanofi have announced promising results of a mid-stage clinical trial of their drug sarilumab as a treatment for rheumatoid arthritis (RA). The Phase 2b trial found greater improvements in patients who received sarilumab (a subcutaneously administered antibody) and methotrexate (the standard RA treatment) than in those who received methotrexate and a placebo.
The 12-week clinical trial included 306 patients whose condition had not improved with methotrexate alone. Participants in the experimental group received five different doses of sarilumab. 49% of those receiving the lowest dose saw their RA symptoms improve by at least 20%, compared with 72% of those who received the highest dose. By comparison, 46.2% of those in the placebo group improved by at least 20%. Patients receiving sarilumab were more likely to have their RA symptoms improve by 50% and 70% as well.
"Following these encouraging Phase 2b results in rheumatoid arthritis, the companies are currently discussing the dose(s) of sarilumab to advance into the Phase 3 portion of the MOBILITY trial," Elias Zerhouni, Sanofi’s president of global research and development, said in a release.
Common adverse side effects of sarilumab included infections, low white blood cell count, and liver function test abnormalities. A separate mid-stage trial found that sarilumab worked no better than a placebo in treating ankylosing spondylitis, a form of spinal arthritis. The companies plan to submit full data from both trials for presentation at a future scientific conference.
Around the Web:
Sanofi and Regeneron Report Positive Phase 2b Trial Results with Sarilumab in Rheumatoid Arthritis [Regeneron Press Release]
Regeneron rheumatoid arthritis drug meets goal [Seattle Post-Intelligencer]