Phase III study shows SAR 153191 effective in RA-Sanofi/Regeneron

Sanofi and Regeneron Pharmaceuticals have announced that in the SARIL-RA-MOBILITY Phase III clinical trial in adults with active Rheumatoid Arthritis (RA) who were inadequate responders to methotrexate (MTX) therapy, SAR 153191 (sarilumab) treatment in combination with MTX improved disease signs and symptoms as well as physical function, and inhibited progression of joint damage. The 52 week trial enrolled approximately 1,200 patients with active, moderate-to-severe RA. Data shows that 66 percent, 58 percent, and 33 percent in the sarilumab 200 mg, sarilumab 150 mg, and placebo groups respectively, all in combination with MTX, demonstrated improvement in signs and symptoms of RA at 24 weeks, as measured by ACR20.

There was also improvement in physical function, as measured by change from baseline in the HAQ-DI at week 16. Finally the group receiving the 200 mg dose of sarilumab + MTX had a reduction of approximately 90 percent in the radiographic progression assessed by the mTSS compared to the radiographic progression with placebo + MTX at week 52. There was a higher incidence of treatment emergent adverse events leading to withdrawal in the sarilumab treatment groups compared to placebo (13.9 percent in 200 mg, 12.5 percent in 150 mg and 4.7 percent in placebo). Additional analyses of efficacy and safety data from the SARIL-RA-MOBILITY study will be presented at a future medical conference.