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Phase 3 Study Supports Sarilumab for MTX-Resistant RA

(EULAR 2014) In a Phase 3 study of the anti-IL6R monoclonal antibody sarilumab, two doses of the drug proved significantly more efficacious than placebo against active rheumatoid arthritis.

The interleukin (IL)-6R antagonist sarilumab continues to show encouraging results against rheumatoid arthritis (RA), echoing at 24 weeks the positive outcomes reported last year for 12 weeks.

Reductions in severity judged by American College of Rheumatology (ACR) scores remain significantly better than those for placebo in Phase 3 of the SARIL-RA-MOBILITY trial, Mark Genovese MD of Stanford University Medical Center reported at the 2014 annual meeting of the European Union League Against Rheumatism (EULAR) in Paris last week.

The trial randomized early 1200 patients with moderate to severe RA inadequately responsive to methotrexate to receive additional placebo or either 150 mg or 200 mg of subcutaneous sarilumab every other week. Both doses proved significantly superior to placebo at all levels of ACR scoring:

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Reductions in other disease activity scores (DAS28CRP and CDAI) scores, as well as van der Heijde modified Total Sharp Scores, were significantly better than placebo at 52 weeks.

Safety findings, most commonly infections, were consistent with previous reports. The drug has also been tried for ankylosing spondylitis, with disappointing results.