Regeneron Pharmaceuticals Inc. (NASDAQ: REGN) scored a win in a late-stage trial for the treatment of rheumatoid arthritis (RA). The company, in conjunction with Sanofi, announced that a Phase 3 monotherapy study met its primary endpoint demonstrating that sarilumab was superior to adalimumab (marketed by AbbVie as Humira) in improving signs and symptoms in patients with active RA at week 24.
The study enrolled 369 adult patients with active RA who were inadequate responders to, intolerant of or inappropriate candidates for methotrexate. Patients were randomized to receive either subcutaneous sarilumab monotherapy (200 mg every two weeks) or adalimumab monotherapy (40 mg every two weeks); patients who did not respond adequately to adalimumab could increase to weekly dosing.
The incidence of adverse events (64% for both groups), serious adverse events (5% for sarilumab versus 7% for adalimumab), infections (29% for sarilumab versus 28% for adalimumab), and serious infections (1% for both groups) were generally similar between groups.
Janet van Adelsberg, M.D., Senior Director, Clinical Sciences, Immunology and Inflammation, Regeneron, commented:
In this study, sarilumab monotherapy provided stronger efficacy than adalimumab monotherapy. Adalimumab is one of the most commonly used biologic medicines in RA. This is the first time an IL-6 receptor blocker delivered subcutaneously has demonstrated superiority over adalimumab monotherapy in RA.
Dr. Simon Cooper, MBBS VP, Global Project Head, Immunology and Inflammation, Sanofi, added:
Despite the availability of a wide range of treatment options, we believe that new therapies are needed to further address unmet needs of RA patients. These data suggest that sarilumab, if approved, may be an option for patients unable to tolerate or take methotrexate, and we look forward to sharing further details at an upcoming medical congress.
Shares of Regeneron were trading up 1% at $382.00, with a consensus analyst price target of $507.30 and a 52-week trading range of $350.26 to $605.93.