Positive phase 3 results announced for sirukumab to treat RA

GlaxoSmithKline announced the receipt of positive results from a phase 3 study of sirukumab for the treatment of patients with moderate-to-severe rheumatoid arthritis and the company expects to submit regulatory applications in 2016, according to a company press release.

The complete results of three phase 3 studies of 1,670, 559 and 878 patients with rheumatoid arthritis (RA) who did not respond to conventional or anti-tumor necrosis factor disease-modifying anti-rheumatic drugs (DMARDs) will be presented at upcoming scientific conferences and submitted for publication in peer-reviewed journals, according to the release.

The studies investigated the efficacy and safety of either 50 mg or 100 mg of subcutaneously administered sirukumab every 4 or 2 weeks, respectively, in combination with background, conventional DMARDs, or as monotherapy in a head-to-head trial with adalimumab (Humira, AbbVie). Sirukumab is believed to selectively target interleukin-6 cytokines implicated in autoimmune diseases.

GlaxoSmithKline entered into a partnership with Janssen to develop and commercialize sirukumab in December 2011 following Janssen’s development of the monoclonal antibody. The agreement allows both companies to research sirukumab for indications other than RA, and in November, GlaxoSmithKline announced the initiation of a phase 3 study of patients with giant cell arteritis.

Reference: https://www.gsk.com.