GlaxoSmithKline on Wednesday announced that it has received positive late-stage study results for sirukumab in the treatment of patients with moderately to severely active rheumatoid arthritis (RA). The experimental human anti-interleukin (IL)-6 monoclonal antibody is being developed in collaboration with Johnson & Johnson's Janssen division.
GlaxoSmithKline noted that no unexpected safety findings relative to the known effects of anti-IL-6 inhibitors were observed in the three pivotal trials. The studies included SIRROUND-D, which enrolled patients with moderately to severely active RA who were unresponsive to disease-modifying antirheumatic drugs, and SIRROUND-H, which compared sirukumab with AbbVie's Humira (adalimumab) in biologic-naïve patients with moderately to severely active RA who were intolerant to methotrexate, who were considered inappropriate for treatment with methotrexate or who were unresponsive to methotrexate. Meanwhile, the third trial, called SIRROUND-T, included patients with active RA who were unresponsive or intolerant to anti-TNF agents.
The drugmaker added that long-term safety and efficacy data are currently being collected in ongoing extensions of the studies, while the company plans to submit data from the trials for presentation at future research conferences and publication in peer-reviewed journals.
GlaxoSmithKline stated that regulatory submissions for sirukumab in the treatment of rheumatoid arthritis are expected next year. The company previously highlighted the drug as one of as many as 20 assets that could be submitted for marketing authorisation by 2020.
