GlaxoSmithKline announced positive topline data from the Phase 3 program studying sirukumab, an investigational human anti-IL-6 monoclonal antibody, for the treatment of patients with a diagnosis of moderately to severely active rheumatoid arthritis (RA).
RA, a systemic inflammatory disease that manifests itself in multiple joints in the body, usually affects the lining of the joints (synovial membrane), but can also affect other organs. Out of every 100,000 people, 41 are diagnosed with RA every year and about 1.3 million Americans have RA. Sirukumab, IL-6 monoclonal antibody, has been developed to selectively bind to the IL-6 cytokine, a protein thought involved in autoimmune diseases and whose overproduction plays a significant role in the pathology of RA. The drug is not yet approved as a treatment for any condition.
Long-term efficacy and safety data are being gathered in ongoing extensions of the Phase III clinical trials testing sirukumab (50mg and 100mg) administered subcutaneously in combination with modifying anti-rheumatic drugs (DMARDs) or as monotherapy every four or two weeks, respectively. Three trials are considered pivotal:
SIRROUND-D (CNTO136ARA3002), a randomized, parallel group, multicenter, double-blind, and placebo-controlled clinical trial to evaluate the long-term safety and efficacy of CNTO 136 (sirukumab) in 1,670 RA patients who are unresponsive to treatment with DMARDs or anti-TNF alpha agents. The trial’s primary endpoint was the assessment of subcutaneous sirukumab efficacy measured by the reduction of RA signs and symptoms, and the inhibition of radiographic progression.
SIRROUND-H (CNTO136ARA3005), a randomized, parallel group, multicenter, double-blind clinical trial investigating the efficacy of sirukumab monotherapy compared with adalimumab monotherapy in 559 biologic naïve subjects with active rheumatoid arthritis who are either intolerant to methotrexate, considered unsuitable for methotrexate treatment or are inadequate responders to methotrexate.
SIRROUND-T (CNTO136ARA3003), a randomized, parallel group, multicenter, double-blind, and placebo-controlled clinical trial to evaluate the long-term safety and efficacy of CNTO 136 (sirukumab) in 878 RA patients who are unresponsive to treatment with DMARDs or anti-TNF alpha agents.
Sirukumab is being developed and commercialized by GlaxoSmithkline in collaboration Janssen Biologics. Regulatory applications for the drug as a treatment for RA are expected to be filed in 2016. The trials’ full outcomes will be presented at upcoming scientific meetings and submitted for publication in peer-reviewed scientific journals.