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Positive Phase III Results Support Regulatory Filing for Arthritis Drug Sirukumab
Positive results have been reported from the phase III clinical program investigating sirukumab (GlaxoSmithKline/Janssen Biologics) for the treatment of patients with active moderate-to-severe rheumatoid arthritis (RA).
Sirukumab is an investigational human anti-interleukin (IL)-6 monoclonal antibody that selectively binds with high affinity to the IL-6 cytokine, a naturally occurring protein that is believed to play a role in autoimmune conditions.
SIRROUND-D was a randomized, double-blind, placebo-controlled, parallel-group study involving 1,670 patients with active moderate-to-severe RA who were unresponsive to disease-modifying antirheumatic drugs (DMARDs). The study’s primary objective was to assess the efficacy of subcutaneous sirukumab, as measured by reductions in the signs and symptoms of RA and by inhibition of radiographic progression.
SIRROUND-H was a randomized, double-blind, parallel-group study comparing subcutaneous sirukumab with adalimumab (an anti-tumor necrosis factor [TNF] monoclonal antibody), each administered as monotherapy in 559 biologic-naïve patients with active moderate-to-severe RA who were intolerant to methotrexate, who were considered inappropriate for treatment with methotrexate, or who were unresponsive to methotrexate. The study’s primary objective was to assess the efficacy of each treatment as monotherapy.
SIRROUND-T was a randomized, double-blind, placebo-controlled, parallel-group study of sirukumab in 878 patients with active RA who were unresponsive to or intolerant of anti-TNF agents. The study’s primary objective was to assess the efficacy of subcutaneous sirukumab, as measured by reductions in the signs and symptoms of RA.
The global phase III clinical program in patients with active RA comprises five studies investigating sirukumab 50 mg and 100 mg administered subcutaneously in combination with conventional DMARDs or as monotherapy every four or two weeks, respectively.
The studies enrolled Japanese patients (SIRROUND-M) unresponsive to methotrexate or sulfasalazine; patients unresponsive to DMARDs (SIRROUND-D); patients receiving sirukumab monotherapy in comparison with adalimumab in biologic-naïve patients unresponsive to DMARDs (SIRROUND-H); patients unresponsive to anti-TNF agents and other biologic agents (SIRROUND-T); and patients who completed SIRROUND-D and SIRROUND-T (long-term extension trial, SIRROUND-LTE).
The phase III program began in August 2012 to investigate sirukumab for the treatment of patients with active moderate-to-severe RA. GlaxoSmithKline announced the start of a phase III study of sirukumab in patients with giant cell arteritis in November 2015.
A regulatory application for sirukumab for RA is anticipated in 2016.
Source: GlaxoSmithKline; December 16, 2015.