GlaxoSmithKline commences new study of giant cell arteritis therapy

GlaxoSmithKline has announced the commencement of a new clinical trial assessing a promising new therapy for giant cell arteritis.

The phase III randomised, double-blind, placebo-controlled study, dubbed SIRRESTA, will evaluate the efficacy and safety of two subcutaneous doses of sirukumab with a pre-specified tapering dose of prednisone for the treatment of the disease.

A key aim of this study will be to assess whether treatment with sirukumab can reduce the duration of steroid treatment typical in clinical practice, with a 52-week double-blind treatment phase to be followed by a 104-week long-term extension phase.

Giant cell arteritis is characterised by the inflammation of large and medium-sized arteries, predominantly in the head and neck, and can cause severe headache, visual loss, jaw and muscular pain or permanent sight loss.

Paul-Peter Tak, senior vice-president for GlaxoSmithKline's immuno-inflammation research and development operations, said: "The use of high-dose steroids to treat giant cell arteritis can cause severe side effects with prolonged use. Alternative treatments are required, and we believe sirukumab could be an important option for patients with this disease."

Sirukumab is also currently under investigation for rheumatoid arthritis and is yet to be approved anywhere in the world.