GSK begins Phase III study of sirukumab in giant cell arteritis
pharmafile | November 26, 2015 | News story | Business Services, Research and Development, Sales and Marketing | GSK, Janssen
GSK today announced it has begun a Phase III study evaluating sirukumab, a human anti-interleukin (IL)-6 monoclonal antibody, for the treatment of patients with giant cell arteritis (GCA).
GCA is a disease characterised by inflammation of large and medium sized arteries predominantly in the head and neck. It almost exclusively occurs in people aged 50 years or over, (most commonly in patients aged 60 or over), with patients typically experiencing severe headaches, visual loss, jaw and muscular pain and a risk of permanent sight loss if the condition is not treated promptly.
GCA affects around one in 4,500 people in the UK each year, is three times more common in women than in men, and seven times more common in white people than in black people.
Because the current mainstay of treatment is with high doses of steroids to rapidly reduce the inflammation and prevent sight loss, patients risk side effects including osteoporosis, cataract, hypertension and type 2 diabetes mellitus.
Efforts to reduce such effects see steroid doses tapered after remission to lower, maintenance levels. However, disease relapse is common during steroid taper and remission with steroids is often followed by subsequent relapse requiring repeat high dose treatment.
The phase III randomised, double-blind, placebo-controlled study, SIRRESTA, will evaluate the efficacy and safety of two subcutaneous doses of sirukumab (100mg every two weeks and 50mg every four weeks) with a pre-specified tapering dose of the steroid prednisone.
This approach aims to confirm specifically whether treatment with sirukumab can reduce the duration of steroid treatment typical in clinical practice- thus minimising risk of side effects. The study comprises a one-year double-blind treatment phase and a two-year long term extension phase, with the primary endpoint being the proportion of patients that achieve sustained remission.
Paul-Peter Tak, senior vice president, GSK Immuno-Inflammation R&D, says: “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.
“The start of our study with sirukumab for GCA…marks the progress we are making to apply our knowledge of the underlying cause of a variety of immune-mediated inflammatory diseases and explore the potential of our immuno-inflammation pipeline to treat multiple conditions.”
Sirukumab is an investigational human anti-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. It is in Phase III development for rheumatoid arthritis (RA) and GCA, but is as yet not approved as a treatment for any indication anywhere in the world.
A collaboration agreement signed by GSK and Janssen Biologics in 2011 gives both companies the option to investigate sirukumab for other indications beyond RA, and Janssen has the right to opt into the GCA programme at any stage of development.
Joel Levy
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