SIRRESTA: the evaluation of efficacy and safety of Sirukumab for giant cell arteritis treatment Essay

GlaxoSmithKline plc (NYSEGSK) is entering the final phase III study related to the treatment of patients suffering from giant cell arteritis in order to evaluate the efficacy and safety profile of sirukumab. Sirukumab is a human antiinterleukin (IL)6 monoclonal antibody for giant cell arteritis treatment.

The study is named as SIRRESTA. The study is divided into two parts one is of 52 week doubleblind treatment phase and a 104 week long term extended phase. The main emphasis of the study is to achieve the number of patients that achieved the sustained remission. The study is a phase III randomized, doubleblind, placebocontrolled study. The main aim of the study is to evaluate the efficacy and safety profile with two subcutaneous doses of sirukumab first dose is of 100 mg every two weeks and second dose is of 50mg every four weeks along with prescheduled reducing dose of prednisone. With the help of this technique, we will get evidence about sirukumab to be helpful in reducing the duration of steroid treatment.

Giant cell arteritis is a disease in which medium and large sized arteries specifically get inflamed. This disease normally affects the patients who are above age 50. The symptoms include severe headache, jaw and muscular pain, visual loss, and in some cases permanent sight loss if not treated aggressively. High doses of steroids are used to manage the inflammation and to prevent any untoward serious effects like sight loss. As high doses of steroids can produce very severe side effects so a tapering dose of steroids started after the remission of severe symptoms and the patient is maintained on maintenance dose. The chances of relapse are always there during the maintenance treatment. The side effect profile of steroids is very severe, which includes osteoporosis, hypertension, cataract, and type2 diabetes mellitus.

Senior Vice President, GSK ImmunoInflammation R&D, PaulPeter Tak narrated The high steroids doses usage for a long duration to treat giant cell arteritis can lead to severe side effects. Substitute treatments are essentially needed to cover up this gap and we believe sirukumab has an important role for the patients with this disease. The start of our study for GCA, which is undergoing investigation for rheumatoid arthritis, proves the progress we are making to apply our knowledge of the underlying cause of a variety of immunemediated inflammatory diseases and explore the potential of our immunoinflammation pipeline to treat multiple conditions.

Sirukumab is not approved for the treatment of any indication anywhere in the world.

About Sirukumab

Sirukumab falls in a category of an investigational human antiIL6 monoclonal antibody that selectively binds with high affinity to the IL6 cytokine, which believed to play a vital role in autoimmune conditions.

The licensing and codevelopment collaboration agreement, which took place in December 2011 between GSK and Janssen, which enables the companies to investigate in other conditions excluding RA. In August of 2012, a phase III programme started to investigate sirukumab for the treatment of active RA.

This program is full funded by GSK.