GSK announces start of Phase III study of sirukumab in giant cell arteritis
![](/46/pdcnewsitem/03/82/00/GSK.png)
Study approach will specifically answer whether treatment with sirukumab can reduce the duration of steroid treatment typical in clinical practice.
GSK has announced that dosing has commenced in 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, a disease characterised by inflammation of large and medium sized arteries predominantly in the head and neck, occurs in people aged 50 years or over. Patients typically experience severe headache, visual loss, jaw and muscular pain and may be at risk of permanent sight loss if not treated promptly. The mainstay of treatment is with high doses of steroids to rapidly reduce the inflammation and prevent sight loss. To minimise side effects that can occur with high doses and long term use, steroids are tapered after remission to lower maintenance doses. However, disease relapse is common during steroid taper and remission with steroids is often followed by subsequent relapse requiring repeat high dose treatment. As a result over 70% of patients experience significant side effects from steroids such as osteoporosis, cataract, hypertension and type 2 diabetes mellitus.
The Phase III randomised, double-blind, placebo-controlled study (named the “SIRRESTA” study) will evaluate the efficacy and safety of two subcutaneous doses of sirukumab (100 mg every 2 weeks and 50 mg every 4 weeks) with a pre-specified tapering dose of prednisone for the treatment of GCA. This approach will specifically answer whether treatment with sirukumab can reduce the duration of steroid treatment typical in clinical practice. The study comprises two distinct parts: a 52 week double-blind treatment phase (Part A) and a 104 week long term extension phase (Part B). The primary endpoint of the study is the proportion of patients that achieve sustained remission.
Paul-Peter Tak, Senior Vice President, GSK Immuno-Inflammation R&D, 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. The start of our study with sirukumab for GCA, which is currently under investigation for rheumatoid arthritis, 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.”
Related News
-
News CPHI Podcast Series: the power of digital marketing in pharma
Digital marketing is a valuable tool for many industries, and the pharmaceutical and healthcare industry is no exception. The CPHI Podcast Series covers how marketing can be used by companies to increase their engagement and overcome challenges.&n... -
News Novel approach to creating sustainable packaging from rice husks
Researchers have created a new approach to the designing of eco-friendly nanofibres extracted from rice husks, addressing the critical need for sustainable packaging materials in food and biopharmaceutical products. -
News BioNTech to begin mRNA vaccine manufacturing in Rwanda by 2025
German biotechnology company BioNTech has stated their intentions to begin production at their mRNA vaccine factory in Rwanda by 2025, which will mark the first foreign mRNA vaccine manufacturing site on the continent of Africa. -
News Identifying Alzheimer’s Disease biomarker proteins with whole blood tests
A University of Manchester spin-out pharmaceutical company, PharmaKure, has reported successful study results for the quantification of Alzheimer’s Disease biomarker proteins with a whole blood test. -
News Bill & Melinda Gates Foundation to boost mRNA vaccine initiatives in Africa with USD $40m
To address vaccine inequality and accessibility issues, the Bill & Melinda Gates Foundation aims to deliver USD $40m to various biotech companies and vaccine manufacturers in support of mRNA vaccine development. -
News CPHI Podcast Series: Exploring neurological frontiers in Alzheimer's and beyond
The next episode of the CPHI Podcast Series delves into the science and background behind some recent developments in the field of Alzheimer's disease and neurological disorders. -
News Is patient centricity the future of pharmaceutical manufacturing?
In this interview with Sandra Sánchez y Oldenhage, President of PharmAdvice, she speaks to the importance of considering patients in the manufacturing stages of the pharmaceutical supply chain, and how it can redefine healthcare. -
News CPHI Podcast Series: How to leverage AI for Drug Discovery
Artificial intelligence is the topic of debate in the latest episode from the CPHI Podcast Series, where Digital Editor Lucy Chard speaks with Bill Whitford of DPS Group about the integration of AI in healthcare.
Position your company at the heart of the global Pharma industry with a CPHI Online membership
-
Your products and solutions visible to thousands of visitors within the largest Pharma marketplace
-
Generate high-quality, engaged leads for your business, all year round
-
Promote your business as the industry’s thought-leader by hosting your reports, brochures and videos within your profile
-
Your company’s profile boosted at all participating CPHI events
-
An easy-to-use platform with a detailed dashboard showing your leads and performance