Tocilizumab effects on adipokines in Rheumatoid Arthritis
Research type
Research Study
Full title
Observational study on the effects of IL-6 inhibitor therapy on adipokines in patients with rheumatoid arthritis
IRAS ID
167859
Contact name
John P.H Wilding
Contact email
Clinicaltrials.gov Identifier
ISRCTN70800019, ISRCTN reference number
Duration of Study in the UK
0 years, 4 months, 1 days
Research summary
Rheumatoid arthritis (RA) is a chronic inflammatory condition associated with joint inflammation and significant disability. Cardiovascular disease is a major contributor to decreased life expectancy in this condition.
Human adipose tissue (body fat) produces a number of inflammatory mediators (‘adipokines’). Some of these factors, for example leptin, TNF-alpha, IL-6, visfatin, resistin and SPARC may also increase the risk of cardiovascular disease, whereas adiponectin appears protective. Rheumatoid arthritis is associated with higher circulating levels of leptin, TNF-alpha and IL-6 and lower circulating adiponectin, which may contribute to increased cardiovascular risk.
Tocilizumab is a drug that blocks IL-6 used in the treatment of rheumatoid arthritis; because IL-6 controls production of other adipokines, we are interested to find out if tocilizumab therapy results in favourable changes in circulating adipokine concentrations (ie reduces pro-inflammatory adipokines and increases adiponectin), and improved blood fats thus resulting in a more favourable cardiovascular risk profile.
The study involves analysing samples already collected from subjects with rheumatoid arthritis during a previous study (ACT-NEUTS) in 2010-2011. As part of the ACT-NEUTS study these individuals provided fasting blood samples before and on three occasions over a 12 month period after tocilizumab therapy. With the patients’ consent, we seek to utilise the already collected samples for this new study. No further blood samples will be collected as part of our study. Plasma adipokines, blood fats and inflammatory markers will be measured in samples that were obtained at baseline and approximately one, 6 and 12 months after commencement of Tocilizumab therapy. Relevant clinical and pharmacological information regarding study subjects will be obtained using hospital medical datasets and data collected for the original study.
If Tocilizumab therapy is associated with favourable metabolic changes in cardiovascular risk factors, this could have important implications for treatment choices in rheumatoid arthritis.
REC name
London - City & East Research Ethics Committee
REC reference
15/LO/0544
Date of REC Opinion
17 Apr 2015
REC opinion
Further Information Favourable Opinion