Predicting response to biologic therapy
Research type
Research Study
Full title
Identification of transcriptomic biomarkers that predict the response to biologic therapy in Rheumatoid Arthritis in routine clinical practice
IRAS ID
217620
Contact name
Duncan Porter
Contact email
Sponsor organisation
NHS Greater Glasgow and Clyde
Duration of Study in the UK
2 years, 11 months, 31 days
Research summary
Biological drugs are an important part of the treatment of patients with rheumatoid arthritis who do not respond to conventional therapy. Many patients respond very well to the first biologic drug they receive but others fail to respond, and need to switch to alternative therapy. This 'trial and error' approach involves periods of uncontrolled disease activity with pain, stiffness and disability until the optimal therapy is found. The ability to predict which patient will respond to which therapy ("personalised medicine") would improve the quality of life of patients. A previous study has identified three gene expression profiles that show promise in their ability to predict response to two types of biologic drugs - TNF inhibitors (etanercept and adalimumab) and rituximab. More research is now required:
1) The findings have to be validated in an independent cohort before it can be certain that the signatures truly predict response with sufficient accuracy to be useful in directing patient treatment in routine clinical practice.
2) Patients who take part in randomised controlled trials are not representative of the whole patient population, so the generalisability of the prediction also needs to be tested.
3) There are other biologic drugs being used to treat rheumatoid arthritis, and it would be very valuable if gene expression profiles that predict their response could also be identified.
4) If testing for a patient's gene expression profile is expensive, we need to understand if testing would be affordable in the context of any health gains that accrue. Health economic modelling can assess this question.
5) If testing is to be used to direct treatment, then the results must be available very quickly. A pilot study will be done to identify what challenges may arise in delivering such a service.REC name
East of Scotland Research Ethics Service REC 2
REC reference
17/ES/0093
Date of REC Opinion
31 Jul 2017
REC opinion
Further Information Favourable Opinion