ABIRISK MS
Research type
Research Study
Full title
Anti-Biopharmaceutical Immunization: Prediction and analysis of clinical relevance to minimize the risk of immunization in multiple sclerosis patients on interferon-beta treatment.
IRAS ID
125288
Contact name
Rachel A Farrell
Contact email
Sponsor organisation
Joint Research Office, UCL
Duration of Study in the UK
2 years, 2 months, days
Research summary
Biopharmaceuticals (BPs) are drugs which are based on naturally occurring proteins (antibodies, receptors, cytokines, enzymes, toxins), nucleic acids (DNA, RNA) or attenuated micro-organisms and are increasingly being used throughout medicine. The immune system of the patient may recognise these drugs as being foreign and, in the context of biopharmaceuticals (BP), immunogenicity refers to this immune response against these drugs. The development of specific anti-drug antibodys (ADA) represents a major factor reducing the efficacy of these drugs due to their neutralisation.
Interferon-beta (IFNbeta) is a standard first-line treatment for patients with relapsing-remitting multiple sclerosis (RRMS). Binding antibodies (BAbs) are antibodies that bind to the drug but do not necessarily inhibit its biological action. Neutralising antibodies (NAbs) are a subset of these which reduce the bio-efficacy of the drug. Several studies have shown that NAbs against IFN beta evolve in approximately 20% of treated MS patients. The frequency of NAbs is dependent on the IFN beta preparation used and if persistent, reduce the efficacy of IFN beta treatment. BAbs may be detected within the first month of therapy and Nabs develop somewhat later – usually between 6 – 18 months. It seems that people who develop higher titres of BAbs are more likely to develop NAbs. Here we propose to investigate early BAb evolution, their potential to predict NAbs, and if BAbs diminish IFN beta bioavailability.REC name
South East Scotland REC 02
REC reference
15/SS/0036
Date of REC Opinion
2 Mar 2015
REC opinion
Favourable Opinion