EPIC

• Research type

  Research Study

• Full title

  Establishing the salience of type 1 interferon pathway blockade in the central mechanisms of SLE related fatigue

• IRAS ID

  344046

• Contact name

  NEIL BASU

• Contact email

  Neil.Basu@glasgow.ac.uk

• Sponsor organisation

  NHS GG&C

• Clinicaltrials.gov Identifier

  NCT06784076

• Duration of Study in the UK

  2 years, 0 months, 6 days

• Research summary

  Systemic Lupus Erythematosus (SLE) is a disorder of the immune system which can affect multiple body organs. Fatigue is one of the commonest complaints, leaving patients disabled with poor quality of life. The problem remains pervasive even when the disease is otherwise well controlled. The precise causes of this symptom are unknown and require investigation if specific treatments are to be developed in the future.

  Fatigue is a problem across many chronic diseases, especially those of the immune system. Elements of the immune system are therefore considered to be potential causes of fatigue. In particular, inflammatory proteins called interferons have been identified. These proteins are used to treat patients with hepatitis C following which most experience acute fatigue and 1/3 persisting fatigue. Preliminary studies, using standard strength MRI scans, in this patient group implicate increases in glutamate (a major brain chemical) in the brain's basal ganglia as a possible mediator of this interferon induced fatigue.
  
  However, standard strength MRI scans are notoriously poor at robustly measuring glutamate and so we now propose to better investigate the possible role of interferons and their alteration of basal ganglia glutamate levels in the generation of fatigue. We aim to study 20 fatigued SLE patients who will undertake a stronger MRI scan (which can robustly measure glutamate) prior to and following receipt of a 16 week course of a licenced SLE therapy which is know to block the activity of interferons (anifrolumab). We predict that blocking interferons will reduce basal ganglia glutamate levels and so helping us better understand the mechanism of fatigue in this patient group.

  Anifrolumab received a marketing authorisation in the USA in July 2021 and in the EU on 14 February 2022 for the treatment of SLE in adults with moderate to severe disease.

• REC name

  London - Riverside Research Ethics Committee

• REC reference

  25/LO/0181

• Date of REC Opinion

  8 Apr 2025

• REC opinion

  Further Information Favourable Opinion