ERYTHRO-Retrospective SLE Anifrolumab chart review study

• Research type

  Research Study

• Full title

  ERYTHRO - Retrospective Medical Chart Review Study to Describe the Experience of SLE Patients Treated with Anifrolumab in the Early Access Program

• IRAS ID

  334442

• Contact name

  Edward Vital

• Contact email

  e.m.j.vital@leeds.ac.uk

• Sponsor organisation

  AstraZeneca

• Clinicaltrials.gov Identifier

  N/A, N/A

• Duration of Study in the UK

  0 years, 7 months, 29 days

• Research summary

  This is a non-interventional multicenter and fully retrospective medical chart review study on patients with Systemic Lupus Erythematosus (SLE) receiving Anifrolumab under the Early Access Program in their routine standard of care. Systemic Lupus Erythematosus is a chronic auto-immune disease characterized by alternating periods of disease activity, exacerbation or flares and less commonly remission. There is considerable variability across patients in terms of clinical manifestations of SLE, including involvement of multiple organ systems which require an individualized treatment approach.

  Anifrolumab has been developed as an add-on therapy for SLE and was issued a marketing authorization in
  European Union on 14 February 2022. Currently, there is an early access program on anifrolumab treatment in adult patients with active systemic lupus erythematosus. It is important to generate evidence about the experience of patients who are prescribed anifrolumab in routine clinical care.

  This retrospective chart review study aims to learn more about systemic lupus erythematosus and the experience of patients using anifrolumab. We want to better understand the disease and associated health problems. There are no patients visits required, they will only attend their clinic appointment as part of their routine appointment.
  
  Past data are collected for a period of 12 to 18 months, starting from around 6 to 9 months prior to the first Anifrolumab treatment to until 6 to 9 months after the first treatment. The duration of data collection for which past data are collected will depend on how long the patient is treated with Anifrolumab under the early access program.

  Lay summary of study results: Overall, this study demonstrated patient experience after receiving anifrolumab treatment in reaching important treatment goals in a real-world setting. The primary objectives showed decreases in SLE disease activity (measured by SLEDAI-2K) and its impact on daily functioning (measured by PGA). The secondary and exploratory objectives further supported the treatment benefit associated with anifrolumab with observed increases in SLE remission rate, LLDAS attainment and decreases in flares and CLASI skin manifestations.

• REC name

  South Central - Hampshire A Research Ethics Committee

• REC reference

  23/SC/0342

• Date of REC Opinion

  24 Sep 2023

• REC opinion

  Favourable Opinion