It will provide the first ever comprehensive evidence on the comparative effectiveness, tolerability and cost-effectiveness of oral ciclosporin, subcutaneous methotrexate, subcutaneous dupilumab and an oral janus kinase inhibitor (JAKi).
These represent the four key classes of therapy, with ciclosporin being the only licensed ‘standard’ agent, methotrexate the most commonly prescribed standard agent, dupilumab as a novel biologic therapy and JAKi as a novel oral therapy. BEACON will also inform the optimal treatment pathway over 12 months. These data will translate into improved health outcomes, minimise treatment switching, and enable healthcare commissioning based on clinical evidence and value for money.
BEACON will serve as a future platform for comparisons across the large pipeline of emerging novel therapies as it will permit the inclusion of additional treatment arms in a future multi-arm multi-stage platform trial. BEACON, to our knowledge, represents the first platform trial for inflammatory skin disease.
A platform design offers a highly efficient way of comparing novel agents with best available treatment (statistical, operational and cost efficiency) whilst accommodating changes to the standard of care over time. An aligned bioresource for biomarker discovery will inform future personalised therapy and will capitalise on existing bio-resourcing infrastructure.
To inform implementation of the findings a process evaluation will run within the trial exploring patients’ expectations of treatment, experiences in the trial, experiences of treatment(s) and the process of switching treatments.
All trial participants will be invited to enrol into the UK-Irish Atopic Eczema Systemic Therapy Register (A-STAR) for long-term follow up. A-STAR is an observational study running in the UK and Ireland, collecting data on the short and long-term safety and effectiveness of systemic treatments for people with atopic eczema funded by the British Skin Foundation and the British Association of Dermatologists.