Atopic eczema (atopic dermatitis) is the most common form of eczema, a condition that causes the skin to become itchy, dry and cracked. Atopic eczema is more common in children, often developing before their first birthday. But it may also develop for the first time in adults. It's usually a long-term (chronic) condition, although it can improve significantly, or even clear completely, in some children as they get older.
The trial will involve around 536 adults with moderate to severe eczema who need a systemic treatment. They will either receive ciclosporin as an oral capsule, methotrexate self-injection, dupilumab self-injection or a janus kinase inhibitor (JAKi) for up to one year. The treatment they receive will be decided at random. Patients will know which treatment they have received but the trained person assessing the eczema will not know to avoid bias.
Patients will have between 6 and 14 check-ups at hospital over a year as per normal NHS care and fill in some questionnaires in between visits. The success of the different treatments will be determined by looking at participants’ skin using a reliable eczema score and by asking participants about things like itching, other symptoms and quality of life. We will collect information about side effects and also see whether the treatments offer value for money for our NHS.
Professor Catherine Smith and Dr Andrew Pink are leading the BEACON trial. Professor Smith is a Consultant Dermatologist at St. John’s Institute of Dermatology, lead for national eczema and psoriasis services and has a strong record in eczema research. Dr Pink is a Consultant Dermatologist, also at St. John’s Institute of Dermatology and runs the large clinical trials team at St. John’s.
This trial will provide the first comprehensive head to head evidence on the comparative effectiveness, tolerability and cost effectiveness of four key systemic agents used to treat moderate-severe adult eczema. It 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 is the first platform trial for inflammatory skin disease.
An aligned bioresource for biomarker discovery will inform future personalised therapy and will capitalise on existing bio-resourcing infrastructure.
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.