The Challenge
Psoriasis is a chronic inflammatory skin condition that presents as scaly, painful patches of skin. It can range from mild to severe, and injection treatments that affect the immune system (called biologics) can be prescribed for people who have more severe psoriasis. Biologics are effective at controlling psoriasis, however, individuals with well-controlled psoriasis (clear/nearly clear skin) often need to continue their biologic treatment indefinitely, which can be burdensome. The need for regular injections, frequent hospital follow-ups, and potential side effects, such as infections, can impact a patient's quality of life. Moreover, the cost of long-term biologic treatment for healthcare systems like the NHS is substantial.
Currently, everyone receives the same dose of biologic long-term, however, research indicates that a proportion of individuals can sustain control of their psoriasis with less treatment. If we could tailor (or ‘personalize’) the dose of biologic to each individual, we could reduce the burden and costs of long-term treatment.
PLAN-psoriasis feasibility trial
The PLAN-psoriasis feasibility trial (isrctn.com/ISRCTN17922845) is investigating whether personalized treatment is acceptable and practical for individuals with psoriasis with well-controlled psoriasis who are receiving biologics, and healthcare professionals. By reducing the treatment burden, personalized treatment may not only improve patient outcomes but also help alleviate some of the financial pressures on healthcare systems.
Participants in the PLAN-psoriasis feasibility trial are randomized to one of three treatment plans for 1 year:
Patient-led ‘as needed’ treatment: Participants pause their biologic treatment and restart it if and when their psoriasis reappears or worsens. This strategy allows individuals to take an active role in personalizing the treatment of their condition.
Therapeutic Drug Monitoring (TDM)-guided treatment: The dose of biologic treatment is adjusted based on the concentration of drug in the blood, as measured through a blood test, and other individual factors such as body weight. Using data to inform dosage in this way enables treatment to be personalized.
Standard care: Participants continue their biologic treatment at the usual prescribed dose to manage psoriasis.
The study is led by St John’s Institute of Dermatology at King’s College London, UK, and opened to recruitment in November 2024. It is being conducted at multiple dermatology centers across the UK. It is funded by the National Institute for Health and Care Research (NIHR) and the National Psoriasis Foundation and also supported by the Psoriasis Association (lead UK charity for individuals affected by psoriasis). A total of 90 participants are being recruited, and the findings will be disseminated through scientific conferences, peer-reviewed journals, and patient networks.
To minimize the healthcare burden for study participants and reduce the need for face-to-face study visits, the team at St John’s Institute of Dermatology sought a digital solution to empower patients to submit patient-reported outcome measures remotely – the ‘mySkin app’.
mySkin app
The mySkin app leverages RADAR-base, a versatile platform for remote monitoring developed by The Hyve, and delivers a tailored solution for the project’s requirements. Key aspects of the solution include:
1. Self-Enrolment and eConsent
Participants can gain access to the mySkin app through a QR code, administered by the study team. Their corresponding home page can also be personalized (study group specified, date of last dose, date of next dose, today’s tasks)
Options discussed included using Keycloak for basic participant registration or a more advanced solution with ORY for registering various user types.
Consent is recorded via an approval button, simplifying the process while maintaining compliance.
Future plans include enabling sell-enrollment in the app along with eConsent
2. Data Collection
Collection of demographic and clinical data (including details of their skin condition, quality of life, and mood) at baseline and follow-up every 3 months for 1 year through surveys.
Integration of push notifications and emails to remind participants of upcoming surveys, leveraging RADAR-base’s scheduling capabilities.
3. Camera Integration
Participants can submit self-taken photos of affected areas of skin (trunk, legs, worst site).
Images are uploaded to the RADAR-base backend for storage, with resizing options to ensure high-quality data for algorithm development.
Instructions for capturing high-quality images are provided within the app.
4. Personalised Data Feedback Dashboard
A dashboard allows participants to view summaries of their self-reported disease measures over time, wellbeing trends, and treatment details, once they have completed the study.
Step-by-step instructions and images for the self-sampling of blood are embedded.
The dashboard builds upon the clinician dashboard developed under the IMI H2O project and is optimized for mobile use.
5. Calendar for Treatment Log and Notifications
Participants can log treatment doses and receive notifications for scheduled doses.
The "My Tasks" page provides a comprehensive overview of upcoming survey dates and medication doses, helping individuals stay organized and on track with their medication schedules and survey participation.
Information can be self-entered by participants or pulled from integrated systems in future updates.
6. Ad hoc clinic visit request
Participants can contact the study team to arrange an urgent in-person ad hoc clinic visit and upload images of their skin,
A simple, secure button facilitates contact via email or phone.
Throughout the PLAN-psoriasis feasibility trial, participants are asked to complete surveys and submit photographs of their skin every three months using the mySkin app to track changes in their psoriasis. Blood samples will be taken at the start and end of the study, with an additional self-taken blood sample midway through (step-by-step instructions for self-sampling are embedded within the mySkin app). Face-to-face clinic visits take place at the start and end (12 months) of the study and participants have the option to request an in-person ad hoc clinic visit if they feel their psoriasis is worsening or if they have concerns about their treatment. Additionally, a small subset of participants and healthcare professionals will be invited to take part in an optional interview at the study's conclusion to gather insights about their experiences during the study.
The Impact
The personalized treatment plans in the PLAN-psoriasis feasibility trial represent a promising step forward in the management of psoriasis, offering a more tailored and potentially less burdensome treatment approach. By formally evaluating the feasibility of innovative personalized treatment strategies, the study aims to advance the field toward ultimately improving the lives of people living with psoriasis. The mySkin app is empowering participants to actively monitor and manage their psoriasis while contributing valuable insights to research. By integrating personalized treatment plans and user-friendly digital tools, this project exemplifies a patient-centered approach to chronic disease management. The findings from the PLAN-psoriasis feasibility trial will inform larger studies, driving advancements in personalized healthcare and reducing treatment burden for patients and healthcare systems.