Characterising the risk of malignancy in patients with atopic dermatitis prescribed immune suppressive medications

Study type
Protocol
Date of Approval
Study reference ID
21_000444
Lay Summary

People on immune suppressive medications may develop cancer more often than the general population. Immune suppressive medications are often prescribed to patients with atopic dermatitis, which is the most common form of eczema. This study looks to understand if patients with this condition prescribed immune suppressive medications are more likely to develop cancer than patients not prescribed these treatments.

Technical Summary

Atopic dermatitis is a common condition affecting 11-20% of children and 5-10% of adults in the United Kingdom. Treatment varies upon severity, with initial treatment prescribed in primary care being emoillients and topical corticosteroids. In a proportion of patients, this treatment is insufficient, and the patient continue to suffer from itching, dry skin, bleeding, recurrent skin infections, pain, sleep disturbance, reduced quality of life and work productivity. In moderate and severe atopic dermatitis that is refractory to topical corticosteroids, there are a number of treatment modalities including UV light treatment, calcineurin inhibitors, immune suppressive therapies (IST) and biologics. Immune suppressive medications have been linked to increased risk of malignancy. Interestingly, patients with rheumatoid arthritis prescribed IST have a reduced incidence of cancer compared to those who do not receive these medications. To date, studies examining the association of IST in patients with atopic dermatitis with cancer have been limited to 24 months. Considering that the development of malignant lesions can take many years, there is a need to research whether there is an association over a long time period.
By utilising CPRD we will be able to characterise patients with atopic dermatitis, if they have a diagnosis of cancer, and the dates of cancer. Since electronic healthcare records document prescription of IST under shared care pathways, we will be able to establish an association between IST and the time until cancer or potent steroid until cancer. Patients with moderate/severe atopic dermatitis, identified through the use of potent steroids will be grouped into a cohort of patients on ISTs and those who are not. Patients will be matched on comorbidities that may be linked to cancer and the cohorts compared through a cox proportional hazards model. An additional analysis will be conducted using inverse probability weighting for the same cancer outcome.

Health Outcomes to be Measured

Time to cancer diagnosis
Incidence of cancer
Time to haematological cancer diagnosis
Incidence of haematological cancer diagnosis
Ranked analysis of cancer diagnosis

Collaborators

Simon Wan Yau Ming - Chief Investigator - Health iQ Ltd ( UK ) t/a CorEvitas
Simon Wan Yau Ming - Corresponding Applicant - Health iQ Ltd ( UK ) t/a CorEvitas
Rebeka McClintock - Collaborator - Health iQ Ltd ( UK ) t/a CorEvitas