People with atopic dermatitis who took the drug Dupixent had a four times greater risk of developing a rare skin cancer than those who didn’t, a recent study has found.
Drugwatch reports the findings of study, published in the Journal of the American Academy of Dermatology, has been confirned by a second analysis, published in Dermalogic Therapy.
It showed the risk of cutaneous T-cell lymphoma (CTCL) was highest in patients over 60 and within the first year of using the drug.
Dupixent, which is the brand name of dupilumab, is produced by Sanofi and Regeneron, and has been prescribed to more than 1m people worldwide to help treat atopic dermatitis (AD) and other conditions.
What is it?
Dupixent is a biologic medication, meaning it’s made from living cells designed to target specific areas of the immune system. It works by blocking specific proteins that cause inflammation.
The medication can treat or be used as an additional therapy for several chronic conditions, including:
Bullous pemphigoid: a skin ailment that results in fluid-filled blisters.
Chronic obstructive pulmonary disease: An airway and lung disease that makes it hard to breathe.
Chronic spontaneous urticaria: Skin welts that are itchy, red and last at least six weeks.
Eosinophilic esophagitis: An immune system disease that makes swallowing difficult.
Moderate to severe uncontrolled eczema: Also known as atopic dermatitis (AD), this causes itchy, dry patches of skin.
Oral steroid-dependent asthma: Asthma that requires steroids and is hard to manage.
Prurigo nodularis: A skin condition that results in itchy skin bumps.
Uncontrolled chronic rhinosinusitis with nasal polyps: An inflammatory sinus disease with small, benign growths in your sinuses and nasal passages.
Uncontrolled moderate-to-severe eosinophilic asthma: Asthma caused by high numbers of white blood cells in your airways.
Symptoms of CTCL
CTCL often looks like other common skin conditions, which may delay diagnosis. According to Mayo Clinic, symptoms can include:
- A widespread, itchy, scaly rash;
- Discoloured patches on the skin;
- Enlarged lymph nodes;
- Hair loss;
- Scaly patches or raised skin that might be itchy;
- Skin lumps that may break open; and
- Thickened skin on the soles of the feet or palms.
FDA monitoring
Dupixent has worked well for many patients, but it’s also been linked to serious side effects, reports Drugwatch.
According to the US Food & Drug Administration’s Adverse Event Reporting System (FAERS), more than 87 000 adverse events involving Dupixent and dupilumab have been reported so far in 2025. Among these are reports of CTCL.
FAERS data are based on self-reports, which can’t prove that the drug directly caused the events. Additionally, the data may not be entirely accurate.
In late 2024, the FDA placed Dupixent on its watch list for potential regulatory action. As of August 2025, the agency has not released an update on its evaluation.
Several law firms are investigating claims from patients who developed CTCL after using Dupixent.
Study details
Dupilumab therapy for atopic dermatitis is associated with increased risk of cutaneous T cell lymphoma: A retrospective cohort study
Iraj Hasan, Lauren Parsons, Sabrina Duran, Zachary Zinn.
Abstract
Background
Dupilumab, a human monoclonal antibody targeting the interleukin 4 alpha receptor, is used for treatment of moderate to severe atopic dermatitis (AD). Previous studies have reported diagnoses of cutaneous T cell lymphoma (CTCL) after dupilumab use.
Objective
Investigate the risk of CTCL after dupilumab use in patients with AD.
Methods
Using the TrinetX database, incidence of cutaneous and lymphoid malignancies including CTCL was compared between a cohort of patients with AD who used dupilumab and a cohort of patients with AD who never used dupilumab. A second analysis excluding prior disease-modifying antirheumatic drug use was performed. Propensity score matching was performed to control for covariates.
Results
An increased risk of CTCL was found in the cohort of AD patients who used dupilumab (odds ratio 4.1003, 95% confidence interval 2.055-8.192). The increased risk persisted after exclusion of prior disease-modifying antirheumatic drug use. Risk was not increased for other cutaneous or lymphoid malignancies. Most (27/41) cases of CTCL were diagnosed more than one year after dupilumab use.
Limitations
There is potential for misclassification in the database. Severity of AD could not be assessed. Association between dupilumab and CTCL does not prove causality.
Conclusion
Dupilumab use is associated with an increased risk of CTCL in patients with AD in this cohort.
Journal of the American Academy of Dermatology article (Open access)
Drugwatch article – Studies Tie Dupixent to Increased Risk of Cancer (Open access)
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