Patients with persistently controlled atopic dermatitis who had their doses reduced were able to maintain their low disease activity.
Patients on Dupixent (dupilumab) who have controlled atopic dermatitis (AD) can successfully have their dose reduced and maintain stable low disease activity. The findings were published in Allergy: European Journal of Allergy & Clinical Immunology.
Researchers in the Netherlands evaluated a patient-centered dosing regimen for patients with controlled AD with 90 adults with AD who were treated with Dupixent. Type 2 inflammation is common in atopic diseases, and Dupixent targets key drivers of type 2 inflammation, including interleukin (IL)-4 and IL-13.
“Continuing the standard dosage in patients with persistently controlled AD might lead to overtreatment and an increase in adverse events (e.g. injection side reactions, conjunctivitis),” the researchers noted.
The patient-centered dosing regimen is based on tapering protocols of biologics in other diseases, such as rheumatoid arthritis. In this study, patients were eligible for their dose to be reduced after being treated with Dupixent for 52 weeks and when disease activity was controlled, which was defined as Eczema Area and Severity Index (EASI) score of 7 or less.
For patients with EASI ≤ 7, their dosage interval was prolonged to every 3 weeks, which reduced dosage to 66% of the standard dosage. Patients who continued to have controlled disease activity then prolonged interval to every 4 weeks (double the original interval), which reduced dosage to 50% of the standard dosage. Patients with persistently controlled disease reduced their dosage even more to every 6 weeks, and finally to every 8 weeks. The dosage interval was shortened for patients with increased pruritus scores or physician-reported disease severity scores.
After 52 weeks of treatment, patients were divided into 3 groups:
The patients were followed up for at least 91 weeks. The mean age of patients was 42.4 years, and the majority were male (65.6%). During the first 52 weeks of treatment with Dupixent, the median EASI score dropped from 17.9 at baseline to 2.7.
Group A maintained stable disease severity with a median EASI score of 6.4 after 52 weeks and 5.4 after a mean duration of 115 weeks. At 52 weeks, 50% had controlled AD; at 85 weeks, 40% had controlled AD; and at 115 weeks, 50% had controlled AD.
Groups B and C also maintained stable disease with no significant difference in EASI score between 52 weeks, when the tapering started, and the end of the study (mean 141 weeks for Group B and 140 weeks for Group C). After at least 3 months on a dosage interval of every 4 weeks, 83.3% of patients in group B and 86.7% of patients in group C had controlled AD. At the end of the study, when patients in group C had moved to dosing every 6 or 8 weeks, 93.3% of patients had controlled AD.
Numeric Rating Scale (NRS) pruritus temporarily increased after prolonging the dosing interval, but these changes were small and scores remained low, the researchers noted. “The clinical relevance of these differences are questionable as the changes in NRS scores were small and inconsistent and median NRS scores remained ≤4, which is also considered as a treatment target,” they wrote.
One of the limitations noted was that more research is needed to understand unsuccessful dose reduction because patients who shortened their intervals were not included. In addition, a direct comparison between patients on standard dosing and dose reduction is not feasible since patients in group A who did not have their dose tapered had higher disease severity scores than patients in groups B and C.
“These findings are the first step toward personalized dupilumab treatment for controlled AD patients in clinical practice,” the authors concluded.