The safety of dupilumab allows treatment of atopic dermatitis without routine laboratory monitoring
The first comprehensive analysis of laboratory data from 3 clinical trials with dupilumab assessed the incidence of clinically significant changes in hematological or biochemical parameters in patients with moderate to severe atopic dermatitis.
Introduction
Long-term treatment of atopic dermatitis with common immunosuppressants is limited by significant side effects and the need for regular monitoring of hematologic and organ toxicity. Dupilumab is a monoclonal antibody that blocks the shared subunit of the receptor for interleukin 4 and 13 and is approved for the treatment of patients over 12 years old with inadequately controlled moderate to severe atopic dermatitis.
Dupilumab has demonstrated efficacy and a favorable safety profile in 3 studies lasting up to 52 weeks in patients who were inadequately controlled on topical therapy. The aim of a recently published pooled analysis of data from these 3 studies (SOLO 1, SOLO 2, and CHRONOS) was to further characterize the laboratory safety of dupilumab in this patient population.
Analyzed Data
The pooled analysis included data from 1376 patients from the 16-week SOLO 1 and 2 studies and from 740 patients from the 52-week CHRONOS study. All studies were randomized, double-blind, and compared weekly and biweekly dosing of dupilumab with placebo. Patients in the CHRONOS study followed a standardized regimen of topical corticosteroids.
Findings
Mild decreases in platelet and neutrophil counts were observed in patients receiving dupilumab compared to baseline and placebo.
Some patients on dupilumab experienced a mild transient increase in eosinophil counts; however, grade 3 eosinophilia was reported in < 1% of patients in both the dupilumab and placebo groups, and no adverse events related to eosinophilia occurred.
All studies with dupilumab showed a mild decrease in lactate dehydrogenase levels.
No clinically significant differences were observed between therapeutic groups in hematological parameters, blood biochemistry, or urine analysis.
Conclusion
The results of the presented analysis support the use of dupilumab as a long-term systemic treatment for moderate to severe atopic dermatitis without the need for routine laboratory monitoring of patients in everyday practice.
(zza)
Source: Wollenberg A., Beck L. A., Blauvelt A. et al. Laboratory safety of dupilumab in moderate-to-severe atopic dermatitis: results from three phase III trials (LIBERTY AD SOLO 1, LIBERTY AD SOLO 2, LIBERTY AD CHRONOS). Br J Dermatol 2020; 182 (5): 1120−1135, doi: 10.1111/bjd.18434.
Did you like this article? Would you like to comment on it? Write to us. We are interested in your opinion. We will not publish it, but we will gladly answer you.
