Use of dupilumab in patients with atopic dermatitis and comorbidities usually excluded from clinical trials

Abstract

Introduction: randomized controlled clinical trials constitute the standard for evaluating drug efficacy and safety; however, their strict exclusion criteria limit the representativeness of the population encountered in routine clinical practice. In this context, biologic therapies have substantially improved disease control in patients with atopic dermatitis (AD) who are refractory to conventional treatments or have contraindications to their use. Dupilumab, a monoclonal antibody targeting the IL-4/IL-13 pathway, has demonstrated efficacy and safety across different clinical scenarios.

Objectives: to describe the clinical course of patients with AD treated with dupilumab in situations commonly considered exclusion criteria in pivotal clinical trials.

Materials and methods: we present a case series of 10 patients with moderate-to-severe AD and relevant comorbidities, including active malignancies, human immunodeficiency virus infection, tuberculosis, hepatitis B, and lactation.

Results: all patients showed significant clinical improvement in eczema severity and pruritus, without exacerbation of underlying comorbidities or the occurrence of serious adverse events.

Conclusions: this real-world experience supports the use of dupilumab in diverse patient populations and suggests a potential role for future IL-13–targeted therapies in complex clinical settings.