Protocol for Observational Safety Study of Dupilumab for Atopic Eczema

Atopic dermatitis skin texture
Atopic dermatitis skin texture
A protocol for an investigator-initiated multicenter safety study comparing dupilumab with other systemic immunomodulating therapies in adults, adolescents, and children with moderate to severe atopic eczema is outlined.

An international team of researchers comprising the TREatment of ATopic eczema (TREAT) Registry Taskforce has published a proposed protocol for a European safety study of dupilumab, in addition to other systemic therapies, in patients with atopic eczema. The protocol was published in the British Journal of Dermatology.

Patients enrolled in the safety study, according to the researchers, will have a physician diagnosis of atopic eczema and are either starting on or switching to a new systemic immunomodulating therapy. The investigators will aim to enroll a similar number of patients treated with dupilumab as patients treated with other contemporaneous comparators. Patients will be assessed on a 6-monthly basis on treatment and annually off treatment to analyze adverse events (AEs) and reasons for therapy changes. A 5-year follow-up duration is the goal for each patient.

For the primary end point, the TREAT Registry Taskforce suggests using the incidence rate ratio (IRR) of cancer in the follow-up period in dupilumab-treated patients vs patients treated with other immunomodulating therapies. Additional end points will include IRRS of serious adverse events (SAEs), IRRs of other AEs of special interest, and the dupilumab discontinuation rate due to AEs. The investigators assume a 20% dropout rate in all patients.

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According to the Taskforce, data from each registry will be pooled and compared in terms of differences in IRRs of malignancies or serious infections, in addition to other AEs of interest. The Taskforce notes that a limitation of the study will be that treatment with dupilumab will be based on access to the drug, rather than based on disease severity.

“The observational nature of the study, using the platform of registries of the TREAT Registry Taskforce,” the researchers wrote with regard to the study’s strengths, “guarantees the collection of data from patients in a routine clinical care setting.”

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Bosma AL, Spuls PI, Garcia-Doval I, et al. TREatment of ATopic eczema (TREAT) Registry Taskforce: protocol for a European safety study of dupilumab and other systemic therapies in patients with atopic eczema [published online August 24, 2019]. Br J Dermatol. doi:10.1111/bjd.18452