FRADEN

The objective of this trial was to evaluate outcomes related to dupilumab-induced ocular adverse events (IOAEs) and dupilumab-induced facial erythema (FDE) following a switch to tralokinumab or a Janus kinase (JAKi) inhibitor.

This retrospective study included 106 patients who discontinued dupilumab due to OADs and/or FDE. The primary endpoint was the proportion of patients who experienced resolution or improvement of adverse events (AEs) between discontinuation of dupilumab and 3 to 6 months of treatment with tralokinumab or a JAKi; the secondary endpoint was the percentage of patients with controlled AD, defined as scores of 0/1 on the Investigator Global Assessment (IGA) between M3 and M6.

The proportions of patients experiencing resolution or improvement of DADs (92% vs. 72%; p 0.0244) and DEFs (85% vs. 33%; p 0.0006) were higher with the JAKi than with tralokinumab. The proportion of patients achieving an IGA score of 0/1 increased from M0–M3 to M6 (22% vs. 42%; p 0.0067) in the JAKi group and remained similar (32% vs. 35%) in the tralokinumab group. However, 57% of patients discontinued the new treatment after an average of 8 months, primarily due to a lack of efficacy.

The JAKi appears to be more effective than tralokinumab in managing dupilumab-induced adverse events; however, both of these strategies may prove ineffective in controlling atopic dermatitis.

For more information, see the publication at https://www.sciencedirect.com/science/article/abs/pii/S2213219824012418?via=ihub

The objective of this trial was to determine whether prenatal consumption of prebiotics could prevent the onset of atopic dermatitis in children at high risk for atopy.

The PREGRALL multicenter, randomized, double-blind clinical trial took place from February 2018 to April 2023. The follow-up period extended from the 20th week of gestation in pregnant women until their infants reached one year of age. Women with a history of atopy diagnosed by a physician (asthma, allergic rhinitis, atopic dermatitis, or food allergy) were selected to participate in the study. The women were randomized to receive a daily dose of a prebiotic (n = 188) or a placebo (n = 188 participants) starting in the 20th week of pregnancy through delivery. The primary outcome measure was the onset of AD at one year of age in at-risk children. Secondary outcome measures included the severity of AD, quality of life, tolerance to prebiotics, and the prevalence of other atopic diseases.

Among the 376 pregnant women included in the trial, prebiotic supplementation did not prevent AD at one year of age (Intent-to-Treat [ITT] analysis odds ratio: 1.01; 95% confidence interval: 0.59–1.74; p = 0.97) nor did it reduce the severity of the condition in their children. Subgroup analyses based on breastfeeding status or mode of delivery revealed no differences. No effect on allergen sensitization or food allergies was observed.

We found no evidence that maternal prebiotic intervention protects against AD at one year of age in infants at risk for allergic diseases. Future studies should explore a combination of strategies to identify effective ways to prevent eczema before it develops

The project is ongoing, and the children will be followed until age 5. 

This clinical trial is also linked to a translational research project exploring immunological and transcriptomic parameters associated with prebiotic supplementation during pregnancy (results to follow). 

To learn more, see the publication at https://academic.oup.com/bjd/article-abstract/194/3/441/8326321?redirectedFrom=fulltext&login=true

FIRST is a prospective cohort of patients with atopic dermatitis affiliated with the IMMINeNT multidisciplinary prospective cohort. The purpose of this project is to establish a prospective clinical and biological database, the “IMMINeNT cohort,” of adult patients with chronic immune-mediated inflammatory diseases (MIMI) who are being treated at one of the participating centers for the following conditions: angioedema, severe atopic dermatitis, lupus, systemic sclerosis, multiple sclerosis (MS), severe asthma, psoriatic arthritis, and Behçet’s disease.

The main scientific objectives of this database are to identify new biomarkers and determinants associated with disease activity and severity, quality of life, and infection risk in patients with IMM, as well as to conduct health economic studies using administrative health databases. The inclusion of patients with various IMM conditions will enable the conduct of transdisciplinary studies.

The IMMINeNT project is coordinated by Prof. David Launay, under the supervision of Prof. Delphine STAUMONT-SALLE for the atopic dermatitis cohort.

For more information: https://www.fhu-precise.fr/la-cohorte-fhu

Dupilumab is one of the pioneering systemic treatments available for atopic dermatitis. While dupilumab provides rapid and substantial control of the disease in the short term, it is crucial to evaluate the efficacy of long-term treatment strategies. We hypothesize that spacing out dupilumab injections in adolescents and adults with controlled atopic dermatitis represents a promising maintenance therapy option. This randomized clinical trial aims to compare a tapering strategy involving extended-interval dupilumab injections with the standard dupilumab treatment regimen in patients with controlled atopic dermatitis. This multicenter, randomized, controlled non-inferiority trial will enroll 256 adolescents and adults with controlled atopic dermatitis who have been treated with a dose of dupilumab consistent with the recommended dosage for at least 12 months, across thirty-one university hospitals. Participants will be randomly assigned in a 1:1 ratio to the experimental group (gradual injection spacing strategy) and the control group (standard maintenance therapy). The primary endpoint will be the area under the curve of the atopic dermatitis control score (ADCT) recorded weekly for one year.

For more information, click this link to view the protocol publication: https://pmc.ncbi.nlm.nih.gov/articles/PMC12797520/pdf/13063_2025_Article_9325.pdf