Effectiveness of dupilumab treatment in 95 patients with atopic dermatitis: daily practice data

Background: Dupilumab is the first biologic registered for the treatment of moderate-to-severe atopic dermatitis (AD), and efficacy was shown in phase III clinical trials (primary outcome at week 16 was reached in 38% of patients). Currently, there are limited daily practice data available for dupilumab, especially when it is combined with systemic immunosuppressants. Objectives: To evaluate dupilumab treatment in daily practice in patients with AD. Methods: In this observational cohort study, we prospectively included all adult patients with AD who had been treated with dupilumab in two university hospitals in the Netherlands. Concomitant systemic immunosuppressive treatment was monitored. Physician-reported outcome measures and patient-reported outcome measures (PROMs) after ≥ 12 we

Contact allergy in children with and without atopic dermatitis; which are the frequent allergens?

Background: Data on contact allergies in children are poor. This study aims to identify the occurrence of contact allergies and relevance of allergens in children. This will allow better identification of potential sensitizers and improve patients' care in children. Patients and methods: We retrospectively analyzed data of children aged 0-18 years, that were patchtested with at least the European base line series between 1996-2013 in 3 University Hospitals across the Netherlands. Patchtesting was performed using the TRUE-test (n=322) and Trolab/Hermal/ Chemotechnique allergens (n=690). Additional patch tests series were also analyzed. Preliminary results: 1012 Children (male 38%, mean age 13 years) were included, of which 531 (52%) developed ≥1 positive reaction. The most frequent reactions were found to nickel (16,4%: 164/998), cocamidopropylbetaine (15,9%: 54/339), Fragrancemix-I (9,8%: 99/1008), amerchol-L-101 (8,8%: 30/339) and woolalcohols (6,1%: 62/1009). In children with atopic dermatitis (AD) the most common reaction was to cocamidopropylbetaine, although this difference was not significant compared to children without AD. Reactions to woolalcohols were significantly more common in children with AD (p=0,04). Strikingly, significantly less positive reactions to woolalcohols were found testing with the TRUE-test (n=4) compared to testing with Trolab/Hermal/Chemotechnique patchtest preparations (n=55) (

Real-world reported adverse events related to systemic immunomodulating therapy in patients with atopic dermatitis: results from the TREAT NL (TREatment of ATopic eczema, the Netherlands) registry

Background: Evidence on the (long-term) safety of systemic immunomodulating therapies in atopic dermatitis (AD) generated by real-world data is sparse.Objectives: To describe real-world reported adverse drug reactions (AEs) related to systemic immunomodulating therapy in patients with AD and to compare the incidence rates of AEs with the Summaries of Product Characteristics (SmPCs).Methods: We conducted an observational prospective multi-centre cohort study, using the TREAT NL registry. All severe AEs, AEs of special interest and serious AEs in adult and paediatric patients on systemic immunomodulating treatment (ciclosporin, methotrexate, azathioprine, mycophenolic acid, dupilumab, tralokinumab, baricitinib and upadacitinib) were assessed. Incidences rates of all (potentially) drug-related AEs were standardized in patient years and compared to the cumulative incidences in the associated SmPCs.Results: We collected 422 patient years of safety data from 266 patients, of whom 129 (48.5%) reported a total of 224 (potentially) drug-related AEs. Compared to dupilumab's SmPC, higher incidence rates were found for four AEs (reported >= 5 times): eosinophilia, blepharitis, dry eyes and head and neck erythema (i.e. dupilumab facial redness). A higher incidence rate of fatigue was found in patients on oral methotrexate in our cohort compared to the SmPC. Two new drug-related AEs (reported >= 5 times) were found in patients on dupilumab, including non-infectious conjunctivitis and meibomian gland dysfunction.Conclusions: Real-world reported AEs captured in AD patient registries can add information on the estimated incidence of AEs and benefit clinical decision aids. Future studies using data derived from the TREAT NL registry combined with data from other registries within the TREAT Registry Taskforce will provide more information on (rare) AEs associated with immunomodulating therapy in AD patients.Dermatology-oncolog

Long-term effectiveness and safety of treatment with dupilumab in patients with atopic dermatitis: Results of the TREAT NL (TREatment of ATopic eczema, the Netherlands) registry

Background: Evidence on long-term dupilumab treatment for atopic dermatitis in daily practice is lacking. Objective: To investigate patient characteristics, treatment aspects, effectiveness, and safety of up to 84 weeks of dupilumab treatment. Methods: An observational prospective cohort study was conducted of patients with atopic dermatitis starting dupilumab in routine clinical care. Results: Of the 221 included patients, 103 used systemic therapy at baseline. At 84 weeks, we found a change of −15.2 (SE, 1.7) for the Eczema Area and Severity Index, −16.9 (SE, 1.4) for the Patient-Oriented Eczema Measure, and −17.2 (SE, 1.6) for the Dermatology Life Quality Index. We found a trend for improvement over time for the Investigator Global Assessment and Numerical Rating Scale for pruritus. Severe (n = 79) including serious (n = 11) adverse events were observed in 69 patients. Eye complaints were most frequently reported (n = 46). Twenty-one patients adjusted the regular dosing schedule, and 14 patients discontinued treatment, mainly due to ineffectiveness (n = 7). Limitations: Only adverse events of severe and serious nature were registered for feasibility reasons. Conclusion: Daily practice dupilumab treatment of up to 84 weeks is generally well-tolerated, apart from the reporting of eye complaints. It can be considered a long-term effective treatment for atopic dermatitis in combination with topical and initial concomitant systemic treatment, showing a sustained improvement of signs, symptoms, and quality of life

The BIOMarkers in Atopic Dermatitis and Psoriasis (BIOMAP) Glossary: developing a lingua franca to facilitate data harmonisation and cross-cohort analyses

Dear Editor, BIOMAP (BIOMarkers in Atopic dermatitis and Psoriasis) is a large European consortium aiming to advance personalised medicine for atopic dermatitis and psoriasis by identifying biomarkers which predict therapeutic response and disease progression. BIOMAP brings together clinicians, researchers, patient organisations and pharmaceutical industry partners and encompasses data from over 60 individual studies, including randomised clinical trials, population-based cohorts and deeply-phenotyped disease registries. The curation and harmonisation of data and bio-samples from these established studies will facilitate cross-cohort clinical and molecular analyses, increasing the potential to identify small effect estimates and to better stratify disease subtypes. This letter serves to disseminate BIOMAP's pathway to data harmonisation and will inform future collaborative research endeavours