Implementing Federated Analysis using DataSHIELD in the DREAM TO TREAT Atopic Dermatitis Registries Collaboration.

Many new biologic treatments and small molecule agents are emerging and being approved for treating atopic dermatitis (AD). Robust evidence, based on large sample sizes from real-world clinical settings, are needed to investigate the use of these new therapies, However, adequate sample sizes of patient data are difficult to obtain within one country alone, requiring international collaboration and data aggregation. To address this need for cooperative research, we investigated the feasibility for an international collaboration of registries to gather data from real-world clinical settings on patients' use of new systemic treatments for AD by creating a federated network between national registries that enables an analysis environment protecting privacy of information and ensuring compliance with General Data Protection Regulation.

A pan-European register-based observational study of abrocitinib and conventional systemic therapies in moderate and severe atopic dermatitis: the DREAM TO TREAT AD study protocol.

Background: Atopic dermatitis (AD) is a common chronic inflammatory skin condition. Currently, there is a lack of real-world evidence regarding the effectiveness of systemic therapies for moderate-to-severe AD. Abrocitinib is a novel Janus kinase 1 selective inhibitor licensed for AD in adults and adolescents requiring systemic treatment.

Measuring health-related quality of life in patients with peripheral vascular malformations with PROMIS® computerized adaptive tests.

Background: The Patient-Reported Outcomes Measurement Information System (PROMIS) computerized adaptive tests (CATs) have been recommended for measuring health-related quality of life (HRQoL) in rare diseases.

Objective: To assess whether PROMIS CATs reliably measure HRQoL core outcome domains in adults with vascular malformations, and if so, to establish reference values for this population.

Methods: In this prospective cohort study, adult patients with vascular malformations at our tertiary referral center were invited to complete PROMIS CATs measuring HRQoL core outcome domains, followed by a retest seven days after completing the first questionnaires.

Living network meta-analysis to compare nemolizumab against other available targeted systemic treatments for atopic dermatitis.

Nemolizumab is a new biologic approved to treat atopic dermatitis. In this perspective piece, we use results from our living systematic review and network meta-analysis to provide perspective on the relative efficacy of nemolizumab compared with other approved targeted systemic treatments.

A Quality Analysis of the Measurement Properties of the Clinician-Reported Outcome Measures for Vitiligo and of the Studies Assessing Them: A Systematic Review.

Evaluating the measurement properties (MPs) of Clinician-Reported Outcome Measures (ClinROMs) is crucial for selecting appropriate instruments for vitiligo assessment. This review critically appraises the existing evidence on the MPs of the ClinROMs used in vitiligo. A systematic search was conducted in PubMed, Embase, and the Cochrane Library up to 20 February 2024, identifying validated ClinROMs in vitiligo.

Quality Analysis of Measurement Properties of Patient-Reported Outcome Measures for Vitiligo and of the Studies Assessing Them: A Systematic Review.

Evaluating measurement properties (MPs) of Patient Reported Outcome Measures (PROMs) in vitiligo is essential for evidence-based recommendations and identifying research gaps. This study assesses the quality of PROMs used in vitiligo. A systematic search of PubMed, Embase, and the Cochrane Library (up to 20 February 2024) included studies on PROM analysis or development, excluding those validating other tools.

Outcome measurement in pemphigus clinical research: a scoping review on heterogeneity in outcome reporting and definitions.

Background: Pemphigus is an autoimmune bullous disease (AIBD) and has two main subtypes, pemphigus vulgaris (PV) and pemphigus foliaceus (PF). For adequate interpretation and comparison of clinical studies in pemphigus, it is essential to have outcomes and outcome measurement instruments (OMIs) that are well-defined, uniform and relevant.

Objectives: To provide a comprehensive overview of previously reported outcomes and OMIs in pemphigus clinical research over the past two decades.

Impact of COVID-19 disease and vaccination on dermatological immune-mediated inflammatory diseases atopic dermatitis, psoriasis, and vitiligo: a Target2B! substudy.

During the COVID-19 pandemic, the daily life of many patients with dermatological immune-mediated inflammatory diseases (DIMIDs), such as atopic dermatitis (AD), psoriasis, and vitiligo, was impacted by social restrictions caused by (fear of) morbidity, mortality associated with COVID-19, and vaccine hesitancy. This prospective observational, multicenter, multidisciplinary cohort study explored the impact of COVID-19 disease and vaccination on DIMIDs, specifically AD, psoriasis, and vitiligo. Data from patients with DIMIDs were collected as part of the Target2B! study (between February 2021 and October 2022).

International consensus on methotrexate dosing for patients with atopic dermatitis: An eDelphi study.

Background: Despite the widespread off-label use of methotrexate (MTX) for the treatment of atopic dermatitis (AD), there is limited high-quality evidence on dosing regimens and existing guidelines do not provide clear recommendations regarding dosing strategies.

Objective: The aim of this study was to achieve international consensus among AD experts to standardize the dosing regimen for MTX treatment in adults and children with AD.

Methods: An electronic Delphi (eDelphi) study was conducted from October 2021 to September 2022.

The UPDATE trial (UVB Phototherapy in Dermatology for ATopic Eczema): study protocol for a randomized controlled trial of narrowband UVB with optimal topical therapy versus optimal topical therapy in patients with atopic eczema.

Background: Narrowband ultraviolet B (NB-UVB) phototherapy is commonly prescribed for patients with moderate-to-severe atopic eczema (AE). The efficacy of NB-UVB, however, has not yet properly been established, as current evidence is of low certainty. Our aim is to assess the short-term and long-term (cost-)effectiveness and safety of NB-UVB in adult AE patients by performing a pragmatic, multicenter, prospective, randomized, open-label, blinded-endpoint (PROBE) trial.

Responsiveness of the condition-specific Outcome measures for VAscular MAlformations (OVAMA) questionnaire to measure symptoms and appearance in patients with vascular malformations.

Background: Evidence-based guidelines for the treatment of vascular malformations (VMs) are not readily available, possibly due to the diversity in methods used to evaluate treatment efficacy in clinical research, complicating the aggregation and comparison of study results. The Outcome measures for VAscular MAlformations (OVAMA) questionnaire was developed to measure uniformly symptoms and appearance (i.e.

Measuring Signs of Atopic Dermatitis in Clinical Practice: A HOME-CP Consensus Statement.

Importance: Outcome measurement is an essential component of value-based health care and can aid patient care, quality improvement, and clinical effectiveness evidence generation. The Harmonising Outcome Measures for Eczema Clinical Practice initiative aims to identify a list of validated, feasible, outcome measurement instruments recommended to measure atopic dermatitis (AD) in the clinical practice setting. The clinical practice set is a list of instruments that clinicians can pick and choose from to suit their needs in the context of clinical care.

Suppressed IgG4 class switching in dupilumab- and TNF inhibitor-treated patients after mRNA vaccination.

Background: The noninflammatory immunoglobulin G4 (IgG4) is linked to tolerance and is unique to humans. Although poorly understood, prolonged antigenic stimulation and IL-4-signaling along the T helper 2-axis may be instrumental in IgG4 class switching. Recently, repeated SARS-CoV-2 mRNA vaccination has been linked to IgG4 skewing.

The wide variety of methotrexate dosing regimens for the treatment of atopic dermatitis: a systematic review.

Methotrexate is an off-label therapy for atopic dermatitis. A lack of consensus on dosing regimens poses a risk of underdosing and ineffective treatment or overdosing and increased risk of side effects. This systematic review summarizes the available evidence on dosing regimens.