Publications by authors named "Spuls P"
The Eczema Area and Severity Index is an investigator-assessed instrument reporting clinical signs of atopic dermatitis. The instrument is extensively validated in both adult and paediatric populations and recommended as a core outcome measure to assess clinical signs by the Harmonising Outcome Measures for Eczema initiative in clinical trials and was recently recommended as an option to measure signs in clinical practice. Here, we review the validation of the instrument using standard assessment criteria, explore controversies and challenges to its universal applicability and highlight future electronic adaptations.
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- * Current guidelines advise TB screening and preventive treatment prior to starting anti-TNF therapy, extending to other biologic therapies despite differing mechanisms of action.
- * New evidence suggests that some emerging therapies might not significantly raise TB reactivation risk, prompting calls to revise existing recommendations to better reflect individual patient risks and drug safety.
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.
Article Synopsis
- - The study evaluates the efficacy and safety of the new biologic medication lebrikizumab for treating atopic dermatitis in comparison to other systemic treatments, using a systematic network meta-analysis of clinical trials.
- - Data was gathered from various medical databases, focusing on trials that assessed treatment effects for at least 8 weeks in patients with moderate to severe atopic dermatitis, with analysis conducted using random-effects Bayesian methods.
- - Key outcomes measured include the improvement in eczema severity (using scales like EASI and POEM), safety indicators such as serious adverse events, and the ability of participants to achieve significant improvements in their condition.
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.
View Article and Find Full Text PDFBackground: 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.
View Article and Find Full Text PDFImportance: 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.
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- The study explores how patients on immunosuppressants (ISPs) respond to SARS-CoV-2 infections compared to healthy controls, particularly looking at antibody levels post-infection.
- Patients with immune-mediated inflammatory diseases (IMIDs) on different ISP therapies showed variable antibody responses, with those on anti-CD20 and sphingosine-1 phosphate therapies having lower antibody levels.
- Despite lower antibody titers, the breakthrough infections in these patients were mostly mild, indicating that ISPs may not severely impede the overall immune response to SARS-CoV-2.
Sex stratification of adverse events should be included in studies about skin disease.
J Eur Acad Dermatol Venereol
April 2024
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.
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- Core outcome sets (COSs) for skin diseases are standardized outcomes that should be measured in clinical trials, and the number of COSs is growing globally, highlighting potential overlaps in concepts.
- The study aims to conduct a scoping review to categorize and map all outcomes related to COS initiatives for skin diseases, using databases like PubMed and Embase, and involving stakeholder input.
- The research is funded by the Department of Dermatology at Northwestern University, does not require ethical approval due to the nature of the study, and results will be shared through publications and social media.
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.
View Article and Find Full Text PDFBackground: The Harmonising Outcome Measures for Eczema (HOME) initiative has agreed upon the Core Outcome Set (COS) for use in atopic dermatitis (AD) clinical trials, but additional guidance is needed to maximize its uptake.
Objectives: To provide answers to some of the commonly asked questions about using the HOME COS; to provide data to help with the interpretation of trial results; and to support sample size calculations for future trials.
Methods And Results: We provide practical guidance on the use of the HOME COS for investigators planning clinical trials in patients with AD.
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.
Phototherapy for atopic dermatitis: A survey of European practice.
J Eur Acad Dermatol Venereol
March 2024
Background: Phototherapy is used to treat atopic dermatitis (AD). Evidence for its efficacy, impact on quality of life, cost-effectiveness and short- and long-term safety with real-life usage is weak.
Objectives: We established a taskforce to examine how phototherapy is currently being used as a treatment for AD across the United Kingdom and Europe to inform our understanding and guide future research into management of patients with AD using UV-based phototherapies.
Article Synopsis
- The study investigates how combining methotrexate with adalimumab treatment affects drug concentration and response in psoriasis patients.
- A population PK-PD model was created from data collected over 49 weeks from 59 patients, revealing that methotrexate cotreatment reduces the development of antidrug antibodies, which can enhance the effectiveness of adalimumab.
- Overall, the findings suggest that using methotrexate alongside adalimumab can lead to better treatment outcomes by increasing adalimumab levels and potentially improving clinical responses.
Article Synopsis
- A systematic review and network meta-analysis evaluated the efficacy of systemic treatments for atopic dermatitis, focusing on binary outcomes from randomized trials that lasted at least 8 weeks.
- The analysis included 83 trials with over 22,000 participants, comparing treatments based on their success rates in improving symptoms as measured by the Eczema Area and Severity Index (EASI) and Investigator Global Assessment (IGA).
- Results indicated that abrocitinib and upadacitinib had higher odds of achieving significant symptom improvement compared to dupilumab, while other treatments like baricitinib and tralokinumab showed lower odds of success.
Treat-to-target (T2T) is a pragmatic therapeutic strategy being gradually introduced into dermatology after adoption in several other clinical areas. Atopic dermatitis (AD), one of the most common inflammatory skin diseases, may also benefit from this structured and practical therapeutic approach. We aimed to evaluate existing data regarding the T2T approach in dermatology, with a specific focus on AD, as well as the views of International Eczema Council (IEC) members on the potential application of a T2T approach to AD management.
View Article and Find Full Text PDFClinician-reported outcome measures for the assessment of vitiligo: A scoping review.
J Eur Acad Dermatol Venereol
November 2023
Clinician-reported outcome measures (ClinROMs) are essential for assessment of vitiligo in clinical trials and daily practice. Several instruments have been developed and tested to measure, for example, vitiligo extent, repigmentation and activity. The goal of this review was to identify all introductory publications of ClinROMs for vitiligo that include at least some aspects of validation and to describe the instruments' characteristics, intention for use and practical strengths and limitations.
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