Safety, pharmacokinetics, and pharmacodynamics of sofnobrutinib, a novel non-covalent BTK inhibitor, in healthy subjects: First-in-human phase I study.

Bruton's tyrosine kinase (BTK) is a potential therapeutic target for allergic and autoimmune diseases. This first-in-human phase I study evaluated safety, pharmacokinetic, and pharmacodynamic profiles of sofnobrutinib (formerly AS-0871), a highly selective, orally available, non-covalent BTK inhibitor, in healthy adult subjects. Single ascending doses (SAD; 5-900 mg) and multiple ascending doses (MAD; 50-300 mg twice daily [b.

The construct validity, responsiveness, reliability and interpretability of the Recap of atopic eczema questionnaire (RECAP) in children.

Background: The Recap of atopic eczema questionnaire (RECAP) was developed to measure eczema control in patients with atopic dermatitis (AD). The measurement properties of RECAP have not yet been validated in caregivers of children with AD.

Objectives: To assess the construct validity, responsiveness, reliability and interpretability of the Dutch proxy version of RECAP.

EDP-297: A novel, farnesoid X receptor agonist-Results of a phase I study in healthy subjects.

EDP-297 is a farnesoid X receptor agonist under development for treating nonalcoholic steatohepatitis. The pharmacokinetic (PK), pharmacodynamic (PD), food effect, and safety were evaluated in a single ascending dose (SAD) and multiple ascending dose (MAD) phase I study. Healthy subjects received single EDP-297 doses of 20-600 μg or once daily doses of 5-90 μg for 14 days.

Content validity of the Recap of atopic eczema (RECAP) instrument in Dutch, English and German to measure eczema control in young people with atopic eczema: a cognitive interview study.

Background: Recap of atopic eczema (RECAP) is a patient-reported outcome measure assessing eczema control. This instrument has been developed and validated in the UK. There are self-reported and proxy-reported versions in English, Dutch and German.

Vesicular hand eczema transcriptome analysis provides insights into its pathophysiology.

Hand eczema is a common inflammatory skin condition of the hands whose pathogenesis is largely unknown. More insight and knowledge of the disease on a more fundamental level might lead to a better understanding of the biological processes involved, which could provide possible new treatment strategies. We aimed to profile the transcriptome of lesional palmar epidermal skin of patients suffering from vesicular hand eczema using RNA-sequencing.

Eczema control and treatment satisfaction in atopic dermatitis patients treated with dupilumab - a cross-sectional study from the BioDay registry.

Background: Eczema control is a new construct to be measured in atopic dermatitis (AD).

Objectives: Measuring patient-perceived eczema control and treatment satisfaction in AD patients, treated with dupilumab between 16 and 52 weeks.

Methods: Cross-sectional questionnaire study.

Interpretability of the Quality Of Life in Hand Eczema Questionnaire.

The Quality Of Life in Hand Eczema Questionnaire (QOLHEQ) is used to measure impairment of health-related quality of life in hand eczema. Here, we prospectively studied the interpretability of international QOLHEQ scores at three time points: baseline, after 1-3 days (T), and after 4-12 weeks (T). Adult patients with hand eczema completed the QOLHEQ and anchor questions for overall assessment of health-related quality of life impairment.

Effect of dupilumab on hand eczema in patients with atopic dermatitis: An observational study.

Systemic treatment options for chronic hand eczema are limited. Dupilumab is used in atopic dermatitis (AD) but is not licensed for (isolated) hand eczema. In this observational prospective study we aimed to determine the response of hand eczema to dupilumab in patients with AD.

[Ocular symptoms associated with dupilumab in atopic dermatitis].

Background: Dupilumab, the first registered biological for the treatment of atopic dermatitis, frequently causes adverse ocular events. These often take the form of mild conjunctivitis or blepharoconjunctivitis, however, more serious adverse ocular events have also been reported, including limbal stem cell insufficiency.

Case Description: A 56-year-old man was treated with dupilumab for severe atopic dermatitis.

Hand eczema among Dutch beekeepers - a cross-sectional study.

Background And Objectives: Studies of beekeepers have mostly focused on contact allergy to propolis. The overall prevalence of hand eczema (HE) in beekeepers has not been studied. Our objectives were to gain insight into the prevalence of HE in the Dutch beekeeper population; to define the impact of beekeeping activities on HE and vice versa; and to determine associated factors.

Which outcomes have been measured in hand eczema trials? A systematic review.

The considerable heterogeneity of outcomes and measurement instruments in hand eczema trials substantially limits the evidence synthesis concerning therapeutic and preventive interventions. Therefore, the Hand Eczema Core Outcome Set (HECOS) initiative is developing a core outcome set for future trials. The first objective was to identify outcomes that were measured in previous trials, to group them in domains, and to identify their measurement instruments.

European Surveillance System on Contact Allergies (ESSCA): Contact allergies in relation to body sites in patients with allergic contact dermatitis.

Background: Analyses of the European Surveillance System on Contact Allergies (ESSCA) database have focused primarily on the prevalence of contact allergies to the European baseline series, both overall and in subgroups of patients. However, affected body sites have hitherto not been addressed.

Objective: To determine the prevalence of contact allergies for distinct body sites in patients with allergic contact dermatitis (ACD).

Study protocol: efficacy of oral alitretinoin versus oral cyclosporine A in patients with severe recurrent vesicular hand eczema (ALICsA): a randomised prospective open-label trial with blinded outcome assessment.

Introduction: Systemic treatment with alitretinoin is registered for all clinical types of severe chronic hand eczema. However, it is especially effective in the hyperkeratotic subtype and less effective in non-hyperkeratotic forms. Cyclosporine A (cyclosporine) is prescribed for hand eczema in daily practice as well.

Presenteeism in a Dutch hand eczema population-a cross-sectional survey.

Background: Presenteeism (attending work despite complaints and ill health, which should prompt rest and absence) has been overlooked in the field of hand eczema.

Objectives: To examine the 1-year prevalence of presenteeism related to hand eczema in a population of hand eczema patients who visited a tertiary referral centre. Secondary objectives: to identify intrinsic/extrinsic reasons for presenteeism and to evaluate associated factors.

Guideline for translation and national validation of the Quality of Life in Hand Eczema Questionnaire (QOLHEQ).

There is a need for well-developed and validated questionnaires to measure patient reported outcomes. The Quality of Life in Hand Eczema Questionnaire (QOLHEQ) is such a validated instrument measuring disease-specific health-related quality of life in hand eczema patients. A re-validation of measurement properties is required before an instrument is used in a new population.

Cross-Cultural Validation of the Quality of Life in Hand Eczema Questionnaire (QOLHEQ).

The Quality of Life in Hand Eczema Questionnaire (QOLHEQ) is the only instrument assessing disease-specific health-related quality of life in patients with hand eczema. It is available in eight language versions. In this study we assessed if the items of different language versions of the QOLHEQ yield comparable values across countries.