Yael Anne Leshem

Inconsistent outcome reporting in randomized controlled trials (RCTs) of topical anti-inflammatory treatments for atopic dermatitis (AD) limits comparability. We evaluated uptake and reporting of Harmonising Outcome Measures for Eczema (HOME) core instruments [Eczema Area and Severity Index (EASI), Patient-Oriented Eczema Measure (POEM), itch numerical rating scale (NRS) and Dermatology Life Quality Index (DLQI)] in RCTs of topical AD treatments published from 2018 onward. Among 49 RCTs, EASI was most frequently reported (83.7%), followed by DLQI (34.7%), itch NRS (30.6%) and POEM (26.5%). Inadequate reporting led to substantial participant-level data waste, reaching up to 67.2% for DLQI. In summary, HOME core outcome uptake and standardized reporting remain limited.

The effects of systemic JAKi exposure in MF/SS appear context-dependent and should not be interpreted as a homogeneous entity. Although disease worsening was observed in several patients initially diagnosed with presumed inflammatory dermatoses, causality cannot necessarily be inferred and may reflect, among other factors, underlying MF/SS biology, referral bias or concurrent immunosuppressive influences. In patients with post-transplant MF/SS receiving JAKi for graft-versus-host disease, MF/SS progression may reflect impaired immune surveillance or other disease-related factors rather than a direct effect of JAKi. These findings underscore the complexity of interpreting JAKi exposure in MF/SS and highlight the need for prospective studies to better define risks across clinical settings.

Background: Heterogeneity in outcome reporting and inconsistent use of outcome measurement instruments in allergy and clinical immunology research affects the comparability, synthesis, and clinical applicability of study findings. Harmonisation efforts, particularly Core Outcome Set (COS) development, aim to address these challenges by establishing standardised, evidence‐based and consensus‐driven outcome recommendations. This systematic review aims to map available COS and other harmonisation processes (HP) in allergy and clinical immunology, evaluate their methodological approaches, and assess their alignment with established development standards. Methods: We systematically searched MEDLINE, EMBASE, and the COMET Initiative database until June 7, 2024 to identify COS and HP. We included studies if they provided recommendations on ‘core’ outcomes and/or outcome measurement instruments. Data extraction included disease focus, methodological approach, stakeholder involvement, and adherence to the Core Outcome Set‐STAndards for Development criteria. We synthesised the data at the initiative (process) level rather than the publication level because harmonisation initiatives are frequently iterative and reported across multiple papers (e.g., protocol, Delphi rounds, consensus statement, and subsequent instrument‐selection outputs). Results: A total of 15,612 records were identified, with 44 studies (representing 22 initiatives both finished and in development) meeting inclusion criteria. The majority of initiatives focused on asthma ( n = 9), followed by eczema (atopic dermatitis n = 2; hand eczema = 1; eczema = 1), urticaria ( n = 2), allergic rhinitis ( n = 2), chronic rhinosinusitis ( n = 1), celiac disease ( n = 1), Immunoglobulin E (IgE)—mediated food allergy ( n = 1), eosinophilic esophagitis ( n = 1), and hereditary angioedema ( n = 1). No COS or HP addressed drug allergy, anaphylaxis, or other immune‐mediated allergic conditions. ‘Quality of life’ was consistently included in all COS with ‘signs and symptoms’, ‘exacerbations’ and ‘disease control’ frequently selected as well. Methodological approaches to COS development varied widely, with most employing Delphi surveys, consensus meetings, and stakeholder involvement, though levels of engagement differed. COS developers inconsistently adhered to Core Outcome Set‐STAndards for Development criteria, with some initiatives demonstrating rigorous methodology while others lacked transparency in key developmental steps. Conclusion: This review highlights growing efforts to harmonise outcome assessment in allergy and clinical immunology. Major gaps remain in coverage and methodological rigour. Quality of life and patient‐reported symptoms are frequently recommended outcomes, yet definitions and measurement tools are inconsistent. Strengthening methodological consistency and expanding COS development to neglected areas are critical next steps to improve outcome reliability and comparability in the field.

Janus kinase inhibitors (JAKis) are increasingly used in patients with mycosis fungoides (MF)/Sézary syndrome (SS), often outside of intentional lymphoma-directed treatment, yet their real-world impact remains uncertain and poorly characterized. Our multicentre experience suggests that disease acceleration may occur in specific clinical contexts, particularly in patients initially diagnosed with dermatitis who were later recognized as having MF/SS while receiving JAKis. It remains uncertain whether this acceleration represents a direct drug-related effect. Observations in post-transplant settings warrant further investigation, particularly given ruxolitinib’s role in this context. However, symptom-focused benefit may be observed in carefully selected patients. Collectively, these findings highlight that the use of JAKis in treating patients with MF/SS should be undertaken with caution.

Background: Numeric measures of atopic dermatitis (AD) disease severity are translated into severity bands to describe disease burden. Severity bands for clinician‐reported outcomes (ClinROs), such as SCORing Atopic Dermatitis (SCORAD) and the Eczema Area and Severity Index (EASI), and patient‐reported outcomes (PROs), such as the Dermatology Life Quality Index (DLQI), Patient‐Oriented Eczema Measure (POEM) and SCORAD Sleep Loss and Pruritus Visual Analog Scales (VAS), are clinically meaningful tools for physicians and patients. Objectives: To develop severity bands for AD measures using a large data set from global, randomized, placebo‐controlled clinical trials of dupilumab in adults with moderate‐to‐severe AD. Methods: Disease severity data from 2822 adults and approximately 30,000 visits (excluding first visit) from five clinical trials were pooled. ClinROs and PROs were anchored to 5‐level Investigator's Global Assessment and Patient Global Assessment of Disease Status questionnaires, respectively, based on correlation strength. Means (via spline regression), frequencies, medians and modes were used to select thresholds for five severity categories for each outcome measure. Goodness‐of‐fit and concordance were calculated using R ² and weighted κ ‐coefficients. Results: All measures demonstrated high goodness‐of‐fit, and most demonstrated high concordance with the respective anchors ( R ² : 0.981–0.999; quadratic weighted κ ‐coefficients: 0.207–0.831). PROs showed reasonable agreement with previously published bands, while ClinROs displayed severity strata that differed from previously published bands. For the first time, severity bands for SCORAD Sleep Loss VAS were assessed. Conclusions: This severity bands analysis of ClinROs and PROs using a substantial, global, clinical trial data set of adults with moderate‐to‐severe AD, which included utilizing frequency crossover and spline regression as novel methodologies, may aid in the interpretation of AD disease severity and stratification in adult clinical trial settings. In agreement with other diseases, quality of life moderately correlates with clinical measures of severity. Further validation will provide additional insight for clinical practice applications.

Introduction Patients with atopic dermatitis (AD) have a high atopic comorbidity burden. Although traditionally seen as beginning with AD and progressing to other atopic comorbidities, the “atopic march” model does not fit all patients. This manuscript describes the onset of atopic comorbidities among children newly diagnosed with AD. Methods This retrospective, observational, cohort study used data from the Israeli Maccabi Healthcare Services. Patients (< 18 years) first diagnosed with AD during 2000–2019 with ≥ 12-month enrollment before and after AD diagnosis were included. Outcomes included cumulative asthma, allergic rhinitis (AR), and food allergy (FA) prevalence. Patients were grouped by age at AD diagnosis (< 3, 3–5, 6–11, and 12–17 years). Results Of 177,081 included patients, 60.4% were < 3 years old at AD diagnosis. The baseline asthma prevalence (at or before AD diagnosis) was lower in children aged < 3 versus ≥ 3 years at AD diagnosis (10.6% versus 26.3–28.5%). The baseline AR prevalence increased with age from 2.2% (< 3 years) to 23.2% (12–17 years), while FA decreased from 4.9% (< 3 years) to 2.1% (12–17 years). Cumulative asthma and FA prevalence increased sharply in the year following AD diagnosis among children diagnosed at < 3 years old. The cumulative ≥ 1 asthma/AR/FA prevalence increased to approximately 50% by 10 years after AD diagnosis. Conclusions Children diagnosed with AD at an early age mostly acquire atopic comorbidities within 1 year following AD diagnosis, while children diagnosed later have often already developed them. Eventually, all pediatric patients with AD display a similar, significant burden of atopic multimorbidity. Graphical abstract available for this article. Trial Registration Not applicable.