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Background The main conventional systemic treatments for atopic dermatitis (AD) are methotrexate (MTX) and ciclosporin (CyA). Dupilumab was the first novel systemic agent to enter routine clinical practice. There are no head-to-head randomized controlled trials or real-world studies comparing these agents directly. Network meta-analyses provide indirect comparative efficacy and safety data and have shown strong evidence for dupilumab and CyA. Objectives To compare the real-world clinical effectiveness and safety of CyA, dupilumab and MTX in AD. Methods We compared the effectiveness and safety of these systemic agents in a prospective observational cohort study of adult and paediatric patients recruited into the UK–Irish Atopic eczema Systemic TherApy Register (A-STAR). Treatment effectiveness measures included Eczema Area and Severity Index (EASI), Patient-Oriented Eczema Measure (POEM), Peak Pruritus Numerical Rating Scale (PP-NRS), Dermatology Life Quality Index (DLQI) and children's DLQI (cDLQI). The minimum duration of treatment was 28 days and follow-up was 12 months. Adjusted Cox-regression analysis was used to compare the hazard ratios of achieving EASI-50, EASI-75 and EASI-90 over time, and linear mixed-effects models were used to estimate changes in efficacy scores. Treatment safety was assessed by examining adverse events (AEs) at follow-up visits. Results We included 488 patients (311 adults and 177 children/adolescents) on dupilumab (n = 282), MTX (n = 149) or CyA (n = 57). CyA and MTX were primarily used as the first-line treatment, while dupilumab was mainly a second-line systemic treatment as per UK National Institute of Clinical and Care Excellence (NICE) recommendations. EASI-50, EASI-75 and EASI-90 were achieved more rapidly in the dupilumab and CyA groups compared with MTX. After adjustment for previous severity, the reduction in EASI, POEM, PP-NRS and DLQI was greater for patients treated with dupilumab compared with MTX. In patients with severe disease the reduction in EASI, POEM and PP-NRS was even greater with CyA. The incidence rates of AEs were similar across groups (734, 654 and 594 per 10 000 person-month on CyA, dupilumab and MTX, respectively). Conclusions This real-world comparison of CyA, dupilumab and MTX in AD suggests that dupilumab is consistently more effective than MTX and that CyA is most effective in very severe disease within 1 year of follow-up. [ABSTRACT FROM AUTHOR]

Aim: To measure the impact of type 1 and 2 diabetes mellitus (T1D and T2D) on the QoL of a person's family members/partner and assess if there is any difference in family impact. Methods: A cross‐sectional study, recruited online through patient support groups, involved UK family members/partners of people with diabetes completing the Family Reported Outcome Measure‐16 (FROM‐16). Results: Two hundred and sixty‐one family members/partners (mean age = 57.9 years, SD = 13.8; females = 68.2%) of people with diabetes (mean age = 57.7, SD = 20.6; females = 38.3%; T1D n = 100; T2D n = 161) completed the FROM‐16. The overall FROM‐16 mean score was 10.47, SD = 7.8, suggesting a moderate effect on the QoL of family members of people with diabetes. A quarter (24.5%) of family members experienced a 'very large effect' or 'extremely large effect' on their QoL. The family impact of T1D (mean FROM‐16 = 12.61, SD = 7.9) was greater than that of T2D (mean = 9.15, SD = 7.5, p < 0.01), with being 'female' and 'parents of children and adolescents' rendered as significant predictors of greater impact. Family members of T2D had a lower risk of experiencing a high family impact (FROM‐16 score >16) compared with T1D (RR 0.561, 95% CI 0.371–0.849). Conclusions: Compared to T2D, family members of T1D experience a greater impact on their QoL, particularly those caring for children and adolescents. These findings have clinical and resource implications, indicating a need to assess this impact as a part of routine diabetes care to support impacted family members. The FROM‐16 could assess this impact in routine practice and further facilitate referral of family members to appropriate support services. [ABSTRACT FROM AUTHOR]

Background Primary endpoint measures in clinical trials are typically measures of disease severity, with patient-reported outcome measures (PROMs) relegated as secondary endpoints. However, validation of some PROMs may be more rigorous than that of disease severity measures, which could provide support for a primary role for PROMs. Objectives This study reports on 24 peer reviewed journal articles that used the Dermatology Life Quality Index (DLQI) as primary outcome, derived from a systematic review of randomized controlled trials (RCTs) utlizing DLQI, covering all diseases and interventions. Methods The study protocol was prospectively published on the PROSPERO database, and the study followed PRISMA guidelines. Searches were made using MEDLINE, The Cochrane Library, Embase, Web of Science, Scopus, CINAHL (EBSCO) and PsycINFO databases and records were combined into an Endnote database. Records were filtered for duplicates and selected based on study inclusion/exclusion criteria. Full-text articles were sourced and data were extracted by two reviewers into a bespoke REDCap database, with a third reviewer adjudicating disagreements. The Jadad scoring method was used to determine risk of bias. Results Of the 3220 publications retrieved from online searching, 457 articles met the eligibility criteria and included 198 587 patients. DLQI scores were used as primary outcomes in 24 (5.3%) of these studies comprising 15 different diseases and 3436 patients. Most study interventions (17 of 24 studies, 68%) were systemic drugs, with biologics (liraglutide, alefacept, secukinumab, ustekinumab, adalimumab) accounting for 5 of 25 pharmacological interventions (20%). Topical treatments comprised 32% (8 studies), whereas nonpharmacological interventions (n = 8) were 24% of the total interventions (N = 33). Three studies used nontraditional medicines. Eight studies were multicentred (33.3%), with trials conducted in at least 14 different countries, and four studies (16.7%) were conducted in multiple countries. The Jadad risk of bias scale showed that bias was uncertain or low, as 87.5% of studies had Jadad scores of ≥ 3. Conclusions This study provides evidence for use of the DLQI as a primary outcome in clinical trials. Researchers and clinicians can use this data to inform decisions about further use of the DLQI as a primary outcome. [ABSTRACT FROM AUTHOR]

Introduction: Data concerning the global burden of hidradenitis suppurativa (HS) are limited. Reported prevalence estimates vary between 0.0003% and 4.1%, and data from various geographical regions are still to be collected. Previously reported prevalences have been limited by the methodological approach and source of data. This has resulted in great heterogeneity as prevalence data from physician-diagnosed cases poorly match those of self-reported apparent HS disease. Methods: The Global Hidradenitis Suppurativa Atlas (GHiSA) introduces an innovative approach to determine the global prevalence of HS. This approach involves using a previously validated questionnaire to screen apparently healthy adults accompanying a patient to a non-dermatological outpatient clinic visit in a hospital or a private/family medicine clinic. The screening questionnaire (i.e., the index test) is combined with a subsequent physician-based in-person validation (i.e., the reference standard) of the participants who screen positive. Approximately ten percent of the screen-negative participants are also clinically assessed to verify the diagnostic precision of the test. The local prevalence (pi) will be estimated from each country that submits the number of patients who are HS positive according to the index test and clinical examination (n), and the corresponding total number of observations (N). Conclusion: The GHiSA Global Prevalence studies are currently running simultaneously in 58 countries across six continents (Africa, Europe, Australia, North America, South America, and Asia). The goal of the combined global proportion is the generation of a single summary (i.e., proportional meta-analysis), which will be done after a logit transformation and synthesized using a random-effects model. The novel standardization of the Global Prevalence Studies conducted through GHiSA enables direct international comparisons, which were previously not possible due to substantial heterogeneity in past HS prevalence studies. [ABSTRACT FROM AUTHOR]