Validation of the Investigator Global Assessment of Chronic Hand Eczema (IGA-CHE): a new clinician reported outcome measure of CHE severity.

The Investigator Global Assessment of Chronic Hand Eczema (IGA-CHE) is a novel Clinician-Reported Outcome measure that allows investigators to assess cross-sectional CHE global disease severity using clinical characteristics of erythema, scaling, lichenification/hyperkeratosis, vesiculation, oedema, and fissures as guidelines for overall severity assessment. This study aimed to evaluate the psychometric properties of the IGA-CHE for use as an outcome measure in CHE clinical trials and clinical practice. Psychometric analyses were performed using data from a sample of 280 patients with moderate to severe CHE from a phase 3 trial of delgocitinib cream, pooled across treatment groups. Test-retest reliability results were moderate to strong with kappa coefficients ranging from 0.63 to 0.76. Correlations with measures assessing related concepts were moderate or strong (range 0.65-0.72) and exceeded a priori hypotheses, providing evidence of convergent validity. Known-groups validity was supported by statistically significant differences between severity groups (< 0.001). Within-group effect sizes were consistently larger for improved groups compared to stable groups, providing evidence of ability to detect change. Anchor-based analyses generated within-subject meaningful change estimates ranging from - 0.8 to - 2.3. A correlation weighted average suggested a single value of - 1.7 in change from baseline. These findings provide evidence the IGA-CHE scale has strong reliability, construct validity, and ability to detect change, supporting its use as an endpoint in CHE clinical trials and clinical practice. Based on the evidence, 2-level changes in IGA-CHE score are considered a conservative meaningful change threshold; however, findings also indicate 1-level change in IGA-CHE scores reflects a clinically meaningful improvement for patients.Clinical trial registration: NCT04871711.

The management of Chronic Hand Eczema: A retrospective patient record review.

BACKGROUND: Chronic Hand Eczema (CHE) is a heterogeneous fluctuating inflammatory disease that represents a significant burden. Effective treatment options for moderate to severe CHE are limited. OBJECTIVES: To assess how patients with moderate to severe CHE are treated in clinical practice. METHODS: A retrospective, physician-led patient record review assessed the demographic, clinical and treatment characteristics of patients aged ≥18 years with CHE across seven countries. Each participating physician was requested to review records for their three most recent patients with moderate to severe CHE treated with a topical or systemic therapy. RESULTS: A total of 264 physicians, of whom 88.6% were dermatologists and 70.1% were predominantly or partly hospital-based, reviewed the records of 792 patients. Signs were present on hands only in 56.4% of patients and the mean time on current treatment was 16.7 months. Overall, 62.9% of patients received systemic therapy and almost one-quarter (23.4%) were treated with a biologic; 28.6% of patients were only treated with topical corticosteroids and/or topical calcineurin inhibitors. CONCLUSION: In patients with moderate to severe CHE, most received systemic therapy with one-quarter on biologic therapy. However, given that many of these treatments have limited evidence of efficacy in CHE, there is a need for studies specifically in patients with CHE as well as new therapeutic options.

Matching-Adjusted Indirect Comparison of Long-Term Efficacy and Safety Outcomes for Calcipotriol Plus Betamethasone Dipropionate Foam Versus Halobetasol Proprionate Plus Tazarotene Lotion in the Treatment of Plaque Psoriasis.

INTRODUCTION: To date, there have been no head-to-head clinical studies comparing calcipotriol 0.005% plus betamethasone dipropionate 0.064% (Cal/BD) aerosol foam and halobetasol propionate 0.01% plus tazarotene 0.045% (HP/Taz) lotion for the treatment of plaque psoriasis. However, the efficacy of 4 weeks of Cal/BD foam and 8 weeks of HP/Taz lotion has been compared using a matching-adjusted indirect comparison (MAIC) approach. Here, we compare the efficacy and safety of Cal/BD foam and HP/Taz lotion for up to 52 weeks. METHODS: An unanchored MAIC was conducted using individual patient data from the PSO-LONG Cal/BD foam trial and a 52-week, open-label phase 3 study of HP/Taz lotion (NCT02462083). Key outcomes of interest were Physician's Global Assessment (PGA) success (PGA 0/1 with ≥ 2-point improvement) after 4 or 8 weeks of open-label therapy; the proportion of patients who had body surface area affected (BSA) ≤ 3 after open-label therapy who maintained BSA ≤ 3 to week 52; and adverse events (AEs). RESULTS: After matching, patients were statistically significantly more likely to have PGA success after 4 weeks of Cal/BD foam than after 8 weeks of HP/Taz lotion (84.5% versus 54.4%; p < 0.01). At week 52, 92.5% and 92.4% of patients receiving proactive and reactive Cal/BD foam, respectively, maintained BSA ≤ 3, compared with 49.3% of those treated with HP/Taz lotion (both p < 0.01). Treatment-related AEs, AEs leading to withdrawal, and AEs associated with drug application (dermatitis, application site pain, and pruritus) were significantly rarer with Cal/BD foam than with HP/Taz lotion (all p < 0.01). CONCLUSIONS: Cal/BD aerosol foam demonstrated significantly greater efficacy than HP/Taz lotion, and had a more favorable safety profile, compared with HP/Taz lotion, for up to 52 weeks. Proactive Cal/BD foam maintenance therapy and reactive use of Cal/BD foam following relapse both had significant advantages over HP/Taz lotion.

Matching-adjusted indirect comparison of efficacy outcomes in trials of calcipotriol plus betamethasone dipropionate foam and cream formulations for the treatment of plaque psoriasis.

BACKGROUND AND OBJECTIVES: Once-daily, fixed-combination calcipotriol 50 µg/g (Cal) plus betamethasone dipropionate 0.5 mg/g (BD) is available in aerosol foam and cream formulations. As no head-to-head data are available, we use a matching-adjusted indirect comparison (MAIC) approach to compare Cal/BD foam and cream. METHODS: Anchored and unanchored MAIC analyses were conducted using individual patient data (IPD) from five Cal/BD foam trials and two trials of Cal/BD cream. Outcomes of interest were the proportion of patients with Physician's Global Assessment (PGA) success and the mean reduction in modified Psoriasis Area and Severity Index (mPASI). RESULTS: In the anchored MAIC, patients were more likely to achieve PGA success after 4 weeks of Cal/BD foam than after 8 weeks of Cal/BD cream and had larger mean improvements in mPASI (p < .01 in EU mPASI analysis). In unanchored analyses, 4 weeks of Cal/BD foam treatment was statistically significantly more efficacious in inducing PGA success than 8 weeks of Cal/BD cream (p < .01 in five of six comparisons). Mean reductions in mPASI were consistently statistically significantly greater with Cal/BD foam than with Cal/BD cream. CONCLUSIONS: Use of Cal/BD foam consistently shows significantly greater improvements in PGA and mPASI outcomes, compared with Cal/BD cream.

Clinical, patient and estimated cost benefits of proactive management versus reactive management with calcipotriol/betamethasone dipropionate foam for the treatment of plaque psoriasis in Finland.

BACKGROUND: Proactive management of plaque psoriasis with twice-weekly topical calcipotriol/betamethasone dipropionate (Cal/BD) foam has a demonstrated clinical benefit in preventing disease relapse compared to reactive management, where Cal/BD foam is only given as rescue therapy once-daily for four weeks after relapse. The impact of proactive management with Cal/BD foam on a wider range of clinical responses is not yet known, nor is its potential cost-effectiveness in the healthcare system of Finland. METHODS: This study involved a post-hoc analysis exploring the clinical and patient-reported benefits of proactive versus reactive management with Cal/BD foam observed in the PSO-LONG trial (NCT02899962). A range of response criteria based on modified psoriasis area and severity index (mPASI) and dermatology life quality index (DLQI) were analyzed, and the cost-effectiveness of proactive versus reactive management was estimated in a Finnish healthcare setting. RESULTS AND CONCLUSION: The analysis found a consistent clinical benefit of proactive management compared to reactive management on all response criteria, and a markedly lower cost-per-responder for the response criteria of mPASI 75, mPASI ≤ 2 and DLQ1 ≤ 1. The analysis was robust to sensitivity analyses on key inputs and demonstrates the cost and clinical benefits of proactive over reactive management of plaque psoriasis with Cal/BD foam in the Finnish healthcare setting.

The Effect on BSA of Proactive Management versus Reactive Management of Psoriasis With Fixed-Dose Cal/BD Foam in the PSO-LONG Study.

Reduction of psoriasis body surface area (BSA) is associated with improved patient quality of life. Post-hoc analyses of the PSO-LONG study compared impact on BSA of proactive management versus reactive management strategies using calcipotriol/betamethasone dipropionate (Cal/BD) foam. Mean BSA values, as well as normalized area under the curves (AUCs) for patient BSA were assessed. Analyses found that after the PSO-LONG study’s four-week open-label lead-in phase, when all patients received once-daily Cal/BD foam, mean BSA was significantly reduced. Thereafter, mean BSA remained at lower levels in patients on proactive management compared to reactive management. This was reflected in AUC BSA, which was consistently lower in the proactive management arm. Treatment-related differences were statistically significant when analyzing the full analysis set (FAS) population, as well as when restricting the analysis to study completers. Additional analyses restricted the dataset to include only observations from psoriasis remission periods, or periods of disease relapse. Treatment-related differences in AUC were statistically significant in observations during remission, but not during relapse. This could be expected given the trial’s design, wherein all patients who relapsed were offered the same rescue therapy with once daily Cal/BD foam. Similarly, for patients who dropped out, there was no treatment-related difference in mean BSA during the two weeks preceding dropout, likely due to the common occurrence of relapse in these patients. This paper found that proactive management, in addition to preventing more relapses as previously shown, also maintained BSA at a lower level during remission than reactive management. J Drugs Dermatol. 20(5):567-570. doi:10.36849/JDD.5870.

Characteristics of non-response in the Danish Health Interview Surveys, 1987-1994.

BACKGROUND: The types and quantity of non-response in surveys influence the extent to which the results may be generalized. This study analysed trends in non-response in the Danish Health Interview Surveys from 1987 to 1994 and used the National Patient Registry to assess whether non-response biased the estimated population prevalence of morbidity when solely based on responders. METHODS: The data were for the 23,096 adults sampled for the Danish Health Interview Surveys in 1987, 1991 and 1994. All were followed using the National Patient Registry to obtain such information as hospital admissions. RESULTS: Non-response increased from 20.0% in 1987 to 22.6% in 1994. Four combinations of background variables characterized the non-response: gender and age; gender and civil status; county of residence and age; survey year and age. Non-respondents and respondents had identical gender- and age-standardized hospital admission rates for approximately 5 years before and 2 years after data collection, but non-respondents had a significantly higher rate immediately before and during data collection. Admissions rates were analysed according to reasons for non-response. Refusers had a lower admission rate than respondents before data collection but similar during and after data collection. The rate was higher during the whole period among ill or disabled non-respondents. Among people who could not be contacted during the data collection period a higher admission rate was only found immediately before and during data collection. CONCLUSIONS: Although admission rates differed between respondents and non-respondents these differences were too small to bias the estimated population prevalence of morbidity when solely based on respondents.

Use of hormone replacement therapy among Danish nurses at increased risk of osteoporosis.

Observational studies and recent randomized trials have shown that postmenopausal hormone replacement therapy (HRT) may reduce the risk of osteoporotic fractures by about 30 to 40%. In this study we used a log linear graphical model to determine whether women with a known increased risk of osteoporosis were more likely to use HRT than other women and to examine whether women at increased risk modified this risk through their lifestyle. Cox regression analysis was used to analyze if women at risk of osteoporosis used HRT longer than women not at risk. Participants were Danish female nurses who, in 1993, were between 50 and 69 years of age (N=14,865). Data were collected from postal questionnaires. We concluded that nurses with a known family history of osteoporosis more often used HRT than nurses without this risk. No other direct associations were found between biological risk factors and ever use of HRT. The presence of biological risk factors of osteoporosis was not consistently modified by a healthier lifestyle. Nurses with a low body mass index (BMI) with a known family history of osteoporosis continued to use HRT longer than nurses without these risk factors.

Do age and social relations moderate the relationship between self-rated health and mortality among adult Danes?

It is well established that self-rated health (SRH) predicts mortality even after controlling for a wide range of factors. We explored the extent to which age and social relations (structural and functional) influenced the relationship between SRH and mortality (after 13 years follow-up) in a representative sample of adult Danes (N=6693). After controlling for socioeconomic status, illness, and lifestyle variables, we found that age moderated the SRH-mortality relationship such that it was present for respondents under 55 but absent for respondents over 56. In addition, weaker structural (but not functional) social relations increased mortality directly but neither structural nor functional social relations moderated the SRH-mortality relationship. We discuss the theoretical and practical implications of these findings.

Lifestyle factors and choice of hormone replacement therapy among Danish nurses.

BACKGROUND: Studies have found that women who use hormone replacement therapy (HRT) are healthier or report better health than non-users. This study examines the association between lifestyle factors, self-reported health and the use of HRT in Danish female nurses above the age of 50 years. METHODS: Postal questionnaires were used for data collection. Two cohorts were examined, a younger including women between 50 and 59 years and an older including women of 60 years and above. RESULTS: Of the 14,071 nurses included, 5,528 (39%) reported ever using HRT. In both cohorts, ever using HRT was positively associated (odds ratio > 1) with intake of vitamin supplements, alcohol consumption at weekends, consulting a physician, use of medicine, and previous use of oral contraceptives. Only a few differences were found between former and current users of HRT. A highly significant association was found between ever using HRT and self-reported poor health. CONCLUSIONS: In this study use of HRT was not found to be associated with a particularly healthy lifestyle or better health. Therefore, these factors should be specifically considered in studies evaluating the effect of HRT.