Randomized controlled observer-blinded treatment of chronic foot eczema with iontophoresis and bath-PUVA

The aim of this study was to investigate the effect of iontophoresis combined with local psoralen plus ultraviolet A (PUVA) therapy in chronic foot eczema. A randomized, observer-blinded, multi-centre study was conducted in 48 patients with chronic moderate-to-severe foot eczema randomized to one of 3 groups: In the iontophoresis group local bath-PUVA was preceded by iontophoresis. In the PUVA group only local PUVA was given. The corticosteroid group was treated with fluticasone. All treatments were given for 8 weeks, with an 8-week follow-up period. The primary efficacy parameter was eczema score described by Rosén et al. Secondary efficacy parameters were a global impression by the patient, and the Dermatology Life Quality Index (DLQI). The eczema score and the DLQI decreased significantly over time. There were no significant differences in the decrease in eczema score (p=0.053) and DLQI values (p=0.563) between the 3 treatments. The DLQI values in our chronic foot eczema patients were high. There was no obvious advantage of local bath-PUVA with or with-out iontophoresis over local steroid therapy

The effectiveness of antibacterial therapeutic clothing compared with non-antibacterial therapeutic clothing in patients with moderate-to-severe atopic dermatitis: A randomized controlled, observer-blind pragmatic trial (ABC trial)

BACKGROUND Increased Staphylococcus aureus (SA) colonization is considered an important factor in the pathogenesis of atopic dermatitis (AD). Antibacterial therapeutic clothing aims to reduce SA colonization and AD inflammation, however its role in the management of AD remains poorly understood. OBJECTIVE To investigate the effectiveness of antibacterial therapeutic clothing plus standard topical treatment in patients with moderate-to-severe AD, compared to standard therapeutic clothing plus standard topical treatment. If effectiveness is demonstrated, the cost-effectiveness will be evaluated. METHODS A pragmatic, double-blinded, multicenter, randomized, controlled, trial (NCT04297215) was conducted in patients of all ages with moderate-to-severe AD. Patients were centrally randomized 1:1:1 to receive standard therapeutic clothing, antibacterial clothing based on chitosan or silver. The primary outcome was the between-group difference in Eczema Area and Severity Index (EASI) measured over 52 weeks. Secondary outcomes included patient-reported outcomes, topical corticosteroid use, SA colonization, safety, and cost-effectiveness. Outcomes were assessed by means of (generalized) linear mixed model analyses. RESULTS Between March 16, 2020, and December 20, 2021, 171 patients were enrolled. In the analyses 159 patients were included (n=54 in the standard therapeutic clothing group, n=50 in the chitosan group and n=55 in the silver group). Adherence was high (median: 7 nights/week, IQR: 3-7). Median EASI scores at baseline, 4, 12, 26 and 52 weeks were in the standard therapeutic clothing group 11.8, 4.3, 4.6, 4.2, 3.6 compared to 11.3, 5.0, 3.0, 3.0, 4.4 in the chitosan and 11.6, 5.0, 5.4, 4.6 and 5.8 in the silver group. No differences in EASI over 52 weeks between the standard therapeutic clothing, chitosan (-0.1, 95%CI: -0.3 to 0.2, p=0.53), and silver group (-0.1, 95%CI: -0.3 to 0.2, p=0.58) were found. However, a small significant (P=0.035) group-by-time interaction effect between the standard and silver group was found, in which the silver group performed worse after 26 weeks. No differences between groups were found in patient-reported outcomes, topical corticosteroid use, SA skin colonization, and healthcare utilization. No severe adverse events or silver absorption were observed. CONCLUSIONS The results of this study suggest no additional benefits of antibacterial agents in therapeutic clothing in patients with moderate-to-severe AD

Effectiveness of antibacterial therapeutic clothing vs. nonantibacterial therapeutic clothing in patients with moderate-to-severe atopic dermatitis: a randomized controlled observer-blind pragmatic trial (ABC trial)

Background Increased Staphylococcus aureus (SA) colonization is considered an important factor in the pathogenesis of atopic dermatitis (AD). Antibacterial therapeutic clothing aims to reduce SA colonization and AD inflammation; however, its role in the management of AD remains poorly understood. Objectives To investigate the effectiveness of antibacterial therapeutic clothing+standard topical treatment in patients with moderate-to-severe AD vs. standard therapeutic clothing+standard topical treatment; and, if effectiveness was demonstrated, to demonstrate its cost-effectiveness. Methods A pragmatic double-blinded multicentre randomized controlled trial (NCT04297215) was conducted in patients of all ages with moderate-to-severe AD. Patients were centrally randomized 1:1:1 to receive standard therapeutic clothing or antibacterial clothing based on chitosan or silver. The primary outcome was the between-group difference in Eczema Area and Severity Index (EASI) measured over 52 weeks. Secondary outcomes included patient-reported outcomes (PROs), topical corticosteroid (TCS) use, SA colonization, safety and cost-effectiveness. Outcomes were assessed by means of (generalized) linear mixed-model analyses. Results Between 16 March 2020 and 20 December 2021, 171 patients were enrolled. In total, 159 patients were included (54 in the standard therapeutic clothing group, 50 in the chitosan group and 55 in the silver group). Adherence was high [median 7 nights a week wear (interquartile range 3–7)]. Median EASI scores at baseline and at 4, 12, 26 and 52 weeks were 11.8, 4.3, 4.6, 4.2 and 3.6, respectively, in the standard therapeutic clothing group vs. 11.3, 5.0, 3.0, 3.0 and 4.4, respectively, in the chitosan group, and 11.6, 5.0, 5.4, 4.6 and 5.8, respectively, in the silver group. No differences in EASI over 52 weeks between the standard therapeutic clothing group, the chitosan group [–0.1, 95% confidence interval (CI) –0.3 to 0.2; P=0.53] or the silver group (–0.1, 95% CI –0.3 to 0.2; P=0.58) were found. However, a small significant group×time interaction effect between the standard and silver groups was found (P=0.03), in which the silver group performed worse after 26 weeks. No differences between groups were found in PROs, TCS use, SA skin colonization and healthcare utilization. No severe adverse events or silver absorption were observed. Conclusions The results of this study suggest no additional benefits of antibacterial agents in therapeutic clothing in patients with moderate-to-severe AD

Impairment in work and activities of daily life in patients with psoriasis:results of the prospective BioCAPTURE registry

Background: Little is known about the extent of impairments in work and activities of daily life (ADL) in patients with psoriasis, and the influence of contextual factors such as disease-related characteristics and treatment. Therefore, this study aimed to assess these impairments in patients with psoriasis who started using biologicals/small molecule inhibitors. Methods: Using data from the prospective BioCAPTURE registry, we collected patient, disease, and treatment parameters, as well as work/ADL impairments at baseline, 6 and 12 months. Changes in impairment parameters and correlations between impairment and patient/disease characteristics were assessed using generalized estimating equations. Results: We included 194 patients in our analysis. After biological initiation, disease activity decreased significantly (PASI 11.2 at baseline versus 3.9 at 12 months, p &lt; 0.001). Work-for-pay in this cohort was lower than in the Dutch general population (53% versus 67%, p = 0.01). In patients who had work-for-pay, presenteeism improved over time (5% at baseline versus 0% at 12 months, p = 0.04). Up to half of the patients reported impairments in ADL, which did not change over time. Associations between impairments and contextual factors varied, but all impairments were associated with worse mental/physical general functioning. Conclusion: Patients with psoriasis using biologicals are less likely to have work-for-pay. Treatment improves the work productivity of employed patients, but we were unable to detect changes in ADL performance.</p

Successful tapering of dupilumab in patients with atopic dermatitis with low disease activity: a large pragmatic daily practice study from the BioDay registry

BACKGROUND: Limited data are available regarding patient-centred dosing of dupilumab for atopic dermatitis (AD) in daily practice. OBJECTIVES: To evaluate our patient-centred dupilumab dosing regimen in daily practice, to assess prognostic factors for successful tapering and to estimate medication-related cost savings. METHODS: This prospective multicentre study included adult patients with AD, participating in the BioDay registry, treated with dupilumab for ≥ 1.3 years. Interval prolongation was considered in the case of dupilumab standard dose for ≥ 1 year and persistent controlled AD [Eczema Area and Severity Index (EASI) ≤ 7; ≥ 6 months]. Primary endpoints were the mean EASI and Numeric Rating Scale (NRS)-pruritus after the start of tapering. Prognostic factors for successful tapering were analysed with logistic regression and a cost-savings analysis was performed. RESULTS: A total of 595 patients were included, of whom 401 patients [mean EASI 2.5 (SD 2.3); NRS-pruritus of 2.4 (SD 1.9) at the start of tapering] prolonged their dupilumab interval. In 83.3% of these patients tapering was successful; most patients used dupilumab every 3 or 4 weeks (Q3W/Q4W). A significant small increase was observed for EASI (highest mean 3.5) and NRS-pruritus (highest mean 3.2) (P < 0.001); however, scores remained low. Predicting successful tapering showed nonsignificant odds ratios for all incorporated variables. The estimated cost savings was €3 977 033.98 for 401 patients between January 2019 and June 2022. CONCLUSIONS: This study showed successful tapering of dupilumab in 83.3% of patients with AD who attempted tapering, while maintaining controlled disease and with the majority using Q3W/Q4W. Interval prolongation can be beneficial both for the patient and from a socio-economic perspective

Dupilumab provides sustained effectiveness on patient-reported outcomes and favorable safety in patients with moderate-to-severe atopic dermatitis: up to 5-year results from the daily practice BioDay Registry

Background: Long-term daily practice data on patient-reported benefits of dupilumab for atopic dermatitis (AD) remains limited. Objective: To evaluate patient-reported outcome measures (PROMs) and the safety of dupilumab in patients with moderate-to-severe AD over a follow-up period of up to 5 years. Methods: Data were extracted from the prospective, multicenter BioDay registry (October 2017–2022) of patients with moderate-to-severe AD treated with dupilumab in daily practice. Results: In total 1223 patients, 1108 adults and 115 pediatric patients were included. After ≥1 year of treatment, mean Patient-Oriented Eczema Measure (POEM), Dermatology Life Quality Index (DLQI), Numeric rating scale (NRS)-pruritus ranged between 7.8 and 8.7, 3.5 and 4.2, and 2.9 and 3.1 in adults, respectively, whilst these patient-reported outcome measures (PROMs) ranged between 8.9 and 10.9, 4.4 and 6.4, and 3.0 and 3.7 in pediatric patients, respectively. At follow-up, overall work impairment decreased from 40.1% to 16.3% to 13.3% in adults. Furthermore, class I obesity and itch-dominant patients generally had less favorable treatment response. Of all patients, 66.8% reported ≥1 adverse event, with conjunctivitis being the most common (33.7%). Limitations: The overall percentage of missing values for selected PROMs was 26% in adults and 46% in pediatric patients. Conclusion: In addition to favorable safety, dupilumab has demonstrated sustained effectiveness across various PROMs, underscoring the treatment benefits from patients' perspectives

Impairment in work and activities of daily life in patients with psoriasis: results of the prospective BioCAPTURE registry

Background: Little is known about the extent of impairments in work and activities of daily life (ADL) in patients with psoriasis, and the influence of contextual factors such as disease-related characteristics and treatment. Therefore, this study aimed to assess these impairments in patients with psoriasis who started using biologicals/small molecule inhibitors. Methods: Using data from the prospective BioCAPTURE registry, we collected patient, disease, and treatment parameters, as well as work/ADL impairments at baseline, 6 and 12 months. Changes in impairment parameters and correlations between impairment and patient/disease characteristics were assessed using generalized estimating equations. Results: We included 194 patients in our analysis. After biological initiation, disease activity decreased significantly (PASI 11.2 at baseline versus 3.9 at 12 months, p < 0.001). Work-for-pay in this cohort was lower than in the Dutch general population (53% versus 67%, p = 0.01). In patients who had work-for-pay, presenteeism improved over time (5% at baseline versus 0% at 12 months, p = 0.04). Up to half of the patients reported impairments in ADL, which did not change over time. Associations between impairments and contextual factors varied, but all impairments were associated with worse mental/physical general functioning. Conclusion: Patients with psoriasis using biologicals are less likely to have work-for-pay. Treatment improves the work productivity of employed patients, but we were unable to detect changes in ADL performance