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. Patients from the Dutch BioDay registry completed the Atopic Dermatitis Control Test (ADCT), Recap of Atopic Eczema (RECAP) and Treatment Satisfaction Questionnaire for Medication, Version II (TSQM v. II), along with other Patient Reported Outcome Measures (PROMs). Results 104/157 patients responded (response rate 66.2%). Median ADCT score was 4 (interquartile range [IQR] 5); median RECAP score was 5 (IQR 6); median TSQM v.II global satisfaction score was 83.3 (IQR 25.0). According to the ADCT, 38.5-66.3% perceived their AD was 'in control', depending on the interpretability method used. Minimally clinically important difference (MCID) of >= 4 points for the DLQI and POEM was achieved respectively in N = 66 (84.6%) and N = 63 (78.8%) patients. Conclusion When considering the favorable scores on other PROMs and the TSQM v. II, and comparing these to the relatively low percentage of patients perceiving control according to the ADCT, interpretability of eczema control still appears difficult. Treatment satisfaction in the studied cohort was high

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

Daily Practice Experience of Baricitinib Treatment for Patients with Difficult-to-Treat Atopic Dermatitis:Results from the BioDay Registry

Clinical trials have shown that baricitinib, an oral selective Janus kinase 1/2 inhibitor, is effective for the treatment of moderate-to-severe atopic dermatitis. However, daily practice data are limited. Therefore, this multicentre prospective study evaluated the effectiveness and safety of 16-weeks' treatment with baricitinib in adult patients with moderate-to-severe atopic dermatitis in daily practice. A total of 51 patients from the BioDay registry treated with baricitinib were included and evaluated at baseline and after 4, 8 and 16 weeks of treatment. Effectiveness was assessed using clinician- and patient-reported outcome measurements. Adverse events and laboratory assessments were evaluated at every visit. At week 16, the probability (95% confidence interval) of achieving Eczema Area and Severity Index ≤ 7 and numerical rating scale pruritus ≤ 4 was 29.4% (13.1-53.5) and 20.5% (8.8-40.9), respectively. No significant difference in effectiveness was found between dupilumab non-responders and responders. Twenty-two (43.2%) patients discontinued baricitinib treatment due to ineffectiveness, adverse events or both (31.4%, 9.8% and 2.0%, respectively). Most frequently reported adverse events were nausea (n = 6, 11.8%), urinary tract infection (n = 5, 9.8%) and herpes simplex infection (n = 4, 7.8%). In conclusion, baricitinib can be an effective treatment option for moderate-to-severe atopic dermatitis, including patients with non-responsiveness on dupilumab. However, effectiveness of baricitinib is heterogeneous, which is reflected by the high discontinuation rate in this difficult-to-treat cohort

Real-world Experience of Abrocitinib Treatment in Patients with Atopic Dermatitis and Hand Eczema: Up to 28-week Results from the BioDay Registry

Limited daily practice data on the effect of abrocitinib in patients with atopic dermatitis are available. The aim of this multicentre prospective study is to evaluate the effectiveness and safety of abrocitinib in patients with atopic dermatitis treated in daily practice. In a subgroup, the effectiveness of abrocitinib on hand eczema was evaluated. A total of 103 patients from the BioDay registry were included in the study: week 4 (n = 95), week 16 (n = 61) and week 28 (n = 39). At week 28, the Eczema Area and Severity Index (EASI)-50/75/90 was achieved by 81.8%, 57.6%, and 18.2%, respectively, and the weekly average pruritus numerical rating scale ≤ 4 by 62.9%. The effectiveness of abrocitinib was not significantly different between dupilumab non-responders and dupilumab-naïve patients/responders, and between upadacitinib non-responders and upadacitinib-naïve patients/responders. Mean ± standard deviation Hand Eczema Severity Index decreased from 27.4 ± 27.7 at baseline to 7.7 ± 12.1 at week 28 (n = 31). Thirty-two patients (31.1%) discontinued treatment due to ineffectiveness (n = 17), adverse events (n = 9) or both (n = 3). The most frequently reported adverse event was nausea (n = 28). In conclusion, abrocitinib is an effective treatment for atopic dermatitis and can be effective for patients with previous inadequate response to dupilumab or upadacitinib. Furthermore, hand eczema can improve in patients treated with abrocitinib for atopic dermatitis

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

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