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Long-term daily practice data on patient-reported benefits of dupilumab for atopic dermatitis (AD) remains limited. 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. 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. 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%). The overall percentage of missing values for selected PROMs was 26% in adults and 46% in pediatric patients. In addition to favorable safety, dupilumab has demonstrated sustained effectiveness across various PROMs, underscoring the treatment benefits from patients' perspectives. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

In patients with humoral autoimmune diseases antinuclear antibodies (ANAs) and joint pain are commonly found.[3] In this study, we aimed to provide insight into ANA development during dupilumab treatment in AD patients. Keywords: antinuclear antibodies; atopic dermatitis; autoimmunity; dupilumab; enthesitis; inflammatory arthritis EN antinuclear antibodies atopic dermatitis autoimmunity dupilumab enthesitis inflammatory arthritis 582 585 4 05/10/23 20230501 NES 230501 Key messages Dupilumab-associated muscle and/or joint pain is frequently reported as a side effect in atopic dermatitis patients. During dupilumab treatment only two patients switched from ANA negative to positive after 107 and 109 weeks of dupilumab treatment, respectively, of which one patient was previously diagnosed with rheumatoid arthritis (Table 2). [Extracted from the article]

Clinical trials showed that upadacitinib, a selective Janus kinase-1 inhibitor, is effective for treatment of moderate-to-severe atopic dermatitis. However, daily practice studies are limited. This multicentre prospective study evaluated the effectiveness of 16 weeks of upadacitinib treatment for moderate-to-severe atopic dermatitis in adult patients, including those with previous inadequate response to dupilumab and/or baricitinib, in daily practice. A total of 47 patients from the Dutch BioDay registry treated with upadacitinib were included. Patients were evaluated at baseline, and after 4, 8 and 16 weeks of treatment. Effectiveness was assessed by clinician- and patient-reported outcome measurements. Safety was assessed by adverse events and laboratory assessments. Overall, the probabilities (95% confidence intervals) of achieving Eczema Area and Severity Index ≤7 and Numerical Rating Scale – pruritus ≤4 were 73.0% (53.7–86.3) and 69.4% (48.7–84.4), respectively. The effectiveness of upadacitinib was comparable in patients with inadequate response to dupilumab and/or baricitinib and in patients who were naïve for these treatments or who had stopped such treatments due to adverse events. Fourteen (29.8%) patients discontinued upadacitinib due to ineffectiveness, adverse events or both (8.5%, 14.9% and 6.4%, respectively). Most frequently reported adverse events were acneiform eruptions (n=10, 21.3%), herpes simplex (n=6, 12.8%), nausea and airway infections (both n=4, 8.5%). In conclusion, upadacitinib is an effective treatment for patients with moderate-to-severe atopic dermatitis, including those with previous inadequate response to dupilumab and/ or baricitinib treatment. [ABSTRACT FROM AUTHOR]

Background: Dupilumab has proven to be an effective and safe treatment for atopic dermatitis (AD) in pediatric patients in clinical trials. However, few daily practice studies are available. The aim of this study is to evaluate the effect of 28 weeks dupilumab treatment on effectiveness, safety, and serum biomarkers in pediatric patients with moderate‐to‐severe AD in daily practice. Methods: Patients visited the outpatient clinic at baseline, 4, 16, and 28 weeks of treatment. Disease severity was assessed by the Eczema Area and Severity Index (EASI), Investigator Global Assessment (IGA), Numeric Rating Scale (NRS)‐pruritus and ‐pain, and the Patient‐Oriented Eczema Measure (POEM). Side effects were evaluated. Nineteen severity‐associated serum biomarkers were measured. Predicted‐EASI (p‐EASI) was calculated. Results: Sixty‐one patients were included. Respectively 75.4%, 49.2%, and 24.6% reached EASI‐50, EASI‐75, and EASI‐90 and 36.1% achieved an IGA‐score (almost) clear. Improvement of ≥4 points on POEM, NRS‐pruritus, and NRS‐pain was reached by 84.7%, 45.3%, and 77.4%, respectively. Most reported side effects were conjunctivitis (n = 10) and headache (n = 4). Biomarkers TARC, PARC, periostin, sIL‐2Ra, and eotaxin‐3 significantly decreased during treatment. The p‐EASI showed a significant correlation with disease severity. Conclusion: Dupilumab treatment significantly improved disease severity and disease‐associated symptoms and decreased severity‐associated serum biomarkers in pediatric AD patients in daily practice. [ABSTRACT FROM AUTHOR]

Background: At present, no real‐world studies are available on different dupilumab dosing regimens in controlled atopic dermatitis (AD). The aim of this study was to clinically evaluate a patient‐centered dupilumab dosing regimen in patients with controlled AD and to relate this to serum drug levels and serum biomarkers. Methods: Ninety adult AD patients from the prospective BioDay registry were included based on their dupilumab administration interval according to a predefined patient‐centered dosing regimen. Group A (n = 30) did not fulfill the criteria for interval prolongation and continued using the standard dupilumab dosage (300 mg/2 weeks), group B (n = 30) prolonged dupilumab interval with 50% (300 mg/4 weeks), and group C (n = 30) prolonged dupilumab interval with 66%–75% (300 mg/6–8 weeks). AD severity score, patient‐reported outcomes, serum dupilumab levels, and serum biomarkers were analyzed over time. Results: Disease severity scores did not significantly change over time during the tapering period in any of the groups. In groups B and C, the Numeric Rating Scale (NRS)‐pruritus temporarily significantly increased after interval prolongation but remained low (median NRS‐pruritus≤4). Median dupilumab levels remained stable in group A (standard dosage), but significantly decreased in groups B and C (24.1 mg/L (IQR = 17.1–45.6); 12.5 mg/L (IQR = 1.7–22.3)) compared with the levels during the standard dosage (88.2 mg/L [IQR = 67.1–123.0, p <.001]). Disease severity biomarker levels (CCL17/CCL18) remained low in all study groups during the whole observation period. Conclusions: This study showed that dose reduction was successful in a subgroup of patients with controlled AD by using a patient‐centered dosing regimen. These patients showed stable low disease activity and low severity biomarkers over time. [ABSTRACT FROM AUTHOR]

Additionally, occurrence of both AD eyelid involvement and AD facial involvement in the past year was significantly higher in patients with moderate-to-severe OSD compared to patients with no or mild OSD ( I n i = 28 (90.3%) vs. I n i = 18 (46.2%), I p i = <.001 and I n i = 31 (100.0%) vs. I n i = 33 (84.6%), I p i = .030 respectively). Keywords: atopic dermatitis; goblet cell; ocular surface disease EN atopic dermatitis goblet cell ocular surface disease 801 805 5 06/01/22 20220601 NES 220601 Key Messages In a single-centre study, we assessed ocular surface disease prevalence in moderate-to-severe atopic dermatitis. Diagnosing OSD is important since it may be associated with chronic limbitis, possibly leading to irreversible limbal stem cell deficiency and subsequently to irreversible long-term visual loss.3 In our study, lower conjunctival GCD was found in patients with OSD, compared to patients without OSD. However, by comparing GCD of patients with OSD to GCD of healthy controls described in the literature, we can conclude that moderate-to-severe AD patients with OSD have lower GC counts. [Extracted from the article]

Eczema control is a new construct to be measured in atopic dermatitis (AD). Measuring patient-perceived eczema control and treatment satisfaction in AD patients, treated with dupilumab between 16 and 52 weeks. 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). 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. 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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]