Dupilumab with Topical Corticosteroids Provides Rapid and Sustained Improvement in Adults with Moderate-to-Severe Atopic Dermatitis Across Anatomic Regions Over 52 Weeks

Blauvelt, Andrew; Bruin‐Weller, Marjolein de; Simpson, Eric L.; Chen, Zhe; Zhang, Annie; Shumel, Brad

doi:10.1007/s13555-021-00638-1

Cited by 11 publications

(5 citation statements)

References 35 publications

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“…The findings of PROLEAD were also comparable with real-world data from the BIOREP registry [29]. A similar improvement in mean percentage change in EASI scores was observed across the four body regions in PROLEAD as was reported in the posthoc analysis of LIBERTY AD CHRONOS, a phase 3, randomised, double-blind, placebo-controlled 1-year trial of dupilumab in combination with TCS in patients with moderate-to-severe AD [12]. Prior systemic AD treatment did not impact treatment response to dupilumab in PROLEAD and this was also evident in the CHRONOS post-hoc analysis [30].…”

Section: Discussionsupporting

confidence: 81%

“…In a pooled analysis of these two 16-week studies with identical design, dupilumab significantly improved signs, symptoms and QoL compared with placebo and showed a favourable safety profile [ 11 ]. In a phase 3 randomised, controlled clinical study (LIBERTY AD CHRONOS), combination therapy with dupilumab and topical corticosteroids (TCS) showed improvements in signs of moderate-to-severe AD [ 12 ].…”

Section: Introductionmentioning

confidence: 99%

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Dupilumab Demonstrates Rapid Onset of Action in Improving Signs, Symptoms and Quality of Life in Adults with Atopic Dermatitis

Augustin

Bauer

Ertner³

et al. 2023

Dermatol Ther (Heidelb)

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Introduction: Dupilumab has significantly improved the signs, symptoms and quality of life (QoL) of patients with moderate-to-severe atopic dermatitis (AD) in randomised, controlled clinical trials. However, there is a need to assess the effectiveness and safety of dupilumab in real-world clinical practice. The PROLEAD study was designed to examine the effectiveness and safety of dupilumab in moderate-to-severe AD in a real-world setting in Germany. Here, we present 12-week effectiveness and safety results with dupilumab from PROLEAD. Methods: PROLEAD is a multicentre, prospective, non-interventional study being conducted at 126 routine care sites across Germany. Adults with moderate-to-severe AD who require systemic therapy were treated with dupilumab as indicated by the Summary of Product Characteristics. Data collected included physician assessments (EASI, BSA, SCORAD, and IGA) and patient-reported outcomes (PROs [POEM, DLQI, EQ-5D-5L, Peak Pruritus NRS and MOS Sleep Scale]). Results: Of 839 patients assessed for eligibility, 828 were included. The full analysis and safety analysis sets comprised 775 and 818 patients, respectively. The number of patients receiving concomitant therapy decreased from baseline to Week 12. Mean (standard deviation [SD]) percentage change in EASI score from baseline to Week 12 was -67.5% (48.4%) and was comparable across the four body regions. The propor-

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Section: Discussionsupporting

confidence: 81%

Section: Introductionmentioning

confidence: 99%

Dupilumab Demonstrates Rapid Onset of Action in Improving Signs, Symptoms and Quality of Life in Adults with Atopic Dermatitis

Augustin

Bauer

Ertner³

et al. 2023

Dermatol Ther (Heidelb)

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“…An explanation for the difference in findings might be that they reported on the percentage of patients with AD involvement in specific body areas (ie, extent of AD lesions), while clinical trials and the present study analyzed both severity and extent of AD lesions of the affected body regions. 6,31,32 Remarkably, while head neck dermatitis is frequently reported as an AE during dupilumab treatment, 33 only 1 patient in this study discontinued treatment for this reason.…”

Section: Discussionmentioning

confidence: 76%

“…Similar findings were reported in post hoc analyses of clinical trials in both adults and children. 31,32 Conversely, the daily practice study of Vittrup et al 6 stated that dupilumab was unable to effectively treat AD in the head and neck region. An explanation for the difference in findings might be that they reported on the percentage of patients with AD involvement in specific body areas (ie, extent of AD lesions), while clinical trials and the present study analyzed both severity and extent of AD lesions of the affected body regions.…”

Section: Discussionmentioning

confidence: 99%

Long-Term Effectiveness and Reasons for Discontinuation of Dupilumab in Patients With Atopic Dermatitis

Boesjes,

Kamphuis,

de Graaf

et al. 2024

JAMA Dermatol

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ImportanceLimited data are available on the long-term effectiveness and safety of dupilumab for atopic dermatitis (AD) in daily practice.ObjectiveTo evaluate clinical effectiveness and reasons for discontinuation of dupilumab treatment in children, adults, and older adults with AD with up to 5 years of treatment in daily practice.Design, Setting, and ParticipantsThis prospective multicenter cohort study was conducted using the BioDay registry (4 academic and 10 nonacademic hospitals in the Netherlands) to identify patients with AD of all ages who were treated with dupilumab between October 2017 and December 2022.Main Outcomes and MeasuresClinical effectiveness was evaluated by the Eczema Area and Severity Index (EASI), Investigator Global Assessment (IGA), and numeric rating scale (NRS) for pruritus, stratified by children (&lt;18 years), adults (18-64 years), and older adults (≥65 years). In addition, time to response, treatment responders, EASI subscores, second treatment episodes, and thymus- and activation-related chemokine and eosinophil levels were assessed. For patients who discontinued dupilumab, the reason for discontinuation was evaluated.ResultsIn total, 1286 patients with AD (median [IQR] age, 38 [26-54] years; 726 [56.6%] male) were treated with dupilumab, including 130 children, 1025 adults, and 131 older adults. The median (IQR) follow-up time was 87.5 (32.0-157.0) weeks. Most patients maintained controlled AD, with EASI of 7 or lower and NRS for pruritus of 4 or lower varying between 78.6% and 92.3% and 72.2% and 88.2% for up to 5 years of treatment, respectively, while up to 70.5% of all patients prolonged the dosing interval to mostly 300 mg every 3 or 4 weeks. Mean EASI and NRS for pruritus were 2.7 (95% CI, 1.2-4.2) and 3.5 (95% CI, 2.7-4.3), respectively, after 5 years of treatment. Statistically significant differences between age groups were found over time for EASI and IGA; however, differences were rather small (week 52: EASI, 0.3-1.6; IGA, 0.12-0.26). No statistically significant differences between age groups were found for NRS for pruritus. Median thymus- and activation-related chemokine levels considerably decreased from 1751 pg/mL (95% CI, 1614-1900 pg/mL) to 390 pg/mL (95% CI, 368-413 pg/mL) after 6 months of treatment and remained low. Median eosinophil levels temporarily increased up to week 16, with a subsequently statistically significant decrease over time. In total, 306 patients (23.8%) discontinued dupilumab after a median (IQR) of 54.0 (29.0-110.00) weeks, with adverse events among 98 patients (7.6%) and ineffectiveness among 85 patients (6.6%) as the most frequently reported reasons. Forty-one patients (3.2%) restarted dupilumab, and most of these patients recaptured response.Conclusions and RelevanceIn this cohort study with up to 5 years of follow-up, dupilumab maintained its clinical effectiveness, while two-thirds of patients tapered to a dosing interval of every 3 or 4 weeks. Treatment was discontinued in 23.8% of patients mainly due to adverse events and/or ineffectiveness.

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“…In addition, similar improvements of the head and neck region as elsewhere have been observed in children and adolescents. 42,[60][61][62] However, in clinical practice, some patients have responded that dupilumab is not as effective in treating the face and neck as the trunk and extremities. In such cases, combinations may increase efficacy, but the safety of combinations on the face in infants and children is also a matter of concern.…”

Section: Discussionmentioning

confidence: 99%

A Review of Dupilumab in the Treatment of Atopic Dermatitis in Infants and Children

Wang,

Gao,

Zhang

2024

DDDT

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Atopic dermatitis (AD), a common pruritic and chronic inflammatory skin disease, has a major impact on a patient’s quality of life. It is characterized by dry, itchy, and eczema-like rashes. AD is more prevalent in young children and has been linked to a variety of other allergy disorders. Traditional drug therapy has certain limitations for treating young children with AD. However, biologics have good clinical application prospects in the medical treatment of young patients. Dupilumab, a fully human monoclonal antibody, specifically binds to the IL-4 Rα subunit, inhibiting IL-4 and IL-13 signaling and blocking the occurrence of type 2 inflammatory response. It has a good effect on treating infants and children with moderate-to-severe AD. This review explores the safety and efficacy of dupilumab in the treatment of AD in infants and children and the impact of early intervention on AD progression, with the aim of informing clinical practice in the use of dupilumab for the treatment of young patients with AD.

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Dupilumab with Topical Corticosteroids Provides Rapid and Sustained Improvement in Adults with Moderate-to-Severe Atopic Dermatitis Across Anatomic Regions Over 52 Weeks

Cited by 11 publications

References 35 publications

Dupilumab Demonstrates Rapid Onset of Action in Improving Signs, Symptoms and Quality of Life in Adults with Atopic Dermatitis

Dupilumab Demonstrates Rapid Onset of Action in Improving Signs, Symptoms and Quality of Life in Adults with Atopic Dermatitis

Long-Term Effectiveness and Reasons for Discontinuation of Dupilumab in Patients With Atopic Dermatitis

A Review of Dupilumab in the Treatment of Atopic Dermatitis in Infants and Children

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