Dupilumab for the treatment of atopic dermatitis: real-world data from the Czech Republic BIOREP registry

Kojanová, Martina; Tánczosová, Milena; Štrosová, Daniela; Cetkovská, Petra; Fialová, Jorga; Doležal, Tomáš; Machovcová, Alena; Gkalpakiotis, Spyridon

doi:10.1080/09546634.2022.2043545

Cited by 14 publications

(18 citation statements)

References 38 publications

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“…Proportion of patients achieving EASI-50, EASI-75 and EASI-90 in TREATgermany was 77.1%, 57.1% and 25.7%, respectively, at Week 12. 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].…”

Section: Discussionsupporting

confidence: 81%

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%

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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“…Other long-term studies support that absolute median EASI scores decrease to approximately 2.0-3.0 5,13,18 after 1year of treatment with dupilumab and that around 60% of patients has achieved EASI 90 after 104 weeks of therapy. 9 Importantly, while we only identified few patients with AEs related to facial redness or rosacea-like inflammation, we observed that the proportion of patients reporting persistent AD in the head-and-neck area remained very high at week 104. Though the patients with 104 weeks follow-up are limited to those with sufficient follow-up time and still receiving dupilumab treatment, these findings highlight an important limitation of dupilumab treatment in AD patients.…”

Section: Effectivenessmentioning

confidence: 63%

“…7 One in four patients reported conjunctivitis, which is comparable to other studies with long follow-up, 5,6,13,15,16 while also markedly higher than selected studies with up to 2-year follow-up. 9,14,17 Differences in reporting patterns and specific focus on conjunctivitis and preventive initiatives with artificial tears might explain the differences. Consistent with previous results 13 most (66.7%) cases of conjunctivitis were considered mild-to-moderate.…”

Section: Safetymentioning

confidence: 99%

“…This is slightly higher than in other long-term studies, where dropouts were 4-8%. 6,9,15,33,34 Of the 16 discontinuations due to AEs, only one reported eye problems as the cause. Fourteen reports used the more general term 'side effects' and four of them had a previous AE report of eye inflammation.…”

Section: Discontinuation and Drug Survivalmentioning

confidence: 99%

“…[2][3][4][5] However, few studies have so far investigated the same daily-practice parameters and drug survival beyond 52-weeks' follow-up, and none have been based on nationwide complete datasets. [6][7][8][9] We examined the short-and long-term safety, effectiveness and drug survival of dupilumab treatment in a Danish nationwide cohort of patients with moderate-to-severe AD. The cohort is embedded in the prospective, multicentre Severe and ChRonic Atopic dermatitis Treatment CoHort (SCRATCH) registry, including virtually all Danish patients treated with dupilumab for AD.…”

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confidence: 99%

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A nationwide 104 weeks real‐world study of dupilumab in adults with atopic dermatitis: Ineffectiveness in head‐and‐neck dermatitis

Vittrup

Krogh²,

Larsen

et al. 2023

Acad Dermatol Venereol

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Atopic dermatitis (AD) is a chronic, pruritic, inflammatory skin disease that is common in adults. 1 Most patients obtain disease control with trigger avoidance, and frequent use of emollients and anti-inflammatory topical treatments. However, some patients need systemic therapy to reduce AD activity and severity. A few systemic immunomodulating drugs have traditionally been used for the treatment of AD including methotrexate and azathioprine, although only cyclosporine is approved in Europe.Dupilumab, a monoclonal antibody targeting the IL-4Rα-subunit of the IL4 and IL13-receptor, reduces type 2 inflammation. In January 2018, dupilumab was approved in Denmark for treatment of adults with moderate-tosevere AD. Real-world evidence studies have confirmed the

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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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Dupilumab for the treatment of atopic dermatitis: real-world data from the Czech Republic BIOREP registry

Cited by 14 publications

References 38 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

A nationwide 104 weeks real‐world study of dupilumab in adults with atopic dermatitis: Ineffectiveness in head‐and‐neck dermatitis

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

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