104-week safety and effectiveness of dupilumab in the treatment of severe atopic dermatitis. The experience of 5 reference dermatology units in Spain

Pereyra‐Rodriguez, José Juan; Domínguez-Cruz, J.J.; Hita, J. C. Armario; Ruiz‐Villaverde, Ricardo

doi:10.1016/j.abd.2020.08.030

Cited by 3 publications

(3 citation statements)

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“…Real‐world evidence studies have confirmed the short‐term effectiveness and safety of dupilumab in adults with AD 2–5 . 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 6–9 …”

Section: Introductionmentioning

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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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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Section: Introductionmentioning

confidence: 99%

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confidence: 99%

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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“… 7 On the other hand, there is an assumption that the lack of more effective and accessible medications through SUS for severe AD conditions may be causing EE in these treatment-refractory patients. 8 …”

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confidence: 99%

Erythroderma: clinical and etiological study of 88 cases seen in a tertiary hospital over 25 years

Kondo,

Samesima e Singh,

Araújo

et al. 2024

Anais Brasileiros de Dermatologia

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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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104-week safety and effectiveness of dupilumab in the treatment of severe atopic dermatitis. The experience of 5 reference dermatology units in Spain

Cited by 3 publications

References 5 publications

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

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

Erythroderma: clinical and etiological study of 88 cases seen in a tertiary hospital over 25 years

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

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