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JAMA Dermatology

<jats:sec id="ab-doi240027-4"><jats:title>Importance</jats:title><jats:p>Limited data are available on the long-term effectiveness and safety of dupilumab for atopic dermatitis (AD) in daily practice.</jats:p></jats:sec><jats:sec id="ab-doi240027-5"><jats:title>Objective</jats:title><jats:p>To 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.</jats:p></jats:sec><jats:sec id="ab-doi240027-6"><jats:title>Design, Setting, and Participants</jats:title><jats:p>This 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.</jats:p></jats:sec><jats:sec id="ab-doi240027-7"><jats:title>Main Outcomes and Measures</jats:title><jats:p>Clinical 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 (&amp;amp;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.</jats:p></jats:sec><jats:sec id="ab-doi240027-8"><jats:title>Results</jats:title><jats:p>In 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.</jats:p></jats:sec><jats:sec id="ab-doi240027-9"><jats:title>Conclusions and Relevance</jats:title><jats:p>In 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.</jats:p></jats:sec>

Dupilumab shows long-term effectiveness in a large cohort of treatment-refractory atopic dermatitis patients in daily practice: 52-week results from the Dutch BioDay registry.

J Am Acad Dermatol

Dupilumab maintains long-term disease control in adults with moderate-to-severe atopic dermatitis as measured by well-controlled weeks: results from the LIBERTY AD CHRONOS clinical trial.

Dermatol Ther (Heidelb)

Dupilumab shows long-term safety and efficacy in patients with moderate to severe atopic dermatitis enrolled in a phase 3 open-label extension study.

A nationwide 104 weeks real-world study of dupilumab in adults with atopic dermatitis: ineffectiveness in head-and-neck dermatitis.

J Eur Acad Dermatol Venereol

Longer dupilumab dosing intervals in adult patients with atopic dermatitis: experience from a French multicentre retrospective cohort study.

Br J Dermatol

Patient-centered dupilumab dosing regimen leads to successful dose reduction in persistently controlled atopic dermatitis.

Allergy

Dupilumab dose spacing after initial successful treatment or adverse events in adult patients with atopic dermatitis: a retrospective analysis.

Dermatol Ther

Successful tapering of dupilumab in patients with atopic dermatitis with low disease activity: a large pragmatic daily practice study from the BioDay registry.

Efficacy and safety of multiple dupilumab dose regimens after initial successful treatment in patients with atopic dermatitis: a randomized clinical trial.

JAMA Dermatol

Two-year efficacy, safety, and drug survival of dupilumab for atopic dermatitis: a real-world Canadian multicenter retrospective study.

JAAD Int

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

An Bras Dermatol

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

J Dermatolog Treat

Dupilumab provides acceptable safety and sustained efficacy for up to 4 years in an open-label study of adults with moderate-to-severe atopic dermatitis.

Am J Clin Dermatol

What the Eczema Area and Severity Index score tells us about the severity of atopic dermatitis: an interpretability study.

A systematic review of Investigator Global Assessment (IGA) in atopic dermatitis (AD) trials: many options, no standards.

Assessment of pruritus intensity: prospective study on validity and reliability of the visual analogue scale, numerical rating scale and verbal rating scale in 471 patients with chronic pruritus.

Acta Derm Venereol

Treat-to-target in atopic dermatitis: an international consensus on a set of core decision points for systemic therapies.

Long-term management of moderate-to-severe atopic dermatitis with dupilumab and concomitant topical corticosteroids (LIBERTY AD CHRONOS): a 1-year, randomised, double-blinded, placebo-controlled, phase 3 trial.

Lancet

Dupilumab-induced hypereosinophilia: review of the literature and algorithm proposal for clinical management.

Expert Rev Respir Med

Biomarkers for atopic dermatitis: a systematic review and meta-analysis.

Curr Opin Allergy Clin Immunol

Real-life effectiveness and safety of dupilumab in adolescents with atopic dermatitis: a 52-week single-center retrospective study.

Dupilumab improves clinical scores in children and adolescents with moderate to severe atopic dermatitis: a real-world, single-center study.

J Allergy Clin Immunol Pract

A 52-week update of a multicentre Italian real-world experience on effectiveness and safety of dupilumab in adolescents with moderate-to-severe atopic dermatitis.

Effect of dupilumab on blood eosinophil counts in patients with asthma, chronic rhinosinusitis with nasal polyps, atopic dermatitis, or eosinophilic esophagitis.

Dupilumab therapy of atopic dermatitis of the elderly: a multicentre, real-life study.

Dupilumab with topical corticosteroids provides rapid and sustained improvement in adults with moderate-to-severe atopic dermatitis across anatomic regions over 52 weeks.

Dupilumab demonstrates rapid and consistent improvement in extent and signs of atopic dermatitis across all anatomical regions in pediatric patients 6 years of age and older.

Facial and neck erythema associated with dupilumab treatment: a systematic review.

Reasons for discontinuation of dupilumab in adult atopic dermatitis in clinical practice.

Evaluation of long-term efficacy, safety, and reasons for discontinuation of dupilumab for moderate to severe atopic dermatitis in clinical practice: a retrospective cohort study.

Long-term drug survival of dupilumab and associated predictors in moderate-to-severe atopic dermatitis: a real-world prospective cohort study.

Global, regional, and national cancer incidence and death for 29 cancer groups in 2019 and trends analysis of the global cancer burden, 1990-2019.

J Hematol Oncol

Limited data are available on the long-term effectiveness and safety of dupilumab for atopic dermatitis (AD) in daily practice.
To 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.
This 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.
Clinical 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 (<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.
In 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.
In 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.

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

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

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

Clinical Summary

What was studied

Key findings

Clinical implications

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