Dupilumab Provides Favorable Safety and Sustained Efficacy for up to 3 Years in an Open-Label Study of Adults with Moderate-to-Severe Atopic Dermatitis.
Adult
Antibodies, Monoclonal, Humanized
/ administration & dosage
Conjunctivitis
/ chemically induced
Dermatitis, Atopic
/ diagnosis
Female
Headache
/ chemically induced
Humans
Injection Site Reaction
/ epidemiology
Injections, Subcutaneous
/ adverse effects
Male
Medication Adherence
/ statistics & numerical data
Middle Aged
Nasopharyngitis
/ chemically induced
Respiratory Tract Infections
/ chemically induced
Self Report
/ statistics & numerical data
Severity of Illness Index
Time Factors
Treatment Outcome
Journal
American journal of clinical dermatology
ISSN: 1179-1888
Titre abrégé: Am J Clin Dermatol
Pays: New Zealand
ID NLM: 100895290
Informations de publication
Date de publication:
Aug 2020
Aug 2020
Historique:
pubmed:
20
6
2020
medline:
18
5
2021
entrez:
20
6
2020
Statut:
ppublish
Résumé
Management of moderate-to-severe atopic dermatitis (AD) commonly requires long-term treatment. The aim of this study was to report the safety and efficacy of dupilumab treatment for up to 3 years in adults with moderate-to-severe AD. This ongoing, multicenter, open-label extension study (LIBERTY AD OLE; NCT01949311) assessed dupilumab treatment in adults previously enrolled in dupilumab trials. Patients received dupilumab 300 mg weekly up to 148 weeks. The primary outcome was safety. Of 2677 patients enrolled and treated, 347 reached week 148. Mean self-reported drug compliance was 98.2%. Safety data were consistent with previously reported trials (270.1 adverse events [AEs]/100 patient-years; 6.9 serious AEs/100 patient-years) and the known dupilumab safety profile. Common AEs (≥ 5% of patients) included nasopharyngitis, AD, upper respiratory tract infection, conjunctivitis, headache, oral herpes, and injection-site reactions. AD signs and symptoms showed sustained improvements during treatment with mean (standard deviation, mean percentage change from parent study baseline) Eczema Area and Severity Index 1.4 (3.2, - 95.4%) and weekly Pruritus Numerical Rating Scale 2.2 (1.8, - 65.4%) at week 148. No control arm; fewer patients at later time points; regimen different from the approved 300 mg every 2 weeks dose. These safety and efficacy results support dupilumab as a continuous long-term treatment for adults with moderate-to-severe AD. ClinicalTrials.gov: NCT01949311. Dupilumab provides favorable safety and sustained efficacy for up to 3 years in an open-label study of adults with moderate-to-severe atopic dermatitis (MP4 139831 kb).
Sections du résumé
BACKGROUND
BACKGROUND
Management of moderate-to-severe atopic dermatitis (AD) commonly requires long-term treatment.
OBJECTIVE
OBJECTIVE
The aim of this study was to report the safety and efficacy of dupilumab treatment for up to 3 years in adults with moderate-to-severe AD.
METHODS
METHODS
This ongoing, multicenter, open-label extension study (LIBERTY AD OLE; NCT01949311) assessed dupilumab treatment in adults previously enrolled in dupilumab trials. Patients received dupilumab 300 mg weekly up to 148 weeks. The primary outcome was safety.
RESULTS
RESULTS
Of 2677 patients enrolled and treated, 347 reached week 148. Mean self-reported drug compliance was 98.2%. Safety data were consistent with previously reported trials (270.1 adverse events [AEs]/100 patient-years; 6.9 serious AEs/100 patient-years) and the known dupilumab safety profile. Common AEs (≥ 5% of patients) included nasopharyngitis, AD, upper respiratory tract infection, conjunctivitis, headache, oral herpes, and injection-site reactions. AD signs and symptoms showed sustained improvements during treatment with mean (standard deviation, mean percentage change from parent study baseline) Eczema Area and Severity Index 1.4 (3.2, - 95.4%) and weekly Pruritus Numerical Rating Scale 2.2 (1.8, - 65.4%) at week 148.
LIMITATIONS
CONCLUSIONS
No control arm; fewer patients at later time points; regimen different from the approved 300 mg every 2 weeks dose.
CONCLUSION
CONCLUSIONS
These safety and efficacy results support dupilumab as a continuous long-term treatment for adults with moderate-to-severe AD.
TRIAL REGISTRATION
BACKGROUND
ClinicalTrials.gov: NCT01949311. Dupilumab provides favorable safety and sustained efficacy for up to 3 years in an open-label study of adults with moderate-to-severe atopic dermatitis (MP4 139831 kb).
Identifiants
pubmed: 32557382
doi: 10.1007/s40257-020-00527-x
pii: 10.1007/s40257-020-00527-x
pmc: PMC7371647
doi:
Substances chimiques
Antibodies, Monoclonal, Humanized
0
dupilumab
420K487FSG
Banques de données
ClinicalTrials.gov
['NCT01949311']
Types de publication
Clinical Trial, Phase III
Journal Article
Multicenter Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
567-577Références
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