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Dupilumab provides favourable long‐term safety and efficacy in children aged ≥ 6 to < 12 years with uncontrolled severe atopic dermatitis: results from an open‐label phase IIa study and subsequent phase III open‐label extension study
- Source :
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British Journal of Dermatology . May2021, Vol. 184 Issue 5, p857-870. 14p. - Publication Year :
- 2021
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Abstract
- Summary: Background: Children aged ≥ 6 to < 12 years with severe atopic dermatitis (AD) have limited treatment options. In a 16‐week, randomized, placebo‐controlled, phase III trial in children, dupilumab, a monoclonal antibody inhibiting interleukin (IL)‐4/IL‐13 signalling, significantly improved signs and symptoms with acceptable safety; longer‐term safety and efficacy data are lacking. Objectives: To report the pharmacokinetic profile and long‐term safety and efficacy of dupilumab in children (aged ≥ 6 to < 12 years) with severe AD. Methods: Children (aged ≥ 6 to < 12 years) with severe AD were enrolled in a global, multicentre, phase IIa, open‐label, ascending‐dose, sequential cohort study and subsequent open‐label extension (OLE) study. Patients received single‐dose dupilumab 2 or 4 mg kg−1 followed by 8‐week pharmacokinetic sampling, then 2 or 4 mg kg−1 weekly for 4 weeks (phase IIa), followed by the same weekly regimen (OLE). Primary endpoints were dupilumab concentration–time profile and treatment‐emergent adverse events (TEAEs); secondary assessments included Eczema Area and Severity Index (EASI) and Peak Pruritus Numeric Rating Scale (PP‐NRS) score. Results: Of 38 children enrolled, 37 completed phase IIa and 33 continued to the OLE. Nonlinear, target‐mediated pharmacokinetics characterized dupilumab concentrations (week 24–48 mean serum concentrations: 2 mg kg−1, 61–77 mg L−1; 4 mg kg−1, 143–181 mg L−1). TEAEs were mostly mild to moderate and transient; none led to treatment discontinuation. The most commonly reported TEAEs were nasopharyngitis (2 mg kg−1, 47%; 4 mg kg−1, 56%) and AD exacerbation (29% and 13%, respectively). Single‐dose dupilumab rapidly improved AD with further improvements through week 52. Mean EASI and PP‐NRS improved by −37%/−33% and −17%/−20% at week 2 (phase IIa) and −92%/−84% and −70%/−58% at week 52 (OLE), respectively. Conclusions: These safety and efficacy results support the use of dupilumab as a continuous long‐term treatment for children aged ≥ 6 to < 12 years with severe AD. What is already known about this topic?Severe atopic dermatitis (AD) has a marked negative impact on patient quality of life and can cause financial burden owing to a lack of effective treatments.Dupilumab significantly improved signs and symptoms of AD with an acceptable safety profile in a 16‐week randomized, double‐blind, placebo‐controlled phase III study in children aged ≥ 6 to < 12 years with severe AD. What does this study add?This study extends information on the safety, efficacy and pharmacokinetic profile of dupilumab treatment for up to 52 weeks in children aged ≥ 6 to < 12 years with severe AD.The results support the use of dupilumab as a continuous long‐term treatment for children aged ≥ 6 to < 12 years with severe AD. Linked Comment: Sibbald. Br J Dermatol 2021; 184:792–793. [ABSTRACT FROM AUTHOR]
Details
- Language :
- English
- ISSN :
- 00070963
- Volume :
- 184
- Issue :
- 5
- Database :
- Academic Search Index
- Journal :
- British Journal of Dermatology
- Publication Type :
- Academic Journal
- Accession number :
- 150144577
- Full Text :
- https://doi.org/10.1111/bjd.19460