P68: Dupilumab provides improvement in sleep in children aged ≥ 6 years with severe atopic dermatitis (AD) and adolescents with moderate‐to‐severe AD
Notice bibliographique
Résumé
A. Paller,1,2 A. Wollenberg,3 E. Simpson,4 L. Beck,5 C.-h. Hong,6,7 D. Marcoux,8 Z. Chen,9 N. Levit,9 A. Bansal,9 A. Rossi10 and J. Chao9 1Northwestern University Feinberg School of Medicine, Chicago, IL, USA; 2Ann and Robert H. Lurie Children’s Hospital, Chicago, IL, USA; 3University Hospital, Ludwig-Maximilian University Munich, Munich, Germany; 4Oregon Health and Science University, Portland, OR, USA; 5University of Rochester Medical Center, Rochester, NY, USA; 6University of British Columbia, Surrey, BC, Canada; 7Probity Medical Research, Waterloo, ON, Canada; 8University of Montreal and Sainte-Justine University Medical Center, Montreal, QC, Canada; 9Regeneron Pharmaceuticals, Tarrytown, NY, USA; and 10Sanofi Genzyme, Cambridge, MA, USA Sleep disturbance reduces the quality of life in patients with atopic dermatitis (AD). We analysed the effect of dupilumab treatment on sleep in children and adolescents with AD. Patients aged ≥ 6 to < 12 years with severe AD in the phase III LIBERTY AD PEDS trial (NCT03345914) and aged ≥ 12 to < 18 years with moderate-to-severe AD in the phase III LIBERTY AD ADOL trial (NCT03054428) received subcutaneous dupilumab or placebo for 16 weeks. In PEDS, all patients received concomitant topical corticosteroids. We report US Food and Drug Administration-approved dupilumab doses [300 mg every 4 weeks (Q4W) if weighing < 30 kg; 200 mg Q2W if weighing ≥ 30 and < 60 kg; 300 mg Q2W if weighing ≥ 60 kg], and the additional European Medicines Agency-approved dose (300 mg Q4W for those weighing ≥ 30 kg in PEDS) vs. weight-matched placebo regimens. Sleep disturbance was assessed by mean and least squares mean change from baseline in SCORing AD (SCORAD) sleep loss visual analogue scale score and the proportions of patients responding ‘not at all’/‘only a little’ to the affected sleep item on the Children’s Dermatology Life Quality Index (CDLQI) at week 16. Statistical significance was calculated vs. matched placebo. At baseline, sleep was suboptimal in PEDS and ADOL patients. In PEDS, mean baseline SCORAD sleep loss scores were 6·8 for dupilumab < 30 kg (n = 61), 6·4 for placebo < 30 kg (n = 61), 6·7 for dupilumab ≥ 30 kg Q4W (n = 61), 5·2 for dupilumab ≥ 30 kg Q2W (n = 59) and 5·7 for placebo ≥ 30 kg (n = 62). In ADOL, the mean baseline SCORAD sleep loss scores were 5·5 dupilumab < 60 kg (n = 43), 5·6 for placebo < 60 kg (n = 43), 5·4 for dupilumab ≥ 60 kg (n = 39) and 5·7 for placebo ≥ 60 kg (n = 42). Treatment with dupilumab regimens vs. matched placebo for 16 weeks significantly reduced sleep loss scores in PEDS [< 30 kg: –4·6 vs. –2·0 (P < 0·001); ≥ 30 kg: Q4W/Q2W –3·9 (P < 0·001)/–4·5 (P < 0·001) vs. –2·1] and ADOL [< 60 kg: –3·4 vs. –0·3 (P < 0·001); ≥ 60 kg: –3·8 vs. –2·0 (P < 0·01)]. In PEDS, sleep improvement in dupilumab vs. placebo groups was significant by week 2 for the < 30 kg (P < 0·01) and ≥ 30 kg Q2W (P < 0·05) groups, and by week 12 for the ≥ 30 kg Q4W group (P < 0·01); in ADOL, effects were seen by week 1 (< 60 kg; P < 0·01) and week 4 (≥ 60 kg; P < 0·01). At week 16, more dupilumab-treated than placebo-treated patients reported no/little affected sleep in both PEDS [< 30 kg: 82% vs. 41%; ≥ 30 kg: Q4W 85%/Q2W 90% vs. 52% (all P < 0·001)] and ADOL [< 60 kg: 70% vs. 14% (P < 0·001); ≥ 60 kg: 69% vs. 31% (P < 0·001)], as assessed by the CDLQI sleep item. The safety profile was consistent with the known dupilumab safety profile. Dupilumab provided improved sleep in children with severe AD and adolescents with moderate-to-severe AD. Funding sources: this research was sponsored by Sanofi and Regeneron Pharmaceuticals, Inc.
Récupéré en direct depuis OpenAlex et désinversé. Les résumés ne sont pas conservés dans cette base de données : les index inversés représentent 8,6 Go des 9,3 Go de texte de la base, et le serveur dispose de 13 Go libres.
Comment cette classification a été obtenuedéplier
Prédiction machine sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Le volet Gemma est une étiquette directe du modèle pour chaque travail de la base, lue sur la notice réduite au titre. Le volet Codex est un classifieur appris des 10 348 étiquettes directes de Codex et calibré sur les taux pondérés de l'échantillon; les champs sans appui suffisant ne portent aucun appel Codex. Le mode candidate est l'union des deux volets; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont pas des étiquettes humaines.
Scores du classifieur distillé par catégorie (deux têtes)
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,000 | 0,000 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,001 | 0,001 |
| Bibliométrie | 0,000 | 0,000 |
| Études des sciences et des technologies | 0,000 | 0,000 |
| Communication savante | 0,000 | 0,000 |
| Science ouverte | 0,000 | 0,000 |
| Intégrité de la recherche | 0,000 | 0,001 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,002 | 0,000 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule source (Gemma direct ou Codex distillé), pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».