P68: Dupilumab provides improvement in sleep in children aged ≥ 6 years with severe atopic dermatitis (AD) and adolescents with moderate‐to‐severe AD
Bibliographic record
Abstract
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.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.000 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.002 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".