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Improvement in itch and quality of life compared to placebo at 16 weeks2–4

DUPIXENT with TCS was studied in a Phase 3 clinical trial in children aged 6–11 years old with severe atopic dermatitis (AD), for up to 16 weeks2

Efficacy with DUPIXENT + TCS compared to placebo2

AD-1652: Proportion of child patients achieving a clinically meaningful improvement in peak pruritus NRS at Week 16*2

At 16 weeks, 51% of patients on DUPIXENT + TCS achieved a clinically meaningful ≥4-points improvement in peak pruritus NRS score compared to 12% of patients on placebo + TCS2

AD-1652: Proportion of child patients achieving a clinically meaningful improvement in CDLQI at Week 16†3

At 16 weeks, 77% of patients on DUPIXENT achieved a clinically meaningful ≥6-point improvement in quality of life (CDLQI) compared to 42% of patients on placebo + TCS3

AD-1652: Mean improvement in SCORAD VAS sleep component from baseline to Week 16‡2

The SCORAD VAS sleep component is a scale ranging from 0 (“no sleeplessness”) to 10 (“worst imaginable sleeplessness”).


At 16 weeks, patients on DUPIXENT + TCS achieved reduction in sleep loss of 4.3 LSM change from baseline compared to 2.0 LSM change from baseline for patients on placebo + TCS2

AD-1652: Mean change in PROMIS depressive symptoms score at Week 16§2


At 16 weeks, patients on DUPIXENT + TCS improved measures of depression to 12.8 LSM change from baseline compared to 7.4 LSM change from baseline for patients on placebo + TCS2

AD-1652: Mean change in PROMIS anxiety score at Week||2,4


At 16 weeks, patients on DUPIXENT + TCS improved measures of anxiety to 13.2 LSM change from baseline compared to 10.2 LSM change from baseline for patients on placebo + TCS2,4

AD-1652: A randomised (1:1:1), placebo-controlled, double-blind, parallel-group, Phase 3 trial of child patients aged 6–11 years (N=367) with severe AD whose disease was inadequately controlled by topical treatment, randomised to receive either a) 300 mg DUPIXENT Q4W + TCS (n=122), b) 100 mg or 200mg DUPIXENT Q2W + TCS (n=122) or c) placebo + TCS (n=123) for 16 weeks.2


The co-primary endpoints were the proportion of patients with IGA 0 or 1 at Week 16 and the proportion of patients with EASI-75 at Week 16.2


The key secondary endpoints were the percentage change from baseline in EASI at Week 16 and the percentage change in weekly average of daily peak pruritus NRS.2


Other secondary endpoints were proportion of patients with ≥3-point improvement in peak pruritus NRS, proportion of patients with ≥4-point improvement in peak pruritus NRS, percentage of patients with EASI-50 and EASI-90, percentage change in SCORAD, change in CDLQI and POEM, change from baseline in PROMIS patient anxiety and depression and SCORAD sleep loss scores from baseline.2


*For the peak pruritus Numerical Rating Scale (NRS), patients report the intensity of their itch in the previous 24 hours on a scale from 0 to 10, with higher values indicating worse itching. A clinically meaningful improvement in pruritus is defined as a ≥4-point improvement in pruritus NRS (0–10).5
The CDLQI score is based on a 10-item patient questionnaire that assesses the impact of a skin disease on quality of life of the affected child over the last week. These aspects are symptoms, embarrassment, friendships, clothes, playing, sports, school, bullying, sleep and impact of treatment. Nearly all questions are scored from 0 (not at all) to 3 (very much) with one question adding a score of 3 when school is prevented; all scores are then totalled for the final score. For children there is also a cartoon CDLQI, in which each question is illustrated by a cartoon based on the theme of the question (excludes ‘prevented school’ as a response item).6,7
At baseline in LIBERTY AD PEDS, the mean SCORAD VAS sleep component score was 72.9 and 75.6 in the placebo + TCS and DUPIXENT 300mg Q4W + TCS groups, respectively.2
§At baseline in LIBERTY AD PEDS, the mean PROMIS depressive symptoms score was 55.0 and 58.1 in the placebo + TCS and DUPIXENT 300mg Q4W + TCS groups, respectively.2
||At baseline in LIBERTY AD PEDS, the mean PROMIS anxiety score was 57.3 and 59.8 in the placebo + TCS and DUPIXENT 300mg Q4W + TCS groups, respectively.2

AD, atopic dermatitis; CDLQI, Children Dermatology Life Quality Index; EASI, Eczema Area and Severity Index; IGA, Investigator’s Global Assessment; LSM, least-squares mean; NRS, Numerical Rating Scale; POEM, Patient Oriented Eczema Measure; PROMIS, Patient-Reported Outcomes Measurement Information System; Q2W, once very two weeks; Q4W, once every four weeks; SCORAD, SCORing Atopic Dermatitis; TCS, topical corticosteroids; VAS, visual analogue scale.

References

  1. DUPIXENT Summary of Product Characteristics. September 2021.
  2. Paller AS, et al. J Am Acad Dermatol. 2020;83(5):1282–1293.
  3. Sanofi Data on File. MAT-GB-2005006 (v1.0).
  4. Sanofi Data on File. MAT-GB-2005001 (v1.0).
  5. Phan NQ, et al. Acta Derm Venereol. 2012;92:502–507.
  6. Olsen JR, et al. Br J Dermatol. 2016;174(4)853–861.
  7. Children’s Dermatology Life Quality Index. Available at: https://www.cardiff.ac.uk/medicine/resources/quality-of-life-questionnaires/childrens-dermatology-life-quality-index. Date accessed: September 2021.