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

DUPIXENT was studied in a Phase 3 clinical trial in adolescents with moderate-to-severe atopic dermatitis (AD) as a monotherapy for up to 16 weeks2–4

AD-1526: Proportion of adolescent patients achieving a clinically meaningful improvement in peak pruritus NRS at Week 16*3,4

At 16 weeks, 37% of patients on DUPIXENT achieved a clinically meaningful ≥4-points improvement in peak pruritus NRS score compared to 5% of patients on placebo3

AD-1526: Proportion of adolescent patients achieving a clinically meaningful improvement in CDLQI at Week 16*3,4

At 16 weeks, 61% of patients on DUPIXENT achieved a clinically meaningful ≥6-point improvement in quality of life (CDLQI) compared to 20% of patients on placebo4,5

AD-1526: A randomised, placebo-controlled, double-blind, parallel-group, multicentre, Phase 3 trial of adolescent patients (n=251) with moderate-to-severe AD whose disease was inadequately controlled by topical treatment, randomised to receive either a) 200/300 mg DUPIXENT Q2W (n=82) (licensed dose), b) 300 mg DUPIXENT Q4W (n=84) or c) placebo Q2W for 16 weeks.4


The co-primary endpoints were the proportion of patients with both IGA 0/1 (clear/almost clear) and the proportion of patients achieving 75% improvement in EASI (EASI-75) from baseline to Week 16.3,4


The key secondary endpoints were the percentage change in EASI from baseline to Week 16, the percentage change in peak pruritus NRS score from baseline, proportion of patients with ≥3-point improvement in peak pruritus NRS score from baseline to Week 16, proportion of patients with ≥4-point improvement in peak pruritus NRS score from baseline to Week 16.4


Other secondary endpoints were the proportion of patients achieving at least 50% improvement in EASI (EASI-50), change from baseline in percent body surface area affected (BSA) by AD, percentage change from baseline in SCORing Atopic Dermatitis (SCORAD), and changes from baseline in Children’s Dermatology Life Quality Index (a clinically meaningful improvement in CDLQI is defined as a ≥6-point improvement on a 0–13 scale), Patient-Oriented Eczema Measure (POEM) and SCORAD sleep loss scores from baseline to Week 16.4


*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).2,6


The CDQLI score is based on a 10-item patient questionnaire that assesses six different aspects that may affect quality of life. These aspects are symptoms and feelings, daily activities, leisure, work and school performance, personal relationships, and treatment. Each question is scored from 0 (not at all) to 3 (very much) and then totalled for the final score.7–11


AD, atopic dermatitis; BSA, body surface area; CDLQI, Children’s Dermatology Life Quality Index; EASI, Eczema Area and Severity Index; HADS, Hospital Anxiety and Depression Scale; IGA, Investigator’s Global Assessment; NRS, Numerical Rating Scale; POEM, Patient-Oriented Eczema Measure; QW, once weekly; Q2W, once every two weeks; SCORAD, SCORing Atopic Dermatitis; TCS, topical corticosteroids.

References

  1. DUPIXENT Summary of Product Characteristics. Available at: https://www.medicines.org.uk/emc/product/8553/smpc. Date accessed: December 2020.
  2. Simpson EL, et al. Dupilumab Efficacy and Safety in Adolescents with Moderate-to-Severe Atopic Dermatitis: Results from a Multicenter, Randomized, Placebo Controlled, Double-Blind, Parallel-Group, Phase 3 Study (Presentation 4640) presented at the 27th EADV Congress, Paris, France, September 12–16 2018.
  3. Simpson EL, et al. Dupilumab Efficacy and Safety in Adolescents With Moderate-to-Severe Atopic Dermatitis: Results From a Multicenter, Randomized, Placebo Controlled, Double-Blind, Parallel-Group, Phase 3 Study (Poster PA-17) presented at the 43rd annual Hawaii Dermatology Seminar; Waikoloa, HI, USA, February 17–22 2019.
  4. Paller A, et al. Dupilumab for Adolescents With Moderate-to-Severe Atopic Dermatitis: Results From a Phase 3, Randomized, Double-Blinded Trial (Poster 10051) presented at the 77th annual meeting of the American Academy of Dermatology, Washington, DC, USA, March 1–5 2019.
  5. Sanofi Data on File. SAGB.DUP.19.08.1443. August 2019.
  6. Phan NQ, et al. Acta Derm Venereol. 2012;92:502–507.
  7. © NICE [2018] Dupilumab for treating moderate to severe atopic dermatitis. Available at: https://www.nice.org.uk/guidance/TA534/chapter/1-Recommendations. Date accessed: December 2020. All rights reserved. Subject to notice of rights. NICE guidance is prepared for the National Health Service in England. All NICE guidance is subject to regular review and may be updated or withdrawn. NICE accepts no responsibility for the use of its content in this product/publication.
  8. Fattah D, et al. Chair’s presentation. Dupilumab for treating moderate to severe atopic dermatitis (ID1048) presented at the 2nd Appraisal Committee meeting lead team presentation, May 10 2018.
  9. Simpson EL, et al. Dermatol Ther (Heidelb). 2019 Oct 22. doi:10.1007/s13555-019-00333-2.
  10. Clinical Review Report: Dupilumab (Dupixent): (Sanofi-Aventis Canada Inc.): Indication: Moderate-to-severe atopic dermatitis (AD) [Internet]. Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; 2018 Jul. Appendix 5, Validity of Outcomes Measures. Available at: https:// www.ncbi.nlm.nih.gov/books/NBK539234/. Date accessed: December 2020.