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Rapid and sustained improvement in itch and quality of life versus placebo

DUPIXENT was studied in six Phase 3 clinical trials in adults with moderate-to-severe atopic dermatitis (AD), including more than 2,400 patients worldwide, both as a monotherapy and with TCS for up to 52 weeks1

Rapid improvement compared to placebo + TCS at 16 weeks, sustained over 52 weeks2

CHRONOS: Proportion of adult patients achieving a clinically meaningful improvement in peak pruritus NRS at Week 52*2

A clinically meaningful ≥4-point improvement was seen as early as Week 22


At 52 weeks, 51% of patients on DUPIXENT + TCS achieved a clinically meaningful ≥4-point improvement in peak pruritus NRS score compared to 13% with placebo + TCS2

CHRONOS: Proportion of adult patients achieving a clinically meaningful improvement in DLQI at Week 52†3,4

At 52 weeks, 80% of patients on DUPIXENT + TCS achieved a clinically meaningful improvement in quality of life (DLQI) compared to 30% with placebo + TCS3,4

CHRONOS trial design: A randomised, double-blind, placebo-controlled study of adults with moderate-to-severe atopic dermatitis with prior inadequate response to TCS. 319 patients were randomised to DUPIXENT 300 mg + TCS QW, 106 patients were randomised to DUPIXENT 300 mg + TCS Q2W (licensed dose) and 315 patients were randomised to placebo + TCS for 52 weeks.1 Emollient background regimen/therapy was required during the trial.2


The co-primary endpoints were the proportion of patients with both IGA 0/1 (clear/almost clear) and a ≥2-point reduction from baseline at Week 16 (0–4 scale), and the proportion of patients achieving 75% improvement in EASI (EASI-75) from baseline to Week 16.1


Other evaluated outcomes included: the proportion of patients with improvement of at least 50% and 90% in EASI (EASI-50 and EASI-90, respectively), reduction in itch as measured by the peak pruritus Numerical Rating Scale (NRS), percent change in the SCORing Atopic Dermatitis (SCORAD) scale from baseline to Week 16, mean change from baseline to Week 16 in the Patient Oriented Eczema Measure (POEM), Dermatology Life Quality Index (a clinically meaningful improvement in DLQI is defined as a ≥4-point improvement on a 0 to 30 scale), and Hospital Anxiety and Depression Scale (HADS) scores. Efficacy was also evaluated at Week 52.1


Improvement compared to placebo + TCS following failed ciclosporin therapy5

CAFÉ: Proportion of adult patients achieving a clinically meaningful improvement in peak pruritus NRS at Week 16*5

At 16 weeks, 46% of patients on DUPIXENT + TCS achieved a clinically meaningful improvement in peak pruritus NRS compared to 14% with placebo + TCS5

CAFÉ: Proportion of adult patients achieving a clinically meaningful improvement in DLQI at Week 16†5

At 16 weeks, 88% of patients on DUPIXENT + TCS achieved a clinically meaningful improvement in quality of life (DLQI) compared to 44% with placebo + TCS5

CAFÉ trial design: A 16-week, Phase 3, double-blind, randomised, placebo-controlled trial of adults with severe atopic dermatitis, who are inadequately controlled by, or intolerant of ciclosporin. A total of 325 patients in Europe were randomised into three treatment groups in the 16-week study to receive either DUPIXENT 300 mg + TCS QW, DUPIXENT 300 mg + TCS Q2W (licensed dose) or placebo + TCS. Patients applied moisturisers at least twice daily for the seven days prior to randomisation and throughout the study; stable doses of prescription moisturisers or moisturisers containing additives were permitted if initiated before screening.5


The primary endpoint was the proportion of patients that achieved a 75% or greater improvement in the Eczema Area and Severity Index (EASI-75) score at 16 weeks from baseline.5


Secondary endpoints included: measures of the impact of DUPIXENT on the persistent itch caused by the disease, health-related quality of life measures, and symptoms of anxiety and depression.5


A clinically meaningful improvement in pruritus is defined as a ≥4-point improvement in NRS.1,3
A clinically meaningful improvement in quality of life is defined as ≥4-point improvement on a 0–30 scale in DLQI.1


*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).2,5,6
The DQLI 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 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.7–9


AD, atopic dermatitis; BSA, body surface area; DLQI, 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. September 2021.
  2. Blauvelt A, et al. Lancet. 2017;389(10086):2287–2303.
  3. Sanofi Data on File. SAGB.DUP.17.09.1126. September 2017.
  4. Hongbo Y, et al. J Invest Dermatol. 2005;125(4):659–664.
  5. de Bruin-Weller, et al. Br J Dermatol. 2018;178:1083–1101.
  6. Phan NQ, et al. cta Derm Venereol. 2012;92:502–507.
  7. 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.
  8. 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: September 2021.
  9. © NICE [2018] Dupilumab for treating moderate to severe atopic dermatitis. Available at: https://www.nice.org.uk/guidance/TA534/chapter/1-Recommendations. Date accessed: September 2021. 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.