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Real-world experience from the UK

A retrospective review of adult patients with moderate-to-severe atopic dermatitis (AD) patients from UK hospital patient records2


MANCHESTER (SALFORD): 164 patients from a tertiary centre, review at 3 and 6 months2

Proportion of patients achieving EASI-50, EASI-75 and EASI-90*2,3

In Manchester (Salford) at 6 months, 75% of patients on DUPIXENT achieved a >75% improvement in lesion extent and severity (EASI-75) compared to 62% with DUPIXENT at 3 months2


The effects of DUPIXENT in real-world experience are comparable to results from the Phase 3 clinical trial, CAFÉ2,3

Median EASI score at baseline and review checkpoints*2

At 6 months, a median EASI score of 2.0 was achieved by 94 patients on DUPIXENT, compared to a median EASI score of 23.0 at baseline2

Median DLQI score at baseline and review checkpoints*2

At 6 months, a median DLQI score of 2.0 was achieved by 94 patients on DUPIXENT, compared to a median EASI score of 21.0 at baseline2

A retrospective review of the electronic records of patents receiving DUPIXENT at the Dermatology Centre part of the Manchester (Salford) Royal Hospital NHS Foundation Trust (N=164). Baseline demographics, EASI and DLQI scores were collected at baseline, 3 and 6 months.2

CAFÉ trial design: A 16-week, Phase 3, double-blind, randomised, placebo-controlled trial of adults with moderate-to-severe AD, 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 + topical corticosteroids (TCS) once weekly (QW), DUPIXENT 300 mg + TCS once every two weeks (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.3


The primary endpoint was the proportion of patients that achieved a 75% or greater improvement in the EASI-75 score at 16 weeks from baseline.3


Secondary endpoints included: the percent change from baseline in EASI, SCORing Atopic Dermatitis (SCORAD), weekly average of peak daily pruritus Numerical Rating Scale (NRS) (Weeks 2 and 16) and Global Individual Sign Score (GISS); change from baseline in percent body surface area (BSA) affected by AD, DLQI, Patient-Oriented Eczema Measure (POEM), Hospital Anxiety and Depression Scale (HADS), proportion of patients achieving EASI-50 and EASI-90, ≥4-point reduction in weekly average of peak daily pruritus NRS score, ≥50% improvement from baseline in SCORAD and both Investigator Global Assessment (IGA) 0 or 1 (clear or almost clear) and a 2-point reduction in IGA from baseline at Week 16.3

MANCHESTER (SALFORD)2
(N=164)
Median age (years) 36 (18–87)
Males (%) 59.75
Median baseline EASI Score 23 ± 16
Median baseline DLQI Score 22 ± 10

DUPIXENT safety profile in the Manchester (Salford) study2

  • Overall, 7.69% (12/156) of patients stopped treatment, 1.92% (3/153) on account of severe conjunctivitis at 12 (n=2) and 26 weeks (n=1)2
ADVERSE EVENTS (AEs) n(%)
Eye symptoms 66 (44.30)
Sicca 36 (23.07)
Conjunctivitis 25 (16.02)
Facial erythema 10 (6.41)
Musculoskeletal 6 (3.84)
Alopecia areata 5 (3.20)
Eczema herpeticum 1 (0.64)
Vasovagal episodes 3 (1.92)
Injection site reaction 2 (1.31)
Pneumonia 1 (0.64)
Flu like symptoms 1 (0.64)
DISCONTINUATION n (%)
Total discontinuation 12 (7.8)
Treatment failure 2 (1.28)
Severe conjunctivitis 3 (1.92)
Alopecia areata 1 (0.64)
Pregnancy 2 (1.28)
Vasovagal episode 1 (0.64)
Mode of administration 1 (0.64)
Lost to follow-up 2 (1.28)
  • Learn more about CAFÉ efficacy data, including itch and quality of life

*An EASI score is based on a clinician’s weighted score (0 to 72) of four affected areas grading the physical signs of AD (erythema, oedema/papulation, excoriation, lichenification).4–8
The DLQI 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.5,8


AD, atopic dermatitis; AE, adverse event; BSA, body surface area; DLQI, Dermatology Life Quality Index; EASI, Eczema Area and Severity Index; GISS Global Individual Sign Score; HADS, Hospital Anxiety and Depression Scale; IGA, Investigator Global Assessment; IL, interleukin; NHS, National Health Service; NRS, Numerical Rating Scale; POEM, Patient-Oriented Eczema Measure; QW, once weekly; Q2W, once every two weeks; SCORAD, SCORing Atopic Dermatitis; TCS, topical corticosteroids; UK, United Kingdom.

References

  1. DUPIXENT Summary of Product Characteristics. Available at: https://www.medicines.org.uk/emc/product/8553/smpc. Date accessed: July 2021.
  2. Kreeshan FC, et al. Dermatol Ther (Heidelb). 2021;11(1):149–160.
  3. de Bruin-Weller M, et al. Br J Dermatol. 2018;178:1083–1101.
  4. 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.
  5. 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: July 2021.
  6. EASI User Guide. HOME –Harmonising Outcome Measures for Eczema website. Available at: http://www.homeforeczema.org/documents/easi-user-guide-dec-2016. v2.pdf. Date accessed: July 2021.
  7. Leshem YA, et al. Br J Dermatol. 2015;172(5):1353–1357.
  8. © NICE [2018] Dupilumab for treating moderate to severe atopic dermatitis. Available at: https://www.nice.org.uk/guidance/TA534/chapter/1-Recommendations. Date accessed: July 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.