Printed From:

QUESTIONS ABOUT NOVEL CORONAVIRUS?
CLICK HERE.

Real-world experience from the UK

A prospective 52-week observational cohort study of adults with moderate-to-severe atopic dermatitis (AD)2


SPECIALIST ECZEMA CLINIC: 100 adult patients (≥18 years) treated with DUPIXENT from a specialist eczema clinic between May 2017-November 20192

Mean EASI score and proportion of patients achieving EASI-50, EASI-75 and EASI-90*2

At 52 weeks, a ,mean EASI score of 4.7 was achieved by ,79 patients on DUPIXENT, compared to a mean EASI score of 19.9 at baseline2


At 52 weeks, 86%, 63% and 29% of patients on DUPIXENT achieved EASI-50, EASI -75 and EASI-90, respectively2

Mean DLQI score and proportion of patients achieving ≥4-point improvement in DLQI‡2

At 52 weeks, a mean DLQI score of 4.3 was achieved by 78 patients on DUPIXENT, compared to a mean DLQI score of 15.0 at baseline2


At 52 weeks, 85% of patients on DUPIXENT achieved a ≥4-point improvement in DLQI compared to baseline2

A prospective 52-week observational cohort study of 100 adult patients (≥18 years) with moderate-to-severe AD treated with DUPIXENT from a specialist eczema clinic between May 2017-November 2019. The cohort included 63 men and 37 women; median age 40 years (interquartile range (IQR) 29–50); median body mass index (BMI) 26.7kg/m2 (IQR 23.4–29.9). Scores were collected at baseline, 12 weeks, 24 weeks and 52 weeks of treatment.2

Mean one-week pruritus NRS||2

At 52 weeks, a mean one-week pruritus NRS of 2.1 was achieved by 38 patients on DUPIXENT, compared to a mean one-week pruritus NRS of 6.4 at baseline2

Proportion of patients achieving >10 in GAD-7¶2

At 52 weeks, 7% of patients on DUPIXENT scored >10 in GAD-7, compared to 34% at baseline2

Proportion of patients achieving >10 in PHQ-9#2

At 52 weeks, 7% of patients on DUPIXENT scored >10 in PHQ-9, compared to 38% at baseline2

A prospective 52-week observational cohort study of 100 adult patients (≥18 years) with moderate-to-severe AD treated with DUPIXENT from a specialist eczema clinic between May 2017-November 2019. The cohort included 63 men and 37 women; median age 40 years (interquartile range (IQR) 29–50); median body mass index (BMI) 26.7kg/m2 (IQR 23.4–29.9). Scores were collected at baseline, 12 weeks, 24 weeks and 52 weeks of treatment.2

SPECIALIST ECZEMA CLINIC2
(N=100)
Median age (years) 40
Males (%) 63%
Mean EASI 19.9
Mean DLQI 15.0
Mean one-week pruritus NRS 6.4
Proportion of patients scored >10 in PHQ-9 38%
Proportion of patients scored >10 in GAD-7 34%

DUPIXENT safety profile in the specialist eczema clinic2

  • 94% of patients treated with DUPIXENT experienced ≥1 adverse event (AE) by 52 weeks, with most AEs considered mild or moderate2
MOST COMMON AEs 76
Allergic/DUPIXENT associated conjunctivitis 32
Dry eyes 23
Conjunctivitis (unspecified) 7

*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).3–7

Week 12, 24 and 52 actual mean interval for patient assessment from DUPIXENT initiation 12.2 weeks (standard deviation (SD) ±2.3)), 26.8 weeks (SD ±8.2) and 50.3 weeks (SD ±5.5), respectively.2

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.4,7

§n=86.2

||For peak pruritus NRS, patients reported the maximum itch intensity of their worst itch via an interactive voice/web response system on a scale of 0–10 (‘no itch’ to ‘worst itch imaginable’) during the previous 24 hours daily (Weeks 0–16) or weekly (Weeks 17–52). For weeks with daily peak pruritus NRS score reporting (weeks 0–16), weekly scores were calculated by averaging daily scores. A responder on the peak pruritus NRS scale was defined on the basis of a 3-point or 4-point improvement from baseline. A clinically meaningful improvement in pruritus is defined as a ≥4-point improvement in pruritus NRS (0–10).8

Generalised Anxiety Disorder 7-item scale (GAD-7) is a self-report scale to diagnose anxiety. Scores range from 0–21, since each of the 7 items can be scored from 0 (not at all) to 3 (nearly every day). Higher scores indicate a greater severity of anxiety.9

#Patient Health Questionnaire-9 (PHQ-9) is a 9-item diagnosis instrument for depression, that can be self-administered by the patient and is then verified by a clinician. Scores range from 0–27, since each of the 9 items can be scored from 0 (not at all) to 3 (nearly every day). Higher scores indicate a greater severity of depression.10

**AEs included pneumonia, suicide attempt, depression with suicidal ideation and fracture.2

††No eczema herpeticum/disseminated VZV.2

‡‡14 cases localised to head and neck.2


AD, atopic dermatitis; AE, adverse event; BMI body mass index; DLQI, Dermatology Life Quality Index; EASI, Eczema Area and Severity Index; GAD-7, Generalised Anxiety Disorder 7-item scale; HSV, Herpes Simplex Virus; IL, interleukin; IQR, interquartile range; MCID, minimal clinically important difference; NRS, Numerical Rating Scale; PHQ-9, Patient Health Questionnaire-9; SD, standard deviation; SAE, serious adverse event; UK, United Kingdom; VSV, Varicella Zoster Virus.


References

  1. DUPIXENT Summary of Product Characteristics. Available at: https://www.medicines.org.uk/emc/product/8553/smpc. Date accessed: July 2021.
  2. Sears AV, et al. Br J Dermatol. 2021;184(4):755–757.
  3. 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.
  4. 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.
  5. 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.
  6. Leshem YA, et al. Br J Dermatol. 2015;172(5):1353–1357.
  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: 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.
  8. Blauvelt A, et al. Lancet. 2017;389(10086):2287–2303.
  9. Spitzer RL, et al. Arch Intern Med. 2006;166(10):1092–1097.
  10. Kroenke K, et al. J Gen Intern Med. 2001;16(9):606–613.