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DUPIXENT was studied in adult patients with moderate-to-severe atopic dermatitis (AD) who were inadequately controlled by topical treatments (CHRONOS or SOLO 1 AND 2) or ciclosporin (CAFÉ)1

Recruited adult patients had a long history of disease (Median: 26 years) along with high disease burden1-4

Extensive lesion severity:

30

out of 72

median EASI score

Intense pruritus:

>7

out of 10

median peak severity

Large body surface area affected:

>50%

median

Quality of life strongly impacted:

14

out of 30

median DLQI score

CHRONOS

52-week, randomised, double-blind, placebo-controlled, multi-centre, parallel-group, Phase 3 trial including patients who had moderate-to-severe AD for at least 3 years, and were not adequately controlled by topical treatments2

STUDY STUDY DURATION (WEEKS) NUMBER OF PATIENTS TREATMENT ARMS PRIMARY ENDPOINTS
CHRONOS 52 740* Initial dose of 600 mg DUPIXENT (two 300 mg injections)/matching placebo on day 1, followed by

300 mg DUPIXENT + TCS Q2W/

300 mg DUPIXENT + TCS QW/

matching placebo + TCS
Proportion of patients who achieved both IGA 0/1 (clear/almost clear) and a ≥2-point reduction from baseline at Week 16 (0–4 scale)

Proportion of patients who achieved EASI-75 from baseline at Week 16
*Patients were ≥18 years of age with moderate-to-severe AD defined by IGA score ≥3, an EASI score ≥16, and a minimum BSA involvement of ≥10%.

SOLO 1 and 2

16-week, randomised, double-blind, placebo-controlled, multi-centre, parallel-group, Phase 3 trials with identical design including patients who had moderate-to-severe AD for at least 3 years, and were not adequately controlled by topical treatment3

STUDY STUDY DURATION (WEEKS) NUMBER OF PATIENTS TREATMENT ARMS PRIMARY ENDPOINTS
SOLO 1 16
671*
Initial dose of 600 mg DUPIXENT (two 300 mg injections)/matching placebo on day 1, followed by

300 mg DUPIXENT Q2W as monotherapy/

300 mg DUPIXENT QW as monotherapy/

matching placebo
Proportion of patients who achieved both IGA 0/1 (clear/almost clear)
and a ≥2-point reduction from baseline at Week 16 (0–4 scale)

Proportion of patients who achieved EASI-75 from baseline at Week 16
SOLO 2 16 708*
*Patients were ≥18 years of age with moderate-to-severe AD defined by IGA score ≥3, an EASI score ≥16, and a minimum BSA involvement of ≥10%.

CAFÉ

16-week, randomised, double-blind, placebo-controlled, multi-centre, parallel-group, Phase 3 trial including patients who had severe AD for at least 3 years, and were not adequately controlled by, or were intolerant to ciclosporin4

STUDY STUDY DURATION (WEEKS) NUMBER OF PATIENTS TREATMENT ARMS PRIMARY ENDPOINTS
CAFÉ
16
325*
Initial dose of 600 mg DUPIXENT (two 300 mg injections)/matching placebo on day 1, followed by

300 mg DUPIXENT + TCS Q2W/

300 mg DUPIXENT + TCS QW/

matching placebo + TCS
Proportion of patients who achieved EASI-75 from baseline at Week 16
*Patients were ≥18 years of age with severe AD not adequately controlled, or intolerant to, medium/high potency TCS or oral CsA. Inclusion criteria was defined by IGA score ≥3, an EASI score ≥20, and a minimum BSA involvement of ≥10%.

AD, atopic dermatitis; BSA, body surface area; CsA, ciclosporin; DLQI, Dermatology Life Quality Index; EASI, Eczema Area and Severity Index; IGA, Investigator’s Global Assessment; QW, once weekly; Q2W, once every two weeks; 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. Blauvelt A, et al. Lancet. 2017;389(10086):2287–2303.
  3. Simpson EL, et al. New Engl J Med. 2016;375(24):2335–2348.
  4. de Bruin-Weller, et al. Br J Dermatol. 2018;178:1083–1101.