The Largest Clinical Development Program in Atopic Dermatitis

A total of 917 adult patients in Trials 1 and 2 (16-week trials) and 421 adult patients in Trial 3 (52-week trial) with moderate-to-severe atopic dermatitis not adequately controlled with topical prescription treatments were randomized to DUPIXENT 300 mg Q2W or placebo. For all patients in Trial 3, lesions were treated with concomitant TCS.1

DUPIXENT was evaluated in adult patients whose moderate-to-severe atopic
dermatitis was inadequately controlled on topical Rx therapies1,2,a

Adults
(18+ years of age)1,2
Number of patients >2100
Pivotal trialsb 2 Monotherapy (Trials 1 and 2)
1 Concomitant TCS (Trial 3)
Dosagec An initial dose of 600 mg DUPIXENT
at Week 0 followed by 300 mg Q2Wd
Mean disease duration (years) ≈28 
Mean age (years) 38
Disease severity at baseline
Moderate atopic dermatitis (IGA 3)
52%
Severe atopic dermatitis (IGA 4) 48%
Disease extent at baseline
Mean EASI score
33 out of 72
Mean body surface area involvement 55%
Itch severity at baselinee
Peak Pruritus NRS
7 out of 10

Adult clinical trials included monotherapy (Trials 1 and 2) and with concomitant TCS (Trial 3); all trials initiated with two 300 mg DUPIXENT or placebo subcutaneous injections at Week 0, and emollient background regimen was required.1,2

Disease severity was defined by an IGA score ≥3 in the overall assessment of atopic dermatitis lesions on a severity scale of 0 to 4, an EASI score ≥16 on a scale of 0 to 72, and a minimum body surface area involvement of ≥10%.1

Primary endpoint across all 3 adult pivotal trials: Change from baseline to Week 16 in the proportion of subjects with an IGA 0 (clear) or 1 (almost clear) and a ≥2-point improvement1

EASI, Eczema Area and Surface Index: IGA, Investigator’s Global Assessment; NRS, numerical rating scale; Q2W, once every 2 weeks; TCS, topical corticosteroids.

aThese baseline characteristics are not meant for comparison.

bTrial 4 was a dose‑ranging trial to evaluate the safety of DUPIXENT monotherapy through Week 16. Trial 5 evaluated multiple DUPIXENT monotherapy dose regimens for maintaining treatment response for 36 weeks.

cEmollient background regimen was required.

dStudied vs placebo.

eWeekly averaged Peak Pruritus NRS score (10 indicates the most severe).

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EASI, Eczema Area and Surface Index; IGA, Investigator’s Global Assessment; NRS, numerical rating scale; Q2W, once every 2 weeks; TCS, topical corticosteroids.

Reference:
References:
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  3. Blauvelt A, de Bruin‑Weller M, Gooderham M, et al. Long‑term management of moderate‑to‑severe atopic dermatitis with dupilumab and concomitant topical corticosteroids (LIBERTY AD CHRONOS): a 1‑year, randomised, double‑blinded, placebo‑controlled, phase 3 trial. Lancet. 2017;389(10086):2287‑2303.
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  50. Data on file, Regeneron Pharmaceuticals, Inc.
  51. Phan NQ, Blome C, Fritz F, et al. Assessment of pruritus intensity: prospective study on validity and reliability of the visual analogue scale, numerical rating scale and verbal rating scale in 471 patients with chronic pruritus. Acta Derm Venereol. 2012;92(5):502‑507.
  52. DUPIXENT Prescribing Information.
  53. Data on file, Regeneron Pharmaceuticals, Inc.
  54. Hanifin JM, Thurston M, Omoto M, Cherill R, Tofte SJ, Graeber M; the EASI evaluator group. The eczema area and severity (EASI): assessment of reliability in atopic dermatitis. Exp Dermatol. 2001;10(1):11‑18.
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