Clinical Trial Outcomes Supported by Real-world Data

Clinical Trial Designs and Results in Adults

Itch reduction was experienced by adult patients in Trial 3, and is supported by a real-world study1,3-5

59%
of adult patients treated with DUPIXENT + TCS (n=102) had ≥4-point improvement in Peak Pruritus NRS vs 20% with placebo + TCS (n=299) at Week 16 (secondary endpoint; P<0.0001)1,3,5
66%
of adult patients treated with DUPIXENT + TCS (n=105) had ≥3-point improvement in the Peak Pruritus NRS vs 28% with placebo + TCS (n=306) at Week 16 (secondary endpoint; P<0.0001)5

In a real-world study

65%
of adult patients treated with DUPIXENT (n=89) achieved ≥3-point improvement in Peak Pruritus NRS, as recorded
≥4 months post-index4
  • In DUPIXENT clinical trials, clinically significant improvement in itch was defined as a ≥4-point improvement in Pruritus NRS. The real-world study defined improvement in itch as a ≥3-point improvement in Pruritus NRS1,4

In a real-world study

IGA results, as defined by a real-world study6

66%
of adult patients treated with DUPIXENT (n=187) achieved clear/minimal or mild lesion severity (IGA 0, 1, or 2), as recorded ≥4 months post-index6
  • In DUPIXENT clinical trials, IGA was examined on a 0- to 4-point scale rather than the 0- to 5-point IGA scale in this study. Responders in clinical trials were defined as subjects with IGA 0 or 1 (clear or almost-clear) and a reduction of ≥2-points on a 0- to 4-point IGA scale at Week 164,6

REAL-WORLD STUDY DESIGN: Modernizing Medicine’s electronic medical records (EMR) were evaluated and analyzed 2945 adult patients with ≥1 DUPIXENT prescription in the index period (between April 1, 2017 and November 30, 2017). The study period spanned from April 2016 to March 2018, and included data 12 months before the index date (baseline) and outcomes assessed at least 4 months after the index date (post-index).4,6

Limitations of analysis:
Only a small proportion of patients treated with DUPIXENT had IGA and Pruritus NRS recorded in the EMR prior to, and after the initiation of, therapy with DUPIXENT.1,2 The cohort for itch assessed the real-world effectiveness of DUPIXENT in adult patients with moderate-to-severe itch, as defined by Pruritus NRS ≥3.1 The cohort for the IGA assessed the real-world effectiveness of DUPIXENT in adult patients with moderate-to-severe atopic dermatitis, as defined on the 0- to 5-point IGA scale (0=clear, 1=minimal, 2=mild, 3=moderate, 4=marked, and 5=severe). Clear/minimal lesion severity was defined as patients achieving a post-index IGA score of 0 or 1.6

High rate of real-world persistence demonstrated with DUPIXENT7

79%
of adult patients treated with DUPIXENT (n=1637) remained on therapy at 1 year7

REAL-WORLD STUDY DESIGN: From Truven Marketscan data, 1637 adults were identified with ≥1 DUPIXENT prescription between March 28, 2017 and January 31, 2018, with continuous enrollment during the baseline period. Patients were followed from their first prescription until July 31, 2018, or disenrollment.7

Limitations of analysis:
Kaplan-Meier curves were used to estimate persistence at 6 and 12 months, using a 30-day grace period and assuming 14-day injection frequency. Limitations of this study may be the potential misclassification of persistence due to assumptions regarding injection frequency and grace period. Study includes early adopters of DUPIXENT, therefore as utilization in clinical practice increases over time, further analyses are recommended to confirm these findings.7

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References:
  1. DUPIXENT Prescribing Information.
  2. Simpson EL, Bieber T, Guttman-Yassky E, et al; SOLO 1 and SOLO 2 Investigators. Two phase 3 trials of dupilumab versus placebo in atopic dermatitis. N Engl J Med. 2016;375(24):2335-2348.
  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.
  4. Guttman-Yassky E, Lio PA, Mallya UG, et al. Real-world effectiveness of dupilumab in atopic dermatitis: improvement in itch as assessed by the peak pruritus numerical rating scale (PNRS) in an electronic medical records dataset. Paper presented at: 24th World Congress of Dermatology (WCD); June 10-15, 2019; Milan, Italy.
  5. Data on file, Regeneron Pharmaceuticals, Inc.
  6. Eichenfield LF, Gadkari A, Armstrong AW, et al. Real-world effectiveness of dupilumab based on Investigator Global Assessment (IGA) scores and Peak Pruritus Numerical Rating Scale (PNRS) in an electronic medical records dataset. Poster presented at: 77th Annual Meeting of the Society for Investigative Dermatology (SID); May 8-11, 2019; Chicago, IL.
  7. Silverberg J, Guttman-Yassky E, Gadkari A, et al. Real-world persistence with dupilumab among adults with atopic dermatitis (AD). Poster presented at: 77th Annual Meeting of the Society for Investigative Dermatology (SID); May 8-11, 2019; Chicago, IL.