Clinical Trial Designs and Results in Adults
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 or placebo. For all patients in Trial 3, lesions were treated with concomitant TCS. All patients received 300 mg Q2W following a 600 mg loading dose. Eligible patients had an IGA score ≥3 (overall atopic dermatitis lesion severity scale of 0 to 4), an EASI score ≥16 on a scale of 0 to 72, and body surface area involvement of ≥10%. At baseline, 52% had an IGA score of 3 (moderate atopic dermatitis), 48% had an IGA of 4 (severe atopic dermatitis), mean EASI score was 33, and weekly averaged Peak Pruritus NRS was 7 on a scale of 0 to 10.4
The primary endpoint was the change from baseline in the proportion of subjects with an IGA 0 (clear) or 1 (almost clear) and ≥2-point improvement at Week 16 (38% and 36% of patients treated with DUPIXENT vs 10% and 9% with placebo in Trials 1 and 2, respectively, P<0.001; 39% of patients treated with DUPIXENT + TCS vs 12% with placebo + TCS in Trial 3, P<0.0001). Other endpoints included change from baseline in the proportion of subjects with EASI-75 at Week 16 (improvement of ≥75%; 51% and 44% of patients treated with DUPIXENT vs 15% and 12% with placebo in Trials 1 and 2, respectively, P<0.001; 69% of patients treated with DUPIXENT + TCS vs 23% with placebo + TCS in Trial 3, P<0.0001) and reduction in itch as defined by ≥4-point improvement in the Peak Pruritus NRS at Week 16 (41% and 36% of patients treated with DUPIXENT vs 12% and 10% with placebo in Trials 1 and 2, respectively, P<0.001; 59% of patients with DUPIXENT + TCS vs 20% with placebo + TCS in Trial 3, P<0.0001).4-6
EASI, Eczema Area and Severity Index; IGA, Investigator’s Global Assessment; NRS, numerical rating scale; Q2W, once every 2 weeks; TCS, topical corticosteroids.
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).
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 1.2
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.3
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.3