Assessed mean improvement in Peak Pruritus NRS and EASI scores, patient satisfaction, persistence, and use of concomitant prescription therapies
CLINICAL TRIAL DESIGNS
AND RESULTS IN ADULTS AND ADOLESCENTS
917 adults in SOLO 1 and SOLO 2, 251 adolescents in AD-1526 (16 weeks each), and 421 adults in CHRONOS (52 weeks) with moderate-to-severe atopic dermatitis inadequately controlled with topical Rx therapies were randomized to DUPIXENT or placebo. All patients in CHRONOS received concomitant TCS. All DUPIXENT-treated adults and adolescents ≥60 kg received 300 mg Q2W after a 600 mg loading dose and adolescents <60 kg received 200 mg Q2W after a 400 mg loading dose. Patients had moderate-to-severe disease with an IGA score ≥3 (overall lesion severity scale of 0 to 4), an EASI score ≥16 on a scale of 0 to 72, and BSA involvement ≥10%. At baseline, 52% of adults and 46% of adolescents had an IGA score of 3 (moderate), 48% of adults and 54% of adolescents had an IGA of 4 (severe), mean EASI score was 33 for adults and 36 for adolescents, and weekly averaged Peak Pruritus NRS was 7 for adults and 8 for adolescents on a scale of 0 to 10.1
The primary endpoint in SOLO 1, SOLO 2, CHRONOS, and AD-1526 was the proportion of subjects with an IGA 0 (clear) or 1 (almost clear) and ≥2-point improvement at Week 16 (38% and 36% of adults treated with DUPIXENT vs 10% and 9% with placebo in SOLO 1 and SOLO 2, respectively, P<0.001; 39% of adults treated with DUPIXENT + TCS vs 12% with placebo + TCS in CHRONOS, P<0.0001; and 24% of adolescents treated with DUPIXENT vs 2% with placebo in AD-1526, P<0.001). Other endpoints included the proportion of subjects with EASI-75 at Week 16 (51% and 44% of adults treated with DUPIXENT vs 15% and 12% with placebo in SOLO 1 and SOLO 2, respectively, P<0.001; 69% of adults treated with DUPIXENT + TCS vs 23% with placebo + TCS in CHRONOS, P<0.0001; 42% of adolescents treated with DUPIXENT vs 8% with placebo in AD-1526, P<0.001) and ≥4-point improvement in the Peak Pruritus NRS at Week 16 (41% and 36% of adults treated with DUPIXENT vs 12% and 10% with placebo in SOLO 1 and SOLO 2, respectively, P<0.001; 59% of adults with DUPIXENT + TCS vs 20% with placebo + TCS in CHRONOS, P<0.0001; and 37% of adolescents treated with DUPIXENT vs 5% with placebo in AD-1526, P<0.001).1-4
BSA, body surface area; EASI, Eczema Area and Severity Index; IGA, Investigator’s Global Assessment; NRS, numerical rating scale; Q2W, once every 2 weeks; TCS, topical corticosteroids.
Disease severity and persistency
Mean improvement in
Peak Pruritus NRS
score from
baseline5
- Mean Peak Pruritus NRS score was 6.9 at baseline (n=401) and 2.2 at 18 months (n=75)
baseline5
- Mean EASI score was 16.4 at baseline (n=559) and 3.0 at 18 months (n=75)
AT 1 YEAR6
with DUPIXENT remained on
therapy at 1 year
Of the patients who discontinued therapy,
≈8 of 10 patients returned to DUPIXENT
treatment within 4 months
DISEASE SEVERITY (ITCH/LESION EXTENT
AND SEVERITY) REAL-WORLD STUDY DESIGN
PROSE is an ongoing, longitudinal, prospective, observational registry in the USA and Canada (NCT03428646) of patients aged ≥12 years with moderate-to-severe atopic dermatitis, treated with DUPIXENT in accordance with approved prescribing information (N=563; data presented include 28 adolescents aged ≥12 to <18 years). Data presented here are from the safety analysis set with a cutoff date of October 2020.5
LIMITATIONS OF ANALYSIS
Patients were also treated with other atopic dermatitis medications. While the initial prescription for DUPIXENT had to be in accordance with approved prescribing information, physicians were free thereafter to make any treatment decisions they deemed appropriate. Also, there could be a bias toward better outcomes in patients who continue providing data in this real-world study.5
PERSISTENCY REAL-WORLD
STUDY DESIGN
From IBM MarketScan Commercial and Medicare supplemental databases, 1963 adults were identified who initiated DUPIXENT between March 28, 2017, and March 31, 2018, and followed until September 30, 2018, or disenrollment. Patients received a mean of 8.6 DUPIXENT dispensations from initiation to first discontinuation.6
LIMITATIONS OF ANALYSIS
Kaplan-Meier analysis was used to estimate persistence at 6 and 12 months, assuming a 14-day injection frequency. Limitations of this study may be the potential misclassification of patients in claims-based analyses that rely on International Classification of Disease (ICD) diagnostic codes for population identification. Study included only early initiators of DUPIXENT, which likely reflects more severe patients, potentially reducing generalizability since persistence may be different in a more diverse population of patients who initiate DUPIXENT. Duration of treatment and persistence was based on assumptions about whether and how patients take their treatment, and such assumptions may result in misclassification that could potentially over- or underestimate persistence.6
Patient Satisfaction and Concomitant Treatment Use
AND CONCOMITANT
TREATMENT USE IN A
SURVEY OF ADULT
PATIENTS7
very/extremely/somewhat satisfied with their overall atopic
dermatitis treatment at 30 through 36 months (369 of 425)
ADULT PATIENTS8
taking no concomitant AD therapya at 30-36 months vs 13%
before starting treatment with DUPIXENT
aIncludes topical medications (steroids,
calcineurin inhibitors, crisaborole), systemic steroids
(oral, injection), systemic
immunosuppressants (oral, injection), and ultraviolet therapy.8
PATIENT SATISFACTION/CONCOMITANT TREATMENT USE REAL-WORLD STUDY DESIGN
Based on a prospective, longitudinal patient survey of 699 adult patients who had not been treated with DUPIXENT prior to this study. Surveys were completed at baseline (prior to DUPIXENT treatment) and at Months 1, 2, 3, 6, 9, 12, and 30-36 after initiation of DUPIXENT. Data are from an interim analysis of patients who had completed surveys at 1 month (n=632) through 30-36 months (n=425). Patient-reported satisfaction with current atopic dermatitis treatment was evaluated using the question “How satisfied are you with your current treatment(s) for atopic dermatitis?” with responses on a 7-point Likert scale that ranged from “extremely satisfied” to “extremely dissatisfied.”7-9
LIMITATIONS OF ANALYSIS
The survey data were collected from patients who enrolled in the DUPIXENT patient support program, and these patients may have different perceptions of DUPIXENT vs those who did not enroll. Patients who continue to respond to long-term surveys may be self-selecting for favorable effectiveness and safety. There was also potential for recall bias because outcomes were self-reported. As observed data may bias results. Safety and tolerability data were not collected.7,9