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

Improvement in disease severity at 18 months

Improvement in itch: Mean improvement in Peak Pruritus NRS score from baseline5
68%
Improvement for adults and adolescents treated with DUPIXENT (n=75) at 18 months
Mean Peak Pruritus NRS score was 6.9 at baseline (n=401) and 2.2 at 18 months (n=75)
Reduction in lesion extent and severity: Mean improvement in EASI score from baseline5
82%
Improvement for adults and adolescents treated with DUPIXENT (n=75) at 18 months
Mean EASI score was 16.4 at baseline (n=559) and 3.0 at 18 months (n=75)

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

PATIENT SATISFACTION BASED ON A SURVEY OF ADULT PATIENTS6,7
87%

of adult patients treated with DUPIXENT were

very/extremely/somewhat satisfied with their overall atopic
dermatitis treatment at 30 through 36 months

(369 of 425)

vs 18% before starting (120 of 699)

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.6,7

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

PERSISTENCY: HIGH RATE AT 1 YEAR8
77%
of adult patients treated 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

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.8

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.8

USE OF CONCOMITANT PRESCRIPTION TREATMENT CATEGORIES9
86%
of adult patients treated with DUPIXENT required none or only 1 concomitant prescription treatment category at 30 through 36 months

REAL-WORLD STUDY DESIGN

Based on a prospective, observational, longitudinal patient survey of 698 adult patients prescribed DUPIXENT and enrolled in the patient support program. 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 analysis of patients who had completed surveys through 1 month (n=631) and through 30-36 months (n=425). The use of concomitant prescription treatment categories was measured using the percentage of patients that required atopic dermatitis treatment categories (excluding DUPIXENT for Month 1 to 30-36); the recall period for use of atopic dermatitis therapies was during the past 4 weeks. Concomitant treatment categories were defined as prescription topicals (topical corticosteroid, topical calcineurin inhibitors), PDE4 inhibitor, systemic corticosteroids, systemic immunosuppressants, and phototherapy.10

LIMITATIONS OF ANALYSIS

The survey data were collected from patients who enrolled in the DUPIXENT patient support program, and these patients may have different characteristics and perspectives vs those who did not enroll. Patients who continue to respond to long-term surveys may be self-selecting for favorable effectiveness and safety. As observed data may bias results. Safety and tolerability data were not collected.10