Results from real-world studies

PROSE: PROSE is an ongoing, longitudinal, prospective, observational registry in the USA and Canada (NCT03428646) of patients aged ≥12 years with moderate-to-severe AD, treated with DUPIXENT in accordance with approved prescribing information (N=857; data presented include 55 adolescents aged ≥12 to <18 years). Data presented here are from an interim analysis.
Limitations of analysis: Patients were also treated with other AD 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.^1,2

RETROSPECTIVE DYNAMIC COHORT STUDY: In this retrospective, multicenter, Italian dynamic cohort study, data on 2576 adult patients with moderate-to-severe AD treated with DUPIXENT were collected from 24 dermatological centers from June 2018 to July 2022. Data are from patients observed at 4 months (N=2364), 12 months (N=2066), 24 months (N=1291), 36 months (N=601), and 48 months (N=110).
Limitations of analysis: Limitations include the retrospective nature of the study and dynamic cohort design that hindered considerations regarding drug survival. Patients were also treated with other AD medications. Also, there could be a bias toward better outcomes in patients who continue providing data in the real-world study.³

RELIEVE-AD: RELIEVE-AD is a single-arm, prospective, observational study in patients with moderate-to-severe AD enrolled in DUPIXENT MyWay^® prior to initiating treatment with DUPIXENT. Patients completed multiple surveys over 60 months. At Month 60, participants that responded to the survey at Month 33 and/or Month 48 were recontacted for Month 60 follow-up.
Limitations of analysis: This patient population was self-selected; those who maintain long-term efficacy and safety may be more likely to participate in such surveys. Similarly, patients were recruited through a DUPIXENT patient support program, which may influence patient perceptions of treatment benefit.^4,6

IBM MARKETSCAN: 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.
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.⁵

RELIEVE-AD: RELIEVE-AD is a single-arm, prospective, observational study in patients with moderate-to-severe AD enrolled in DUPIXENT MyWay^® prior to initiating treatment with DUPIXENT. Patients completed multiple surveys over 72 months. At Month 72, participants that responded to the survey at Month 33 and/or Month 48 were recontacted for Month 72 follow-up.
Limitations of analysis: This patient population was self-selected; those who maintain long-term efficacy and safety may be more likely to participate in such surveys. Similarly, patients were recruited through a DUPIXENT patient support program, which may influence patient perceptions of treatment benefit.^6,7

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 10.⁸

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).^8-11