RELIEVE-AD: Atopic dermatitis patients see rapid, sustained improvements with dupilumab

The biologic dupilumab appears to be a hit with atopic dermatitis (AD) patients treated in the real-world setting, with patients experiencing prompt improvements in multiple aspects of disease control that persisted through 1 year, as shown in the results of the RELIEVE-AD* study.

Most patients reported achieving adequate disease control, defined as Atopic Dermatitis Control Tool (ADCT) score of <7, at 1 month after treatment, with further increase at 12 months, according to the investigators.

The proportion of patients with total ADCT score <7 jumped from 5.3 percent at baseline to 60.9 percent at month 1 then to 77.4 percent at month 12 (p<0.001 for both), with the mean ADCT total score decreasing from 15.8 to 6.4 and then to 4.4, respectively. [JAMA Dermatol 2022;158:142-150]

Disease control with dupilumab occurred in parallel with significant reductions in other patient-reported outcomes. At each follow-up, patients described fewer flare events, less itch, reduced skin symptoms, as well as improved sleep, health-related quality of life, and daily activities relative to baseline.

There also was a marked reduction in the use of concomitant AD therapies, including topical (from 68.1 percent to 40.4 percent at 12 months; p<0.001) and systemic (from 34.9 percent to 6.2 percent at 12 months; p<0.001) corticosteroids. This was accompanied by a significant improvement in the patients’ satisfaction with their current treatment (from 17.7 percent to 85.1 at 12 months; p<0.001).

“Although 22.6 percent of patients had an ADCT score of ≥7 (not controlled) at month 12, a substantially smaller proportion of patients (10.3 percent) who completed the survey were ‘somewhat dissatisfied’, ‘very dissatisfied’, or ‘extremely dissatisfied’ with AD treatment,” the investigators noted.

The efficacy findings persisted in a sensitivity analysis that accounted for missing data.

RELIEVE-AD included 699 moderate-to-severe AD patients (mean age 46.6, 61.7 percent female, 73.7 percent White) who initiated dupilumab in the clinical setting through the US patient support program. Of these, 632 and 483 patients completed an online survey at months 1 and 12, respectively. The survey consisted of the ADCT, AD-specific Work Productivity and Activity Impairment Questionnaire, the Dermatology Life Quality Index, numerical rating scales for symptoms, as well as questions regarding concomitant AD therapies, satisfaction with therapy, and sleep.

“Overall, these results are consistent with other studies of dupilumab in the clinical practice setting that reported improvements from baseline and subsequent maintenance of treatment benefits and expands on those findings by assessing patient-reported disease control and satisfaction through 12 months of treatment,” according to the investigators. [Br J Dermatol 2019;181:1072-1074; J Am Acad Dermatol 2019;81:143-151; J Eur Acad Dermatol Venereol 2019;33:1562-1568; Br J Dermatol 2020;182:418-426; Dermatol Ther 2019;32:e12931]

“In all studies in clinical practice, including the current analysis, the most marked improvements were observed between baseline and the first assessment at 1 month. These results support the rapid onset of efficacy, generally 1 to 2 weeks after initiating treatment, that have been reported in clinical trials of dupilumab. These early effects are additionally sustained over 12 months, providing benefits consistent with a previous 52-week CHRONOS trial,” they added. [N Engl J Med 2016;375:2335-2348; J Am Acad Dermatol 2016;75:506-515; Dermatol Ther 2017;7:243-248; Br J Dermatol 2017;177:897-898; J Allergy Clin Immunol 2019;143:155-172; Lancet 2017;389:2287-2303]

The study was limited by the absence of a contemporary control group. Also, the patients who were enrolled may represent a population that self-selects for efficacy and safety, thus potentially biasing the outcomes in a more positive direction.

In this regard, according to the investigators, “it should be noted that the baseline characteristics of those who remained in each [follow-up] assessment appeared to be similar to the initial sample, and that results of the sensitivity analysis … to impute missing data consistently demonstrated the effectiveness of dupilumab treatment.”

*EaRly Real WorLd PatIent EValuation for DupixEnt in Atopic Dermatitis