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Results from the RELIEVE-AD study were consistent with patient-reported outcomes in clinical trials.
New data from the year-long RELIEVE-AD study concluded that dupilumab treatment was associated with rapid and sustained disease control in adult patients with atopic dermatitis for up to 12 months.
This was demonstrated by statistically significant improvements relative to baseline on all patient-reported outcomes including treatment satisfaction.
Investigators led by Bruce Strober, MD, PhD, Yale University School of Medicine, New Haven, cited several clinical trials of patients with moderate-to-severe atopic dermatitis in which dupilumab significantly reduced itch and improved clinical and patient-reported outcomes relative to placebo.
For the RELIEVE-AD study, patient experience was evaluated in the clinical setting regarding disease control and quality of life during the first year following dupilumab initiation, in addition to potential benefits beyond those seen in the clinical trial setting.
The RELIEVE-AD study was a prospective, longitudinal cohort study intended to characterize patient experiences in the clinical practice setting with dupilumab over a 12-month period.
Eligible patients were adults with atopic dermatitis who were prescribed with the biologic in routine clinical practice in the US before being enrolled in the dupilumab patient support program.
The dupilumab patient support program was designed to give patients better access to the biologic as well as provide services including copay assistance programs, nurse educator support, and supplemental injection training.Patient outreach was initiated on January 2018, with the final survey at the 12-month time point completed on January 2020.
Eligibility criteria included being 18 years or older, able to speak and read in English, and had not previously participated in a dupilumab trial or treated with the biologic.
Additionally, sociodemographic, disease characteristics, and prior atopic dermatitis treatment history were collected at baseline. Medical history was also acquired in the form of atopic comorbidities of asthma, eosinophilic esophagitis, nasal polyps, and nonseasonal allergies.
Disease control was assessed using the Atopic Dermatitis Control Tool (ADCT), which included 6 questions that evaluated the severity of atopic dermatitis. The Dermatology Life Quality Index (DLQI) was used to evaluate health-related quality of life.
Investigators evaluated a total of 699 patients, 632 (90.4%) of whom completed the survey during the first month and 483 (69.1%) who completed it at month 12.
Discontinuation of dupilumab was reported by 93 (13.3%) patients, with 17 restarting therapy, resulting in an overall discontinuation rate of 10.9%.
Adverse effects and a lack of efficacy were considered the most common reasons for discontinuation at 22 (3.1%) and 25 (3.6%) patients, respectively.
However, cost issues were cited by 16 patients, while insurance coverage was cited by 12.
Promisingly, the of other therapies for atopic dermatitis was reduced at each follow-up compared to baseline, including topical and systemic corticosteroids which were reduced at month 12 to 40.4% (195 of 483 patients) and 6.2% (30 of 483 patients), respectively.
Additionally, patient satisfaction with treatment was higher than baseline (120 of 699 [17.7%]) at each follow-up to 85.1% (411 of 483) at month 12 (P < .001).
Investigators believed their data was consistent with patient-reported outcomes in clinical trials.
“These results are consistent with those observed in clinical trials and expand on the sustained benefits that may be expected with dupilumab over the course of long-term treatment,” the team wrote.
The study, “Treatment Outcomes Associated With Dupilumab Use in Patients With Atopic Dermatitis1-Year Results From the RELIEVE-AD Study,” was published online in JAMA Dermatology.