Data from the RELIEVE-AD study show long-term control and treatment satisfaction.
Survey data from the RELIEVE-AD study show dupilumab is associated with rapid and sustained control of atopic dermatitis (AD) as well significant improvements in several patient-reported outcomes (PROs) for up to 1 year, providing real-world insight into the patient-perceived, long-term efficacy of the therapy. The PROs included in the study related to function, health-related quality of life (HRQoL), and productivity. The study was recently publishedin the Journal of the American Medical Association Dermatology (JAMA Dermatology).
According to the study investigators, led by Bruce Strober, MD, PhD, cofounder of Central Connecticut Dermatology, Cromwell, and clinical professor of Dermatology at Yale University School of Medicine, previous clinical trials have demonstrated dupilumab’s efficacy across several clinical and PROs relative to placebo, yet greater “characterization of real-world effectiveness from the patient perspective can provide greater understanding of outcomes and may help improve overall AD management,” according to study investigators.
In the study, investigators administered an online survey to 699 adult patients with moderate to severe AD to gauge changes in disease control and PROs over 1 year with dupilumab. The survey was administered prior to and at various time points during a 1-year period after dupilumab initiation.
Patients in the study were from the United States and were previously prescribed dupilumab and then subsequently enrolled in a dupilumab patient support program, which enabled quick access to the dual interleukin (IL)-4/IL-13 inhibitor.
The investigators measured changes in disease control with the AD Control Tool (ADCT) and also evaluated changes in the use of concomitant AD therapies. Additionally, the researchers evaluated changes in skin symptoms (skin pain/soreness, hot/burning feeling, sensitivity to touch) using numerical rating scales, disease flares, HRQoL using the Dermatology Life Quality Index (DLQI), sleep issues using the ADCT item and a stand-alone question, and productivity using the AD-specific Work Productivity and Activity Impairment Questionnaire.
A total of 632 patients completed the 1 month survey, while 483 of that group completed the end survey at 12 months. It was reported that approximately 61% of patients had adequate disease control at 1 month, while 77.4% of patients had adequate disease control at 12 months. In contrast, only 5.3% of patients had adequate disease control at baseline. Improvements in disease control between baseline and the 1- and 12-month follow-up periods were statistically significant (both P<.001), according to the study.
Around 87% of patients were using greater than or equal to 1 AD treatment at baseline, including topical (68.1%) and systemic corticosteroids (34.9%). At 12 months, however, the use of topical and systemic corticosteroids was reduced to 40.4% and 6.2%, respectively(both P <.001).
Treatment satisfaction was assessed using a stand-alone question with responses on a 7-point Likert scale ranging from “extremely satisfied” to “extremely dissatisfied.” Patient satisfaction with their AD treatment was significantly higher at month 12 than at baseline (85.1% vs 17.7%, respectively; P <.001). Patients continued to report reductions in flares, itch, skin symptoms, as well as improved sleep, HRQoL, and daily activities at each follow-up consult compared with baseline.
While the study’s primary limitation was a lack of control group, the researchers noted that the efficacy of dupilumab has been previously supported by randomized controlled trials.
When asked for comment on the findings, Mio Nakamura, MD, a clinical assistant professor ofdermatology at the University of Michigan Health, Ann Arbor, said that it is important to consider the patient’s perspective in treatment decision-making because it can affect satisfaction and compliance with a prescribed treatment regimen.
Nakamura, who wasn’t involved in the study, added, “This is especially important for the AD population because this is a chronic condition that requires long-term treatment—a prescribed treatment regimen has to be practical and sustainable.”
While most phase 3 clinical trials on AD tend to include PROs, Nakamura noted that the study by Strober and colleagues evaluated multiple domains of the patient experience in the real-life setting, makingthe findings unique and valuable for further understanding the efficacy of dupilumab.
“The results of this study reinforce that dupilumab is a great medication for many patients with AD and leads to improvement in HRQoL in real-life settings,” Nakamura said. “It is important for our field to continue assessing real-life experiences from a patient perspective for various conditions and treatments.”
Benjamin Ungar, MD, assistant professor of dermatology and director of the Rosacea & Seborrheic Dermatitis Clinic at Mount Sinai, New York, New York, told Dermatology Times® that the ultimate goal for dermatologists, and physicians in general, is to address patient concerns and to help them feel better.
However, Ungar noted that much of the morbidity associated with AD is significant, and several of the psychosocial stressors that accompany the condition can be difficult to measure. “While we often have metrics, scores, and clinical considerations from the physician's perspective, it is still crucially important that the patients feel that their condition is improving and that the treatment is effective for them,” he said.
According to Ungar, who wasn’t involved in the RELIEVE-AD study, the findings of the 1-year study still highlight the fact that a substantial proportion of patients with AD still do not achieve adequate disease control after 1 year with dupilumab. As such, he suggests there is still a need for additional effective treatments for AD that can improve outcomes for the individual patient.
“I think that as long as patients are not reporting complete improvement and complete satisfaction [with dupilumab], there's a lot of work to be done,” Ungar explained. “A very critical goal that I think we all have is to individualize and personalize the selection of treatments, as that will help the patient and the doctor treating them achieve the best outcomes possible.”
Strober and colleagues report conflicts of interest. Additionally, Nakamura and Ungar report no relevant conflicts. The RELIEVE-AD study was funded by Sanofi and Regeneron Pharmaceuticals.
Strober B, Mallya UG, Yang M, et al. Treatment outcomes associated with dupilumab use in patients with atopic dermatitis: 1-year results from the RELIEVE-AD study. JAMA Dermatol. 2022;158(2):142-150. doi:10.1001/jamadermatol.2021.4778