Dupilumab manifests improvements in atopic dermatitis (AD) flares, symptoms, and disease control in adults, according to a new study to be presented at AMCP Nexus 2019.
The drug, currently approved for patients with moderate-to-severe AD not being properly managed by topical treatments, is only for use in patients 12 years or older in the U.S. and adults in Europe. This new research assessed the real-world implications of dupilumab on AD flares, skin pain, sensitivity and burning, and the control of AD in adults with the disease. The data were obtained from the patients enrolled in a prospective, longitudinal patient survey in the US called the EaRly REal WorLd Patient EValuation for dupilumab in Atopic Dermatitis (RELIEVE-AD) study. Patients who were invited to participate were adults with AD who had been prescribed dupilumab and were enrolled in its patient support program in the U.S.
Participants were surveyed before they were given dupilumab for a baseline evaluation, and again at one, two, three, six, nine, and 12 months follow-up. This analysis described the baseline and six-month patient-reported outcome data (including AD flares over the past month, skin pain, burning and sensitivity within the last week), and disease control in the last week. An AD flare was defined as itching or redness that exceeds what is typically felt, the spreading of existing lesions, or the formation of new lesions. Burning, pain, and sensitivity of the skin were determined via 0-10 response scales, and the control was evaluated using the 6-item Atopic Dermatitis Control Tool (ADCT), with total scores ranging from 0–24 and scores of less than seven characterized adequate control.
According to the results, 674 of the 1,010 patients responding to the baseline survey reported initiating dupilumab. The response rates of eligible patients were 89.8%, 89.1%, 84.2%, and 74.4% at months one, two, three, and six, respectively. The demographic and clinical findings at months three and six were comparable to those of the full sample. At the six-month point, 41.3% and 23.3% of patients self-reported to experience no or one flare in the past month, respectively, compared to only 3.0% and 10.7% at baseline (both P<0.001).
Furthermore, the average symptom ratings for skin pain, burning, and sensitivity at baseline vs 6 months were 5.9 vs. 1.8, 5.2 vs. 1.6, and 5.5 vs. 1.7, respectively (all P<0.001). The mean ADCT total score dropped from 15.9 at baseline to 6.4 in the first month and 4.8 in the second as well. Similar trends were observed for other ADCT item scores. The researchers report that 73% of patients had sufficiently controlled their AD at month 6, compared to only 5.9% at baseline (P<0.001).
This work was sponsored by Sanofi and Regeneron Pharmaceuticals, Inc.
Strober B, Mallya U, et al. Dupilumab Improves Outcomes in Patients with Atopic Dermatitis in Clinical Practice Results from the EaRly REal WorLd Patient EValuation for Dupilumab in Atopic Dermatitis (RELIEVE AD) Study. Presented at: AMCP Nexus 2019; October 29 – Nov 1; National Harbor, MD.