The efficacy of dupilumab for the treatment of pruritus in adolescents and adults with moderate to severe atopic dermatitis was supported by trial data published in the Journal of the American Academy of Dermatology.
Investigators pooled data from 4 randomized, multicenter, double-blind, placebo-controlled trials of dupilumab: SOLO 1, SOLO 2, AD ADOL, and CHRONOS. SOLO 1, SOLO 2, and CHRONOS enrolled adults (≥18 years); AD ADOL enrolled adolescents (≥12 to <18 years). In SOLO 1 and SOLO 2, adults received dupilumab 300 mg every 2 weeks or placebo monotherapy for 16 weeks. AD ADOL participants also received dupilumab monotherapy every 2 weeks or placebo for 16 weeks; dupilumab doses were adjusted for baseline weight (200 mg if weight <60 kg; 300 mg if ≥60 kg). CHRONOS enrollees received dupilumab 300 mg every 2 weeks or placebo with concomitant topical corticosteroids for up to 52 weeks. Results were pooled from the first 16 weeks of each trial. The primary outcome measure was improvement in Peak Pruritus Numerical Rating Scale (PP-NRS) score from baseline to week 16. The PP-NRS is a validated, 10-point rating scale of patient-reported itch, with 0 denoting “no itch” and 10 denoting “worst itch imaginable.” PP-NRS score was reported using online or telephone-based systems. Least-squares (LS) mean percentage change from baseline in daily and weekly average itch was calculated for the dupilumab and placebo groups.
Data were pooled for 1505 patients, of whom 645 received treatment with dupilumab every 2 weeks. Baseline disease characteristics were comparable across the 4 trial cohorts. Treatment with dupilumab 300 mg every 2 weeks displayed a significantly greater LS mean percentage reduction in daily itch vs placebo as soon as day 2 for adults (P <.01) and day 5 for adolescents (P <.05). LS mean change from baseline in weekly average PP-NRS scores was significantly greater in dupilumab vs placebo groups at all points (all P <.05). Scores continued to improve or were maintained through week 16 (SOLO 1-2, AD ADOL; P <.0001) and week 52 (CHRONOS; P <.0001). At the end of treatment, the dupilumab vs placebo mean percentage changes from baseline in weekly average PP-NRS scores were −47.5% vs −20.5% (pooled SOLO 1 and 2), −47.9% vs −19.0% (AD-ADOL), and −57.3% vs −30.9% (CHRONOS) (all P <.0001).
As a study limitation, investigators cited the short duration of SOLO 1 and 2 and AD ADOL and the relatively small sample of adolescents.
Across 4 randomized clinical trials, dupilumab was associated with rapid and significant improvement in pruritus. Response was sustained through 16 weeks and up to 1 year. “These results support the role of dupilumab in improving itch outcomes associated moderate-to-severe [atopic dermatitis] starting with the first dose of treatment and providing long-term sustained control,” the investigators wrote.
Disclosure: This trial was sponsored by Sanofi and Regeneron Pharmaceuticals, Inc. Please see the original reference for a full list of authors’ disclosures.
Silverberg JI, Yosipovitch G, Simpson EL, et al. Dupilumab treatment results in early and sustained improvements in itch in adolescents and adults with moderate-to-severe atopic dermatitis: analysis of the randomized phase 3 studies SOLO 1 & SOLO 2, AD ADOL, and CHRONOS [published online March 2, 2020]. J Am Acad Dermatol. doi:10.1016/j.jaad.2020.02.060