Abrocitinib Therapy Effective in Patients with Atopic Dermatitis at 2 Years

Abrocitinib therapy leads to clinically meaningful outcomes and improvements in patient-reported outcomes (PROs) among patients with moderate-to-severe atopic dermatitis with up to 2 years of use, new data suggest.1

These findings resulted from the ongoing phase 3 long-term extension trial, JADE EXTEND, a study designed to assess the sustained efficacy of oral abrocitinib in patients with moderate-to-severe atopic dermatitis. It was authored by such investigators as Melinda Gooderham, MD, dermatologist and medical director of the SKiN Centre for Dermatology in Ontario, Canada.

Gooderham et al’s study involved adolescent and adult patients who had previously completed qualifying abrocitinib trials. These included JADE MOA, JADE MONO-1, JADE MONO-2, JADE COMPARE, JADE TEEN, and JADE DARE.

“A planned interim efficacy analysis of abrocitinib treatment for up to 48 weeks reported clinically meaningful improvements in itch and skin clearance in patients with moderate-to-severe [atopic dermatitis],” Gooderham and colleagues wrote.1,2 “Here, we report an update on abrocitinib efficacy and patient-reported outcomes for up to 2 years in JADE EXTEND.”

JADE EXTEND Design

In the analysis, those involved as participants were treated with once-daily oral abrocitinib treatment at doses of 200 mg or 100 mg. Outcomes related to efficacy were monitored by Gooderham and coauthors from Week 2 - Week 112, encompassing a wide array of clinician-reported and patient-reported endpoints. Some of the key measures included by the team were the proportion of participants attaining an Investigator’s Global Assessment (IGA) score of clear or almost clear (0/1) with a 2-point improvement from baseline at a minimum.

Skin clearance was further evaluated using the Eczema Area and Severity Index (EASI), including thresholds of ≤7, as well as percentage improvements of 75%, 90%, and complete clearance (EASI-75, -90, and -100). Symptom relief was assessed using the Peak Pruritus Numerical Rating Scale (PP-NRS), including both ≥4-point improvement and achievement of minimal itch (scores of 0 or 1).

Quality of life and patient-centered outcomes were also evaluated. Among adults, a Dermatology Life Quality Index (DLQI) score of 0 or 1 was evaluated in those showing baseline scores of ≥2. Gooderham and colleauges assessed adolescents via the Children’s DLQI (CDLQI). In their additional endpoints, they included Patient Global Assessment (PtGA) scores of 0 or 1 as well as improvements of 4 points at least in participants’ Patient-Oriented Eczema Measure (POEM) scores. Composite endpoints, such as attainment of both high-level skin clearance levels (EASI-90) and minimal pruritus (PP-NRS 0/1), with or without normalization of quality of life (DLQI 0/1), were also evaluated.

Any disease severity shifts over time were tracked by the investigative team using participants’ EASI scores, alongside least squares mean changes in EASI, CDLQI, DLQI, and POEM. By September 5, 2022, the time of cutoff, not all of those evaluated had reached 112 weeks of abrocitinib use. However, 42% of those included in the 200 mg arm and 56% of those in the 100 mg arm had completed at least 112 weeks of treatment. By the 112-week mark, Gooderham and coauthors noted IGA 0/1 responses among 57% and 52% of those in the 200 mg and 100 mg cohorts, respectively.

They also found EASI ≤7 in 81% and 77% of these individuals, respectively, while EASI-75 responses were seen in 84% and 78%. Higher thresholds of clearance showed EASI-90 in 61% and 54%, respectively, as well as complete clearance (EASI-100) among 26% and 21% of subjects. Pruritus, or itch, improvements were also highlighted by the team, with 70% and 58% gaining a ≥4-point reduction in PP-NRS, respectively. Additionally, they found 43% and 33% achieved scores of 0 or 1, respectively.

Composite outcomes of EASI-90 combined with minimal itch were attained by 37% and 30% of individuals included in the respective dosing cohorts. Patient-reported outcomes at the 112-week mark included DLQI 0/1 in 43% and 41% of adults, CDLQI 0/1 in 59% and 39% of adolescents, PtGA 0/1 in 75% and 72%, and clinically meaningful POEM improvements in 88% and 81% of those receiving 200 mg and 100 mg, respectively.

Conclusions on Long-Term Abrocitinib Use in Atopic Dermatitis

Overall, the investigative team noted, following rapid onset, dose-dependent clinician-reported efficacy measures continued to improve through 2 years of abrocitinib use. They highlighted the substantial number of individuals who achieved high-threshold endpoints along with a minimal level of disease activity.

“Results for patient-reported outcomes complemented the clinical efficacy findings and demonstrate that long-term abrocitinib treatment through 2 years confers meaningful improvements in patient-reported symptoms and quality of life,” Gooderham and colleagues concluded.1

References

1. Gooderham MJ, Silverberg JI, De Bruin-Weller M, et al. Long-term efficacy of abrocitinib in patients with moderate-to-severe atopic dermatitis to 2 years. J Eur Acad Dermatol Venereol. 2026; 00: 1–10. https://doi.org/10.1111/jdv.70439.

2. Reich K, Silverberg JI, Clibborn C, et al. Abrocitinib efficacy and safety in patients with moderate-to-severe atopic dermatitis: Results from phase 3 studies, including the long-term extension JADE EXTEND study. J Eur Acad Dermatol Venereol. 2023 Oct;37(10):2056-2066. doi: 10.1111/jdv.19280. Epub 2023 Jul 11. Erratum in: J Eur Acad Dermatol Venereol. 2023 Dec;37(12):2608-2609. doi: 10.1111/jdv.19563. PMID: 37335885.