JADE EXTEND Data Show Abrocitinib Efficacy Holds and Deepens Through 2 Years of Treatment

Long-term treatment with abrocitinib produced clinically meaningful improvements in skin clearance, itch control, and quality of life that persisted — and in many cases continued to deepen — over 2 years in patients with moderate to severe atopic dermatitis (AD), according to updated data from the JADE EXTEND long-term extension study published in the Journal of the European Academy of Dermatology and Venereology.¹

The findings from JADE EXTEND (NCT03422822), a phase 3 long-term extension trial, represent the most comprehensive look yet at abrocitinib's durability across a population of more than 1700 adults and adolescents.² The study drew patients from 6 qualifying trials — MONO-1 (NCT03349060), MONO-2 (NCT03575871), compARE (NCT04116047), TEEN (NCT03796676), MOA (NCT03915496), and DARE — who continued on consistent doses of abrocitinib 200 mg or 100 mg once daily, with no dose changes permitted during the extension.

“The majority of patients with moderate to severe AD at baseline achieved a mild AD phenotype (EASI ≤ 7) within 12 weeks of treatment and this continued to be observed throughout the study,” the authors stated. “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.”

Response Rates at 2 Years

At week 112, efficacy responses remained robust across both doses. Among patients receiving abrocitinib 200 mg, 57% achieved an Investigator's Global Assessment score of 0 or 1 (IGA 0/1), compared with 52% in the 100 mg group. EASI-75 was achieved by 84% and 78% of patients in the 200 mg and 100 mg arms, respectively, and EASI-90 by 61% and 54%. Complete skin clearance (EASI-100) was reached by 26% of patients on the higher dose and 21% on the lower dose — a meaningful proportion given the severity of disease at enrollment, where nearly all patients had moderate to severe AD with a mean baseline EASI approaching 30 and greater than 45% body surface area involvement.

Itch control followed a similar pattern. A ≥4-point improvement in Peak Pruritus Numerical Rating Scale (PP-NRS4) was reported by 70% and 58% of patients in the 200 mg and 100 mg arms, respectively, while 43% and 33% achieved PP-NRS scores of 0 or 1 — indicating near-complete or complete itch resolution — at Week 112.

Trajectory of Response Over Time

An important feature of the data is the trajectory. Response rates were not simply maintained from earlier time points; they continued to increase from week 12 through week 48, with benefits observed throughout the full 112-week period. The proportion of patients with moderate to severe AD at baseline who achieved a mild phenotype (EASI ≤7) grew from approximately 60% at week 12 to up to 80% by week 112. Disease severity overall stabilized, with few patients experiencing a 2-grade worsening over time and continued stabilization observed even beyond week 96.

Composite and Patient-Reported Outcomes

The study evaluated a stringent composite endpoint of EASI-90 plus PP-NRS 0/1 — aligned with recently published minimal disease activity criteria for AD — which was achieved by 37% and 30% of patients in the 200 mg and 100 mg groups at week 112. Notably, the proportion meeting this composite grew from week 2 through week 12 and remained durable throughout the treatment period, providing evidence for long-term disease control rather than plateau or attrition of benefit.

Patient-reported outcomes reinforced the clinical picture. At week 112, 75% and 72% of patients across the 2 dose groups achieved a Patient Global Assessment score of 0 or 1, and 88% and 81% reported a clinically meaningful improvement in Patient-Oriented Eczema Measure (POEM ≥4). Among adult patients, 43% and 41% achieved a Dermatology Life Quality Index score of 0 or 1, reflecting minimal impact on daily functioning.

Tolerability and Discontinuation

Of 955 patients in the 200 mg group and 753 in the 100 mg group, 403 (42%) and 425 (56%) reached at least 112 weeks of abrocitinib exposure. Discontinuation due to adverse events was reported for 13.5% and 12.6% of patients in the respective arms. Lack of efficacy accounted for 3.7% and 9.8% of discontinuations — with the authors noting that some patients on the lower dose who did not respond adequately might have benefited from dose escalation, which was not permitted under the study protocol. The most common overall reason for stopping treatment was patient or guardian withdrawal, not treatment failure or tolerability concerns. Six deaths occurred across the study population; these have been detailed separately in an integrated safety analysis.

Context and Limitations

The authors acknowledge several study limitations, including the absence of a placebo arm in the extension period and the reality that not all enrolled patients had reached the week 112 timepoint at data cut-off. Two methods of missing data imputation — observed data and modified non-responder imputation — were reported in parallel to provide the most transparent account of long-term efficacy. The study also excluded patients who had switched from dupilumab or participated in the REGIMEN trial, to avoid confounding by drug switching or dose variation.

Taken together, the JADE EXTEND data support abrocitinib as a durable, dose-dependent treatment option for patients with moderate to severe AD requiring long-term systemic therapy, with a substantial proportion reaching high-threshold response targets and minimal disease activity criteria over 2 years of continuous treatment.

References

1. Gooderham MJ, Silverberg JI, De Bruin-Weller M, Kircik L, Thaçi D, Zhao Z, 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. doi:10.1111/jdv.70439
2. Reich K, Silverberg JI, Papp KA, 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;37(10):2056-2066. doi:10.1111/jdv.19280