Real-World Abrocitinib Study Shows Most Patients Maintain Consistent Dosing in Atopic Dermatitis Treatment

Most patients with moderate-to-severe atopic dermatitis maintained consistent abrocitinib dosing throughout treatment in an international expanded access study simulating real-world use, with treatment-emergent adverse events accounting for dose changes in only a minority of cases. The JADE REAL protocol study found that 65.0% of patients initiated on abrocitinib 100 mg daily and 62.0% of those started on 200 mg daily continued their initial dose without modification over a mean treatment duration of 379.1 days.

The findings emerge from the first study designed to simulate real-world flexible dosing patterns with the oral Janus kinase (JAK)-1 selective inhibitor abrocitinib in individuals with moderate-to-severe atopic dermatitis. Investigators, led by Raj Chovatiya, MD, PhD, MSCI, of the Center for Medical Dermatology + Immunology Research, Chicago, IL, enrolled 312 patients aged ≥12 years in this global expanded access protocol study, which ran from 2020 through September 2024 to provide treatment access for patients lacking adequate therapeutic options at enrollment.

Atopic dermatitis is a chronic inflammatory skin disorder with a relapsing and remitting course that requires long-term treatment, including systemic therapies for moderate-to-severe cases. Abrocitinib received FDA approval in January 2022 as a once-daily oral treatment at recommended doses of 100 mg and 200 mg for individuals aged ≥12 years with moderate-to-severe atopic dermatitis. The objective of JADE REAL was to evaluate the dosing patterns of abrocitinib (consistent dosing vs dose escalation and reduction) and incidence of treatment-emergent adverse events (TEAEs) leading to a change in dose in adolescent and adult patients with moderate-to-severe AD in a protocol that expanded access to the medication in a manner corresponding to real-world use.

The study enrolled 312 individuals with moderate-to-severe disease defined by an Investigator's Global Assessment (IGA) score of ≥3 or an Eczema Area and Severity Index (EASI) score of ≥16 at baseline. Investigators initiated treatment at either 100 mg or 200 mg daily at their discretion, with flexibility to adjust dosing throughout the treatment period. Patients could use concomitant topical medications as needed.

FINDINGS

Chovatiya and colleagues found correlations between initial dosing patterns and demographics and disease severity. Among the 120 participants (38.5%) started on 100 mg daily, investigators more frequently selected this dose for patients aged 12 to <18 years (16.7% vs 6.8%) and ≥65 years (15.8% vs 7.8%), Black or African American patients (20.0% vs 9.9%), and those with moderate disease severity. Conversely, the 192 participants (61.5%) initiated on 200 mg daily more commonly included those aged 18 to <65 years (85.4% vs 67.5%), those self-identified as Asian (17.7% vs 8.3%), and those with severe disease.

Dose modification patterns showed remarkable consistency across both starting doses. Among participants beginning treatment at 100 mg daily, 78 (65.0%) maintained continuous dosing while 42 (35.0%) experienced ≥1 dose change, including 12 patients (28.6%) with >1 dose change. Similarly, among those starting at 200 mg daily, 119 (62.0%) continued unchanged dosing while 73 (38.0%) had ≥1 dose modification, with 33 individuals (45.2%) experiencing >1 dose change.

Treatment-emergent adverse events prompted dose reductions in 27 participants (8.7%) and dose escalations in 12 (3.8%). The most common adverse events leading to dose reduction included nausea, thrombocytopenia, acne, fatigue, and folliculitis, each occurring in 1.0% to 1.3% of participants. Atopic dermatitis represented the only adverse event occurring in ≥1% of patients (3.2%) that led to dose escalation, suggesting inadequate disease control as the primary driver for dose increases.

The study's unique design integrated elements from both clinical trials and real-world studies, the researchers wrote, allowing modification of dosing based on individualresponse and tolerance. This approach may better reflect clinical practice patterns compared to fixed-dose clinical trials, where dose modifications typically follow predetermined protocols, the authors stated.

The research team, concluded that the results support clinical decision-making around initial dose selection and subsequent dose modifications. They noted that treatment-emergent adverse events did not represent the primary reason for dose reductions, suggesting that factors beyond safety considerations influence dosing decisions in clinical practice.

The investigators emphasized that JADE REAL demonstrated the potential benefits of flexible dosing strategies and may simulate real-world use patterns of oral Janus kinase inhibitors in atopic dermatitis management. The study's completion in September 2024 provides contemporary data on abrocitinib use patterns as clinicians gain experience with this therapeutic class.

These findings carry implications for clinical practice by suggesting that most patients can maintain their initial abrocitinib dose selection throughout treatment, while providing reassurance that dose modifications remain safe and feasible when clinically indicated. The data may inform treatment algorithms and help clinicians set appropriate expectations for long-term atopic dermatitis management with oral JAK inhibitors.