Study Highlights Interim Results on Abrocitinib for Adolescents, Adults with Atopic Dermatitis

Abrocitinib treatment of atopic dermatitis leads to rapid improvements in disease severity, new findings suggest, and this is maintained up to the 72-week mark in patients for whom approved systemic drugs were inadequate.1

These data resulted from the JADE REAL analysis (NCT04564755), designed as a multicenter, open-label, expanded access protocol. JADE REAL was conducted in 2020 in several different countries such as the US, Austria, Australia, Canada, and the Netherlands, looking at the oral, once-daily, Janus kinase (JAK) 1-selective inhibitor known as abrocitinib.

This abstract was authored in part by Christine Bangert from the Medical University of Vienna in Austria. The paper was titled ‘Abrocitinib for the treatment of adolescents and adults with moderate-to-severe atopic dermatitis: interim results from an expanded access protocol (JADE REAL).’

“The primary study objective was to provide early access to abrocitinib to patients with moderate-to-severe [atopic dermatitis] for whom available and approved topical and systemic medications for [atopic dermatitis] were inadequate,” Bangert and colleagues wrote.1

Design and Findings

Abrocitinib was approved by the US Food and Drug Administration (FDA) for adults in 2022 and expanded for adolescents by 2023.2

The investigators of the new interim analysis looked at adolescent and adult individuals that were determined to qualify if they had been treated with either 100 mg or 200 mg of abrocitinib per-day. Dosages had been determined previously.1

Any changes made to the participants' dosages, either raising the amount from 100 mg to 200 mg or lowering it from 200 mg to 100 mg, were permitted by the research team throughout the treatment period. Subjects were also allowed by the team to implement topicals for atopic dermatitis alongside their medication use.

During their analysis, the investigators also allowed participants to continue receiving abrocitinib until they chose to leave the study, until the drug became available locally, or until the sponsor discontinued the study within their country.

The investigative team assessed safety as a secondary measure by monitoring treatment-emergent adverse events (TEAEs). Efficacy evaluations by the team included the noting of shifts from the point of baseline in subjects' Eczema Area and Severity Index (EASI) total scores, Peak Pruritus Numerical Rating Scale (PP-NRS), body surface area involvement, and Patient-Oriented Eczema Measure (POEM) scores during several different points in time.

A total of 277 participants' data were evaluated in the team's interim analysis. The investigators noted that they excluded those from Australia and Belgium given that the expanded access program was shown to be still active in those regions as of the data cutoff date in May 2024.

The research team noted that among the participants who reported their racial categories, 70% were shown to be White and 15.5% to be Black or African American. The team further expressed that the subjects' median age had been 34 years, ranging from 12 - 84 years, with 12.3% of these individuals being labeled as 65 years of age or older.

It was reported that 56% of the study's participants had used at least a single systemic therapy previously. Such therapies included dupilumab (23.8%), corticosteroids (25.6%), or cyclosporine (5.8%). Alterations to doses were noted by the team as being made for 32.4% of the subjects initially given 100 mg and 42% of the subjects given 200 mg.1

By the 72-week mark, the investigators noted that the subjects experienced significant improvements. They found that there was an average reduction of 80.3% in participants' EASI total scores, a 5.5-point reduction in PP-NRS, 76.1% in %BSA involvement, and a reduction of 13.3 points in their POEM scores.1

A total of about 78% reported TEAEs. The investigators added that TEAEs labeled as more severe were seen in 4.7% and serious adverse events were seen in 5.4%. They added that total of 7.9% of the participants ended their treatment with abrocitinib as a result of adverse events but remained in the study, whereas 2.9% concluded the study entirely as a result of TEAEs.1

The most commonly reported TEAEs were found to be COVID-19 among 17.7%, and nausea among 15.9%. The researchers highlighted that nearly all cases of nausea and all but a single case of COVID-19 were shown to be mild or moderate in severity.

“Results may reflect real-world use of abrocitinib with dose selection and adjustments by individual healthcare professionals," they wrote. "More patients on abrocitinib 200 mg had a dose change following initiation."1

References

1. Bangert C, Gooderham M, Chan G, et al. Abrocitinib for the treatment of adolescents and adults with moderate-to-severe atopic dermatitis: interim results from an expanded access protocol (JADE REAL). Presented as part of the 2024 Revolutionizing Atopic Dermatitis Mid-Year Virtual Update. December 8, 2024.
2. FDA Approves Pfizer's Supplemental New Drug Application for CIBINQO® (abrocitinib). Pfizer. News release. https://www.pfizer.com/news/press-release/press-release-detail/fda-approves-pfizers-supplemental-new-drug-application. Date accessed: December 19, 2024.