Abrocitinib Efficacious for Patients with Atopic Dermatitis in Real-World Setting

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Abrocitinib therapy leads to substantial improvements in atopic dermatitis symptoms and life quality within a real-world setting, according to recent findings, with few serious adverse events noted.¹

This new research was led by Jose Carlos Armario-Hita, from the department of dermatology at the University of Cádiz’s University Hospital of Puerto Real in Spain. The drug itself is a selective Janus kinase (JAK)1 inhibitor recommended as a monotherapy or combined with topical corticosteroids (TCS), though the investigators highlighted that combining it with potent immunosuppressants have not been thoroughly studied.²

Armario-Hita added that the drug has been approved for a year, so their team sought to assess abrocitinib in real-world settings within Spanish hospitals.

“Consequently, we conducted a retrospective observational noninterventional study under real clinical practice conditions of patients treated with abrocitinib 100 or 200 mg orally in 15 hospitals in Spain to assess both efficacy and safety,” Armario-Hita and colleagues wrote.

Trial Design

The investigators used a multicenter observational trial design across 15 hospitals in Spain, recruiting adult participants with moderate-to-severe atopic dermatitis who had initiated abrocitinib therapy between May 2023 - March 2024. These subjects had to have received a diagnosis from a dermatologist.

A score on the Eczema Area and Severity Index (EASI) over 21, the presentation of moderate-to-severe eczema, and either intolerance, lack of control, or contraindication to cyclosporine A were necessary given Spanish funding criteria. Either 100 or 200 mg doses of abrocitinib were given by the research team to patients, with patients over 65 years of age beginning at a dose of 100 mg.

No washout period was needed for those switching from other types of treatments, and concurrent implementation of TCS or antihistamines was permitted. The investigators’ collection included duration of disease, demographic data, comorbidities, and prior therapies (biologic, systemic, and JAK inhibitors).

During each meeting, the investigators evaluated subjects through the use of EASI, SCORing atopic dermatitis (SCORAD),Investigator Global Assessment (IGA), body surface area assessment, and the numerical rating scale of the peak pruritus (PP-NRS), as well as the Dermatology Life Quality Index (DLQI).

The team determined that follow-up interactions would take place at the 4, 12, and 24-week mark. The blood tests used by the investigators helped assess participants’ complete blood count, and liver, lipid, CPK, and IgE profiles. They also monitored adverse events (AEs) over the 24-week follow-up.

Findings

Overall, the study cohort was made up of 76 total subjects and an average age of 33.93 years. A total of 57.89% were noted as male, and the research team added that 36.84% had not received any advanced therapies prior to abrocitinib.

The team determined that subjects’ mean scores at baseline were DLQI 15.01, SCORAD 47.04, and EASI 21.79. They noted major improvements by the 24-week mark, with EASI decreasing to 2.81, and 70.58% of participants showing an EASI 75 improvement.

Despite these conclusions, the investigators did report that 18.42% had decided to discontinue therapy, mostly resulting from inefficacy or AEs. They did find that the safety profile was favorable, noting that 22.37% of subjects had reported mild AEs and only a single serious case of cutaneous lymphoma.

The research team later acknowledged the inherent limitations of real-world studies in the conclusion of their research summary.

“On the one hand, the absence of a washout period in most patients could influence the maintenance of therapeutic effects of their previous AD treatment at the beginning, especially those under biological treatments,” they wrote. “However, the medium-term follow-up up to Week 24 counteracts this limitation. On the other hand, the absence of a control group and the allocation of 100 mg vs. 200 mg doses are limitations inherent in observational studies reflecting real-world daily practice.”

References

1. ^{Armario-Hita JC, Pereyra-Rodriguez JJ, Ruiz-Villaverde R, et al. Treatment of atopic dermatitis with abrocitinib in real practice in Spain: efficacy and safety results from a 24-week multicenter study. Int J Dermatol. https://doi.org/10.1111/ijd.17344.}
2. ^{Wollenberg A, Barbarot S, Bieber T, Christen-Zaech S, Deleuran M, Fink-Wagner A, et al. Consensus-based European guidelines for treatment of atopic eczema (atopic dermatitis) in adults and children: part I. J Eur Acad Dermatol Venereol. 2018; 32(5): 657–682.}