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This analysis highlights the efficacy and safety of abrocitinib among patients with atopic dermatitis in China, as well as the medication’s impact on patients’ blood biomarkers.
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Abrocitinib treatment of atopic dermatitis in routine clinical practice is well-tolerated and leads to swift and sustained improvements in severity, according to recent findings, with a normalization of blood biomarkers following treatment.1
This analysis of the impact of abrocitinib on those with moderate-to-severe atopic dermatitis in routine clinical practice was authored in part by Zheng Li, from the department of dermatology at the National Clinical Research Center for Aging and Medicine’s Shanghai Institute of Dermatology.
The investigators highlighted the highly selective JAK1 inhibitor’s approval around the world for atopic dermatitis since 2022. Li and colleagues noted recent real-world clinical practices with small samples and their findings regarding the efficacy of abrocitinib for both treatment-naïve and non-responsive individuals given available systemic therapies.2
“However, the real-world data for abrocitinib after its post-marketing is scarce,” Li and colleagues wrote. “Herein, we conducted a prospective study by enrolling 117 Chinese patients diagnosed with moderate-to-severe [atopic dermatitis].”1
The investigative team provided trial participants with laboratory screenings prior to enrollment, with information gathered including lipid profiles, blood count and chemistry panels, and hepatitis and tuberculosis (TB) tests. They highlighted the lack of a washout period that had been needed for prior treatments.
Initially, all of those participating in the study were prescribed 100 mg of oral abrocitinib on a once-per-day basis. At 5 points in time, the investigators assessed subjects: baseline and the 2, 4, 8, and 12-week marks after they initiated abrocitinib therapy. Itch Numeric Rating Scale (Itch-NRS), Eczema Area and Severity Index (EASI), Sleep Numeric Rating Scale (Sleep-NRS), and peak values from the previous 72 hours were assessed by the investigative team during each interaction.
In addition, they evaluated subjects’ Investigator’s Global Assessment (IGA) and Severity Scoring of Atopic Dermatitis (SCORAD) index scores. While the subjects had originally been provided 100 mg once-daily, participants whose Itch-NRS scores dipped by under 4 points at the 2-week mark or who did not at least reduce their EASI score by 50% at the 4-week mark, were advised by the team to raise their dosage to 200 mg.
The investigators encouraged subjects during treatment to carry on utilizing topical corticosteroids, moisturizers, and topical calcineurin inhibitors. However, they did not specifically monitor these products throughout their analysis of subjects.
The analysis also involved monitoring of adverse events (AEs) and laboratory parameters throughout the 12-week period of treatment. In terms of laboratory measurements, the research team looked at serum immunoglobulin E (IgE) levels, blood eosinophil counts, and 24 cytokine/chemokine markers.
Overall, they concluded that abrocitinib therapy led to significant and rapid disease severity improvements among patients. The team added that by the 12-week mark, 74.3% of participants had been able to achieve at least a 75% EASI score reduction and 50.5% attained a 90% EASI reduction.
The treatment, compared to dupilumab, was also shown by the investigators to have more reduced Itch-NRS by more at the 2-week mark. Additionally, they found a higher proportion of those treated with abrocitinib achieved EASI-75 by the 4-week mark.
At the 4-week mark, the investigators found both blood eosinophil counts and serum IgE levels were significantly reduced. In terms of predictors of stronger response to medication, 2 examples were identified: lower body mass index (BMI < 24; adjusted OR: 4.01, 95% CI: 1.36–11.73, P < .05) and a lack of prior dupilumab use (adjusted OR: 5.81, 95% CI: 1.8–18.7, P < .01).
The research team concluded that those who responded well to abrocitinib exhibited more pronounced decreases in their Th2-, Th1-, and Treg-related cytokines and chemokines following a period of 4 weeks. This was noted particularly forCCL17, CCL18, IL-5, IL-6, IL-10, TNF-α, and CD25/IL-2Rα.
42.7% of participants reported AEs, with gastrointestinal symptoms shown by the team to be the most frequently observed (17.1%). Among individuals who had tested positive for tuberculosis and been treated with isoniazid prophylaxis, it was found that there was no TB reactivation was detected. While the findings for the medication were largely positive, the investigators highlighted the research’s limitations.
“Our study has several limitations. It was a single-center investigation with restricted representation,” they wrote. “The observation period was relatively brief, necessitating studies with extended medication durations to adequately address issues related to long-term AEs and strategies for drug reduction and withdrawal. Additionally, the proportion of patients lost to follow-up was 13.7%, which may result in selection bias.”1
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