Introduction <p>Abrocitinib constitutes one of the most effective therapeutic agents for the treatment of atopic dermatitis (AD). However, real-world data validating its effectiveness outside randomized controlled trials remain limited and are primarily based on short-term follow-up studies. Herein, we aimed to summarize our 2-year experience with abrocitinib for AD.</p> Methods <p>In this retrospective cohort study, all patients with moderate-to-severe AD who received abrocitinib were included. The following physician- and patient-reported outcomes were collected at baseline and weeks&#xa0;4, 12, 24, 52, and week&#xa0;104: Eczema Area and Severity Index (EASI), SCORing Atopic Dermatitis (SCORAD), Investigator Global Assessment (IGA), Worst Pruritus Numeric Rating Scale (WP-NRS), Dermatology Life Quality Index (DLQI), and a stringent combined outcome (EASI90 and WP-NRS 0/1). Long-term safety was evaluated using clinical and laboratory data and patient-reported adverse events (AEs).</p> Results <p>A total of 23 patients [15 male patients/8 female patients; mean (SD) age 29.1 (11.5) years] were included. The mean (SD) EASI score significantly decreased from baseline to week&#xa0;104 [from 25.0 (11.2) to 3.9 (7.7); <i>p</i> &lt; 0.01], while mean (SD) SCORAD decreased from 67.2 (14.1) to 9.7 (19.3) (<i>p</i> &lt; 0.01). Corresponding EASI75, EASI90, EASI100, and IGA&#xa0;0/1 responses were achieved by 19 (83%), 13 (57%), 12 (52%), and 14 (61%) patients, respectively. Regarding patient-reported outcomes, QoL and itch severity improved significantly up to week&#xa0;104, with 61% and 83% of patients achieving DLQI &lt; 2 and WP-NRS 0/1, respectively. Three patients (13%) discontinued abrocitinib due to AEs, with the remaining AEs being mild in severity.</p> Conclusion <p>This real-world study supports clinical trial findings on the high effectiveness of abrocitinib in the management of AD. Moreover, it confirms that abrocitinib is generally well tolerated and can lead to early and sustained improvement in pruritus and overall QoL. Despite the small sample size, the results of the present real-world study seem to align with previous data on the effectiveness of abrocitinib also in the long-term management of AD, with an acceptable safety profile.</p>

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Long-Term Effectiveness and Safety of Abrocitinib in Patients with Atopic Dermatitis: A Real-World, Retrospective Study

  • Aikaterini Tsiogka,
  • Ioannis-Alexios Koumprentziotis,
  • Ileana Afroditi Kleidona,
  • Aristeidis Vaiopoulos,
  • Michail Bakakis,
  • Eleni Hatzidimitriou,
  • Mariana Vasilopoulou,
  • Theodora Douvali,
  • Alexander Stratigos,
  • Stamatios Gregoriou

摘要

Introduction

Abrocitinib constitutes one of the most effective therapeutic agents for the treatment of atopic dermatitis (AD). However, real-world data validating its effectiveness outside randomized controlled trials remain limited and are primarily based on short-term follow-up studies. Herein, we aimed to summarize our 2-year experience with abrocitinib for AD.

Methods

In this retrospective cohort study, all patients with moderate-to-severe AD who received abrocitinib were included. The following physician- and patient-reported outcomes were collected at baseline and weeks 4, 12, 24, 52, and week 104: Eczema Area and Severity Index (EASI), SCORing Atopic Dermatitis (SCORAD), Investigator Global Assessment (IGA), Worst Pruritus Numeric Rating Scale (WP-NRS), Dermatology Life Quality Index (DLQI), and a stringent combined outcome (EASI90 and WP-NRS 0/1). Long-term safety was evaluated using clinical and laboratory data and patient-reported adverse events (AEs).

Results

A total of 23 patients [15 male patients/8 female patients; mean (SD) age 29.1 (11.5) years] were included. The mean (SD) EASI score significantly decreased from baseline to week 104 [from 25.0 (11.2) to 3.9 (7.7); p < 0.01], while mean (SD) SCORAD decreased from 67.2 (14.1) to 9.7 (19.3) (p < 0.01). Corresponding EASI75, EASI90, EASI100, and IGA 0/1 responses were achieved by 19 (83%), 13 (57%), 12 (52%), and 14 (61%) patients, respectively. Regarding patient-reported outcomes, QoL and itch severity improved significantly up to week 104, with 61% and 83% of patients achieving DLQI < 2 and WP-NRS 0/1, respectively. Three patients (13%) discontinued abrocitinib due to AEs, with the remaining AEs being mild in severity.

Conclusion

This real-world study supports clinical trial findings on the high effectiveness of abrocitinib in the management of AD. Moreover, it confirms that abrocitinib is generally well tolerated and can lead to early and sustained improvement in pruritus and overall QoL. Despite the small sample size, the results of the present real-world study seem to align with previous data on the effectiveness of abrocitinib also in the long-term management of AD, with an acceptable safety profile.