Real-World Effectiveness of Biologic Treatments for Moderate-to-Severe Atopic Dermatitis in Poland in Comparison With Efficacy Reported in Clinical Trials
Author(s)
Witold Owczarek, Prof1, Irena Walecka-Herniczek, Prof2, Gerald Waligora, MSc1, Michal Pochopien, MSc, PhD3, Anna Lanecka, MSc3, Michal Gorecki, MSc3.
1Military Institute of Medicine, Warsaw, Poland, 2National Medical Institute of the Ministry of the Interior and Administration, Warsaw, Poland, 3Clever-Access, Krakow, Poland.
1Military Institute of Medicine, Warsaw, Poland, 2National Medical Institute of the Ministry of the Interior and Administration, Warsaw, Poland, 3Clever-Access, Krakow, Poland.
OBJECTIVES: This study aimed to compare the real-world effectiveness of biologic treatments in patients with moderate-to-severe atopic dermatitis in Poland to clinical trial efficacy.
METHODS: A comprehensive dataset from the drug program B.124 ”Treatment of patients with atopic dermatitis (ICD-10: L20)” of 2,319 patients treated in Poland between 2022 and 2025, was analysed. The dataset provided patient characteristics such as demographic information, dates of qualification to the program, together with counselling visit dates, medications used, and health indices at the counselling visits. The effectiveness of five biologics (abrocitinib, baricitinib, dupilumab, tralokinumab, upadacitinib) was assessed with proportion of patients reaching 75% improvement in the Eczema Area and Severity Index (EASI75) and proportion of 0 or 1 scores on Dermatology Life Quality Index (DLQI 0/1). These outcomes were compared to efficacy results from pivotal trials.
RESULTS: On average, the patients enrolled in the B.124 program were slightly younger (age 34 vs 36), had similar disease severity (EASI75 30 vs 27) and worse quality of life (DLQI 20 vs 16) compared to those included in the clinical trials. Data for abrocitinib, tralokinumab, and upadacitinib were compared with clinical trial results over 16 weeks due to lack of long-term trial data. In this timeframe, the treatments in the drug program showed better EASI75 (77%-81%) compared to clinical trials (56%-77%). Baricitinib and dupilumab data were compared over 52 weeks. The EASI75 response differed between the drug program and clinical trials: for baricitinib, the response was 100% compared to 37%, and for dupilumab it was 95% and 65%, respectively. However, for baricitinib the EASI75 after 52 weeks in the drug program was calculated based on 3 available measurements.
CONCLUSIONS: In real-world settings in Poland, biologic treatments for moderate-to-severe atopic dermatitis show higher effectiveness than observed in clinical trials.
METHODS: A comprehensive dataset from the drug program B.124 ”Treatment of patients with atopic dermatitis (ICD-10: L20)” of 2,319 patients treated in Poland between 2022 and 2025, was analysed. The dataset provided patient characteristics such as demographic information, dates of qualification to the program, together with counselling visit dates, medications used, and health indices at the counselling visits. The effectiveness of five biologics (abrocitinib, baricitinib, dupilumab, tralokinumab, upadacitinib) was assessed with proportion of patients reaching 75% improvement in the Eczema Area and Severity Index (EASI75) and proportion of 0 or 1 scores on Dermatology Life Quality Index (DLQI 0/1). These outcomes were compared to efficacy results from pivotal trials.
RESULTS: On average, the patients enrolled in the B.124 program were slightly younger (age 34 vs 36), had similar disease severity (EASI75 30 vs 27) and worse quality of life (DLQI 20 vs 16) compared to those included in the clinical trials. Data for abrocitinib, tralokinumab, and upadacitinib were compared with clinical trial results over 16 weeks due to lack of long-term trial data. In this timeframe, the treatments in the drug program showed better EASI75 (77%-81%) compared to clinical trials (56%-77%). Baricitinib and dupilumab data were compared over 52 weeks. The EASI75 response differed between the drug program and clinical trials: for baricitinib, the response was 100% compared to 37%, and for dupilumab it was 95% and 65%, respectively. However, for baricitinib the EASI75 after 52 weeks in the drug program was calculated based on 3 available measurements.
CONCLUSIONS: In real-world settings in Poland, biologic treatments for moderate-to-severe atopic dermatitis show higher effectiveness than observed in clinical trials.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
RWD151
Topic
Clinical Outcomes, Real World Data & Information Systems
Topic Subcategory
Health & Insurance Records Systems
Disease
Biologics & Biosimilars, Sensory System Disorders (Ear, Eye, Dental, Skin)