Real-World Effectiveness of Biologic Treatments for Moderate-to-Severe Plaque Psoriasis in Poland in Comparison With Efficacy Reported in Clinical Trials
Author(s)
Witold Owczarek, Prof1, Irena Walecka-Herniczek, Prof2, Michal Pochopien, MSc, PhD3, Anna Lanecka, MSc4, Michal Gorecki, MSc4, Emilie Clay, PhD, MSc3, Piotr Wojciechowski, MSc4, Samuel Aballea, MSc, PhD5, Mondher Toumi, Sr., MSc, PhD, MD6;
1Military Institute of Medicine, Warsaw, Poland, 2National Medical Institute of the Ministry of the Interior and Administration, Warsaw, Poland, 3Clever-Access, Paris, France, 4Clever-Access, Krakow, Poland, 5Clever-Access, Amsterdam, Netherlands, 6InovIntell, Krakow, Poland
1Military Institute of Medicine, Warsaw, Poland, 2National Medical Institute of the Ministry of the Interior and Administration, Warsaw, Poland, 3Clever-Access, Paris, France, 4Clever-Access, Krakow, Poland, 5Clever-Access, Amsterdam, Netherlands, 6InovIntell, Krakow, Poland
Presentation Documents
OBJECTIVES: This study aimed to evaluate the real-world effectiveness of biologic treatments in patients with moderate-to-severe plaque psoriasis in Poland, comparing these outcomes with efficacy data from pivotal clinical trials of the analyzed biologic agents.
METHODS: Data analysis included approximately 5,000 patients treated with 11 biologics under drug program B.47 “Treatment of moderate-to-severe plaque psoriasis (ICD-10: L40.0)” in Poland between 2013 and 2023. The dataset provided patient characteristics such as demographic information, previous therapies, and qualification to program dates, together with counseling visit dates, medications used, and health indices at the counseling visits. Real-world effectiveness of the drugs was assessed with proportion of patients reaching 75% improvement in the Psoriasis Area and Severity Index (PASI75) and proportion of 0 or 1 scores on Dermatology Life Quality Index (DLQI 0/1) at various time points. These outcomes were then compared with efficacy results from pivotal trials.
RESULTS: On average, the patients enrolled in the drug program were younger than those included in the clinical trials (32.4 vs 45.3 years old). Average baseline PASI scores were similar (19.4 vs 20.5), while average baseline DLQI scores were higher among program patients, indicating poorer quality of life (20.8 vs 12.8). In a naïve comparison, both proportions of patients reaching PASI75 and DLQI 0/1 were generally consistent between the program’s and clinical trials’ data, across all biologics and time-points analyzed. However, for several drugs, the effectiveness for B.47 program patients was achieved more rapidly than for those enrolled in the trials.
CONCLUSIONS: In the real-world the effectiveness of biologics for patients with moderate-to-severe plaque psoriasis observed in Polish setting was similar to that observed in clinical trials.
METHODS: Data analysis included approximately 5,000 patients treated with 11 biologics under drug program B.47 “Treatment of moderate-to-severe plaque psoriasis (ICD-10: L40.0)” in Poland between 2013 and 2023. The dataset provided patient characteristics such as demographic information, previous therapies, and qualification to program dates, together with counseling visit dates, medications used, and health indices at the counseling visits. Real-world effectiveness of the drugs was assessed with proportion of patients reaching 75% improvement in the Psoriasis Area and Severity Index (PASI75) and proportion of 0 or 1 scores on Dermatology Life Quality Index (DLQI 0/1) at various time points. These outcomes were then compared with efficacy results from pivotal trials.
RESULTS: On average, the patients enrolled in the drug program were younger than those included in the clinical trials (32.4 vs 45.3 years old). Average baseline PASI scores were similar (19.4 vs 20.5), while average baseline DLQI scores were higher among program patients, indicating poorer quality of life (20.8 vs 12.8). In a naïve comparison, both proportions of patients reaching PASI75 and DLQI 0/1 were generally consistent between the program’s and clinical trials’ data, across all biologics and time-points analyzed. However, for several drugs, the effectiveness for B.47 program patients was achieved more rapidly than for those enrolled in the trials.
CONCLUSIONS: In the real-world the effectiveness of biologics for patients with moderate-to-severe plaque psoriasis observed in Polish setting was similar to that observed in clinical trials.
Conference/Value in Health Info
2025-05, ISPOR 2025, Montréal, Quebec, CA
Value in Health, Volume 28, Issue S1
Code
RWD20
Topic
Real World Data & Information Systems
Disease
SDC: Sensory System Disorders (Ear, Eye, Dental, Skin), STA: Biologics & Biosimilars