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JEADV Clinical Practice
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Evolution of patient demographics, baseline clinical characteristics and outcomes in Phase 3 trials of biologics (TNFi, IL12/23i, IL17i, IL23i), PDE4i and TYK2i for psoriasis

Authors: Peeters, Sara; De Vlam, Kurt; Boonen, Hugo; Guvenc, Canan; Hillary, Tom;

Evolution of patient demographics, baseline clinical characteristics and outcomes in Phase 3 trials of biologics (TNFi, IL12/23i, IL17i, IL23i), PDE4i and TYK2i for psoriasis

Abstract

AbstractBackgroundPsoriasis, a common chronic inflammatory skin disease with major impact on quality of life, is associated with several comorbidities. A better understanding of the pathogenesis of psoriasis has led to the development and approval of new therapeutic strategies such as biologics of different classes (targeting tumour necrosis factor‐α, interleukin (IL) 17 and IL12/23), phosphodiesterase‐4 inhibitors, and janus kinase inhibitors.ObjectivesThe objective of this project was to investigate the evolution of baseline patient characteristics, disease characteristics and outcomes in Phase 3 trials. We hypothesized that the uptake of more effective drugs in the management of patients is reflected in the patient profile considered eligible for clinical trials.MethodsA search in PubMed for Phase 3 trials of biologics, apremilast and deucravacitinib was performed. Forty trials were included and divided into five periods. The first three periods correspond with the chronological development of biologics, Period 4 contains trials of apremilast and Period 5 of deucravacitinib. For each trial, demographics and outcomes were extracted and mean values per period were calculated. Statistical analysis was performed in the biologics group and in the oral therapies group.ResultsBetween Periods 1, 2 and 3: the mean percentage of patients with prior phototherapy (p < 0.001) is different, the mean percentage of patients with prior biologic use (p < 0.001) is higher in Periods 2 and 3, and the outcome variable Psoriasis Area Severity Index (PASI) 100 is more present in recent trials (p < 0.001). Between periods 1 and 3, there are more White patients in Period 1 (p = 0.044) and more patients with baseline Physician Global Assessment 3 in Period 3 (p = 0.041). Between Periods 4 and 5, there are more White patients (p = 0.010) in Period 4, outcome variable PASI 100 and Psoriasis Symptoms and Signs Diary is more present in Period 5 (p = 0.025).ConclusionsThe majority of baseline patient characteristics, disease characteristics and outcome variables remain stable throughout the different periods. Changes in clinical practice were reflected by increased prior biologic use and increased use of PASI 100 as an outcome variable.

Country
Belgium
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Keywords

Science & Technology, disease characteristics, psoriasis, Dermatology, SEVERE PLAQUE PSORIASIS, RANDOMIZED CONTROLLED-TRIAL, PLACEBO-CONTROLLED TRIAL, EFFICACY, patient population characteristics, Diseases of the genitourinary system. Urology, systemic therapy, DOUBLE-BLIND, SAFETY, RL1-803, TO-SEVERE PSORIASIS, MODERATE, CHINESE PATIENTS, biologics, RC870-923, Life Sciences & Biomedicine, disease activity, INTERLEUKIN-12/23 MONOCLONAL-ANTIBODY

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selected citations
These citations are derived from selected sources.
This is an alternative to the "Influence" indicator, which also reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Citations provided by BIP!
popularity
This indicator reflects the "current" impact/attention (the "hype") of an article in the research community at large, based on the underlying citation network.
BIP!Popularity provided by BIP!
influence
This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Influence provided by BIP!
impulse
This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network.
BIP!Impulse provided by BIP!
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Average
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