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

Abstract Background Psoriasis, 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. Objectives The 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. Methods A 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. Results Between 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). Conclusions The 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.

Keywords

• biologics
• disease activity
• disease characteristics
• patient population characteristics
• psoriasis
• systemic therapy