P. Foley1, E. Bulb€ ul Baskan€ 2, I. Hamadah3, S. Lee4, M. Ragab5, T. Tsai6, A. Backer7, F. Dolfi7, S. Malfait7
In a real-life setting, biologic treatments may be prescribed to psoriasis patients with clinical characteristics that may differ from those enrolled in clinical development programmes. Therefore, collection of real-world evidence becomes pivotal: (a) in the characterisation of the patterns of use of biologics in routine clinical practice, and; (b) to understand how these patterns of use are impacted by specific patient characteristics, types of medical practice, structure of healthcare systems, or socioeconomic status of patients.
REALIA is a 12-month non-interventional, prospective, multicentre study. Eligible patients are enrolled in three parallel cohorts depending on the treatment initiated at study entry: (a) conventional systemics (e.g. methotrexate, cyclosporine, or retinoids); (b) secukinumab; (c) other biologics (including biosimilars). The primary objective is to evaluate the real-world effectiveness of conventional systemics, secukinumab and other biologics, assessing the achievement of almost clear to clear skin at the first effectiveness checkpoint (i.e., month 3) in routine clinical practice. Secondary objectives include description of patient characteristics, the correlation of almost clear to clear skin with the psoriasis assessment tool(s) used in clinical practice, treatment patterns, impact on Health Related-Quality of Life, safety and tolerability. Data collection time points are aligned with standard of care in routine practice.
REALIA is expected to enrol approximately 750 patients between December 2016 and June 2018. The targeted study completion is June 2019.
REALIA will explore the real-life effectiveness, impact on quality of life and safety of secukinumab and other systemic treatments in Asia, Pacific and Middle East countries.