PsABIOnd Study and eDaily Substudy Design: Long-Term Effectiveness and Safety of Guselkumab and IL-17 Inhibitors in Routine Clinical Practice in Patients with Psoriatic Arthritis

Abstract

Plain Language Summary Psoriatic arthritis (PsA) is a type of arthritis associated with inflammation that occurs in almost one-third of patients with the inflammatory skin condition psoriasis. PsA can vary between individuals, and typically causes joint pain, swelling and stiffness, affecting both physical and social well-being. Over the past decade, several new PsA treatments have become available. However, there is currently a lack of agreement about the best treatment options. As PsA is a chronic (long-term) disease, the duration of time a patient continues taking a prescribed treatment (termed “treatment persistence”) is important. The randomised clinical trials used to determine if a treatment works use strict rules to select patients. Therefore, large studies from everyday practice are needed to better understand the effectiveness and safety of these PsA treatments for a wider range of patients. PsABIOnd is a real-life study that will compare guselkumab (an interleukin-23 inhibitor) and interleukin-17 inhibitors, which are two relatively new types of PsA treatments. The study will provide information about how long patients remain on these treatments and how effectively and safely they work over a 3-year period. PsABIOnd will also explore the impact of PsA on participants’ lives by collecting information about their quality of life, disease activity and treatment satisfaction. In addition, participants also taking part in the eDaily by PsABIOnd substudy will wear a watch-like device and use a smartphone-based app to record measurements including activity, sleep, pain and well-being to give a detailed picture of PsA and its impact on patients’ daily lives.

Keywords

• Psoriatic arthritis
• Real-world evidence
• Guselkumab
• Biological disease-modifying anti-rheumatic drugs (bDMARDs)
• IL-17 inhibitors
• eHealth