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.

INTRODUCTION

Randomised clinical studies in psoriatic arthritis (PsA) do not always reflect patients in routine clinical practice. Large-scale data from routine practice are needed to better understand drug persistence, effectiveness and long-term safety of therapeutic agents.

METHODS

PsABIOnd is an international, prospective, observational study designed to collect long-term routine care data in patients with PsA who receive guselkumab (an interleukin-23 [IL-23] inhibitor) or an interleukin-17 (IL-17) inhibitor. Adult patients (≥ 18 years) with a confirmed diagnosis of PsA who are starting guselkumab or any approved IL-17 inhibitor as a first, second, third or fourth line of PsA treatment and who provide written informed consent will be eligible to participate. Participants will be followed for a maximum of 36 months (+3 months) from the start of treatment. Study visits will occur in line with the standard of care, approximately every 6 months, plus an additional visit at 3 months after the start of treatment. eDaily by PsABIOnd - aneHealth substudy, will document the impact of these treatments on wellbeing and symptoms in a subgroup of participants over a 24-week (+4 weeks) observation period on treatment.

PLANNED OUTCOMES: The primary objective of PsABIOnd is to evaluate treatment persistence with guselkumab and IL-17 inhibitors. Data sources will include validated electronic patient-reported outcomes (ePROs) and physician-completed assessments. Safety data will be collected through reporting adverse events. The eDaily by PsABIOnd substudy will use wearable and digital technologies for continuous activity and sleep monitoring, and frequent patient eDiary and ePRO collection to provide a more detailed and comprehensive picture of PsA.

TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT05049798.