Efficacy and safety of Guselkumab in biologic-naïve patients with active axial psoriatic arthritis: study design of a phase 4, randomized, double-blind, placebo-controlled trial

Background:
Established criteria for classifying axial psoriatic arthritis (PsA) are lacking, and assessments of disease activity often rely on measures developed for ankylosing spondylitis (AS). There is an unmet need to systematically identify and measure efficacy of treatments for axial PsA patients (pts). Guselkumab (GUS), a selective interleukin (IL)-23p19 inhibitor, was efficacious in improving signs and symptoms of active PsA in 2 phase 3, randomized, placebo (PBO)-controlled studies: DISCOVER-1 and DISCOVER-2. In a post-hoc pooled analysis of DISCOVER-1&2 pts with investigator-confirmed sacroiliitis, GUS-treated pts had greater improvements in axial symptoms compared with PBO.1 Imaging in DISCOVER-1&2 was restricted to the sacroiliac (SI) joints, occurring prior to/at screening as confirmed by the investigator, and locally read.