APEX Study: Inhibition of structural damage progression with Guselkumab in Psoriatic Arthritis Save

Guselkumab, a human IL-23 inhibitor, was evaluated in patients with active psoriatic arthritis (PsA) and shown to have both clinical and radiographic benefits at weeks 24 and 48.

 

The APEX study was a phase 3b, double-blind, placebo-controlled, trial in biologic-naïve active PsA patients (≥3 tender, ≥3 swollen joints; C-reactive protein ≥0.3 mg/dL; ≥2 erosive joints). Patients were randomised to subcutaneous guselkumab (GUS) 100 mg every 4 weeks (Q4W); guselkumab 100 mg at week 0, week 4, then every 8 weeks (Q8W); or placebo every 4 weeks. Primary outcome was the ACR20 response at week 24.

 

From a total of 1020 PsA patients, ACR20 responses were superior for GUS Q4W (66.6%) and GUS Q8W (68.3%) compared to placebo (47.0%) achieved ACR20 at week 24 (P < 0.001). Likewise, GUS Q4W- and Q8W-treated participants had significantly lower rates of radiographic progression versus placebo at week 24 (total vdH-S score LSM change: 0.55 and 0.54 vs 1.35; P = 0.002 and P < 0.001, respectively). 

 

In a recent press release, data continued to show the clinical and radiographic benefits our to week 48. These data were presented at the Inflammatory Skin Disease Summit (ISDS) 2025.