Background/Purpose: VOYAGE 2 is a phase 3 double-blind, placebo/active comparator-controlled trial comparing guselkumab (GUS) with placebo (PBO) and adalimumab (ADA) in patients (pts) with moderate-to-severe PsO. The impact of treatment on patient-reported outcomes (PROs) was evaluated.

Methods: Pts were randomized to GUS 100mg (wks 0 & 4, then q8wks), ADA (80 mg wk 0, 40 mg wk 1, then 40 mg q2 wks), or PBO (wks 0, 4, & 12, then GUS 100mg wks 16 & 20). We evaluated PROs using the Work Limitations Questionnaire [WLQ; work productivity], the Hospital Anxiety & Depression Scale [HADS], and the Medical Outcomes Study 36-Item Short Form (SF-36; health related quality of life) at wk16 (GUS vs PBO) and wk24 (GUS vs ADA) in pts with and without PsA.

Results: In all, 18% of pts reported a history of PsA. At wk16, GUS pts had numerically greater improvements vs PBO in work productivity, anxiety and depression, and SF-36 PCS & MCS scores regardless of PsA status. The least square (LS) mean differences (95% CI; adjusted for baseline value) for GUS vs PBO for all PROs were generally similar between pts with and without PsA. At wk24, GUS pts had numerically greater improvements vs ADA in all PROs regardless of PsA status. The LS mean differences for GUS vs ADA were generally greater for pts with PsA vs pts without PsA (Table).

Conclusion: GUS showed better improvements in all PROs vs PBO at wk16 and vs ADA at wk24. Improvements vs PBO were similar regardless of PsA status, while improvements vs ADA were greater for pts with PsA.