Five‐year maintenance of clinical response and health‐related quality of life improvements in patients with moderate‐to‐severe psoriasis treated with guselkumab: results from VOYAGE 1 and VOYAGE 2*

Abstract

Background Psoriasis is a chronic disease requiring long-term therapy. Objectives Physician- and patient-reported outcomes (PROs) were evaluated through week 252 in VOYAGE 1 and VOYAGE 2. Methods A total of 1829 patients were randomized at baseline to receive guselkumab 100 mg every-8-weeks, placebo, or adalimumab; placebo patients crossed-over to guselkumab at week 16. Adalimumab patients crossed-over to guselkumab at week 52 in VOYAGE 1, and randomized-withdrawal/retreatment occurred at weeks 28-76 in VOYAGE 2; all patients then received open-label guselkumab through week 252. Efficacy and HRQoL endpoints were analyzed through week 252. Safety was monitored through week 264. Results The proportions of patients in the guselkumab group who achieved clinical responses at week 252 in VOYAGE 1 and VOYAGE 2, respectively, were: 84.1% and 82.0% (PASI90); 82.4% and 85.0% (IGA0/1); 52.7% and 53.0% (PASI100); and 54.7% and 55.5% (IGA0). HRQoL endpoints were achieved as follows: 72.7% and 71.1% of patients (Dermatology Life Quality Index 0/1 or no effect on patient’s life); 42.4% and 42.0% (Psoriasis Symptoms and Signs Diary [PSSD] symptom score=0); and 33.0% and 31.0% (PSSD sign score=0). In VOYAGE 2 only, approximately 45% of patients achieved ≥5-point reduction in SF-36 Physical/Mental component scores and 80% reported no anxiety/depression (Hospital Anxiety and Depression scores <8). Similar findings were reported for adalimumab crossovers. These effects were maintained from week 52 in VOYAGE 1 and week 100 in VOYAGE 2. No new safety signals were identified. Conclusions Guselkumab maintains high levels of clinical response and PRO improvement through 5 years in patients with moderate-to-severe psoriasis.