- L’obiettivo del presente studio è stato valutare l’esperienza cumulativa sulla sicurezza di guselkumab nel trattamento della psoriasi, utilizzando i dati aggregati degli studi VOYAGE 1 e 2 durante i 5 anni.
- Il profilo di sicurezza è rimasto stabile e favorevole durante i 5 anni di trattamento continuativo con guselkumab.
Guselkumab effectively treats moderate-to-severe psoriasis.
To evaluate the cumulative safety experience of guselkumab using pooled data from the VOYAGE 1 and 2 studies through 5 years.
Patients were randomized to guselkumab, placebo with crossover to guselkumab at week 16, or adalimumab. The studies were identical through week 24. VOYAGE 1 evaluated continuous guselkumab treatment (adalimumab-crossover-to-guselkumab at week 52), while VOYAGE 2 assessed randomized withdrawal/retreatment (weeks 28-76). Open-label guselkumab treatment was administered starting at week 52 in VOYAGE 1 and week 76 in VOYAGE 2 and continued through week 252. Pooled safety data were adjusted by exposure and analyzed in the guselkumab groups, including placebo-crossover-to-guselkumab (n = 1221) and adalimumab-crossover-to-guselkumab (n = 500), through week 264.
Patients were followed for a total of 7166 patient-years (PY). Overall, 1349 of 1721 guselkumab-treated patients (78.4%) continued treatment through week 252. The rates of adverse and serious adverse events were 149/100 PY and 5.01/100 PY, respectively. Rates of adverse events of interest were low: serious infections (0.85/100 PY), nonmelanoma skin cancer (0.34/100 PY), malignancies other than nonmelanoma skin cancer (0.45/100 PY), and major adverse cardiovascular events (0.29/100 PY). Year-to-year variability was evident, but no increasing trend was observed.
No direct treatment comparisons were possible after week 52.
The safety profile remained consistent and favorable during 5 years of continuous guselkumab treatment of psoriasis.