The following is a summary of “Malignancy rates through 5 years of follow-up in patients with moderate-to-severe psoriasis treated with guselkumab: Pooled results from the VOYAGE 1 and VOYAGE 2 trials,” published in the April 2023 issue of Dermatology by Blauvelt, et al.
The surveillance of malignancy risk in patients receiving long-term immunomodulatory psoriasis treatments is crucial for safety assessment. For a study, researchers sought to report the rates of malignancy in patients with moderate-to-severe psoriasis treated with guselkumab for up to 5 years, compared to both general and psoriasis patient populations.
The study evaluated the cumulative rates of malignancies per 100 patient-years (PY) in 1,721 patients treated with guselkumab from the VOYAGE 1 and 2 trials. Malignancy rates, excluding nonmelanoma skin cancer (NMSC), were compared with Psoriasis Longitudinal Assessment and Registry rates. The study also calculated standardized incidence ratios to compare malignancy rates (excluding NMSC and cervical cancer in situ) between guselkumab-treated patients and the general US population, adjusting for age, sex, and race.
Among the 1,721 guselkumab-treated patients (with over 7,100 PY), 24 cases of NMSC were reported (0.34/100 PY; basal: squamous cell carcinoma ratio, 2.2:1), and 32 cases of malignancies excluding NMSC were reported (0.45/100 PY). For comparison, the malignancy rate excluding NMSC was 0.68/100 PY in the Psoriasis Longitudinal Assessment and Registry. The malignancy rates (excluding NMSC/cervical cancer in situ) in guselkumab-treated patients were similar to those expected in the general US population (standardized incidence ratio = 0.93).
In patients treated with guselkumab for up to 5 years, the malignancy rates were low and generally consistent with those observed in both general and psoriasis patient populations.