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.
J Am Acad Dermatol
; 89(2): 274-282, 2023 08.
Article
em En
| MEDLINE
| ID: mdl-37019386
ABSTRACT
BACKGROUND:
Malignancy risk surveillance among patients receiving long-term immunomodulatory psoriasis treatments remains an important safety objective.OBJECTIVE:
To report malignancy rates in patients with moderate-to-severe psoriasis treated with guselkumab for up to 5 years versus general and psoriasis patient populations.METHODS:
Cumulative rates of malignancies/100 patient-years (PY) were evaluated in 1721 guselkumab-treated patients from VOYAGE 1 and 2. Malignancy rates (excluding nonmelanoma skin cancer [NMSC]) were compared with rates in the Psoriasis Longitudinal Assessment and Registry. Standardized incidence ratios comparing malignancy rates (excluding NMSC and cervical cancer in situ) between guselkumab-treated patients and the general US population using Surveillance, Epidemiology, and End Results data were calculated, adjusting for age, sex, and race.RESULTS:
Of 1721 guselkumab-treated patients (>7100 PY), 24 had NMSC (0.34/100PY; basalsquamous cell carcinoma ratio, 2.21), and 32 had malignancies excluding NMSC (0.45/100PY). For comparison, the malignancy rate excluding NMSC was 0.68/100PY in the Psoriasis Longitudinal Assessment and Registry. Malignancy rates (excluding NMSC/cervical cancer in situ) in guselkumab-treated patients were consistent with those expected in the general US population (standardized incidence ratio = 0.93).LIMITATIONS:
Inherent imprecision in determining malignancy rates.CONCLUSIONS:
In patients treated with guselkumab for up to 5 years, malignancy rates were low and generally consistent with rates in general and psoriasis patient populations.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Psoríase
/
Neoplasias Cutâneas
/
Neoplasias do Colo do Útero
/
Fármacos Dermatológicos
Tipo de estudo:
Clinical_trials
/
Observational_studies
/
Prognostic_studies
/
Risk_factors_studies
Limite:
Female
/
Humans
Idioma:
En
Revista:
J Am Acad Dermatol
Ano de publicação:
2023
Tipo de documento:
Article