Adalimumab in Active and Inactive, Non-Infectious Uveitis: Global Results from the VISUAL I and VISUAL II Trials.
Ocul Immunol Inflamm
; 27(1): 40-50, 2019.
Article
en En
| MEDLINE
| ID: mdl-30015528
ABSTRACT
PURPOSE:
Report global adalimumab safety and efficacy outcomes in patients with non-infectious uveitis.METHODS:
Adults with non-infectious intermediate, posterior, or panuveitis were randomized 11 to receive placebo or adalimumab in the VISUAL I (active uveitis) or VISUAL II (inactive uveitis) trials. Integrated global and Japan substudy results are reported. The primary endpoint was time to treatment failure (TF).RESULTS:
In the integrated studies, TF risk was significantly reduced (hazard ratio [95% CI]) with adalimumab versus placebo (VISUAL I HR = 0.56 [0.40-0.76], p < 0.001; VISUAL II HR = 0.52 [0.37-0.74], p < 0.001). In Japan substudies, no consistent trends were observed between groups (VISUAL I HR = 1.20 [0.41-3.54]; VISUAL II HR = 0.45 [0.20-1.03]). Adverse event rates were similar between treatment groups in both studies (854 to 1063 events/100 participant-years).CONCLUSIONS:
Adalimumab lowered time to TF versus placebo in the integrated population; no consistent trends were observed in Japan substudies. Safety results were consistent between studies.Palabras clave
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Uveítis
/
Adalimumab
/
Antiinflamatorios
Tipo de estudio:
Clinical_trials
Límite:
Adult
/
Female
/
Humans
/
Male
/
Middle aged
País/Región como asunto:
Asia
Idioma:
En
Revista:
Ocul Immunol Inflamm
Asunto de la revista:
ALERGIA E IMUNOLOGIA
/
OFTALMOLOGIA
Año:
2019
Tipo del documento:
Article
País de afiliación:
Japón