immunosuppressants were permitted. The primary efficacy endpoint in both studies was ´time to treatment failure´. Following initial control of disease, a prolongation in time to treatment failure will result in reduced risk of disease flares, inflammation and vision loss. Treatment failure was defined by a outcome based on inflammatory chorioretinal and/or inflammatory retinal vascular lesions, anterior chamber (AC) cell grade, vitreous haze (VH) grade and best corrected visual acuity (BCVA). Study UV I evaluated 217 patients with active uveitis despite treatment with corticosteroids (oral prednisone at a dose of 10 to 60 mg/day). A majority of the 217 patients were female and Caucasian with mean age of 42.7 years. There was no statistically significant demographic difference between the placebo and adalimumab groups. All patients received a standardised dose of prednisone 60 mg/day at study entry followed by a mandatory taper schedule, with complete corticosteroid discontinuation by Week 15. Study UV II evaluated 226 patients with inactive uveitis requiring chronic corticosteroid treatment (oral prednisone 10 to 35 mg/day) at baseline to control their disease. A majority of the 226 patients were female and Caucasian with mean age of 42.5 years. There was no statistically significant demographic difference between the placebo and adalimumab groups. Patients subsequently underwent a mandatory taper schedule, with complete corticosteroid discontinuation by Week 19. Clinical Results Results from both studies demonstrated statistically significant reduction of the risk of treatment failure in patients treated with adalimumab versus patients receiving placebo (See Table 27). Both studies demonstrated an early and sustained effect of adalimumab on the treatment failure rate versus placebo (see Figure 6 and Figure 7).
immunosuppressants were permitted. The primary efficacy endpoint in both studies was ´time to treatment failure´. Following initial control of disease, a prolongation in time to treatment failure will result in reduced risk of disease flares, inflammation and vision loss. Treatment failure was defined by a outcome based on inflammatory chorioretinal and/or inflammatory retinal vascular lesions, anterior chamber (AC) cell grade, vitreous haze (VH) grade and best corrected visual acuity (BCVA). Study UV I evaluated 217 patients with active uveitis despite treatment with corticosteroids (oral prednisone at a dose of 10 to 60 mg/day). A majority of the 217 patients were female and Caucasian with mean age of 42.7 years. There was no statistically significant demographic difference between the placebo and adalimumab groups. All patients received a standardised dose of prednisone 60 mg/day at study entry followed by a mandatory taper schedule, with complete corticosteroid discontinuation by Week 15. Study UV II evaluated 226 patients with inactive uveitis requiring chronic corticosteroid treatment (oral prednisone 10 to 35 mg/day) at baseline to control their disease. A majority of the 226 patients were female and Caucasian with mean age of 42.5 years. There was no statistically significant demographic difference between the placebo and adalimumab groups. Patients subsequently underwent a mandatory taper schedule, with complete corticosteroid discontinuation by Week 19. Clinical Results Results from both studies demonstrated statistically significant reduction of the risk of treatment failure in patients treated with adalimumab versus patients receiving placebo (See Table 27). Both studies demonstrated an early and sustained effect of adalimumab on the treatment failure rate versus placebo (see Figure 6 and Figure 7).
auspar-adalimumab-180625-pi.docx