2 research outputs found
Adalimumab in Patients with Active Noninfectious Uveitis
BACKGROUND:
Patients with noninfectious uveitis are at risk for long-term complications of uncontrolled
inflammation, as well as for the adverse effects of long-term glucocorticoid
therapy. We conducted a trial to assess the efficacy and safety of adalimumab as a
glucocorticoid-sparing agent for the treatment of noninfectious uveitis.
METHODS:
This multinational phase 3 trial involved adults who had active noninfectious intermediate
uveitis, posterior uveitis, or panuveitis despite having received prednisone treatment
for 2 or more weeks. Investigators and patients were unaware of the study-group
assignments. Patients were randomly assigned in a 1:1 ratio to receive adalimumab
(a loading dose of 80 mg followed by a dose of 40 mg every 2 weeks) or matched
placebo. All patients received a mandatory prednisone burst followed by tapering of
prednisone over the course of 15 weeks. The primary efficacy end point was the time
to treatment failure occurring at or after week 6. Treatment failure was a multicomponent
outcome that was based on assessment of new inflammatory lesions, best
corrected visual acuity, anterior chamber cell grade, and vitreous haze grade. Nine
ranked secondary efficacy end points were assessed, and adverse events were reported.
RESULTS:
The median time to treatment failure was 24 weeks in the adalimumab group and 13
weeks in the placebo group. Among the 217 patients in the intention-to-treat population,
those receiving adalimumab were less likely than those in the placebo group to
have treatment failure (hazard ratio, 0.50; 95% confidence interval, 0.36 to 0.70;
P<0.001). Outcomes with regard to three secondary end points (change in anterior
chamber cell grade, change in vitreous haze grade, and change in best corrected visual
acuity) were significantly better in the adalimumab group than in the placebo
group. Adverse events and serious adverse events were reported more frequently
among patients who received adalimumab (1052.4 vs. 971.7 adverse events and 28.8
vs. 13.6 serious adverse events per 100 person-years).
CONCLUSIONS:
In our trial, adalimumab was found to be associated with a lower risk of uveitic flare
or visual impairment and with more adverse events and serious adverse events than
was placebo
Adalimumab in Active and Inactive, Non-Infectious Uveitis: Global Results from the VISUAL I and VISUAL II Trials
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 1:1 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