| Popis: |
OA gold Purpose : To evaluate whether a mycophenolate sodium-based treatment regimen is able to reduce the probability of a relapse compared to corticosteroid therapy alone in patients with non-infectious intermediate uveitis. Methods : Investigator-initiated, phase 3 open, prospective, controlled, randomized national multicenter trial (protocol MYCUV-IIT02). To be eligible, patients had to suffer from a documented at least 6 months history of unilateral or bilateral intermediate uveitis, either idiopathic or due to non-infectious systemic disease, that was active at study entry. All patients received initial treatment with oral prednisolone 1 mg/kg, followed by a slow tapering over 3 months. For maintenance therapy, subjects were randomized in a 1:1 ratio to either mycophenolic sodium 1440 mg/day (Myfortic®, Novartis Pharma) plus prednisolone 5 mg/day (treatment arm) or prednisolone 5mg/day alone (control arm). Maximum treatment duration was 15 months. The primary endpoint was defined as the time from study entry to the first relapse defined as a deterioration of best corrected visual acuity ≥ 3 lines and/or an at least 2-step increase of vitreous haze and/or an at least 2-step increase of anterior chamber cells and/or a new onset or worsening of preexisting cystoid macular edema, proven by optical coherence tomography, and/or a new onset or worsening of retinal vasculitis, proven by fluorescein angiography. Results : Fourty-four subjects at 8 sites were included. Of these, 41 patients (16 males, 25 females; median age 41.5 years, 18.6 – 82.7 years) were eligible for further analysis. Twenty-two patients (53.7 %) were randomized to treatment arm, 19 patients (46.3%) to control arm. In a first analysis using the Kaplan-Meier method, the proportion of relapse-free patients was estimated as 58.2 % in the treatment arm and 26.3 % in the control arm at 9 months after study entry, and as 52.9 % in the treatment arm and 19.7 % in the control arm at 15 months after study entry. The difference between treatment arm and control arm regarding relapse-free survival was statistically significant (log-rank test p = 0.011). Conclusions : During an observation period of 15 months, a combination of mycophenolate sodium plus low-dose corticosteroids resulted in a significant reduction of relapse rate compared to treatment with low-dose corticosteroids alone in patients with non-infectious intermediate uveitis. |
