Can Simvastatin Reduce the Need for Immunomodulatory Drugs to Treat Uveitis?

Objective: To assess the efficacy of simvastatin 80 mg/day versus placebo in patients with noninfectious nonanterior uveitis receiving prednisolone > 10 mg/day. Design: Randomized, double-masked, controlled trial. Subjects: Adult patients with noninfectious nonanterior uveitis on oral prednisolone dose of > 10 mg/day. Methods: Patients were randomly assigned at a 1:1 ratio to receive either simvastatin 80 mg/day or placebo. A total of 32 patients were enrolled (16 in each arm), all of whom completed the primary end point, and 21 reached the 2-year visit (secondary end points). Main Outcome Measures: The primary end point was mean reduction in the daily prednisolone dose at 12 months follow-up. Secondary end points were mean reduction in prednisolone dose at 24 months, percent of patients with a reduction in second-line immunomodulatory agents, time to disease relapse, and adverse events. Results: Our results show that simvastatin 80 mg/day did not have a significant corticosteroid-sparing effect at 12 months (estimate: 3.62; 95% confidence interval [CI]:-8.15 to 15.38; P = 0.54). There was no significant dif-ference between the groups with regard to prednisolone dose or change in dose at 12 and 24 months. There was no difference between the 2 groups in percent of patients with reduction in second-line agent by 24 months. Among patients who achieved disease quiescence, the median time to first relapse was longer for those receiving sim-vastatin (38 weeks, 95% CI: 14-54) than placebo (14 weeks, 95% CI: 12-52), although this was not statistically significant. There was no significant difference in adverse events or serious adverse events between the 2 groups. Conclusions: Simvastatin 80 mg/day did not have an effect on the dose reduction of corticosteroids or conventional immunomodulatory drugs at 1 and 2 years. The results suggest that it may extend the time to disease relapse among those who achieve disease quiescence. Financial Disclosure(s): The author(s) have no proprietary or commercial interest in any materials discussed in this article. Ophthalmology Science 2023;3:100333 & COPY; 2023 Published by Elsevier Inc. on behalf of the American Academy of Ophthalmology. This is an open access article under the CC BY-NC-ND license (http:// creativecommons.org/licenses/by-nc-nd/4.0/).

Automated summary

A randomized controlled trial found no significant difference in efficacy between 80 mg/day simvastatin and placebo in noninfectious nonanterior uveitis patients. The study suggests that simvastatin does not have a corticosteroid-sparing effect but may extend the time to disease relapse for patients achieving disease quiescence.