Adalimumab, Anakinra, and Tocilizumab in Patients With Noninfectious Uveitis: A Multicenter Randomized Controlled Trial.

Abstract

To evaluate the efficacy and safety of adalimumab, anakinra, and tocilizumab in patients with active and refractory noninfectious uveitis (NIU). Multicenter, Bayesian, randomized controlled trial. A total of 112 patients with active, noninfectious, nonanterior uveitis across 27 French centers were enrolled. Participants were randomly assigned (1:1:1) to receive either subcutaneous adalimumab (n = 44; initial dose 80 mg, followed by 40 mg every other week), anakinra (n = 18; 100 mg daily), or tocilizumab (n = 50; 162 mg weekly) for a 16-week treatment period. The primary end point was a reduction of at least 2 steps on the Miami 9-step scale for vitreous haze with a corticosteroid dose of 0.1 mg/kg/d or less at week 16. During interim analyses, anakinra was shown to be ineffective, and this arm was stopped prematurely. By week 16, the primary outcome was achieved in 7 of 44 (16%) and 7 of 50 (14%) patients in the adalimumab and tocilizumab groups, respectively (mean difference -2.0%, 95% credible interval [CrI] -16.8% to +12.3%). Absence of macular edema and retinal vasculitis was seen in 54% and 56%, and in 59% and 57%, respectively (mean differences -2.0% [95% CrI, -14% to +26%] and 2.0% [95% CrI, -31% to +15%]). A prednisone taper to ≤0.1 mg/kg/d at week 16 was reached by 59% and 74% of patients, respectively (mean difference -15%, 95% CrI -4% to +32%). Mild to moderate adverse events occurred in 43% (adalimumab) and 54% (tocilizumab). Adalimumab and tocilizumab show comparable efficacy in active, refractory NIU, whereas anakinra was ineffective. ClinicalTrials.gov Identifier: NCT02929251.