Biologic Strategies for Noninfectious Uveitis in a Randomized Trial

Key Takeaways

• Adalimumab and tocilizumab reached the week 16 corticosteroid-sparing endpoint at similar observed rates of 16% and 14%, respectively. Interim analyses found anakinra ineffective.
• Mild to moderate adverse events were reported in 43% and 54% of the adalimumab and tocilizumab groups, with macular edema and retinal vasculitis absence also reported at week 16.

A head-to-head randomized trial in patients with active, refractory, noninfectious, nonanterior uveitis compared adalimumab, anakinra, and tocilizumab on a corticosteroid-sparing outcome at week 16. At that time point, 16% of patients receiving adalimumab and 14% receiving tocilizumab met the prespecified primary endpoint. Interim analyses found anakinra ineffective, and that treatment arm closed before a full parallel week 16 efficacy comparison was completed.

Researchers conducted a multicenter, Bayesian, randomized controlled trial across 27 French centers in patients with active, noninfectious, nonanterior uveitis, analyzing 112 patients from 114 randomized in a 1:1:1 assignment. Treatment consisted of adalimumab 80 mg initially then 40 mg every other week, anakinra 100 mg daily, or tocilizumab 162 mg weekly. The prespecified endpoint required at least a 2-step reduction on the Miami 9-step vitreous haze scale with corticosteroid use of 0.1 mg/kg/day or less at week 16. Median age was 49 years, 55% were female, 49% had panuveitis, and 71% had bilateral involvement.

In the two fully reported groups, the primary outcome occurred in 7 of 44 patients given adalimumab and 7 of 50 given tocilizumab. The mean difference between those arms was -2.0%, with a 95% credible interval ranging from -16.8% to +12.3%.

At week 16, absence of macular edema was reported in 54% of adalimumab-treated patients and 56% of tocilizumab-treated patients. Absence of retinal vasculitis was reported in 59% and 57% of those two treatment groups, respectively, at week 16. Prednisone tapering to 0.1 mg/kg/day or less at week 16 was reported in 59% and 74%, respectively. Mild to moderate adverse events were reported in 43% of adalimumab-treated patients and 54% of tocilizumab-treated patients.