Tocilizumab for Noninfectious Uveitis: 6-Month Outcomes of STOP-Uveitis
American Journal of Ophthalmology, December 2017
Sepah et al. reported 6-month safety and efficacy outcomes for 2 doses of intravenous (IV) tocilizumab administered to patients with noninfectious intermediate uveitis (NIU). Both doses were efficacious and well tolerated.
STOP-Uveitis is a randomized open-label trial of the safety, efficacy, and bioactivity of tocilizumab that is currently underway at 5 centers in the United States. Thirty-seven patients with NIU were assigned to receive an IV infusion of tocilizumab 4 mg/kg (group 1) or 8 mg/kg (group 2). Infusions were given every 4 weeks through month 6. Main outcome measures were the incidence and severity of systemic and ocular adverse events from baseline through month 6. Secondary outcomes were mean changes in visual acuity (VA), vitreous haze (VH), and central macular thickness (CMT) during the same period.
Of the patients with potential for a 2-step decrease in VH, a mean of 44% achieved this by 6 months (40% in group 1; 46% in group 2). By month 6, the mean change in CMT was –83.88 ± 136.1 μm (–131.5 ± 41.56 μm in group 1; –38.92 ± 13.7 μm in group 2). The mean change in VA was 8.22 ± 11.83 ETDRS letters (10.9 ± 14.6 in group 1; 5.5 ± 7.8 in group 2). There were no significant differences in efficacy or safety between the doses. The safety profile of IV tocilizumab was similar to that in other studies, and no new safety signals were detected. The higher dose was associated with 2 cases of neutropenia. (The neutropenia resolved subsequently in 1 patient, who was continued on the study medication.)
The authors concluded that both doses of IV tocilizumab (4 mg/kg and 8 mg/kg) are safe and effective in patients with NIU, and they noted that the drug may help achieve the overall goal of preventing recurrence or attaining quiescence.
The original article can be found here.