Interim Analyses of Study of Safety and Bioactivity of TOcilizumab in Patients with Non-Infectious UVEITIS: STOP-UVEITIS

Abstract

Purpose : To evaluate the safety and efficacy of tocilizumab (TZB) infusions for non-infectious posterior, intermediate, or panuveitis

Methods : STOP-Uveitis study is a randomized, open-label safety, efficacy and bioactivity clinical study evaluating the role of TCZ in patients with non-infectious uveitis (NIU). Patients with NIU were randomized into one of 2 treatment groups in a ratio of 1:1. Group 1 received intravenous (IV) infusions of 4mg/kg TZB and group 2 received IV infusions of 8mg/kg TZB. Infusions were given every 4 weeks in both groups until month 6 (primary endpoint). Treatment was given on an as needed basis from month 6 onwards until month 12. Primary outcome measures were mean change in visual acuity (VA), vitreous haze (VH) and foveal thickness (FTH) at month 6 in the two groups. Key study inclusion criteria were: 1) diagnosis of NIU; 2) have active uveitis, defined as having at least 1+ VH and/or at least 1+ Vitreous Cell Count (SUN scale); 3) best-corrected ETDRS VA of 20/400 or better in the study eye and 4) discontinuation of all systemic immunomodulatory therapies 30 days prior to the first administration of study drug.

Results : A total of 37 patients were randomized in the study. Baseline characteristics are shown in table 1. Repeated infusions of TZB were well tolerated. Two patients had low neutrophil counts secondary to margination that restored to normal with withholding of treatment. VH decreased by 1 step or more in 73.3% and 81.2% of patients in group 1 (low dose) and 2 (high dose), respectively, at month 6. VH decreased by 2 steps or more in 26.6% and 37.5% of patients in groups 1 and 2, respectively, at month 6. Mean change in FTH was -131.5 µm in group 1 and -38.91 µm in group 2 at month 6. The mean change in VA at month 6 was +10.9 and +5.5 ETDRS letters in group 1 and 2 respectively.

Conclusions : Repeated IV administrations of TZB are well tolerated. TZB (either 4 or 8 mg/kg) is effective in improving VA and reducing VH and FTH. Further monitoring of patients receiving TZB may be helpful to assess the long term safety and benefits of the drug.

This is an abstract that was submitted for the 2016 ARVO Annual Meeting, held in Seattle, Wash., May 1-5, 2016.

 

Table 1 - Baseline Characteristics