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    Researchers find arthritis therapy ‘effective’ for noninfectious uveitis

    Six-month outcomes suggest intravenous administration of tocilizumab safe, well tolerated

    Multiple intravenous administrations of tocilizumab for noninfectious uveitis can be effective in improving visual acuity and reducing vitreous haze.

    Patients with active intermediate and posterior uveitis have detectable levels of interleukin-6 (IL-6) in their vitreous, and IL-6 inhibitors have been investigated as potential treatment in experimental autoimmune uveitis, reported Yasir Jamal Sepah, MBBS, instructor in ophthalmology and visual sciences and director of the Ocular Imaging Research and Reading Center, University of Nebraska, Omaha, NE.

    Monoclonal antibody

    Tocilizumab, a recombinant humanized, anti-human monoclonal antibody, is approved for the treatment of rheumatoid arthritis and juvenile idiopathic arthritis in the United States. The STOP-UVEITIS study was developed to evaluate the effect of tocilizumab on patients with noninfectious uveitis.

    The multicenter study enrolled a total of 37 patients, randomized in a 1:1 ratio to either 4 mg/kg group or 8 mg/kg of tocilizumab. The primary outcome was month 6, and patients were followed for an additional 6 months.

    Patients received a monthly intravenous infusion of tocilizumab starting at baseline until month 5. At month 6, patients received treatment only if they met pre-specified retreatment criteria.

    Primary outcomes were changes in best corrected visual acuity (BCVA), central retinal thickness (CRT), vitreous haze, vitreous cell count, and the steroid-sparing effect of the study drug.

    The key inclusion criteria included presence of active disease, “which was defined as having a vitreous haze score of 1+ on the Standardization of Uveitis Nomenclature (SUN) criteria, treatment-naïve, and patients who were receiving prednisone (10 mg/day), or were at least on one systemic immunotherapy,” Dr. Sepah said.

    Baseline visual acuity had to be 20/400 or better, and patients were washed out of treatment for 30 days prior to first study drug treatment.

    Both the groups had “fairly similar patient population, as far as the baseline demographics and other characteristics are concerned, except for CRT,” Dr. Sepah said.

    In group 1 (the 4mg/kg dosage) versus Group 2 (the 8mg/kg dosage), there was a statistically significant difference between the CRT at baseline.

    Three patients in group 1 had a CRT “in excess of 600 µm at baseline and that did skew the data,” Dr. Sepah said. Even after excluding those 3 subjects, there was still a difference of 50 µm to 60 µm between groups.

    “Similarly, the idiopathic disease was found more commonly in group 2,” he said.

    Repeated infusions of tocilizumab were well tolerated. No significant side effects or adverse events were reported, although 2 patients developed margination of neutrophils that restored to normal level when the study drug was withheld.

    The BCVA improved 8.2 letters in the combined groups, but group 1 “gained almost 11 letters compared with the patients in group 2 who gained 5.5 letters,” Dr. Sepah said.

    There were 18 patients in the study who had baseline visual acuity of 20/40 or worse. Among these 18 patients, there was an improvement of 3.3 letters.

    “Although it may seem small, it was still statistically significant,” Dr. Sepah said. “The rest of the 19 patients had visual acuity of 20/40 or worse and they showed an improvement of almost 13 letters on an average.”

    CRT decreased an average of 83 µm, with a “much larger decrease” in group 1 (131 µm) compared to group 2 (40 µm). There were 15 patients with macular edema at baseline and these patients showed a mean CRT decrease of 194 µm from baseline to month 6. But, he added, at baseline those randomized into group 1 also had a higher mean CRT overall than those randomized to group 2.

    Of the 37 patients, 23 “had the potential to show a decrease of 2 steps in vitreous haze; 10/23 (43.5%) decreased 2 steps—4 in group 1. The vitreous cell count also decreased by 1.2 in the 2 groups, but the between-group difference was not statistically significant.

    Steroid therapy down

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