Gevokizumab in the Treatment of Autoimmune Non-necrotizing Anterior Scleritis: Results of a Phase I/II Clinical Trial

Abstract

To evaluate the safety and potential efficacy of gevokizumab, an anti-interleukin 1β (IL-1β) monoclonal antibody, in the treatment of active, noninfectious, non-necrotizing anterior scleritis. Phase 1/2, open label, nonrandomized, prospective, single-arm pilot trial. Eight patients with active, noninfectious, non-necrotizing anterior scleritis with a scleral inflammatory grade of+1 to+3 in at least 1 eye were enrolled. In 1 patient both eyes were enrolled, for a total of 9 eyes (4 eyes with+1, 1 eye with+2, and 4 eyes with+3). Patients received 1 subcutaneous injection of 60mg gevokizumab at baseline and then every 4weeks for 12weeks. Complete physical and ocular examinations were performed at each visit. The primary outcome was at least a 2-step reduction or reduction to grade 0 in scleral inflammation on a 0 to+4 scale according to a standardized photographic scleritis grading system by 16weeks in the study eye compared to baseline. Secondary outcomes included changes in visual acuity, intraocular pressure, and trends in scleral grading. Participants who met the primary outcome were eligible to continue in the study for up to 52weeks and received additional gevokizumab injections every 4weeks until week 36, followed by 2 safety visits at weeks 40 and 52. Seven eyes from 7 patients met the primary outcome within a median time of 2weeks following the first gevokizumab injection. No definitive changes in visual acuity or intraocular pressure were identified. There were no serious adverse events related to the study drug. A total of 43 adverse effects were reported, with 93% described as mild, 95% as nonocular, and only 14% deemed possibly caused by the investigational treatment. The results of this small study suggest that blockage of IL-1β using gevokizumab may be beneficial in treating active, noninfectious anterior scleritis and that gevokizumab is well tolerated. Larger randomized trials are warranted to assess the true efficacy of gevokizumab in the treatment of non-necrotizing anterior scleritis.