Abstract:
PURPOSE: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. DESIGN:Phase 1/2, open label, nonrandomized, prospective, single-arm pilot trial. METHODS: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 60 mg gevokizumab at baseline and then every 4 weeks for 12 weeks. 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 16 weeks 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 52 weeks and received additional gevokizumab injections every 4 weeks until week 36, followed by 2 safety visits at weeks 40 and 52. RESULTS:Seven eyes from 7 patients met the primary outcome within a median time of 2 weeks 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. CONCLUSIONS: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.
journal_name
Am J Ophthalmoljournal_title
American journal of ophthalmologyauthors
Knickelbein JE,Tucker WR,Bhatt N,Armbrust K,Valent D,Obiyor D,Nussenblatt RB,Sen HNdoi
10.1016/j.ajo.2016.09.017subject
Has Abstractpub_date
2016-12-01 00:00:00pages
104-110eissn
0002-9394issn
1879-1891pii
S0002-9394(16)30459-7journal_volume
172pub_type
临床试验,杂志文章abstract::Using the Octopus automated perimeter, we conducted visual measurements on four separate occasions during a four-week period in six subjects with normal eyes. In 11 of 12 eyes, we found at least one point at which the threshold for light detection determined for that point showed a variance of more than 4 dB between t...
journal_title:American journal of ophthalmology
pub_type: 杂志文章
doi:10.1016/0002-9394(84)90631-7
更新日期:1984-03-01 00:00:00
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journal_title:American journal of ophthalmology
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journal_title:American journal of ophthalmology
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doi:10.1016/j.ajo.2006.11.038
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journal_title:American journal of ophthalmology
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journal_title:American journal of ophthalmology
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journal_title:American journal of ophthalmology
pub_type: 临床试验,杂志文章
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journal_title:American journal of ophthalmology
pub_type: 杂志文章
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