Tocilizumab (TCZ), a recombinant humanized monoclonal antibody, reduced posterior segment inflammation in subjects with non-infectious uveitis (NIU) in a clinical trial, and researchers were able to capture the results using fluorescein angiography (FA), they reported in an index sub-study published in Int J Retin Vitr.
The researchers used data from the Study of the Safety, Tolerability and Bioactivity of Tocilizumab on Patients With Non-Infectious Uveitis (STOP-Uveitis), an open-label clinical trial that assessed the safety and efficacy of repeated intravenous (IV) infusions of a small dose (4 mg/kg) and a large dose (8 mg/kg) of TCZ in subjects with NIU, over the course of 1 hour every 30 days for 6 months.
TCZ, a “steroid-sparing agent,” is an inhibitor of IL-6, which is a pro-inflammatory cytokine involved in uveitis; it has been used as a treatment for patients with refractory uveitis and ocular inflammatory diseases, the researchers said.
The researchers acquired FA images from 2 of the 5 clinical centers that participated in STOP-Uveitis and used the Angiography Scoring for Uveitis Working Group (ASUWOG)’s semiquantitative scoring system that used fluorescein and indocyanine angiography to observe posterior segment inflammation in the subjects.
The 30 subjects (of a total of 37) who completed the 6 months of treatment with Tocilizumab through the STOP-Uveitis clinical trial ─ and also had gradable fluorescein angiography images at baseline and month 6 ─ were included in the index sub-study.
The median FA inflammatory score for the 30 participants improved from 6.00 plus or minus -3.26 at baseline to 2.00 plus or minus 3.40 at month 6 (P =.0006). The difference between the decrease in the median FA inflammatory score for the group that received a lower dose of TCZ (baseline: 7.50±3.56, month 6: 2.00±4.05, P =.019) and the decrease in the score for the group that received a higher dose (baseline: 5.50±2.67, month 6: 2.00±2.50, P =.013) was not statistically significant (P >.05). The inflammatory score worsened for 3 patients through the treatment with TCZ because they had a 1-point increase in capillary leakage at the month 6 visit, the researchers said.
Limitations of the study included a small sample size, limited follow-up, and post-hoc analysis, the researchers said.
“In addition, the study was not statistically powered to compare the efficacy of the two doses and to assess the efficacy among the different causes of uveitis in the study,” they said.
A composite scoring system, which could include best-corrected visual acuity, central retinal thickness, FA inflammatory score, and vitreous haze, may help physicians more accurately assess these patients, the researchers said.
“Fluorescein angiography analyses using an objective scoring system may be employed for assessment of posterior segment inflammation in these patients,” they said. “We propose employing such scoring methods in combination with other outcome measures, to help uveitis specialists make reliable management decisions in patients with noninfectious uveitis.”
Disclosure: Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures.
Sadiq MA, Hassan M, Afridi R, et al. Posterior segment inflammatory outcomes assessed using fluorescein angiography in the STOP-UVEITIS study. Int J Retin Vitr. Published online October 6, 2020. doi: 10.1186/s40942-020-00245-w