Taiwan Journal of Ophthalmology

ORIGINAL ARTICLE
Year
: 2021  |  Volume : 11  |  Issue : 1  |  Page : 64--70

Rituximab for autoimmune retinopathy: Results of a Phase I/II clinical trial


Karen R Armbrust1, Austin R Fox2, Brett G Jeffrey3, Patti Sherry3, H Nida Sen3 
1 Laboratory of Immunology, National Eye Institute, National Institutes of Health, Bethesda, MD; Department of Ophthalmology, Veterans Affairs Health Care System; Department of Ophthalmology and Visual Neurosciences, University of Minnesota Medical School, Minneapolis, MN, USA
2 Laboratory of Immunology, National Eye Institute, National Institutes of Health, Bethesda, MD; Department of Ophthalmology and Visual Sciences, University of Iowa Carver College of Medicine, Iowa City, IA, USA
3 Laboratory of Immunology, National Eye Institute, National Institutes of Health, Bethesda, MD, USA

Correspondence Address:
Dr. H Nida Sen
10 Center Dr., Bldg 10, Room 10N109, Bethesda, MD 20892
USA

PURPOSE: This prospective study evaluates whether rituximab is a safe and potentially effective treatment for nonparaneoplastic autoimmune retinopathy (npAIR). MATERIALS AND METHODS: Five npAIR patients were enrolled in a Phase I/II, prospective, nonrandomized, open-label, single-center study. All patients received a cycle of 1000 mg intravenous rituximab at weeks 0 and 2, with a second cycle of rituximab 6 to 9 months later. Clinical evaluation was performed at baseline, 6 and 12 weeks after each rituximab cycle, and then every 3 months for a total duration of 18 months. The primary outcome for this study was treatment success based on visual field and full-field electroretinography at 6 months. The secondary outcomes included treatment success at months 12 and 18, drug-related adverse events, changes in visual symptoms, and changes in quality of life. RESULTS: Two patients met criteria for treatment success: one based solely on electroretinography and the other based solely on visual field area, but treatment success was not sustained. Clinical response over the course of the 18-month study showed disease stabilization in three patients and treatment failure in two patients. There were no severe drug-related adverse events. CONCLUSION: This is the first clinical trial prospectively evaluating the effect of rituximab in npAIR and, although rituximab was well tolerated, there was no clear-cut clinical improvement conferred by B cell depletion with rituximab.


How to cite this article:
Armbrust KR, Fox AR, Jeffrey BG, Sherry P, Sen H N. Rituximab for autoimmune retinopathy: Results of a Phase I/II clinical trial.Taiwan J Ophthalmol 2021;11:64-70


How to cite this URL:
Armbrust KR, Fox AR, Jeffrey BG, Sherry P, Sen H N. Rituximab for autoimmune retinopathy: Results of a Phase I/II clinical trial. Taiwan J Ophthalmol [serial online] 2021 [cited 2021 Apr 23 ];11:64-70
Available from: https://www.e-tjo.org/article.asp?issn=2211-5056;year=2021;volume=11;issue=1;spage=64;epage=70;aulast=Armbrust;type=0