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

• Published in: Taiwan journal of ophthalmology Vol. 11; no. 1; pp. 64 - 70
• Main Authors: Armbrust, Karen, Fox, Austin, Jeffrey, Brett, Sherry, Patti, Sen, H
• Format: Journal Article
• Language: English
• Published: India Wolters Kluwer - Medknow Publications 01.01.2021; Medknow Publications and Media Pvt. Ltd; Wolters Kluwer - Medknow; Wolters Kluwer Medknow Publications
• Subjects: autoimmunity; B cells; Clinical trials; electroretinography; Original; retinal degeneration; rituximab; visual fields; Autoimmunity; visual fields; retinal degeneration; electroretinography; rituximab
• ISSN: 2211-5056; 2211-5072
• DOI: 10.4103/tjo.tjo_32_20

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.