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

Autor:	Armbrust KR; Laboratory of Immunology, National Eye Institute, National Institutes of Health, Bethesda, MD, USA.; Department of Ophthalmology, Veterans Affairs Health Care System, Minneapolis, MN, USA.; Department of Ophthalmology and Visual Neurosciences, University of Minnesota Medical School, Minneapolis, MN, USA., Fox AR; Laboratory of Immunology, National Eye Institute, National Institutes of Health, Bethesda, MD, USA.; Department of Ophthalmology and Visual Sciences, University of Iowa Carver College of Medicine, Iowa City, IA, USA., Jeffrey BG; Laboratory of Immunology, National Eye Institute, National Institutes of Health, Bethesda, MD, USA., Sherry P; Laboratory of Immunology, National Eye Institute, National Institutes of Health, Bethesda, MD, USA., Sen HN; Laboratory of Immunology, National Eye Institute, National Institutes of Health, Bethesda, MD, USA.
Jazyk:	angličtina
Zdroj:	Taiwan journal of ophthalmology [Taiwan J Ophthalmol] 2020 Jul 27; Vol. 11 (1), pp. 64-70. Date of Electronic Publication: 2020 Jul 27 (Print Publication: 2021).
DOI:	10.4103/tjo.tjo_32_20
Abstrakt:	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. Competing Interests: The authors declare that there are no conflicts of interests of this paper. (Copyright: © 2020 Taiwan J Ophthalmol.)
Databáze:	MEDLINE
Externí odkaz:	Zobrazit plný text záznamu