Dataset Information

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

ABSTRACT:

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.

SUBMITTER: Armbrust KR

PROVIDER: S-EPMC7971443 | biostudies-literature | 2021 Jan-Mar

REPOSITORIES: biostudies-literature

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Publications

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

Armbrust Karen R KR Fox Austin R AR Jeffrey Brett G BG Sherry Patti P Sen H Nida HN

Taiwan journal of ophthalmology 20200727 1

<h4>Purpose</h4>This prospective study evaluates whether rituximab is a safe and potentially effective treatment for nonparaneoplastic autoimmune retinopathy (npAIR).<h4>Materials and methods</h4>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 w ...[more]

PMID: 33767957

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Dataset Information

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

Purpose

Materials and methods

Results

Conclusion

Publications

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

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