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E. B. Suhler, L. L. Lim, S. Pasadhika, S. K. Sharma, P. A. Kurz, T. R. Giles, J. R. Smith, J. T. Rosenbaum; Rituximab in the Treatment of Refractory Scleritis and Non-Infectious Orbital Inflammation: Preliminary Results From a Phase I/II Prospective, Randomized, Dose-Ranging Pilot Study. Invest. Ophthalmol. Vis. Sci. 2008;49(13):1119.
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to determine the safety and efficacy of rituximab (Rituxantm, Genentech), a chimeric monoclonal antibody against the CD20 molecule expressed on B lymphocytes, in the treatment of scleritis and orbital inflammatory disease (OID).
Patients with non-infectious scleritis and OID were enrolled in our prospective study, which was approved by the FDA and our institutional review board. Patients in both arms received two infusions of rituximab at study days 1 and 15. Per protocol, scleritis patients were randomized to receive either 500 mg or 1000 mg infusions, while OID patients all received 1000 mg infusions. Primary endpoints of the study are ability to taper corticosteroids, improvement in patient quality of life assessment, and physician assessment of disease activity. Secondary endpoints include patient pain assessment and improvement in composite endpoints of scleritis or OID activity modified from previous published protocols. Patients were followed monthly for clinical and/or laboratory safety and efficacy assessments. The protocol permitted retreatment between 6 and 12 months after initial infusion. The protocol duration is 48 weeks, with outcome assessment at 24 weeks and at study conclusion.
Thus far, we have enrolled 2 subjects with scleritis and 3 patients with OID, all with at least 24 weeks of study followup. One patient with sclerouveitis had a worsening of intraocular inflammation after one infusion, received rescue therapy with corticosteroids, and was terminated from the study. Our other patient with scleritis was able to reduce corticosteroids over 50% by 24 weeks, and had marked improvement in pain, physician and patient assessment, and scleritis grade. All 3 of our OID patients had significant improvement in physician assessment of disease activity, 2 of 3 had signficant reduction in pain, 2 of 3 had a significant reduction in OID grade, and 1 of 1 on antecedent steroids was able to taper by greater than 50%. No OID patients worsened in any of the outcome criteria. No treatment limiting side effects were noted, although one scleritis patient noted worsened palmar psoriasis. Peripheral B-cell depletion was maintained for the duration of the study in all patients.
rituximab appears to be safe in the treatment of ocular and orbital inflammation, and may have benefit in selected cases. Further follow-up and study is required to clarify the utility of rituximab in the treatment of scleritis, OID, or other ocular inflammatory diseases.
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