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Nicholas J. Butler, Lyndell L. Lim, Tracy R. Giles, Alexandre de Saint Sardos, Amro Ali, Shelly T. Lee, Sirichai Pasadhika, Justine R. Smith, James T. Rosenbaum, Eric B. Suhler; Rituximab In The Treatment Of Refractory Scleritis And Non-infectious Orbital Inflammation: 24 Week Outcomes From A Phase I/II Prospective, Randomized Study. Invest. Ophthalmol. Vis. Sci. 2011;52(14):4251.
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To determine the safety, efficacy, and optimal dosing of rituximab (RTX; Rituxan, Genentech), a chimeric monoclonal antibody against the CD20 molecule expressed on B lymphocytes, in the treatment of scleritis and orbital inflammatory disease (OID).
Non-infectious scleritis and OID patients, refractory to standard therapy, were enrolled in our prospective study between January 2007 and March 2010 and randomized to receive either 500 mg or 1000 mg infusions of RTX on study days 1 and 15. Primary endpoints of the study, measured at 24 and 48 weeks, were corticosteroid (CS) tapering by at least 50% and improvement in validated disease activity grading scores. Secondary endpoints included improvement in the patient’s or physician’s global ocular health assessment and pain reduction. Retreatment was permitted after 24 weeks for initial responders.
20 patients have currently been enrolled; 10 subjects each with scleritis and OID. All patients have completed 24 weeks, and 13 have completed the 48 week protocol. At 24 weeks, 3/10 (30%) scleritis and 6/10 (60%) OID patients achieved CS tapering. Eight of 10 (80%) scleritis patients and 7 of 10 (70%) OID patients had improvement in disease activity scores. Patient and physician global ocular health assessment improved in 9/10 (90%) and 8/10 (80%) scleritis patients, respectively, and in 7/10 (70%) and 8/10 (80%) OID patients. Vision was stable or improved in all patients at week 24, and pain was reduced in 6/10 (60%) scleritis and 7/10 (70%) OID patients. Six of the first 7 (86%) enrolled patients had early post-infusion inflammatory exacerbations; peri-infusional CS decreased this occurrence to 2 of the last 13 (15%) patients. No treatment limiting side effects were noted. Eleven patients have been reinfused thus far (7 scleritis and 4 OID; range 26-48 weeks, mean 33 weeks post-enrollment) for disease recurrence; none have suffered peri-infusional exacerbations at reinfusion.
RTX appears to be an effective agent in the treatment of refractory scleral and orbital inflammation. Treatment with steroids during initial RTX infusion is useful in preventing exacerbation of ocular, orbital, or systemic inflammatory disease. Further follow-up and study are required to clarify optimal dosing and patient subsets that will benefit from RTX treatment for scleritis or OID.
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