Rituximab Therapy for Refractory Scleritis Results of a Phase I/II Dose-Ranging, Randomized, Clinical Trial
Eric B Suhler, Lyndell L Lim, Robert M Beardsley, Tracy R Giles, Sirichai Pasadhika, Shelly T Lee, Alexandre de Saint Sardos, Nicholas J Butler, Justine R Smith, James T Rosenbaum
OPHTHALMOLOGY | ELSEVIER SCIENCE INC | Published : 2014
OBJECTIVE: To determine whether rituximab, a monoclonal antibody against the B-lymphocyte antigen CD20, is effective in the treatment of refractory noninfectious scleritis. DESIGN: Prospective, dose-ranging, randomized, double-masked phase I/II clinical trial. PARTICIPANTS: Twelve patients with noninfectious scleritis refractory to systemic corticosteroid and ≥1 other systemic immunosuppressive agent were enrolled from January 2007 to March 2010. INTERVENTION: Subjects were randomly assigned to 500 (n = 5) or 1000 mg (n = 7) dosing arms of rituximab intravenous infusions (500 or 1000 mg), given at study days 1 and 15. Initial responders with breakthrough inflammation after study week 24 were..View full abstract
E. B. S.: Research Supportd-Department of Veterans'AffairsSupported in part by Genentech (San Francisco, CA). The funding organization had no role in the design or conduct of this research. Funded by a Research to Prevent Blindness grant (unrestricted grant to Casey Eye Institute), the Rosenfeld Family Trust (J. T. R.), and the William and Mary Bauman Foundation. The OHSU Uveitis Clinic has received research support from Genentech, Abbott/Abbvie, Bristol-Myers-Squibb, EyeGate, LuxBio, and Novartis.