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S. T. Lee, L. L. Lim, T. R. Giles, T. L. Liesegang, S. Pasadhika, J. R. Smith, J. T. Rosenbaum, E. B. Suhler; Rituximab in the Treatment of Refractory Scleritis and Non-Infectious Orbital Inflammation: Update From a Phase I/II Prospective, Randomized, Dose-Ranging Pilot Study. Invest. Ophthalmol. Vis. Sci. 2009;50(13):2019.
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To examine the safety and efficacy of rituximab in the treatment of non-infectious scleritis and orbital inflammatory disease (OID).
Patients with non-infectious scleritis or OID refractory or intolerant to oral corticosteroids and at least one other immunosuppressant were enrolled in this prospective, randomized clinical trial. Rituximab infusions were given on study days 1 and 15. Scleritis patients were randomized to 500 mg or 1000 mg of rituximab. OID patients received 1000 mg of rituximab. Patients were followed every 4 weeks and primary outcome assessments were performed at 24 and 48 weeks. Primary outcome measures included 50% or greater reduction in corticosteroid use by week 24, and improvement in standardized activity grading scales for scleritis (SGS) or orbital inflammation (OGS). Secondary outcome measures included improvement in patient’s and physician’s global ocular health assessment, ocular pain, and reduction in analgesic dosing, and improvement in visual acuity.
To date 5 patients have been enrolled for scleritis and 5 patients for OID. One scleritis patient and 4 OID patients have completed the study; the remaining patients have at least 24 weeks of follow-up. 3/5 and 5/5 scleritis patients improved based on primary and secondary outcome measures, respectively. Four scleritis patients were on oral prednisone at the time of enrollment. Of these patients, one was able to reduce steroids by 75%. Three of 5 had improved SGS scores. 4/5 had reduced pain, and all 5 had decreased inflammatory activity by both patient and physician assessment. Three of 5 OID patients had improved OGS scores. Only 2 OID patients were on oral corticosteroid therapy at the time of enrollment. None decreased corticosteroid dose by 50%, but one reduced by 38% at 24 weeks. Four OID patients had both improvement in pain and decreased disease activity based on physician assessment at week 24, with the fifth achieving this by week 48. Of the 4 OID patients who have completed the study, 3 had significant improvement in the OGS score by week 48; the other patient’s score was unchanged from enrollment.Adverse events included transient worsening of inflammation 4 to 8 weeks after infusion in 3 scleritis and 3 OID patients, usually requiring temporary increase in corticosteroid therapy.
Rituximab seems to be effective in the treatment of scleritis and OID. Many patients experienced peri-infusion exacerbations, which may be countered by simultaneous treatment with either IV methylprednisolone or increased oral corticosteroids.
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