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Ana Suelves, Cheryl Arcinue, Jesús María González-Martín, C. Stephen Foster; Assessment of Efficacy and Safety of a Novel Protocol for Pulsed Intravenous Cyclophosphamide for Recalcitrant or Severe Ocular Inflammatory Disease. Invest. Ophthalmol. Vis. Sci. 2013;54(15):120.
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To analyze the success rate of pulsed intravenous (IV) cyclophosphamide (CyP) for non-infectious ocular inflammatory disease and to identify risk factors for failure of therapy.
Retrospective, interventional, cohort study. Through a computer search of the Massachusetts Eye Research and Surgery Institution’s database, we identified 65 patients (110 eyes) who were treated with IV CyP between May 2005 and April 2012. The main outcomes evaluated through review of the electronic health record of each patient were clinical response, corticosteroid-sparing effect, recurrence rate, calculated “risk factors” for failure, visual acuity and adverse reactions.
Pulsed IV CyP achieved complete remission of inflammation (for at least 2 visits) in 54 patients (84.4%). Sustained remission of inflammation occurred in 70% of patients within 3 months, 86.6% of patients within 6 months, and 91.7% within 9 months. The mean time to achieving quiescence was 3.5 months. The success rate in reducing corticosteroid to prednisone 10 mg/day or less within 6 months, while maintaining control of ocular inflammation, was 89.7% (95% Confidence Interval (CI) 81.1-93.5%). The mean duration of clinical remission for those patients who had a positive response to CyP was 32.67 months (95% CI 25.91-39.43). Relapse of vasculitis was observed in 1 patient (1.5%) after completing the course of therapy. Early initiation of therapy during the course of the disease was correlated with a lesser rate of recurrence (p=0.028). The most common adverse effects were nausea (29%) and transient lymphopenia (26%). The mean best-corrected visual acuity (BCVA) improved from 0.59 ± 0.66 at baseline to 0.30 ± 0.54 at 6 months of follow-up (p < 0.001). The mean follow-up period was 31.61 ± 20.47 months.
Pulsed IV CyP employing our protocol results in an extremely high rate of sustained complete remission in patients with recalcitrant and fulminant, vision-threatening ocular inflammatory disorders, with an excellent safety profile in the hands of physicians trained and skilled in the art of this therapy. The protocol makes possible tapering and discontinuing corticosteroids in most patients. Early initiation of therapy may decrease the risk of relapses.
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