Abstract PURPOSE: This study aimed to assess the effectiveness of a steroid-sparing immunosuppressive treatment (IST) protocol in the control of severe or steroid-resistant autoimmune ocular inflammatory diseases. METHODS: We carried out a prospective, non-randomized clinical study. Patients presenting with ocular inflammations that failed to respond adequately to steroids alone after monotherapy for a mean period of 9 +/- 2 months (internal control) were offered the option to switch to a combined IST. The protocol consisted of different immunosuppressive drugs added in a stepladder sequence, where each drug (including the steroids) was administered discontinuously. Main outcome measures were control of inflammation, visual acuity and safety of treatment. RESULTS: A total of 76 subjects (121 affected eyes) enrolled in the IST protocol. Mean length of follow-up was 43 +/- 15 months. Complete control of inflammation was achieved in 86% of patients. During the first year of IST, the rate of inflammatory recurrences/patient was 0.78 +/- 1.13. This ratio diminished further during succeeding follow-up. Mean best corrected visual acuity improved from 0.31 logMAR to 0.24 logMAR (p < 0.001). Blood pressure and uric acid blood levels significantly altered for the worse in the study group. CONCLUSIONS: Immunosuppressive treatment was effective in achieving inflammatory quiescence in a large majority of patients. The study also demonstrated the longterm safety of the protocol and its steroid-sparing effect.
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