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R. W. Lee, R. Greenwood, R. Amer, S. Biester, J. Plskova, J. V. Forrester, A. D. Dick; Tacrolimus Monotherapy versus Tacrolimus and Prednisone for the Maintenance of Disease Remission in Non-Infectious Posterior Segment Intraocular Inflammation. Invest. Ophthalmol. Vis. Sci. 2009;50(13):2024.
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Despite their side-effects, corticosteroids remain a mainstay of long-term therapy for non-infectious posterior segment intraocular inflammation (PSII). Tacrolimus (Tac) is a calcineurin inhibitor which is effective and well tolerated for the treatment of PSII. It has also been used to facilitate steroid-avoidance in solid-organ transplantation. We therefore aimed to evaluate Tac monotherapy (MT) for the maintenance of disease remission in PSII.
In this 4-year, dual-centre, prospective, open-label study, patients requiring a second-line systemic immunosuppressive agent to control their sight-threatening PSII were treated with oral Tac (trough level=8-12ng/ml). Those patients who were subsequently able to taper their prednisone (Pred) to 10mg daily without disease reactivation were randomly assigned to either stop prednisone (MT) or continue 7.5-10mg Pred daily for 9 months (dual-therapy, DT). The primary outcome measure was change in logMAR VA. Secondary outcome measures included rates of patient withdrawal due to treatment inefficacy or intolerance.
Of the 58 patients enrolled, 35 (60.3%) successfully tapered their Pred to 10mg daily. Of these, 16 (27.6%) were randomly allocated to receive Tac monotherapy (MT) and 19 (32.8%) to continue taking Pred (dual-therapy, DT). Mean VA improvement was -0.003 logMAR (95% CI, -0.039 to 0.032) for MT and -0.019 logMAR (95% CI, -0.076 to 0.039) for DT (p=0.31). The proportion of patients who tolerated treatment and maintained disease remission for 9 months after randomisation was also equivalent in both groups (MT=62.5%, DT=68.4%; p=0.52). All MT treatment failures were due to disease reactivation, whereas 50% of DT failures were due to drug intolerance.
Tac MT is as effective as Tac and Pred for the maintenance of disease remission in sight-threatening non-infectious PSII, with treatment success at 9 months in 62.5% of patients. Any advantage of DT in the prevention of disease reactivation is offset by its greater treatment intolerance. This provides evidence supporting the discontinuation of corticosteroid therapy in patients controlled with Tac and 10mg Pred daily (ISRCTN46576063).
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