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Mycophenolate sodium in the treatment of corticosteroid-refractory non-infectious inflammatory uveitis (MySTRI study)

Abstract

Objectives

To evaluate the therapeutic effect and safety profile of next generation mycophenolate sodium (MPS), which is different from mycophenolate mofetil with an enteric-coated formulation, in corticosteroid-refractory non-infectious inflammatory uveitis (CRU) patients.

Methods

Prospective, uncontrolled, open-label interventional case series. Forty consecutive patients at a tertiary uveitis referral centre received 6 months of oral MPS as the treatment regimen with follow-up 12 months. The main outcome measures were best-corrected visual acuity (BCVA), inflammatory index, steroid-sparing effect of tapering prednisone to ≤10 mg daily and side effects.

Results

Mean age of enroled patients was 49 (49 ± 13) years and 29 (72.5%) were female. Thirty-six (90.0%) had bilateral disease. There were 0 (0%) anterior uveitis, 2 (5.0%) intermediate uveitis, 22 (55.0%) posterior uveitis, and 16 (40.0%) panuveitis. Vogt-Koyanagi-Harada disease was the most common diagnosis (17/40, 42.5%), followed by idiopathic panuveitis (8/40, 20%) and idiopathic retinal vasculitis (5/40, 12.5%). LogMAR BCVA improved from 0.9 (SD = 0.09) to 0.31 (SD = 0.08) after 6 months of MPS with good steroid-sparing effect (p = 0.012). Further maintenance in LogMAR BCVA was evident after MPS discontinuation from 6th month to 12th month, from 0.31 (SD = 0.08) to 0.33 (SD = 0.07), respectively (p = 0.81). MPS was the only immunosuppressive drug needed to reach quiescent state in 29 patients (72.5%). The drug-related safety profile was satisfactory.

Conclusion

MPS is an effective steroid-sparing drug for the treatment of CRU. The effect seen was not only during the 6 months of therapy, but also extended to 12 months to maintain BCVA and inflammation control. The side effects were acceptable.

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Fig. 1: Best-corrected visual acuity of the patients over the study period.
Fig. 2: Anterior chamber and vitreous cells SUN grading of the patients over the study period.
Fig. 3: Central foveal thickness of the patients over the study period.
Fig. 4: Steroid-sparing effect of mycophenolate sodium over the study period.

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Funding

CMRPG3B0441, CORPG3C0081.

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Correspondence to Yih-Shiou Hwang MD, PhD.

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The authors declare that they have no conflict of interest.

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Medical Ethics Committee approval # NCT01261169, Chang Gung Memorial Hospital.

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Chen, T.S., Tsang, W.M., Enkh-Amgalan, I. et al. Mycophenolate sodium in the treatment of corticosteroid-refractory non-infectious inflammatory uveitis (MySTRI study). Eye 34, 2098–2105 (2020). https://doi.org/10.1038/s41433-020-1066-y

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