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.
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.
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.
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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Rothova A, Suttorp-van Schulten MS, Frits Treffers W, Kijlstra A. Causes and frequency of blindness in patients with intraocular inflammatory disease. Br J Ophthalmol. 1996;80:332–6.
Jones NP. The Manchester Uveitis Clinic: the first 3000 patients, 2: Uveitis Manifestations, complications, medical and surgical management. Ocul Immunol Inflamm. 2015;23:127–34.
Hughes EH, Dick AD. The pathology and pathogenesis of retinal vasculitis. Neuropathol Appl Neurobiol. 2003;29:325–40.
Verjans GM, van Hagen PM, van der Kooi A, Osterhaus AD, Baarsma GS. Vgamma9Vdelta2 T cells recovered from eyes of patients with Behcet’s disease recognize non-peptide prenyl pyrophosphate antigens. J Neuroimmunol. 2002;130:46–54.
Nussenblatt R. Treating intraocular inflammatory disease in the 21st century. Arch Ophthalmol. 2005;123:1000–1.
Atzeni F, Sarzi-Puttini P, Doria A, Iaccarino L, Capsoni F. Potential off-label use of infliximab in autoimmune and non-autoimmune diseases: a review. Autoimmun Rev. 2005;4:144–52.
Lipsky JJ. Mycophenolate mofetil. Lancet. 1996;348:1357–9.
Larkin G, Lightman S. Mycophenolate mofetil. A useful immunosuppressive in inflammatory eye disease. Ophthalmology. 1999;106:370–4.
Baltatzis S, Tufail F, Yu EN, Vredeveld CM, Foster CS. Mycophenolate mofetil as an immunomodulatory agent in the treatment of chronic ocular inflammatory disorders. Ophthalmology. 2003;110:1061–5.
Thorne JE, Jabs DA, Qazi FA, Nguyen QD, Kempen JH, Dunn JP. Mycophenolate mofetil therapy for inflammatory eye disease. Ophthalmology. 2005;112:1472–7.
Shen E, Rathinam SR, Babu M, Kanakath A, Thundikandy R, Lee SM, et al. Outcomes of Vogt-Koyanagi-Harada disease: a subanalysis from a randomized clinical trial of antimetabolite therapies. Am J Ophthalmol. 2016;168:279–86.
Budde K, Bauer S, Hambach P, Hahn U, Roblitz H, Mai I, et al. Pharmacokinetic and pharmacodynamic comparison of enteric-coated mycophenolate sodium and mycophenolate mofetil in maintenance renal transplant patients. Am J Transpl. 2007;7:888–98.
Kobashigawa J, Miller L, Renlund D, Mentzer R, Alderman E, Bourge R, et al. A randomized active-controlled trial of mycophenolate mofetil in heart transplant recipients. Mycophenolate Mofetil Investigators. Transplantation. 1998;66:507–15.
Budde K, Curtis J, Knoll G, Chan L, Neumayer HH, Seifu Y, et al. Enteric-coated mycophenolate sodium can be safely administered in maintenance renal transplant patients: results of a 1-year study. Am J Transpl. 2004;4:237–43.
Lee PC, Chang SS, Shieh SC, Wu ZC, Wang WM, Wang JD, et al. Cyclosporine or tacrolimus: which is the better partner for myfortic or cellcept? Transpl Proc. 2012;44:137–9.
Hummel M, Yonan N, Ross H, Miller LW, Sechaud R, Balez S, et al. Pharmacokinetics and variability of mycophenolic acid from enteric-coated mycophenolate sodium compared with mycophenolate mofetil in de novo heart transplant recipients. Clin Transpl. 2007;21:18–23.
Jabs DA, Nussenblatt RB, Rosenbaum JT. Standardization of uveitis nomenclature for reporting clinical data. Results of the First International Workshop. Am J Ophthalmol. 2005;140:509–16.
O’Neill TW, Rigby AS, Silman AJ, Barnes C. Validation of the International Study Group criteria for Behcet’s disease. Br J Rheumatol. 1994;33:115–7.
Read RW, Holland GN, Rao NA, Tabbara KF, Ohno S, Arellanes-Garcia L, et al. Revised diagnostic criteria for Vogt-Koyanagi-Harada disease: report of an international committee on nomenclature. Am J Ophthalmol. 2001;131:647–52.
Doycheva D, Zierhut M, Blumenstock G, Sobolewska B, Voykov B, Hohmann J, et al. Mycophenolate sodium for the treatment of chronic non-infectious uveitis of childhood. Br J Ophthalmol. 2016;100:1071–5.
Deuter CME, Engelmann K, Heiligenhaus A, Lanzl I, Mackensen F, Ness T, et al. Enteric-coated mycophenolate sodium in the treatment of non-infectious intermediate uveitis: results of a prospective, controlled, randomised, open-label, early terminated multicentre trial. Br J Ophthalmol. 2018;102:647–53.
Doycheva D, Jagle H, Zierhut M, Deuter C, Blumenstock G, Schiefer U, et al. Mycophenolic acid in the treatment of birdshot chorioretinopathy: long-term follow-up. Br J Ophthalmol. 2015;99:87–91.
Dick AD, Rosenbaum JT, Al-Dhibi HA, Belfort R Jr, Brezin AP, Chee SP, et al. Guidance on noncorticosteroid systemic immunomodulatory therapy in noninfectious uveitis: Fundamentals Of Care for UveitiS (FOCUS) initiative. Ophthalmology. 2018;125:757–73.
Herbort CP Jr, Abu El Asrar AM, Takeuchi M, Pavésio CE, Couto C, Hedayatfar A, et al. Catching the therapeutic window of opportunity in early initial-onset Vogt-Koyanagi-Harada uveitis can cure the disease. Int Ophthalmol. 2019;39:1419–25.
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The authors declare that they have no conflict of interest.
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