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Prospective study of the efficacy and safety of mycophenolate mofetil in patients with noninfectious uveitis and scleritis

the efficacy and safety of mycophenolate mofetil

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Ten patients were enrolled (7 women; median age, 54,5 years) Types of diseases were Vogt-Koyanagi-Harada disease (n=4), retinal vasculitis (n=3) sarcoidosis (n=1), sympathetic ophthalmia (n=1), and scleritis(n=1). Previous treatments were prednisolone only (n=8), prednisolone/cyclosporine/methotrexate (n=1), and prednisolone/methotrexate (n=1)

The number of registrations reached 10 within 6 months after starting the study. All patients who underwent screening were registered."

Hepatotoxicity occurred in one patient. It was considered a drug induced liver injury. Level of liver enzymes improved upon discontinuation of MMF.

MMF was safely continued in 90 % of the noninfectious uveitis/scleritis patients who were steroid-resistant/intolerant. 10 % of the patients experienced hepatotoxicity. Other non-serious systemic symptoms, such as GI symptoms, headache, and fatigue did not occur during the study period. Ocular inflammation of 70 % of patients was controlled (inactive) under prednisolone less than or equal to 5mg/day, topical betamethasone less than or equal to 2 times/day, without STTA. Best-corrected visual acuity and laser flare values both showed improvement and the dose of prednisolone (median, in milligram) improved from 15mg at 0month, to 7.5mg in 3 months, 2.75mg in 6 months, and 0mg at 12 months.

MMF may be safely used as a steroid-sparing agent among Japanese patients with non-infectious uveitis and scleritis. Further research is needed to determine the efficacy of MMF based on different types of diseases.

Dec. 20, 2024

April. 22, 2025

https://www.tandfonline.com/doi/full/10.1080/09273948.2025.2492773

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https://jrct.mhlw.go.jp/latest-detail/jRCTs061220030

Hiyama Tomona

Hiroshima University Hospital

1-2-3 Kasumi, Minami-ku, Hiroshima City, Hiroshima 734-8551,JAPAN

thiyama@hiroshima-u.ac.jp

Hiyama Tomona

Hiroshima University Hospital

1-2-3 Kasumi, Minami-ku, Hiroshima City, Hiroshima 734-8551,JAPAN

+81-82-257-5247

thiyama@hiroshima-u.ac.jp

Complete

June. 09, 2022

Interventional

single arm study

open(masking not used)

active control

single assignment

treatment purpose

1) Age at the time of consent acquisition is 18 years or older
2) Patients who can go to the outpatient clinic every 4 to 12 weeks after the start of administration
3) Patients who have written consent to participate in this study
4) Non-infectious uveitis (intermediate, anterior intermediate, posterior, panuveitis) with a history of at least one eye
5) At least one eye with active eye inflammation for 90 days or more, SUN criteria, over 2 cells in the anterior chamber, over 2 vitreous opacity, retinal choroidal lesions
6) Patients who are visiting our hospital for at least one of the following.
If there is an activity of eye inflammation even after administration of prednisolone, equivalent to 1
mg/ kg, for 4 weeks.
When the anti-inflammatory effect is obtained by oral prednisolone treatment equivalent to 0.5-1mg/ kg and the relapse of inflammation due to the gradual decrease in oral administration is within 90 days before registration.
If oral steroids are more than 10 mg/day are required 90 days before registration.
Uveitis that chronically requires immunosuppressive agents, Behcet's disease, polyfocal chorioretinitis,
retinal vasculitis, chronic recurrent stage Vogt Koyanagi Harada's disease, sympathetic ophthalmia,
When steroids cannot be used for a long time due to side effects.
7) Patients who fall under any of the following.
male (No need for contraception) / Women who consent to contraception before, during, and after discontinuation of this drug for 6 weeks / Women who are judged to be medically infertile.

1) Infectious uveitis
2) Patients who cannot see through the fundus due to binocular cataract, corneal opacity, post-iris adhesion, etc.
3) Chronically low intraocular pressure in both eyes, IOP less than 5 mmHg, 3 months
4) Patients who underwent endovascular surgery within 3 months before the start of administration of this drug.
5) Patients who received immunosuppressive agents other than steroids within 12 months before the start of administration of this drug.
6) Patients positive for hepatitis virus and tuberculosis syphilis.
7) In patients with severe renal disease, serum Cr 1.5 mg / dL or higher or CKD stage 3b or higher.
8) Patients with systemic autoimmune disease.
9) Patients with the following complications, Liver disease, mental illness, seizure and paroxysmal disease, heart disease due to other causes.
10) Patients who have had serious side effects with immunosuppressants in the past.
11) Patients with malignant disease.
12) Patients who fall under the contraindications for MMF.
13) Patients who fall under at least one of the following.
White blood cells less than 2500 / uL, Platelets less than 75000 / uL, hemoglobin less than 9g / dL,
AST / ALT is more than twice the normal upper limit, Creatinine more than 1.5mg / dL
14) Pregnant or lactating females, females who may be pregnant or who wish to have children.
15) Patients who are participating in or willing to participate in other clinical studies while participating in this study.
16) When it is determined that it interferes with, limits, or confuses the evaluation specific to the clinical research plan.
17) Employees of the investigator or the implementing medical institution that are directly
involved in this research or other clinical research, or the family of such employees or the investigator.

Both

Noninfectious uveitis and scleritis

Administration of mycophenolate mofetil

safety

1) Response rate, Based on the efficacy assessment of the Standardization of Uveitis Nomenclature, SUN, for uveitis and the Standardized grading system for scleritis, oral steroids less than 5 mg/day and betamethasone installation less than 2 times/day
2) Time to control eye inflammation
3) Time to treatment success
4) Percentage of treatment success
5) Changes in corrected visual acuity
6) Changes in intraocular pressure
7) Changes in laser flare value
8) Presence or absence of macular edema
9) Changes in central retina film thickness
10) Changes in vitreous opacity
11) Therapeutic effect in middle / posterior / panuveitis and scleritis
12) Percentage of discontinuation of oral administration due to side effects
13) Percentage of discontinuation of oral administration due to drug intolerance
14) Visually related health-related quality of life

+81-82-257-1551

May. 11, 2022

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