# ADalimumab Vs. conventional ImmunoSupprEssion for uveitis(ADVISE) Trial

> **NIH NIH UG1** · JOHNS HOPKINS UNIVERSITY · 2021 · $2,640,821

## Abstract

PROJECT SUMMARY/ABSTRACT
The uveitides are a collection of diseases characterized by intraocular inflammation. Collectively, they are the
5th leading cause of blindness in the US, and the estimated cost of treating them is similar to that of treating
diabetic retinopathy. Non-infectious intermediate, posterior, and panuveitides have the highest rates of visual
loss and typically are treated with oral corticosteroids and immunosuppression. The Multicenter Uveitis Steroid
Treatment (MUST) Trial (a randomized, comparative effectiveness trial, which compared 2 treatment
paradigms for these diseases, systemic therapy with corticosteroids and immunosuppression vs. regional
therapy [the fluocinolone acetonide implant]), and Follow-up Study demonstrated the superiority of the
systemic approach to the regional ocular approach in terms of long-term visual outcomes with essentially no
increase in systemic side effects in the systemic group. One key to systemic therapy's success was the use of
systemic immunosuppression in 88% of participants, coupled with tapering the prednisone to <7.5 mg/day, a
relatively safe dose. The drugs used most often used are azathioprine, methotrexate, mycophenolate,
cyclosporine, and tacrolimus. The alkylating agents, cyclophosphamide and chlorambucil, are used less often
because of concerns about potential increased malignancy risk. Available data suggest that single-agent
conventional, non-alkylating-agent, immunosuppressive drugs are effective in controlling the inflammation
while permitting tapering prednisone to <10 mg/day in ~40-55% of patients; hence, combination therapy often
is needed. Minimizing the daily dose of prednisone is important, as the risk of cardiovascular disease and
mortality increases with the cumulative dose of oral corticosteroids. In June 2016, the fully-human, anti-TNF-α
monoclonal antibody, adalimumab, was approved by the US Food and Drug Administration (FDA) for the
treatment of uveitis. Anti-TNF-α monoclonal antibody therapy has revolutionized the management of the
rheumatic diseases largely due to its superior efficacy compared to conventional Disease Modifying Anti-
Rheumatic Drugs. Data from VISUAL III, the extension of the two phase 3 trials that led to the FDA approval of
adalimumab for the treatment of uveitis, suggest that adalimumab may be superior to conventional
immunosuppression, as ~75% of participants had controlled inflammation with prednisone doses <5 mg/day
sustained through 1 year of follow-up. The ADalimumab Vs. conventional ImmunoSupprEssion for uveitis
(ADVISE) Trial is a randomized, comparative effectiveness trial comparing adalimumab to conventional agent
immunosuppression for patients with non-infectious, intermediate, posterior, and panuveitides. The primary
outcome is the ability to successfully taper prednisone to <7.5 mg/day by 6 months after randomization while
maintaining control of the inflammation. Secondary outcomes include prednisone discontinuation with
inflammatio...

## Key facts

- **NIH application ID:** 10233818
- **Project number:** 5UG1EY028091-04
- **Recipient organization:** JOHNS HOPKINS UNIVERSITY
- **Principal Investigator:** Janet T. Holbrook
- **Activity code:** UG1 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $2,640,821
- **Award type:** 5
- **Project period:** 2018-09-30 → 2023-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10233818

## Citation

> US National Institutes of Health, RePORTER application 10233818, ADalimumab Vs. conventional ImmunoSupprEssion for uveitis(ADVISE) Trial (5UG1EY028091-04). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10233818. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*