Study Demonstrates Ability to Preserve Long-Term Vision for Severe Patients with Uveitis
Research Examines Effectiveness of Leading Treatment Approaches
Researchers comparing leading treatment approaches for patients with severe uveitis have discovered that systemic therapy with oral corticosteroids and immunosuppression can preserve or improve vision in the long term better than regional implant therapy can. The results, published in the May 6, 2017 issue of JAMA, should reassure physicians about the relative safety of this approach, and may lead ophthalmologists to change their treatment protocol for better and safer outcomes.
Douglas Jabs, MD, MBA, Director of the Eye and Vision Research Institute, New York Eye and Ear Infirmary of Mount Sinai, and Professor of Ophthalmology and Medicine, Icahn School of Medicine at Mount Sinai, chaired an international team of researchers as they examined the long-term effects of two treatment approaches for patients with vision-threatening uveitis. Uveitis, the fifth leading cause of vision loss in the United States, is a collection of more than 30 diseases characterized by inflammation inside the eye that damages the tissues; without appropriate treatment, it will often lead to visual impairment or blindness. For more severe cases, treatment generally calls for taking oral corticosteroid and immunosuppressive medications. The alternative is regional therapy, either with repetitive corticosteroid injections or with a surgically placed fluocinolone acetonide implant that releases corticosteroid medication over three years. Since most of the more severe uveitis cases are chronic, long-term therapy is typically needed.
The Multicenter Uveitis Steroid Treatment (MUST) Trial Follow-up Study followed 215 patients from the original MUST Trial for seven years. The MUST Trial and Follow-up Study were conducted at 21 medical centers across the United States, along with two sites in the United Kingdom and Australia. Patients in the Trial had been randomized to receive either systemic treatment with oral corticosteroids and immunosuppression or regional therapy with the fluocinolone acetonide implant. At the seven-year mark, the findings showed that patients taking oral medications had better vision on average, compared to those in the implant group. The results differ from the initial MUST Trial findings and from the earlier five-year results of the MUST Follow-up Study, in which the same patients had similar visual outcomes at both time points.
The MUST Trial and Follow-up Study also showed that there was no significant increase in the risks of systemic side effects for the systemic therapy group compared to implant therapy, with one exception: patients in the systemic group were more likely to receive antibiotics for infections. These outcomes suggest that systemic treatment, if used properly, may be given relatively safely for up to seven years.
“The implication of these data is that oral corticosteroids and immunosuppression may be a preferable initial choice for therapy of the more severe uveitides,” explained Dr. Jabs. They have better visual outcomes long-term, fewer ocular side effects, and no apparent significant increase in the risk of systemic side effects, except for the greater use of antibiotics.”
While the large majority of both groups maintained good vision at the end of seven years, some patients with the fluocinolone acetonide implant did worse in terms of visual acuity. Results of the follow-up study show vision loss occurred more often in the implant group due to damage from inflammatory lesions in the back of the eye, which occurred at the time of relapse of the uveitis. Even though the implant is designed to release corticosteroid medication for three years, the study found that the benefit lasted approximately five years, with relapses beginning at that time. Relapses can be treated with an implant exchange or by switching to systemic therapy.
“Although both treatment approaches control the inflammation in the large majority of patients, for the first five years the implant was better than systemic therapy at controlling inflammation. Hence it has value for those patients where systemic therapy cannot control the inflammation or for those patients who cannot tolerate the oral medications,” said Dr. Jabs. He notes the implant has an important role to play in the management of these diseases. “The visual loss that occurred in the implant group with relapse of the uveitis emphasizes the need of sustained control of inflammation in order to optimize visual outcomes in patients. These patients need close follow-up for reactivation of the inflammation, so that appropriate adjustments to treatment can be made.”
The National Eye Institute (NEI), which is part of the National Institutes of Health, supported the MUST Trial and MUST Trial Follow-up Study.
About the Mount Sinai Health System
The Mount Sinai Health System is New York City's largest integrated delivery system encompassing (with the addition of South Nassau Communities Hospital) eight hospital campuses, a leading medical school, and a vast network of ambulatory practices throughout the greater New York region. Mount Sinai's vision is to produce the safest care, the highest quality, the highest satisfaction, the best access and the best value of any health system in the nation. The Health System includes approximately 7,480 primary and specialty care physicians; 11 joint-venture ambulatory surgery centers; more than 410 ambulatory practices throughout the five boroughs of New York City, Westchester, Long Island, and Florida; and 31 affiliated community health centers. The Icahn School of Medicine is one of three medical schools that have earned distinction by multiple indicators: ranked in the top 20 by U.S. News & World Report's "Best Medical Schools", aligned with a U.S. News & World Report's "Honor Roll" Hospital, No. 12 in the nation for National Institutes of Health funding, and among the top 10 most innovative research institutions as ranked by the journal Nature in its Nature Innovation Index. This reflects a special level of excellence in education, clinical practice, and research. The Mount Sinai Hospital is ranked No. 18 on U.S. News & World Report's "Honor Roll" of top U.S. hospitals; it is one of the nation's top 20 hospitals in Cardiology/Heart Surgery, Gastroenterology/GI Surgery, Geriatrics, Nephrology, and Neurology/Neurosurgery, and in the top 50 in six other specialties in the 2018-2019 "Best Hospitals" issue. Mount Sinai's Kravis Children's Hospital also is ranked nationally in five out of ten pediatric specialties by U.S. News & World Report. The New York Eye and Ear Infirmary of Mount Sinai is ranked 11th nationally for Ophthalmology and 44th for Ear, Nose, and Throat. Mount Sinai Beth Israel, Mount Sinai St. Luke's, Mount Sinai West, and South Nassau Communities Hospital are ranked regionally.