Methods for Identifying Long-Term Adverse Effects of Treatment in Patients with Eye Diseases: The Systemic Immunosuppressive Therapy for Eye Diseases (SITE) Cohort Study

Abstract

Information from the SITE Cohort Study should clarify whether use of these immunosuppressive drugs for ocular inflammation increases the risk of mortality and fatal cancer. This epidemiologic approach may be useful for evaluating long-term risks of systemic therapies for other ocular diseases.

A systematic review and economic evaluation of adalimumab and dexamethasone for treating non-infectious intermediate uveitis, posterior uveitis or panuveitis in adults

“…7,8,34,37 Its poor discriminatory property for detecting changes in the lower VH grades and extensive inter-rater variations have been reported to be limitations of this system. 29,36,38 Inflammation in the AC is assessed on the basis of the number of cells per one field on standard slit-lamp examination or by high-speed optical coherence tomography. 8 Complications of structural changes in the eye as a result of uveitis are typically reported according to the type of complication.…”

Design and Interpretation of Clinic-Based Studies in Uveitis

“…Moreover, clinical questions exist for which well-designed cohort studies, case series, or even single case reports offer the best investigative approach. 20 Most often, in fact, there is a natural interdependence and evolution in the collection of clinical evidence from description, to identification of associations, and then to isolated and controlled testing of cause and effect. Dr. Lawrence Yannuzzi has illustrated these points eloquently in his editorial entitled ''A case for the case report and case series in evidence-based management of retinal disease.…”

Uveitis Treatment Trials—A Cross-study Perspective

“…Specifically, the Systemic Immunosuppression Therapy for Eye Disease (SITE) Study Group has now published long-term, retrospective, multicenter data on over 8500 patients with noninfectious ocular inflammatory disease, including uveitis, followed at selected tertiary referral centers in the United States. 16 The reports have summarized the investigators experience with 5 different immunosuppressive agents to-date: azathioprine, 17 methotrexate, 18 cyclophosphamide, 19 cyclosporine, 20 and mycophenolate mofetil. 21 Similarly, the Multicenter Uveitis Steroid Treatment (MUST) Trial Research Group has recently published 24-month, randomized, multicenter trial data comparing systemic therapy (corticosteroids plus immunosuppression when indicated) to Bausch & Lomb's fluocinolone acetonide intravitreal implant, 0.59 mg (Retisert; implant therapy) for noninfectious intermediate, posterior, or panuveitis.…”

“…[28][29][30][31] Response rate trends from both the SITE Cohort Study reports and the Proctor study suggest similar, although perhaps less dramatic, 12-month improvements in controlling inflammation and corticosteroid sparing success when systemic immunosuppressive therapy was used. In addition, the SITE study data, derived from the same treatment centers using the same analytic approach, 16 suggest the intriguing possibilities, by no means substantiated statistically, that the modest success at controlling inflammation with cyclosporine 20 may have come at the cost of increased corticosteroid exposure, and that mycophenolate mofetil 21 may have been particularly effective at controlling inflammation by 12 months. Cyclophosphamide 19 also appeared to be effective at controlling inflammation, but in a different patient population and with what appeared to be more toxicities and a higher discontinuation rate relative to other agents.…”