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Michael M Altaweel, John H Kempen, Lea T. Drye, Janet T. Holbrook, Douglas A Jabs, Elizabeth A Sugar, Jennifer E Thorne, Multicenter Uveitis Steroid Treatment (MUST) Trial Follow-up Study Research Group; Risks and Quality of Life associated with Fluocinolone Acetonide Intraocular Implant Versus Systemic Anti-inflammatory Therapy for Intermediate, Posterior or Panuveitis: 4.5 year results of The Multicenter Uveitis Steroid Treatment Trial and Follow-up Study. Invest. Ophthalmol. Vis. Sci. 2015;56(7 ):5774.
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To evaluate the risks and quality of life outcomes of fluocinolone acetonide implant therapy versus systemic corticosteroid therapy supplemented with immunosuppression when indicated for intermediate, posterior, and panuveitis.
255 subjects with intermediate, posterior, or panuveitis (479 eyes) randomized to systemic treatment or implant were followed for 54 months. Local and systemic potential complications of the therapies and self-reported health utility, vision-related and generic health-related quality of life (QoL) were studied prospectively.
Over 54 months, phakic eyes developed cataract and required cataract surgery more often in the implant group (hazard ratio (HR)=2.2, p=0.003 and HR=4.0, p<0.0001). IOP elevation measures occurred more frequently in the implant group (range of HR’s=3.7-5.6, p<0.0001), and glaucoma occurred more frequently (26.3% vs. 10.2%, HR=3.0, p=0.0002). In contrast, potential complications of systemic therapy including measures of hypertension, hyperlipidemia, diabetes, bone disease, and hematological and serum chemistry indicators of immunosuppression toxicity did not differ significantly between groups. Indices of quality of life initially favored implant therapy by a modest margin, but summary measures of health utility and vision-related or generic health-related QoL were minimally different by 54 months. The SF-36 physical component summary score favored implant by a small margin (3.17 on a scale of 100, p=0.01). Mean QoL results were favorable in both groups.
Fluocinolone acetonide implant therapy is associated with a clinically important increased risk of glaucoma and cataract with respect to systemic therapy. These complications potentially can be addressed surgically. Despite regular follow-up and available treatment, the implant group had a 16% excess risk of glaucoma, suggesting that careful monitoring and early intervention is warranted to prevent progression. A treatment regimen of systemic corticosteroid and immunosuppressive therapies following consensus recommendations was well tolerated with minimal toxicities. Self-reported QoL measures initially favored implant therapy, but over time the measures converged, with generally favorable QoL in both groups.
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