Christine Fardeau1, Anne Simon2, Benoît Rodde3, Fabiana Viscogliosi4, Pierre Labalette5, Vincent Looten6, Sophie Tézenas du Montcel6, Phuc LeHoang4. 1. Ophthalmology Department, Reference Centre for Rare Diseases, Pitié-Salpétrière Hospital, University Paris VI, DHU Sight Restore, Paris, France. Electronic address: christine.fardeau@aphp.fr. 2. Internal Medicine Department, Pr S. Herson, Pitié-Salpétrière Hospital, University Paris VI, Paris, France. 3. Psychiatry Department, Pitié-Salpétrière Hospital, University Paris VI, Paris, France. 4. Ophthalmology Department, Reference Centre for Rare Diseases, Pitié-Salpétrière Hospital, University Paris VI, DHU Sight Restore, Paris, France. 5. Ophthalmology Department, University Hospital, Lille, France. 6. Department of Biostatistics Public Health and Medical Informatics, Pitié-Salpétrière Hospital, University Paris VI, Paris, France.
Abstract
PURPOSE: Macular edema is the leading cause of vision loss in bilateral chronic noninfectious posterior uveitis, and is currently being treated using corticosteroids, immunosuppressive agents, and biotherapies. The aim of this trial was to assess and compare the efficacy and safety of corticosteroids and interferon-α (IFN-α) in adults with such conditions. DESIGN: Randomized controlled trial. METHODS:Subjects: Adult patients with bilateral posterior autoimmune noninfectious and nontumoral uveitis complicated by macular edema in at least 1 eye. INTERVENTION: Patients received either subcutaneous IFN-α2a, systemic corticosteroids, or no treatment for 4 months. The efficacy and safety were assessed for up to 4 months. MAIN OUTCOME MEASURES: The main endpoint was the change of the central foveal thickness (CFT) obtained by optical coherence tomography. RESULTS:Forty-eight patients were included. In intention-to-treat analysis, the median CFT change showed no significant difference. However, the per-protocol analysis showed a significant difference between groups for both eyes (OD and OS), and for the worse and better eyes. Statistically significant difference was found between the control and corticosteroid groups for the OD (P = .0285), and between the control and IFN-α groups for the OD (P = .0424) and worse eye (P = .0354). Serious adverse events occurred in 2 patients in the IFN group, in 1 patient in the corticosteroid group, and in 2 patients in the control group and were completely resolved after switch. CONCLUSIONS: IFN-α and systemic corticosteroids, compared with no treatment, were associated with significant anatomic and visual improvement shown in the per-protocol study.
RCT Entities:
PURPOSE: Macular edema is the leading cause of vision loss in bilateral chronic noninfectious posterior uveitis, and is currently being treated using corticosteroids, immunosuppressive agents, and biotherapies. The aim of this trial was to assess and compare the efficacy and safety of corticosteroids and interferon-α (IFN-α) in adults with such conditions. DESIGN: Randomized controlled trial. METHODS: Subjects: Adult patients with bilateral posterior autoimmune noninfectious and nontumoral uveitis complicated by macular edema in at least 1 eye. INTERVENTION: Patients received either subcutaneous IFN-α2a, systemic corticosteroids, or no treatment for 4 months. The efficacy and safety were assessed for up to 4 months. MAIN OUTCOME MEASURES: The main endpoint was the change of the central foveal thickness (CFT) obtained by optical coherence tomography. RESULTS: Forty-eight patients were included. In intention-to-treat analysis, the median CFT change showed no significant difference. However, the per-protocol analysis showed a significant difference between groups for both eyes (OD and OS), and for the worse and better eyes. Statistically significant difference was found between the control and corticosteroid groups for the OD (P = .0285), and between the control and IFN-α groups for the OD (P = .0424) and worse eye (P = .0354). Serious adverse events occurred in 2 patients in the IFN group, in 1 patient in the corticosteroid group, and in 2 patients in the control group and were completely resolved after switch. CONCLUSIONS: IFN-α and systemic corticosteroids, compared with no treatment, were associated with significant anatomic and visual improvement shown in the per-protocol study.
Authors: Mathilde Leclercq; M Le Besnerais; V Langlois; N Girszyn; Y Benhamou; C Ngo; H Levesque; M Muraine; J Gueudry Journal: Clin Rheumatol Date: 2018-02-03 Impact factor: 2.980