Friederike Mackensen1,2, Carsten Heinz3, Eva Jakob1,2, Viviane Grewing1,2, Hanns-Martin Lorenz4, Arnd Heiligenhaus3, Regina Max2,4, Matthias D Becker1,2,5. 1. a Department of Ophthalmology , University Hospital of Heidelberg, Heidelberg , Germany. 2. b Interdisciplinary Uveitis Center , University of Heidelberg, Heidelberg , Germany. 3. c Department of Ophthalmology , at St Franziskus Hospital , Münster , Germany. 4. d Department of Internal Medicine V, University Hospital of Heidelberg, Heidelberg, Germany. 5. e Department of Ophthalmology , Triemli Hospital, Zürich , Switzerland.
Abstract
PURPOSE:TNF alpha inhibitors have revolutionized the care of vision-threatening uveitis. This study evaluated the efficacy of adalimumab (ADA) for the treatment of refractory noninfectious uveitis. DESIGN: Randomized, prospective, controlled, two-center clinical trial Methods:Patients with active uveitis despite combined oral low-doseprednisolone and immunosuppression were randomized for additional ADA with corticosteroids in a fixed tapering regime, or corticosteroids only. Primary outcome measure at three months was improved best-corrected visual acuity (BCVA; >2 lines). In case of treatment failure, switch to the other arm was possible. RESULTS:Twenty-five patients (10 ADA, 15 controls) were included. BCVA increased with ADA by > 2 lines in 6/10 patients (60%; mean increase of 0.23 logMAR), but in only 2/15 from controls (13%, mean increase of 0.04 logMAR, Fisher´s exact test p = 0.00221). CONCLUSIONS: The results show superiority of ADA over controls in severe ocular inflammation including anterior uveitis.
RCT Entities:
PURPOSE:TNF alpha inhibitors have revolutionized the care of vision-threatening uveitis. This study evaluated the efficacy of adalimumab (ADA) for the treatment of refractory noninfectious uveitis. DESIGN: Randomized, prospective, controlled, two-center clinical trial Methods:Patients with active uveitis despite combined oral low-dose prednisolone and immunosuppression were randomized for additional ADA with corticosteroids in a fixed tapering regime, or corticosteroids only. Primary outcome measure at three months was improved best-corrected visual acuity (BCVA; >2 lines). In case of treatment failure, switch to the other arm was possible. RESULTS: Twenty-five patients (10 ADA, 15 controls) were included. BCVA increased with ADA by > 2 lines in 6/10 patients (60%; mean increase of 0.23 logMAR), but in only 2/15 from controls (13%, mean increase of 0.04 logMAR, Fisher´s exact test p = 0.00221). CONCLUSIONS: The results show superiority of ADA over controls in severe ocular inflammation including anterior uveitis.
Authors: M D Becker; R Max; A Dimitriou; T Saurenmann; H-M Lorenz; A Jansen; S Lortz; J Grulich-Henn; M Weber Journal: Z Rheumatol Date: 2018-08 Impact factor: 1.372