The primary efficacy end point was the time to treatment failure occurring at or after week 6. All patients received a mandatory prednisone burst followed by tapering of prednisone over the course of 15 weeks. Patients were randomly assigned in a 1:1 ratio to receive adalimumab (a loading dose of 80 mg followed by a dose of 40 mg every 2 weeks) or matched placebo. Investigators and patients were unaware of the study-group assignments.
This multinational phase 3 trial involved adults who had active noninfectious intermediate uveitis, posterior uveitis, or panuveitis despite having received prednisone treatment for 2 or more weeks. We conducted a trial to assess the efficacy and safety of adalimumab as a glucocorticoid-sparing agent for the treatment of noninfectious uveitis. Patients with noninfectious uveitis are at risk for long-term complications of uncontrolled inflammation, as well as for the adverse effects of long-term glucocorticoid therapy.
Franziskus-Hospital Münster, Münster (A.H.), University of Duisburg-Essen, Essen (A.H.), and AbbVie Deutschland, Ludwigshafen (A.C., M.K.) - all in Germany University of Texas Health Science Center, San Antonio (D.S.) Metropolitan Eye Research and Surgery Institute, Palisades Park, NJ (D.S.C.) AbbVie, North Chicago, IL (N.V.K., A.P.S., S.T.) and Casey Eye Institute, Oregon Health and Science University, and VA Portland Health Care System (E.B.S.) - both in Portland. 1 From Duke University, Durham, NC (G.J.J.) University of Bristol, Bristol Eye Hospital, Bristol, and National Institute for Health Research Biomedical Research Centre at Moorfields Eye Hospital and University College London Institute of Ophthalmology, London - both in the United Kingdom (A.D.D.) Université Paris Descartes, Hôpital Cochin, Paris (A.P.B.) Truhlsen Eye Institute, University of Nebraska Medical Center, Omaha (Q.D.N.) Johns Hopkins Medical Institute, Baltimore (J.E.T.) Ghent University Hospital, Ghent, Belgium (P.K.) Laura Bassi Center of Expertise Ocuvac, Medical University of Vienna, Vienna (T.B.-A.) Organización Médica de Investigación, Buenos Aires (P.F.) the Department of Ophthalmology, St.
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