Rheumatology Advance Access originally published online on November 23, 2004
Rheumatology 2005 44(3):342-348; doi:10.1093/rheumatology/keh475
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Rheumatology Vol. 44 No. 3 © British Society for Rheumatology 2004; all rights reserved
Long-term efficacy and safety of etanercept after readministration in patients with active ankylosing spondylitis
1 Department of Gastroenterology/Rheumatology, Charité, Medical University Berlin, Campus Benjamin Franklin, 2 Epidemiology Department, German Rheumatism Research Center Berlin, 3 Immanuel Hospital Berlin, Berlin, 4 Wyeth Pharma, Münster and 5 Center of Rheumatology Ruhrgebiet, Herne, Germany.
Correspondence to: J. Braun, Rheumazentrum Ruhrgebiet, Landgrafenstrasse 15, 44652 Herne, Germany. E-mail: J.Braun{at}rheumazentrum-ruhrgebiet.de
Objectives. Treatment of ankylosing spondylitis (AS) with the tumour necrosis factor 
(TNF-) receptor fusion protein etanercept has shown efficacy in patients with active disease in randomized controlled trials (RCTs) for limited periods. The objective of the study was to assess the long-term efficacy and safety of etanercept over 1 yr, including discontinuation and readministration.
Methods. In this 54-week open observational study, 26 AS patients received 25 mg etanercept subcutaneously twice weekly after several months of discontinuation following a 6-month RCT with the same agent. All patients who developed high disease activity after cessation of etanercept, defined as a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 
4 and pain 4 on a numerical rating scale, entered the study. Standard assessment tools, such as the Bath Ankylosing Spondylitis functional index (BASFI), were used. An intention-to-treat (ITT) and a completer analysis were performed. The results were compared with the baseline values of the open study.
Results. Out of the initial 30 patients, 26 (87%) were eligible for the open extension study after a mean of about 27 weeks. At week 54, 23/26 patients (88%) were still on treatment with etanercept. The ITT analysis showed that 58% (95% confidence interval 39–74%) of the patients achieved a 50% improvement of BASDAI at week 54. According to the Assessments in Ankylosing Spondylitis working group criteria, 8/26 patients (31%) were in partial remission at week 54. Function, metrology and quality of life improved significantly. Only one patient had a serious adverse event that resulted in discontinuation.
Conclusions. This study shows that treatment with etanercept is efficacious and safe after readministration over 1 yr in patients with active AS not taking DMARDs or steroids.
KEY WORDS: Therapy of ankylosing spondylitis, Tumour necrosis factor , Etanercept
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