Rheumatology Advance Access published online on November 23, 2004
Rheumatology, doi:10.1093/rheumatology/keh475
Rheumatology © British Society for Rheumatology 2004; all rights reserved
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1 Department of Gastroenterology/Rheumatology, Charité, Medical University Berlin, Campus Benjamin Franklin, Germany
* To whom correspondence should be addressed. Objective. Treatment of ankylosing spondylitis (AS) with the tumour necrosis factor 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) 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. Conclusion. 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.
Accepted October 12, 2004
Original Papers
Long-term efficacy and safety of etanercept after readministration in patients with active ankylosing pondylitis
2 Epidemiology Department, German Rheumatism Research Center Berlin, Germany
3 Immanuel Hospital Berlin, Berlin, Germany
4 Wyeth Pharma, Münster, Germany
5 Department of Gastroenterology/Rheumatology, Charité, Medical University Berlin, Campus Benjamin Franklin, Germany; Epidemiology Department, German Rheumatism Research Center Berlin, Germany
6 Department of Gastroenterology/Rheumatology, Charité, Medical University Berlin, Campus Benjamin Franklin, Germany; Center of Rheumatology Ruhrgebiet, Herne, Germany
J. Brandt, E-mail: J.Braun{at}rheumazentrum-ruhrgebiet.de
Abstract 
(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.
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.; Etanercept.
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