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Rheumatology Advance Access first published online on March 9, 2005
This version published online on March 15, 2005

Rheumatology, doi:10.1093/rheumatology/keh584
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© The Author 2005. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For Permissions, please email: journals.permissions@oupjournals.org
Received November 3, 2004
Accepted February 1, 2005

Original Papers

Persistent clinical response to the anti-TNF-{alpha} antibody infliximab in patients with ankylosing spondylitis over 3 years

J. Braun 1*, X. Baraliakos 2, J. Brandt 2, J. Listing 3, A. Zink 3, R. Alten 4, G. Burmester 5, E. Gromnica-Ihle 6, H. Kellner 7, M. Schneider 8, H. Sörensen 9, H. Zeidler 10, and J. Sieper 11

1 Rheumatology Medical Center Ruhrgebiet, Herne, Ruhr-University Bochum, Germany; University Medicine Berlin, Campus Benjamin Franklin, Herne, Germany
2 Rheumatology Medical Center Ruhrgebiet, Herne, Ruhr-University Bochum, Germany
3 German Rheumatism Research Center, Berlin, Germany
4 Schlosspark Clinic, Berlin, Germany
5 Charité Hospital, Humboldt University, Berlin, Germany
6 Berlin-Buch Hospital, Berlin, Germany
7 Ludwig Maximilians University, Munich, Germany
8 Heinrich Heine University, Düsseldorf, Germany
9 Immanuel Hospital, Berlin, Germany
10 Medical University, Hannover, Germany
11 University Medicine Berlin, Campus Benjamin Franklin, Herne, Germany; German Rheumatism Research Center, Berlin, Germany

* To whom correspondence should be addressed.
J. Braun, E-mail: J.Braun{at}Rheumazentrum-Ruhrgebiet.de


   Abstract

Objective. Infliximab, a monoclonal antibody against tumour necrosis factor {alpha} (TNF-{alpha}), is approved in Europe for the treatment of patients with active ankylosing spondylitis (AS) who have responded inadequately to conventional therapy. This report provides analyses from a 3-yr extension study, as a follow-up to both the 1- and 2-yr open label extensions of the original 3-month randomized controlled trial of infliximab in patients with AS.

Methods. Of the 49 patients with AS who completed the second year of the study, 46 continued treatment with infliximab 5 mg/kg every 6 weeks up to week 156. The Bath AS Disease Activity Index (BASDAI), the Bath AS Functional Index, the Bath AS Metrology Index, patient's and physician's global assessments, quality of life (Short Form-36), C-reactive protein (CRP) and erythrocyte sedimentation rate were assessed throughout the study period.

Results. The improvement of signs and symptoms observed in the majority of the patients during the first and second year was sustained throughout the third year of the study. Forty-three patients (62% of the 69 patients enrolled at baseline and 93% of the patients who started the third year) completed week 156. In the intention-to-treat analysis, an ASAS ‘5 out of 6’ and ASAS 40% response was seen by 46% and 50% of the patients, respectively. The scores for other efficacy assessments were similar to the values observed at weeks 54 and 102. Median CRP levels remained low (1.5 mg/l at week 156). There were no relevant side-effects and no discontinuation because of drug-related adverse events during the third year of the study.

Conclusions. Patients with AS receiving infliximab for 3 yr showed a durable clinical response without loss of efficacy. Long-term infliximab treatment was well tolerated by patients in this study.

Keywords: Ankylosing spondylitis; Infliximab; TNF-{alpha}.
This is a corrected version of that already published. In the previous version, the affiliations for J. Braun, X. Baraliakos and J. Brandt were given incorrectly. The author would like to apologise for this error.
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