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Title: The European Ankylosing Spondylitis Infliximab Cohort (EASIC): a European multicentre study of long-term outcomes in patients with ankylosing spondylitis treated with infliximab
Authors: Heldmann, F.
Brandt, J.
van der Horst-Bruinsma, I. E.
Landewe, R.
Sieper, J.
Burmester, G. R.
van den Bosch, F.
de Vlam, K.
Gaston, H.
Schewe, S.
Appelboom, T.
Emery, P.
Dougados, M.
Leirisalo-Repo, M.
Breban, M.
Listing, J.
Braun, J.
Issue Date: 2011
Abstract: Objectives To study the long-term efficacy and safety of treatment with infliximab in patients with ankylosing spondylitis (AS) in a real life setting. Methods AS patients from 6 European countries who had finished the 2-year trial ASSERT were invited to participate in the open-label investigator-driven study EASIC. At baseline, 2 groups were formed: patients of group 1 had not been treated with infliximab after ASSERT, while those of group 2 had continuously received it. Patients of group I were further subdivided in group I a: patients with a relapse and 1b: in remission. All patients of group la and 2 continuously received infliximab for 96 weeks, mean dose 5 mg/kg, intervals 6-8 weeks. Patients of group 1b were also treated in case of relapse. Results A total of 103/149 patients (69%) were included in EASIC, 1.3 +/- 0.9 years after the end of ASSERT: 9 in group 1a, 5 in group 1b and 89 in group 2. Most patients were male (83%), mean age 44 years. Most patients of group 2 completed the trial (86%) vs. only 5 of group 1 (33%) mostly due to allergic reactions after readministration of infliximab. In total, there were 22 drop-outs due to 6 adverse events, 4 lack of efficacy, 3 planned pregnancy. All standard assessments indicated beneficial values over time, at week 96 significantly better than at baseline of ASSERT. Conclusion The majority, of patients were continuously and successfully treated with infliximab for 5 years, whereas discontinuation and reintroduction of therapy was less satisfactory due to the frequent occurrence of hypersensitivity reactions. Anti-TNF therapy with infliximab proved to be effective and safe on a long-term basis.
Notes: [Heldmann, F.; Braun, J.] Rheumazentrum Ruhrgebiet, D-44652 Herne, Germany. [Brandt, J.] Rheumapraxis Steglitz Charite, Berlin, Germany. [van der Horst-Bruinsma, I. E.] Vrije Univ Amsterdam Med Ctr, Amsterdam, Netherlands. [Landewe, R.] Acad Ziekenhuis Maastricht, Maastricht, Netherlands. [Sieper, J.] Charite Campus Benjamin Franklin, Berlin, Germany. [Burmester, G. R.] Charite Univ Med Berlin, Berlin, Germany. [van den Bosch, F.] Univ Ziekenhuis Ghent, Ghent, Belgium. [de Vlam, K.] Univ Hosp Leuven, Louvain, Belgium. [Geusens, P.] Univ Hasselt, Genk, Belgium. [Gaston, H.] Univ Cambridge, Cambridge CB2 1TN, England. [Schewe, S.] Klinikum Univ Munich, Munich, Germany. [Appelboom, T.] Hop Erasme Brussels, Brussels, Belgium. [Emery, P.] Univ Leeds, Leeds LS2 9JT, W Yorkshire, England. [Dougados, M.] Hop Cochin Paris, Paris, France. [Leirisalo-Repo, M.] Univ Cent Hosp Helsinki, Helsinki, Finland. [Breban, M.] Hop Ambroise Pare, Boulogne, France. [Listing, J.] Deutsch Rheumaforschungszentrum Berlin, Berlin, Germany.
Keywords: Rheumatology;ankylosing spondylitis; anti-TNF; infliximab
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ISSN: 0392-856X
e-ISSN: 1593-098X
ISI #: 000295351900010
Category: A1
Type: Journal Contribution
Validations: ecoom 2012
Appears in Collections:Research publications

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