Clinical and Experimental Rheumatology | |
The European Ankylosing Spondylitis Infliximab Cohort (EASIC): a European multicentre study of long term outcomes in patients with ankylosing spondylitis treated with infliximab | |
Jurgen Braun1  H. Gaston1  Robert Landewe1  Paul Emery1  T. Appelboom1  Frank Heldmann1  Kurt de Vlam1  J. Brandt1  Filip van den Bosch1  J. Listing1  I.E. van der Horst-Bruinsma1  Gerd R. Burmester1  Stefan Schewe1  Piet Geusens1  Joachim Sieper1  Maxime Dougados1  Marjatta Leirisalo-Repo1  Maxime Breban1  | |
关键词: Ankylosing spondylitis; infliximab; EASIC; long term efficacy; long term safety; EASIC; Infliximab; ankylosing spondylitis; EASIC; | |
DOI : | |
学科分类:医学(综合) | |
来源: Pacini Editore SpA | |
【 摘 要 】
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 1 were further subdivided in group 1a: patients with a relapse and 1b: in remission. All patients of group 1a 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. CONCLUSIONS: 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.
【 授权许可】
Unknown
【 预 览 】
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RO201912020417253ZK.pdf | 1135KB | download |