The European Ankylosing Spondylitis Infliximab Cohort (EASIC): a European multicentre study of long term outcomes in patients with ankylosing spondylitis treated with infliximab

Clinical and Experimental Rheumatology

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