INTRODUCTION: This study is based on the results from a Belgian expanded access 
program in which patients with active refractory and erosive rheumatoid 
arthritis (RA) were treated with intravenous infusions of infliximab in 
combination with methotrexate. The objectives of this study were to evaluate the 
continuation rate of infliximab and its clinical effect over a 7-year period and 
to document the reasons for discontinuation.
METHODS: Between 2000 and 2001, 511 patients with severe and refractory RA were 
enrolled and treated with infliximab. After 7 years, apart from routine clinical 
follow-up, treating rheumatologists were asked to complete a questionnaire 
designed specifically for the present study to evaluate the current therapy with 
infliximab, the level of disease activity (Disease Activity Score in 28 joints 
[DAS28]) and the reasons for infliximab discontinuation.
RESULTS: After 7 years, 160 of 511 patients (31%) were still on infliximab 
treatment. The major reasons for infliximab discontinuation included lack of 
efficacy (104 patients), adverse events (107 patients) and elective change of 
therapy (70 patients). The majority of cases of treatment discontinuation for 
safety reasons occurred during the first 2 years. In contrast, discontinuation 
due to ineffectiveness showed a more constant rate over the 7-year period. Mean 
DAS for patients still on treatment with infliximab decreased from 5.7 (standard 
error [SE] 0.1) at baseline to 3.0 (SE 0.1) at year 4 and remained that low 
until year 7 (3.0 [SE 0.1]). Low disease activity (defined as DAS28<3.2) was 
present in 60.9% of patients, and 45.5% achieved remission (DAS28<2.6). DAS28 at 
the time of treatment discontinuation due to ineffectiveness decreased over the 
7-year period from 5.6 (SE 0.3) in 2001 to 4.8 (SE 0.3) in 2008.
CONCLUSIONS: This observational study revealed that patients who continue to 
receive infliximab experience sustained clinical benefit. The majority of safety 
issues occurred during the first 2 years of infliximab therapy. We observed that 
the DAS at the time of therapy discontinuation showed a trend to decrease over 
time.