Abstract
IntroductionThis 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.MethodsBetween 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.ResultsAfter 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.ConclusionsThis 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.
Highlights
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
Clinical evaluations performed at each infliximab infusion included 28 and 66 of 68 swollen and tender joint counts, erythrocyte sedimentation rate (ESR; mm/hr), C-reactive protein (CRP) level, Health Assessment Questionnaire (HAQ) [4], physician's global assessment of disease activity using a visual analogue scale (VAS; 0 to 100 mm) and patient's global assessment of disease activity (VAS 0 to 100 mm)
Continuation rates of infliximab therapy Of the initial 511 patients enrolled in the study, 507 effectively started infliximab therapy
Summary
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. Anti-TNF agents have become standard treatment for patients with rheumatoid arthritis (RA) refractory to non-biologic disease-modifying anti-rheumatic drug (DMARD) therapy. There is strong evidence in support of the short-term efficacy and safety of these agents [1,2], data from registries and cohorts are extremely important to evaluate the long-term treatment effects and safety issues. Long-term treatment continuation rates reflect safety, efficacy and compliance with therapy. Infliximab, primarily used in combination with methotrexate (MTX), is a highly effective therapy for the majority of RA patients. Increasing the dose or shortening the dosing intervals is a common practice and may differ between countries according to social security regulations or guidelines and national recommendations [3]
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