Abstract
Although there is strong evidence supporting the short-term efficacy and safety of anti-tumour necrosis factor-α agents, few studies have examined the long-term effects. We evaluated 511 patients with long-standing refractory rheumatoid arthritis treated with intravenous infusions of infliximab 3 mg/kg at weeks 0, 2, 6, and 14 and every 8 weeks thereafter for 4 years. Among the initial 511 patients included in the study, 479 could be evaluated; of these, 295 (61.6%) were still receiving infliximab treatment at year 4 of follow-up. The most common reasons for treatment discontinuation were lack of efficacy (65 patients, 13.6%), safety (81 patients, 16.9%), and elective change (38 patients, 7.9%). Analysis of disease activity scores (DAS28 [disease activity score based on the 28-joint count]) over time showed that, after the initial rapid improvement during the first 6 to 22 weeks of therapy, a further decrease in disease activity of 0.2 units in the DAS28 score per year was observed. DAS28 scores, measured at week 14 or 22, were found to predict subsequent discontinuation due to lack of efficacy. In conclusion, long-term maintenance therapy with infliximab 3 mg/kg is effective in producing further reductions in disease activity. Disease activity measured by the DAS28 at week 14 or 22 of infliximab therapy was the best predictor of long-term attrition.
Highlights
After demonstration of effectiveness of anti-tumour necrosis factor (TNF)-α agents in patients with rheumatoid arthritis (RA) [1,2,3], their use has become common practice in treating patients with RA not responding to classical disease modifying anti-rheumatic drugs (DMARDs)
ACR = American College of Rheumatology; AUC = area under the curve; CI = confidence interval; CRP = C-reactive protein; DAS28 = disease activity score based on the 28-joint count; DMARD = disease-modifying anti-rheumatic drug; ESR = erythrocyte sedimentation rate; HAQ = health assessment questionnaire; MTX = methotrexate; RA = rheumatoid arthritis; ROC = receiver operating characteristic; SD = standard deviation; SE = standard error; SF = short form; TNF = anti-tumour necrosis factor; VAS = visual analogue scale
Continuation rates of infliximab therapy Of the initial 511 patients enrolled in the study, 507 effectively started infliximab therapy
Summary
After demonstration of effectiveness of anti-tumour necrosis factor (TNF)-α agents in patients with rheumatoid arthritis (RA) [1,2,3], their use has become common practice in treating patients with RA not responding to classical disease modifying anti-rheumatic drugs (DMARDs). ACR = American College of Rheumatology; AUC = area under the curve; CI = confidence interval; CRP = C-reactive protein; DAS28 = disease activity score based on the 28-joint count; DMARD = disease-modifying anti-rheumatic drug; ESR = erythrocyte sedimentation rate; HAQ = health assessment questionnaire; MTX = methotrexate; RA = rheumatoid arthritis; ROC = receiver operating characteristic; SD = standard deviation; SE = standard error; SF = short form; TNF = anti-tumour necrosis factor; VAS = visual analogue scale. Results of the ATTRACT (Anti-TNF Trial in Rheumatoid Arthritis with Concomitant Therapy) trial suggested that a higher dosage (10 mg/kg every 8 weeks) or a shorter perfusion interval may add benefit, which is reflected by the use of dosage increases in some studies [5,6]
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