Study of the tolerance of infliximab infusions with or without betamethasone premedication in patients with active rheumatoid arthritis

• Published in: Annals of the rheumatic diseases Vol. 64; no. 11; pp. 1647 - 1649
• Main Authors: Sany, J, Kaiser, M J, Jorgensen, C, Trape, G
• Format: Journal Article
• Language: English
• Published: London BMJ Publishing Group Ltd and European League Against Rheumatism 01-11-2005; BMJ; BMJ Publishing Group LTD
• Subjects: Adult; Antibodies, Monoclonal - adverse effects; Antibodies, Monoclonal - therapeutic use; Antirheumatic Agents - adverse effects; Antirheumatic Agents - therapeutic use; Arthritis, Rheumatoid - drug therapy; Arthritis, Rheumatoid - pathology; Betamethasone - therapeutic use; Biological and medical sciences; Bones, joints and connective tissue. Antiinflammatory agents; Concise Report; corticosteroids; Diseases of the osteoarticular system; Double-Blind Method; Drug dosages; Drug Therapy, Combination; Female; Gangrene; HAQ; Health Assessment Questionnaire; Health Status Indicators; Humans; Immunomodulators; Inflammatory joint diseases; Infliximab; infusions; Infusions, Intravenous; Male; Medical sciences; Middle Aged; Pharmacology. Drug treatments; Prospective Studies; Quality of Life; Questionnaires; Rheumatoid arthritis; SF-36; Short Form-36; Treatment Outcome; Tumor Necrosis Factor-alpha - antagonists & inhibitors; Tumor necrosis factor-TNF; Women; Human; Corticosteroid; Diseases of the osteoarticular system; Antiinflammatory agent; Autoimmune disease; Inflammatory joint disease; Monoclonal antibody; Immunomodulator; Chronic; Infliximab; Rheumatoid arthritis; Anticytokine; Fluorine Organic compounds; Immunosuppressive agent; Betamethasone; Tumor necrosis factor α; Premedication
• ISSN: 0003-4967; 1468-2060
• DOI: 10.1136/ard.2005.037499

Objectives: To assess the incidence of infusion reactions in patients with rheumatoid arthritis (RA) receiving infliximab treatment with and without betamethasone premedication. To determine whether patients with an atopic diathesis had a better response to corticosteroid pretreatment than those without, and the course of patients’ functional capacity and quality of life. Patients and methods: A prospective, multicentre, randomised, double blind phase 4 study of 355 patients with RA in two groups: group A received betamethasone and group B placebo, before a 36 week infusion treatment with infliximab. Incidence and severity of infusion reactions from infliximab treatment were assessed. Results: The incidence of reactions to infliximab infusion was <5%. More infusion reactions occurred with betamethasone pretreatment than with placebo. Response to infliximab of patients with atopic backgrounds did not differ in the presence or absence of betamethasone from that of non-atopic patients. Mean Health Assessment Questionnaire score improved by 47% at week 24, quality of life assessed by Short Form-36 improved in mental and physical component subscales. Conclusions: Incidence of infusion reactions with infliximab was low and their severity generally mild, but betamethasone pretreatment did not decrease the incidence and severity of infusion reactions. Betamethasone, therefore, is not recommended as a systematic prophylactic measure, even in atopic patients.