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Infusion-Related Reactions to Infliximab in Patients with Rheumatoid Arthritis in a Clinical Practice Setting: Relationship to Dose, Antihistamine Pretreatment, and Infusion Number
MICHAEL J. WASSERMAN, DEBORAH A. WEBER, JUDITH A. GUTHRIE, VIVIAN P. BYKERK, PETER LEE, and EDWARD C. KEYSTONE
ABSTRACT.
Methods. We followed 113 patients for a mean of 60.6 ± 28.9 weeks, obtaining 10.5 ± 4.9 infusions per patient. Results. We observed 1183 infusions resulting in 104 infusion reactions (8.8%). All reactions resolved within several hours following cessation of the infusion and none was serious enough to warrant hospitalization. Reactions included allergic reactions (pruritis, urticaria) in 4.2% of infusions, cardiopulmonary (hypotension, hypertension, tachycardia) in 3.0%, and miscellaneous reactions (headache, nausea, vomiting) in 2.0%. Reactions occurred in 8.0% of 3 mg/kg infusions and in 10.3% of 5 mg/kg infusions. Reactions occurred in 13.2% of infusions that involved antihistamine pretreatment compared to only 7.5% of infusions that involved no pretreatment. At both infliximab doses, there was a similar frequency of infusion reactions in patients pretreated due to a previous infusion (12.6%) compared to those pretreated strictly based on infusion number (14.7%). A number of the reactions involving antihistamine pretreatment may be explained by known side effects of diphenhydramine, including headache, dizziness, nausea, and palpitations. Conclusion. Infusion-related reactions to infliximab were infrequent, rarely severe, and easily manageable. The frequency of reactions was equivalent in patients treated with 3 mg/kg compared to 5 mg/kg. Reactions were significantly more frequent in infusions where patients were pretreated with the antihistamine diphenhydramine, compared to those not involving pretreatment. (J Rheumatol 2004;31:1912-7) Key Indexing Terms:
RHEUMATOID ARTHRITIS
From the Rebecca MacDonald Centre for Arthritis and Autoimmune Disease, Division of Advanced Therapeutics, Mount Sinai Hospital, University of Toronto, Toronto, Ontario, Canada. M.J. Wasserman, PhD; D.A. Weber, RN, CCRC; J.A. Guthrie, MSc, CCRC; V.P. Bykerk, MD, FRCPC, Assistant Professor of Medicine; P. Lee, MD, FRCPC, Professor of Medicine; E.C. Keystone, MD, FRCPC, Professor of Medicine, University of Toronto. Address reprint requests to Dr. E.C. Keystone, Rebecca MacDonald Centre for Arthritis and Autoimmune Disease, Joseph and Wolf Lebovic Building, Mount Sinai Hospital, 60 Murray Street, 2nd Floor, Toronto, Ontario M5T 3L9. E-mail: edkeystone@mtsinai.on.ca Submitted December 12, 2003; revision accepted April 29, 2004. |