Infusion-related reactions to infliximab in patients with rheumatoid arthritis in a clinical practice setting: relationship to dose, antihistamine pretreatment, and infusion number.
OBJECTIVE
We describe infusion-related reactions to infliximab (during infusion or within 1 hour postinfusion) in patients with active rheumatoid arthritis (RA) treated in a quaternary care center.


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 (pruritus, 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.


CONCLUSIONS
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.
Wasserman
Michael J
MJ
Rebecca MacDonald Centre for Arthritis and Autoimmune Disease, Division of Advanced Therapeutics, Mount Sinai Hospital, University of Toronto, Toronto, Ontario, Canada.
Weber
Deborah A
DA
Guthrie
Judith A
JA
Bykerk
Vivian P
VP
Lee
Peter
P
Keystone
Edward C
EC
D000293:Adolescent; D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000627:therapeutic use; D018501:Antirheumatic Agents / Q000009:adverse effects / Q000627:therapeutic use; D001172:Arthritis, Rheumatoid / Q000188:drug therapy*; D004155:Diphenhydramine / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D006634:Histamine H1 Antagonists / Q000627:therapeutic use*; D006801:Humans; D006967:Hypersensitivity / Q000276:immunology; D000069285:Infliximab; D007262:Infusions, Intravenous / Q000009:adverse effects; D008875:Middle Aged; D010044:Outpatient Clinics, Hospital
D000911:Antibodies, Monoclonal; D018501:Antirheumatic Agents; D006634:Histamine H1 Antagonists; D004155:Diphenhydramine; D000069285:Infliximab