Premedication and infusion reactions with infliximab: results from a pediatric inflammatory bowel disease consortium.
BACKGROUND
Infusion reactions (IRs) are the most common adverse events associated with the use of infliximab for inflammatory bowel disease (IBD). Antipyretics, antihistamines, and corticosteroids have been used to prevent the development of IRs, but their efficacy is not known. We studied the proportion of pediatric patients receiving infliximab for IBD that developed IRs and the potential effects of premedication on IR.


METHODS
Uniformly collected data from a cohort of pediatric patients with IBD enrolled between January 2000 and May 2003 at 6 pediatric centers were analyzed. Data were retrospectively reviewed and analyzed.


RESULTS
A total of 1652 infusions given to 243 patients in 6 centers was analyzed. Overall, 60 IRs were recorded in 40 patients (3.6% of infusions, 16.5% of patients). Thirty-three of 243 patients received premedication before the first IR (group 1). Two hundred ten patients did not receive premedication until the development of IRs, if at all (group 2). IRs were more common among patients in group 1 than in group 2 (12/33 versus 28/210, P < 0.01). Of the 28 patients in group 2 with IRs, 10 began receiving premedication with each subsequent infusion, 12 continued without premedications, and 6 had no further infusions recorded. Two of 10 who began receiving premedication had a subsequent IR versus 6 of 12 who did not receive premedication (P = 0.15).


CONCLUSIONS
IRs occur in a small proportion of infusions among pediatric patients receiving infliximab for IBD. Premedication does not seem to prevent the development of IRs; however, once an IR has occurred, premedication may be indicated to prevent subsequent IRs.
Jacobstein
Douglas A
DA
Department of Pediatric Gastroenterology and Nutrition, Children's Hospital of Philadelphia, Pennsylvania 19104, USA.
Markowitz
Jonathan E
JE
Kirschner
Barbara S
BS
Ferry
George
G
Cohen
Stanley A
SA
Gold
Benjamin D
BD
Winter
Harland S
HS
Heyman
Melvin B
MB
Baldassano
Robert N
RN
D000293:Adolescent; D018712:Analgesics, Non-Narcotic / Q000008:administration & dosage*; D000911:Antibodies, Monoclonal / Q000008:administration & dosage / Q000009:adverse effects*; D002648:Child; D002675:Child, Preschool; D004342:Drug Hypersensitivity / Q000209:etiology / Q000517:prevention & control*; D005260:Female; D005765:Gastrointestinal Agents / Q000008:administration & dosage / Q000009:adverse effects*; D005938:Glucocorticoids / Q000008:administration & dosage*; D006634:Histamine H1 Antagonists / Q000008:administration & dosage*; D006801:Humans; D015212:Inflammatory Bowel Diseases / Q000188:drug therapy; D000069285:Infliximab; D007263:Infusions, Parenteral; D008297:Male; D011292:Premedication; D012189:Retrospective Studies
D018712:Analgesics, Non-Narcotic; D000911:Antibodies, Monoclonal; D005765:Gastrointestinal Agents; D005938:Glucocorticoids; D006634:Histamine H1 Antagonists; D000069285:Infliximab