Severe infusion reactions to infliximab: aetiology, immunogenicity and risk factors in patients with inflammatory bowel disease (original) (raw)
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Canadian Journal of Gastroenterology and Hepatology, 2015
BACKGROUND: Although infliximab is an effective therapy for inflammatory bowel disease (IBD), it is associated with dermatological events and infusion reactions. It is not known whether a relationship between these adverse events (AEs) and infliximab trough levels (ITLs) exists.OBJECTIVES: To report the prevalence of infliximab-associated AEs in IBD patients receiving stable maintenance infliximab therapy, and to correlate ITLs with dermatological and infusion reactions to infliximab.METHODS: Adult IBD patients receiving stable maintenance infliximab therapy were recruited from the University of Alberta Infusion Clinic (Edmonton, Alberta). ITLs were measured in blood samples collected before infusion, and the patients’ records were reviewed for dermatological and infusion reactions to infliximab.RESULTS: One-quarter (18 of 71 [25.4%]) of patients experienced dermatological or infusion reactions to infliximab: nine (12.7%) dermatological events and nine (12.7%) infusion reactions. Th...
The American Journal of Gastroenterology, 2018
Inflammatory bowel disease (IBD) affects 439 per 100,000 adults in the United States and is associated with significant morbidity and mortality [1, 2]. Infliximab is one of the more effective treatments for IBD, but a main safety concern of infliximab is an antibody-induced infusion reaction [3]. The incidence of an acute infliximab infusion reaction is ~6.5% with mild, moderate, or severe reactions occurring in 3.1, 1.2, and 1% of infusions, respectively [4]. Given concerns of infusion reactions, infliximab is FDAapproved to be administered over 2 h or more. However, this represents a significant inconvenience to those individuals who receive regular maintenance infusions [3]. Recently, studies suggest that a shorter infusion time over 30-60 min may be safe in patients receiving infliximab therapy [5-13]. Thus, at University of California, San Francisco (UCSF), we adopted an accelerated infliximab infusion protocol in June 2017 similar to published literature [5-13]. In this retrospective study, we compared the frequency of reactions associated with 1-h infliximab infusions to that of 2-h infusions in IBD patients. We hypothesize that there is no difference in infusion reaction rates between the comparison groups.
Expert opinion on drug safety, 2017
Safety data of the 'real life' use of an infliximab biosimilar, CT-P13 in inflammatory bowel disease (IBD) are still lacking. Our aim was to assess the frequency and characteristics of infusion reactions during CT-P13 therapy in 13 Hungarian and 1 Czech IBD centres. Clinical and safety data was registered at fixed appointments. Trough levels and anti-drug antibody (ADA) concentration were measured by ELISA. Association between demographic, clinical, laboratory parameters and infusion reaction rates were evaluated statistically. Three hundred and eighty-four IBD patients were included. Twenty-eight Hungarian IBD patients (9.6%) developed infusion reaction during the treatment, 64.3% of them was previously exposed to anti TNF therapy. No infusion reaction occurred in the Czech population. CT-P13 therapy had to be stopped in 17 patients who developed infusion reaction and was switched to adalimumab in 12 patients. However in 39.3% of patients developing infusion reaction CT-P13...
Inflammatory bowel …, 2002
Infliximab, a chimeric human/murine monoclonal antibody directed against the proinflammatory cytokine tumor necrosis factor alpha, is an effective therapy for Crohn's disease (CD) and rheumatoid arthritis refractory to standard medical treatment. We report a case of adult respiratory distress syndrome associated with infliximab therapy. A 33-year-old white male presented with an exacerbation of CD and was treated with his second infliximab infusion (15 months following the first infusion). Within 7 days he developed arthralgias, myalgias, and fever, followed by respiratory failure. He re-quired intubation and mechanical ventilation. Open lung biopsy demonstrated eosinophilic pneumonia. Human antichimeric antibodies were present at high concentrations. An extensive investigation for infectious etiologies was negative. The patient was treated with intravenous corticosteroids, and fully recovered after a prolonged hospitalization. We review the infectious and immunologic complications of infliximab.