Incidence and Management of Infusion Reactions to Infliximab in a Prospective Real-world Community Registry

Abstract

Objective.Infliximab (IFX) is a therapeutic monoclonal antibody targeting tumor necrosis factor-α indicated in the treatment of chronic inflammatory diseases. IFX is administered by intravenous infusion and may be associated with different types of infusion reactions.Methods.RemiTRAC Infusion (NCT00723905) is a Canadian observational registry in which patients receiving IFX are followed prospectively to document premedication use, adverse events, infusion reactions, and the management of infusion reactions. The primary endpoint was to assess factors associated with infusion reactions.Results.There were 1632 patients enrolled and 24,852 infusions recorded. Most patients (63.1%) were treated for rheumatologic conditions such as rheumatoid arthritis, ankylosing spondylitis, or psoriatic arthritis. Of the 1632 patients, 201 (12.3%) reported at least 1 infusion reaction. Three hundred twenty-two infusions were associated with an infusion reaction (1.3%), and most were mild to moderate in severity (95%). The most common infusion reactions were pruritus (19.9%), flushing (9.9%), or dyspnea (6.2%). Multivariate analysis showed that antihistamines premedication, number of previous infusion reactions, and female sex were significantly associated with an increased incidence of infusion reactions (p < 0.0011). The use of any concomitant immunosuppressant or corticosteroids did not influence the incidence of infusion reactions. Antihistamine premedication was associated with an increased incidence of infusion reactions (OR 1.58, p = 0.0007).Conclusion.This registry shows that in community-based infusion clinics, infusion reactions to IFX are uncommon and mild to moderate in nature. Antihistamines, intravenous steroids, and acetaminophen are widely used as preventative premedication, although this study showed an absence of benefit with their use.

Frequency and characteristics of infusion reactions during biosimilar infliximab treatment in inflammatory bowel diseases: results from Central European nationwide cohort

“…Several possible mechanisms may be in the background of infusion reactions including cytokine release (immune cell hyperactivation, direct apoptosis, complement-mediated lysis, antibody-dependent cellular toxicity), IgE-mediated hypersensitivity reactions to IFX, IgG anaphlyaxis, complement activation, or direct mast cell degranulation [13][14][15]. The most frequent symptoms of infusion reaction are pruritus, flushing, dyspnea, chest discomfort, hypertension, myalgia, nausea, urticaria, headache, rash, and dizziness [16]. Although there is no specific guideline for the treatment of IFX-related infusion reactions, according to therapeutic recommendations based on case reports and expert opinions, temporary attenuation of the infusion rate or temporary interruption of the infusion with the administration of medications for symptom control are usually eligible.…”

Frequency of Severe Infusion Reactions Associated With Outpatient Infusion of Infliximab Without Premedications

“…The reported severe reaction frequency is estimated between 0.04 and 1 % 1, 2, 11 , and we would have expected approximately between 1 and 9 severe reactions. Infusing infliximab over 1 hour rather than 3 and omitting standard pre-medications does not appear to increase the risk for severe infusion reactions.…”

Efficacy and Safety of Infliximab Tolerance Induction in Patients with Inflammatory Bowel Diseases who Experienced Acute Infusion Reactions

“…One way to prevent the occurrence of IHR could be the systematic administration of a premedication with corticosteroids and/or antihistamines prior to each IFX infusion; however, the data on the usefulness of such procedures remain controversial [28]. The use of premedication with antihistamines has been shown to increase IHR [9], whereas corticosteroids are believed to decrease the specific ADA formation that may reduce IHR [29]. Episodic IFX treatment is associated with the formation of ADA and is therefore no longer recommended [30].…”

“…As IFX is a chimeric monoclonal antibody IgG1 (75% human and 25% murine) [6], it can be recognized as a foreign protein-derived agent, and one of the most common type of adverse events are acute and delayed infusion reactions, which occurred in 5-10% of patients depending on the studies [7][8][9]. Acute reactions, also called immediate hypersensitivity reactions (IHR), are defined by their occurrence in the first 24 h after IFX infusion [10,11].…”