Denis Choquette1, Rafat Faraawi1, Andrew Chow1, Jude Rodrigues1, William J Bensen1, Francois Nantel2. 1. From the Institut de Rhumatologie de Montréal, Montréal, Quebec; McMaster University, Hamilton; Credit Valley Hospital, Mississauga; Clinical Research and Arthritis Centre, Windsor; Janssen Inc., Toronto, Ontario, Canada.D. Choquette, MD, Institut de Rhumatologie de Montréal; R. Faraawi, MD, McMaster University; A. Chow, MD, Credit Valley Hospital; J. Rodrigues, MD, Clinical Research and Arthritis Centre; W.J. Bensen, MD, McMaster University; F. Nantel, PhD, Janssen Inc. 2. From the Institut de Rhumatologie de Montréal, Montréal, Quebec; McMaster University, Hamilton; Credit Valley Hospital, Mississauga; Clinical Research and Arthritis Centre, Windsor; Janssen Inc., Toronto, Ontario, Canada.D. Choquette, MD, Institut de Rhumatologie de Montréal; R. Faraawi, MD, McMaster University; A. Chow, MD, Credit Valley Hospital; J. Rodrigues, MD, Clinical Research and Arthritis Centre; W.J. Bensen, MD, McMaster University; F. Nantel, PhD, Janssen Inc. fnantel@its.jnj.com.
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.
OBJECTIVE:Infliximab (IFX) is a therapeutic monoclonal antibody targeting tumornecrosis 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.
Authors: Joseph Picoraro; Gabriel Winberry; Corey A Siegel; Wael El-Matary; Jonathan Moses; Andrew Grossman; K T Park Journal: Inflamm Bowel Dis Date: 2017-01 Impact factor: 5.325