Infusion Related Reactions in Patients Receiving Infliximab

Incidence, Risk Factors and Immunologic Mechanisms of Infusion Related Reactions in Patients With Chronic Inflammatory Disease Receiving Infliximab

Infliximab is the active ingredient in a drug currently sold by the trade names Remicade, Remsima and Inflectra. Infliximab neutralizes tumor necrosis factor (TNF) α, a chemical messenger (cytokine) in the immune system, and belongs to a class of drugs called "TNF inhibitors". 8-55% of patients receiving infliximab have an infusion reaction. Infusion reactions are unintended reactions that occur during infusion of the drug and up to 14 days after. The incidence varies widely in different studies and seems difficult to determine due to variations in reporting of reactions, different definitions of reactions and retrospective data collection. The aim of this study is to estimate the incidence of infusion related reactions and investigate risk factors and immunological mechanisms of infusion reactions to infliximab in patients with a chronic inflammatory disease.

Study Overview

• Status: Active, not recruiting
• Conditions: Chronic Inflammatory Disease

Detailed Description

Background: Infliximab is the active ingredient in a drug currently sold by the trade names Remicade, Remsima and Inflectra. Infliximab neutralizes tumor necrosis factor (TNF) α, a chemical messenger (cytokine) in the immune system, and belongs to a class of drugs called "TNF inhibitors". This class of drug comprises effective, biological agents used in the treatment of chronic inflammatory diseases. The use of TNF inhibitors is increasing, and infliximab is the third bestselling drug by value in Norway in 2013. By being a recombinant monoclonal antibody with a murine region, infliximab is associated with infusion reactions. 8-55% of patients receiving infliximab have an infusion reaction. Infusion reactions are unintended reactions that occur during infusion of the drug and up to 14 days after. The incidence varies widely in different studies and seems difficult to determine due to variations in reporting of reactions, different definitions of reactions and retrospective data collection. Protective factors, risk factors and the causes of the reactions are not well known. Different treatment strategies are being used, but evidence of efficacy varies.

Aim: The aim of this study is to estimate the incidence of infusion related reactions and investigate risk factors and immunological mechanisms of infusion reactions to infliximab in patients with a chronic inflammatory disease.

Primary objective:

Estimate the incidence of infusion reactions in patients with chronic inflammatory disease receiving infliximab

Secondary objectives:

• Evaluate the correlation between infusion reactions and the formation of antibodies to infliximab.
• Identify individual risk factors for infusion reactions to infliximab.
• Identify immunological mechanisms of infusion reactions to infliximab.
• Identify immunomodulatory effects and immunological changes in the patients during treatment with infliximab.

Study population: The study will be a prospective, longitudinal study where all departments with patients starting infliximab or switching infliximab from one supplier to another in the Western Norway Health Region (Helse Vest RHF) are invited to participate.

• Study Type: Observational
• Enrollment (Actual): 125

Contacts and Locations

Study Locations

• Norway
  • Bergen, Norway
    • Haukeland University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

The study will be a prospective, longitudinal study where all departments with patients starting infliximab or switching infliximab from one supplier to another in the Western Norway Regional Health Authority (Helse Vest RHF) are invited to participate.

Description

Inclusion Criteria:

• Patients treated with Infliximab due to chronic inflammatory disease included before start of treatment
• Weight at least 15 kg
• Control groups which may be included for investigations of secondary outcomes: age, gender, disease matched patients not receiving infliximab, healthy blood donors, other patients receiving pneumococci and influenza vaccines

Exclusion Criteria:

• Patients not completing treatment within Health Region
• Patients not able to complete sampling procedure

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Infliximab; Patients treated with Infliximab

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
incidence of infusion reactions	participants will be followed for the duration of treatment, an expected average of 62 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
antibodies to infliximab	Specific IgG and IgE against ifliximab	followed for the duration of treatment, an expected average of 62 weeks
immunological mechanisms of infusion reactions to infliximab	allergy tests, cytokines, complement	baseline (before infusion), during reaction, 12-24 hours after reaction
autoantibodies and other immunological changes in the patients during treatment with infliximab		followed for the duration of treatment, an expected average of 62 weeks
individual risk factors for infusion reactions to infliximab	HLA type, allergic predisposition	baseline
antibodies to pneumococci and influenza		baseline and 6-8 weeks after vaccination

Collaborators and Investigators

• Sponsor: Haukeland University Hospital
• Investigators: Study Director: Torunn Apelseth, MD, PhD, Laboratory of Clinical Biochemistry, Haukeland University Hospital

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): January 1, 2025

Study Registration Dates

• First Submitted: November 28, 2014
• First Submitted That Met QC Criteria: January 3, 2015
• First Posted (Estimated): January 6, 2015

Study Record Updates

• Last Update Posted (Actual): August 1, 2023
• Last Update Submitted That Met QC Criteria: July 31, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 2014/1368

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO