Infusion Reaction to Monoclonal Antibodies in Outpatient Infusion Units of a University Hospital – A Two-year Retrospective Study


Introduction: Monoclonal antibodies have revolutionized the treatment of immune-mediated inflammatory diseases (eg, rheumatoid arthritis [RA], Crohn's disease [CD], and psoriasis) as well as malignant diseases. Currently, there are about 100 monoclonal antibodies and even more are expected in the coming years. Knowledge of not only their mechanism of action but also their adverse event profile is tantamount. One of the distinctive side effects of these drugs is the potential for non-allergic and allergic infusion reactions caused by cytokine release. These adverse reactions should be monitored and managed immediately for patient welfare and safety.

General Objective: To determine the prevalence of infusion reaction among patients given monoclonal antibodies at outpatient infusion units of a University Hospital, from July 2015 to July 2017.

Methodology: This is a two-year retrospective study at the University of Santo Tomas Hospital (USTH), a tertiary teaching hospital. A chart review of patients seen at the USTH Benavides Cancer Institute (BCI) and Joint and Bone Center (JBC) were gathered. Patients who received monoclonal antibodies namely rituximab, infliximab, bevacizumab, tocilizumab, belimumab, brentuximab, pembrolizumab, trastuzumab, pertuzumab, nimotuzumab and eculizumab from July 2015 to July 2017 were included in the study.

Results: Majority of patients were in the 61 to 70 years age group (25.7%); the median age of the population was 53 years and the majority were females (64.9%). The most common indication for monoclonal antibody infusion is rheumatoid arthritis (28.4%). More than one-fourth of the patients did not receive premedications (28.4%) but a good number (25.7%) received at least two drugs: paracetamol plus diphenhydramine plus corticosteroids followed by 17.6% who received paracetamol plus diphenhydramine. The authors found a significant difference in the occurrence of infusion reaction between those that were given premedications compared to those who were not given premedications (p=0.032). The most common monoclonal antibodies administered were rituximab (28.4%); tocilizumab (23%); and infliximab (14.9%). However, only rituximab (9.5%), infliximab (2.7%) and bevacizumab (1.4%) had infusion reactions. The overall incidence rate of infusion reaction to monoclonal antibodies was 14%. The onset was within 2 hours with most infusion reactions occurring in the first cycle. Ninety percent were classified as grade 2 infusion reactions. Management of these reactions included rescue medications and brief interruption of infusion. No hospitalization nor recurrence of infusion reaction on the resumption of infusion occurred.

Conclusions: The prevalence rate of infusion reaction to monoclonal antibodies was 14% in this present single-center two-year retrospective study. All adverse events were graded mild to moderate (grade 2) in severity, and were all accordingly managed successfully in the outpatient setting.

Keywords: infusion reaction, monoclonal antibodies, prevalence

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