Clinical Features of Adverse Drug Reactions of Monoclonal Antibodies in Korea

Background: Recently monoclonal antibodies (mAbs) are widely used in various clinical fields. Although their safety was demonstrated prior to approval, targeted pharmacovigilance is essential for the recognition and assessment of adverse drug reactions (ADRs). The purpose of this study is to identify the frequency and major clinical features of ADRs referred to mAbs in Koreaa.

Methods: ADRs attributed to eighteen mAbs submitted spontaneously to the Korea Adverse Event Reporting System (KAERS) were extracted from the database for January 2000 to June 2014. We analyzed these reports for information related to patient’s characteristics and types or ADRs.

Results: A total of 17,346 ADRs were obtained from 8,591 patients. The most frequent symptoms of ADRs were abnormalities of leukocytes (9.0%), followed by infections (6.3%), drug eruptions (6.2%) and drug fevers (3.4%). Hypersensitivity reactions were reported almost ten percent. Furthermore mAbs induced total 5,545 serious ADRs from 2,862 patients, including severe infections (9.6%), neutropenia (9.3%), drug fever (4.1%) and visual dysfunctions (2.8%). 279 patients died due to ADRs of mAbs. The mAbs with the highest number of ADR reports were rituximab (20.3%), followed by adalimumab (16.7%), cetuximab (15.0%) and bevacizumab (13.9%).

Conclusions: Near ten percent of the ADRs were allergic-like, and no previously unrecognized ADRs were observed. Increased awareness among healthcare professionals is required to signal and prevent the consequences of adverse reactions caused by monoclonal antibodies.