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An event is serious (based on the ICH definition) when the patient outcome is:
* death
* life-threatening
* hospitalisation
* disability
* congenital anomaly
* other medically important event
A 52-year-old man developed anti-evolocumab antibodies following COVID-19 vaccination. Eventually, the man exhibited treatment failure secondary to the presence of anti-evolocumab antibodies while being treated with evolocumab for hyperlipidaemia [time to reaction onset and outcome not stated; not all routes and dosages stated].
The man had been diagnosed with hyperlipidaemia and coronary artery disease. He had been receiving therapy with fenofibrate, ezetimibe and simvastatin, with a suboptimal control of LDL-C at 92 mg/dL. Subsequently, he started receiving therapy with SC evolocumab 140mg injection every 2 weeks. Thereafter, his LDL-C levels decreased to 17 mg/dL. He had been receiving therapy with evolocumab for subsequent 2 years, with LDL-C levels stable below 45 mg/dL. However, despite strict adherence to evolocumab therapy for 2 years, his LDL-C levels significantly increased from 44 mg/dL to 121 mg/dL, observed between two lipid panels performed 9 months apart. He reported that, he had received the second dose of COVID-19 vaccine [COVID-19 mRNA vaccine], 1 month prior to the latest lipid panel testing. Based on investigations, he was found to have developed evolocumab-specific antibodies due to COVID-19 vaccine, leading to evolocumab treatment failure.
Reference
- Park BJ, et al. EVOLOCUMAB TREATMENT FAILURE FOLLOWING COVID-19 MRNA VACCINATION. Journal of the American College of Cardiology 79 (Suppl.): 2390, No. 9, 8 Mar 2022. Available from: URL: 10.1016/S0735-1097%2822%2903381-2 [abstract] [DOI]