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Abstract Details

Real world safety of Alemtuzumab in the treatment of Multiple Sclerosis – Australian cohort study
Multiple Sclerosis
P7 - Poster Session 7 (5:30 PM-6:30 PM)
9-007

To review the safety of alemtuzumab in the treatment of relapsing remitting multiple sclerosis (RRMS) in an Australian cohort.

 
Alemtuzumab is a highly efficacious treatment for RRMS. Use is complicated by serious adverse events including infusion reactions, infections and secondary autoimmune disease. Post-marketing adverse events including stroke, cervicocephalic arterial disease, fatal infections and rarer autoimmune (AI) disease have led the European Medicine’s Agency to advise that use be restricted to refractory cases. To optimise safety in Australia, a mandatory blood monitoring program (Bloodwatch) was developed to facilitate rapid recognition and management of AI adverse events.

A multi-centre, retrospective audit of alemtuzumab safety was conducted including patients from four Queensland tertiary hospitals. All patients treated with Alemtuzumab for RRMS between May 2015 and June 2019 were included in the study. Data was collected regarding adverse events as well as patient demographics, disease severity and medication history.

 

There were 218 patients, of whom 69% were female with a mean age of 40.4 years. Twenty percent of patients were commenced on alemtuzumab as first line therapy. Mean EDSS at treatment onset was 2.7. Secondary AI events occurred in 57 patients (26.4%). Thyroid complications occurred in 53 patients (24.5%), renal disease in 2 patients (0.9%) and idiopathic thrombocytopenia in 4 patients (1.8%). Infusion reactions and infective complications were rare. There were no cerebrovascular events, novel AI or deaths in this cohort.

Alemtuzumab treatment in this cohort was associated with adverse events, particularly secondary AI disease, in line with previously reported cohorts. No cardiac or cerebrovascular events occurred. Compliance with blood monitoring was very high and most AI were identified pre-symptomatically. Alemtuzumab has been introduced safely in an Australian cohort with utilisation of a novel, mandatory, blood monitoring program.

Authors/Disclosures
Joel Corbett, MBBS (The Prince Charles Hospital)
PRESENTER
No disclosure on file
Stefan Blum, PhD, FRACP (Princess Alexandra Hospital) The institution of Dr. Blum has received research support from Merck. The institution of Dr. Blum has received research support from MSRA. The institution of Dr. Blum has received research support from PA Research Foundation.
Mike Boggild, MD, FRACP Dr. Boggild has nothing to disclose.
Simon Broadley, PhD, FRACP (Griffith University School of Medicine) The institution of Dr. Broadley has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Roche. The institution of Dr. Broadley has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Alexion. The institution of Dr. Broadley has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Merck. Dr. Broadley has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Biogen. Dr. Broadley has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Novartis. Dr. Broadley has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Sage. The institution of Dr. Broadley has received research support from NHMRC. The institution of Dr. Broadley has received research support from ARC. The institution of Dr. Broadley has received research support from GCH Foundation. The institution of Dr. Broadley has received research support from NHMRC.
Pamela A. McCombe, MD (Dr PA McCombe Medical Pty Ltd) Dr. McCombe has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biogen. Dr. McCombe has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Dr. McCombe has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Genzyme. The institution of Dr. McCombe has received research support from Motor Neurone Disease Resaerch Institute of Australia.