Real world safety of Alemtuzumab in the treatment of Multiple Sclerosis - Australian cohort study

Abstract

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

Background: 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.

Design/Methods: 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.

Results: 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.

Conclusions: 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.

Disclosure: Dr. Corbett has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Biogen, CSL Behring. Dr. Blum has nothing to disclose. Dr. Boggild has nothing to disclose. Dr. Broadley has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Honoraria for participation in advisory boards (Bayer Schering, Biogen, Merck Serono, Novartis, and Sanofi); conference travel sponsorship (Bayer Schering, Biogen, Merck Serono, Novartis, and Sanofi); speaker honoraria (Biogen and Genzyme).. Dr. Broadley has received research support from Unencumbered research grant (Biogen).. Dr. McCombe has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with received honoraria and consulting fees from Novartis, Bayer Schering and Sanofi and travel grants from Novartis, Biogen and Bayer Schering..