Abstract Details

Title A Real-World, Single-Center, Retrospective Cohort Analysis of Alemtuzumab Clinical and Safety Outcomes in Persons with Relapsing Multiple Sclerosis

Topic Multiple Sclerosis

Presentation(s) P8 - Poster Session 8 (8:00 AM-9:00 AM)

Poster/Presentation
Number 9-018

Objective To investigate the real-world safety profile and clinical outcomes associated with alemtuzumab, in persons with MS.

Background Alemtuzumab is a second-line therapy for relapsing multiple sclerosis; this drug targets CD52 and leads to rapid depletion of T- and B- lymphocytes. Phase III trials demonstrated improvement in relapse rate, neurological disability, and MRI outcomes compared to active controls.

Design/Methods This is a retrospective electronic chart review of a cohort of RMS-patients treated with alemtuzumab. In addition to descriptive characteristics, we used paired t-tests to assess MS-related pre/post clinical outcomes including: timed 25-foot walk (T25FW), modified 9-hole peg test (m9HPT), symbol digit modality test (SDMT), and expanded disability status scale (EDSS). We determined safety outcomes from chart-reported documentation, laboratory value abnormalities, and relapse rates as determined by expert MS clinicians.

Results Sixty patients were included in this analysis (155 person-years); baseline mean age was 44.7 years, disease duration 11.0 years, with 80% women. All patients were RMS; median number of prior MS treatments was 4. Average follow-up time from first infusion was 31.5 months, with a range from 4 to 50 months; during this period, 75% of patients remained relapse-free. There were no statistically significant pre/post changes in T25FW or m9HPT; however pre/post EDSS scores improved (3.32 to 3.09; p=0.01, paired t-test) as did SDMT (52.3 to 53.15; p=0.05). Regarding safety, 85% of patients experienced ≥1 adverse event (excluding MS relapses), six (10%) serious requiring hospitalization (metapneumovirus/neutropenia); 58.3% percent reported ≥1 infusion reaction, none requiring hospitalization. Notable thyroid dysfunction developed in 20.0% of patients in the follow-up period; no cases of immune thrombocytopenia. These are conservative estimates of adverse events based on the retrospective methods.

Conclusions We found the overall safety profile of alemtuzumab to be similar to that reported in prior Phase III trials. We found a significant mean pre/post improvement in EDSS and SDMT.

Authors/Disclosures
Christopher Hemond, MD (University of Massachusetts Memorial Medical Center) PRESENTER	The institution of Dr. Hemond has received research support from Consorium of Multiple Sclerosis Centers. The institution of Dr. Hemond has received research support from National Institute Of Neurological Disorders And Stroke of the National Institutes of Health. Dr. Hemond has received personal compensation in the range of $0-$499 for serving as a Member of Data Safety and Monitoring Board with National Institute Of Neurological Disorders And Stroke of the National Institutes of Health.
	No disclosure on file
Farnaz Khalighinejad, MD	Dr. Khalighinejad has nothing to disclose.
	No disclosure on file
	No disclosure on file

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Abstract Details