Abstract Details

Title Spontaneous Intracerebral Hemorrhage During Administration of Alemtuzumab for Multiple Sclerosis: A Case Series

Topic Multiple Sclerosis

Presentation(s) S26 - MS and CNS Inflammatory Disease: Clinical Considerations II (1:44 PM-1:55 PM)

Poster/Presentation
Number 005

Objective To report five cases of spontaneous intracerebral hemorrhage (ICH) that occurred during the initial week of alemtuzumab administration for MS.

Background One well-known ICH due to immune thrombocytopenia occurred during the Phase 2 CAMS223 study 19 months after alemtuzumab, and another ICH was reported 27 months after alemtuzumab with normal platelet count. ICH has not been reported during the initial week of alemtuzumab administration.

Design/Methods We retrospectively identified five cases of spontaneous ICH that occurred during the initial week of alemtuzumab administration from four MS centers. Patient characteristics, infusion center records, and pertinent diagnostic studies were reviewed, including blood pressure trends throughout the infusion week and platelet counts pre- and post-alemtuzumab.

Results All five patients were females ages 38-49 with RRMS of 8-21 years duration and exposure to ≥2 previous DMTs. None had a history of bleeding disorder, stroke, ICH, hypertension, or aneurysm. No unusual side effects occurred during the infusion. In each case, spontaneous ICH occurred after leaving the infusion center on Day 3, 4, or 5 of alemtuzumab. 4 of 5 ICHs were basal ganglia and one was lobar, suggesting hypertension as the etiology. In 4 of 5 patients, blood pressure trended upward throughout the infusion week, with increases in mean SBP of 18, 22, 24, and 57mmHg on the final infusion day compared to Infusion Day 1 (≥20% above baseline). Platelet counts decreased by ≥30% in each patient (mean -40.1%) on day of ICH compared to pre-alemtuzumab; 3 of 5 patients were mildly thrombocytopenic (100,000-150,000 x 10⁹/L).

Conclusions Rising SBP throughout the infusion week was the only harbinger of ICH in these five patients with spontaneous ICH during alemtuzumab administration. Mild thrombocytopenia may have contributed. An increase in mean SBP of ≥20mmHg or ≥20% above baseline during the infusion week should prompt concern for elevated ICH risk during alemtuzumab administration.

Authors/Disclosures
Christina Azevedo, MD, FAAN (University of Southern California) PRESENTER	Dr. Azevedo has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Sanofi Genzyme. Dr. Azevedo has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Zenas Biopharma. Dr. Azevedo has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Genentech. Dr. Azevedo has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Horizon Therapeutics. Dr. Azevedo has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for EMD Serono. Dr. Azevedo has received personal compensation in the range of $500-$4,999 for serving as an Expert Witness for Wood, Smith, Henning & Berman LLP. The institution of Dr. Azevedo has received research support from National Multiple Sclerosis Society. The institution of Dr. Azevedo has received research support from National Institutes of Health/National Institutes of Neurological Disorders and Stroke. The institution of Dr. Azevedo has received research support from National Multiple Sclerosis Society.
Christen Kutz (Colorado Springs Neurological Associates)	No disclosure on file
Amy L. Dix, PA (Association of Neurology PAs)	Ms. Dix has nothing to disclose.
Aaron L. Boster, MD (Ohiohealth)	Dr. Boster has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for sanofi. Dr. Boster has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for roche. Dr. Boster has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for novartis. Dr. Boster has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Medtronic. Dr. Boster has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Serono. The institution of Dr. Boster has received research support from Sanofi. The institution of Dr. Boster has received research support from Roche.
Nerses Sanossian, MD, FAAN (Department of Neurology, USC)	Dr. Sanossian has received personal compensation for serving as an employee of Univeristy of Southern California. Dr. Sanossian has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Medtronic. Dr. Sanossian has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Genentech. Dr. Sanossian has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Portola. The institution of Dr. Sanossian has received research support from Diffusion Pharma.
Jeffrey M. Kaplan, MD (Kansas City MS and Headache Center)	Dr. Kaplan has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Lundbeck. Dr. Kaplan has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for EMD Serono. Dr. Kaplan has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for biohaven. Dr. Kaplan has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi. Dr. Kaplan has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Bristol Myers Squibb. Dr. Kaplan 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. Kaplan has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Allergan. Dr. Kaplan has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Lilly. Dr. Kaplan has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for EMD Serono. Dr. Kaplan has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Teva. Dr. Kaplan has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Alexion. Dr. Kaplan has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Sanofi. Dr. Kaplan has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Biogen. Dr. Kaplan has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Amgen. Dr. Kaplan has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Viela. Dr. Kaplan has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Biohaven. Dr. Kaplan has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Lundbeck.

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