Abstract Details

Title Outcomes in Alemtuzumab-Treated Patients With Thyroid Adverse Events: 6-Year Pooled CARE-MS Data

Topic Multiple Sclerosis

Presentation(s) MS and CNS Inflammatory Disease Posters (7:00 AM-5:00 PM)

Poster/Presentation
Number 198

Objective To characterize thyroid adverse events (AEs) over 6 years in alemtuzumab-treated patients from the CARE-MS core and extension trials.

Background In the CARE-MS trials (NCT00530348; NCT00548405; NCT00930553), alemtuzumab improved outcomes in RRMS patients, but many experienced thyroid AEs.

Design/Methods

A panel of 3 independent endocrinologists reviewed and adjudicated all reported cases of thyroid-related laboratory abnormalities and AEs. Cases with no consensus diagnosis, pre-existing cases, and events occurring after Y6 were excluded from the final analysis.

Results Over 6 years, 378/811 (47%) alemtuzumab-treated patients were reported as having a thyroid event. Following adjudication, 288 cases were confirmed, 60 cases had no consensus diagnosis, 23 were pre-existing, and 7 were post-Y6. Cases with a consensus diagnosis were adjudicated to Graves’ disease or Hashimoto’s disease switching to hyperthyroidism (41.6%), Hashimoto’s disease or Grave’s disease switching to hypothyroidism (20.2%), transient thyroiditis (9.7%), or uncertain (28.5%). Oral thyroid medications were given to 80.2% of patients (levothyroxine [60.1%], and methimazole/thiamazole [42.0%]); 11% underwent thyroidectomy and 7% underwent radioiodine therapy. Thyroid outcomes as of last follow-up were recovered (54.8%), ongoing (45%), and unknown (0.2%). Within 2 years of the last alemtuzumab course, 83% of thyroid AEs were reported (98% within 4 years). Number of alemtuzumab courses were similar in patients with vs without thyroid AEs; MS disease outcomes were also similar between these groups (annualized relapse rate: 0.20 vs 0.21; mean EDSS score change: −0.07 vs +0.11; proportion with stable/improved EDSS scores: 82% vs 79%; proportions MRI disease activity-free: 60%-77% per year vs 60%-76% per year; and median cumulative brain volume loss: −1.10% vs −1.26%).

Conclusions

Graves’ disease was considered the most common diagnosis but TSH receptor Ab testing would be required to accurately classify the majority of thyroid AEs. No differences in 6-year MS disease outcomes were seen between patients with and without thyroid AEs.

Authors/Disclosures
Colin Dayan PRESENTER	Colin Dayan has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Provention Bio. Colin Dayan has received personal compensation in the range of $500-$4,999 for serving as a Consultant for NovoNordisk. Colin Dayan has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sanofi Genzyme. Colin Dayan has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Janssen. Colin Dayan has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Eli-Lilly. Colin Dayan has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Sanofi-Genzyme. Colin Dayan has received personal compensation in the range of $5,000-$9,999 for serving as an Expert Witness for Provention Bio. Colin Dayan has received intellectual property interests from a discovery or technology relating to health care.
	No disclosure on file
	No disclosure on file
	No disclosure on file
Samuel F. Hunter, MD, PhD (Advanced Neurosciences Institute)	The institution of Dr. Hunter has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Abbview. The institution of Dr. Hunter has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for EMDSerono. The institution of Dr. Hunter has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Genentech. The institution of Dr. Hunter has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Sanofi. The institution of Dr. Hunter has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Osmotica. Dr. Hunter has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Janssen. Dr. Hunter has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Biogen. Dr. Hunter has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for EMDSerono. Dr. Hunter has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Genentech. Dr. Hunter has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Novartis. Dr. Hunter has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Sanofi. The institution of Dr. Hunter has received research support from Biogen. The institution of Dr. Hunter has received research support from Abbvie. The institution of Dr. Hunter has received research support from Genentech/Roche. The institution of Dr. Hunter has received research support from Janssen. The institution of Dr. Hunter has received research support from Novartis. The institution of Dr. Hunter has received research support from Osmotica. The institution of Dr. Hunter has received research support from Sanofi. Dr. Hunter has received intellectual property interests from a discovery or technology relating to health care. Dr. Hunter has received personal compensation in the range of $5,000-$9,999 for serving as a Speaker with MS Views and News. Dr. Hunter has a non-compensated relationship as a CEO - Volunteer with NeuroNexes/Novel Pharmaceutics Institute that is relevant to AAN interests or activities. Dr. Hunter has a non-compensated relationship as a Writing support with Novartis Pharmaceuticals that is relevant to AAN interests or activities. Dr. Hunter has a non-compensated relationship as a Writing Support with Osmotica that is relevant to AAN interests or activities. Dr. Hunter has a non-compensated relationship as a Writing support with Mallinckrodt that is relevant to AAN interests or activities. Dr. Hunter has a non-compensated relationship as a Writing Support with Sanofi that is relevant to AAN interests or activities.
Krzysztof W. Selmaj (University of Warmia and Mazury)	Krzysztof W. Selmaj has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biogen. Krzysztof W. Selmaj has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Krzysztof W. Selmaj has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Roche. Krzysztof W. Selmaj has received personal compensation in the range of $500-$4,999 for serving as a Consultant for BMS. Krzysztof W. Selmaj has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Astra. Krzysztof W. Selmaj has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Merck. Krzysztof W. Selmaj has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for BMS. Krzysztof W. Selmaj has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Astra. Krzysztof W. Selmaj has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Biogen. Krzysztof W. Selmaj has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Roche. Krzysztof W. Selmaj has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Novartis. Krzysztof W. Selmaj has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for BMS. Krzysztof W. Selmaj has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Merck.
Hans-Peter Hartung, MD, FAAN (Heinrich Heine University Medical Faculty)	Dr. Hartung has received personal compensation in the range of $500-$4,999 for serving as a Consultant for BMS Celgene. Dr. Hartung has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Geneuro. Dr. Hartung has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Dr. Hartung 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. Hartung has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Merck. Dr. Hartung has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Bayer. Dr. Hartung has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for TG Therapeutics. Dr. Hartung has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche. Dr. Hartung has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Frontiers Neurology.
Eva Havrdova, MD (Neurologicka Klinika 1 LF UK)	Dr. Havrdova has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Merck. Dr. Havrdova has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sanofi. Dr. Havrdova has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biogen. Dr. Havrdova has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Dr. Havrdova has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Roche. Dr. Havrdova has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Merck. Dr. Havrdova has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi.
Christopher C. LaGanke, MD (North Central Neurology Associates, PC)	Dr. LaGanke has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for EMD Serono. Dr. LaGanke has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi. Dr. LaGanke has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Biogen. Dr. LaGanke has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Sanofi. Dr. LaGanke has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Novartis. Dr. LaGanke has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for GSK. Dr. LaGanke has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Serono EMD. Dr. LaGanke has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Genentech. Dr. LaGanke has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Bristol Myers Squibb. Dr. LaGanke has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for TG Therapeutics.
Tjalf Ziemssen, MD, FAAN (University Clinic Dresden)	Dr. Ziemssen has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Roche. Dr. Ziemssen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Dr. Ziemssen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for BMS . Dr. Ziemssen has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Merck. Dr. Ziemssen has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Roche. Dr. Ziemssen has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Novartis. Dr. Ziemssen has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Merck. Dr. Ziemssen has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Sanofi. Dr. Ziemssen has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for TEVA. Dr. Ziemssen has received personal compensation in the range of $500-$4,999 for serving as an officer or member of the Board of Directors for Dresden Internation University. The institution of Dr. Ziemssen has received research support from Novartis. The institution of Dr. Ziemssen has received research support from Merck. The institution of Dr. Ziemssen has received research support from Sanofi. The institution of Dr. Ziemssen has received research support from BMS. The institution of Dr. Ziemssen has received research support from Roche.
Bart Van Wijmeersch, MD, PhD (Rehabilitation & MS-Centre Overpelt)	Prof. Van Wijmeersch has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biogen. Prof. Van Wijmeersch has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi. Prof. Van Wijmeersch has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Merck. Prof. Van Wijmeersch has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Prof. Van Wijmeersch has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Celgene/Bristol Myers Group. Prof. Van Wijmeersch has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche. Prof. Van Wijmeersch has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Janssen Pharmaceutics. Prof. Van Wijmeersch has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Biogen. Prof. Van Wijmeersch has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Merck. Prof. Van Wijmeersch has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Sanofi. Prof. Van Wijmeersch has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Novartis. Prof. Van Wijmeersch has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Roche. The institution of Prof. Van Wijmeersch has received research support from Merck. The institution of Prof. Van Wijmeersch has received research support from Roche.
Sven G. Meuth (Uniklinik Düsseldorf, Klinik für Neurologie)	Sven G. Meuth has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Merck. Sven G. Meuth has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Novartis. Sven G. Meuth has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Almirall. Sven G. Meuth has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Celgene. Sven G. Meuth has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Genzyme. Sven G. Meuth has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biogen. Sven G. Meuth has received personal compensation in the range of $500-$4,999 for serving as a Consultant for TEVA. Sven G. Meuth has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Roche.
David H. Margolin, MD, PhD (Genzyme Corporation)	Dr. Margolin has received personal compensation for serving as an employee of uniQure, Inc.. Dr. Margolin has stock in Cerevance, Inc. Dr. Margolin has stock in Datacubed Health. Dr. Margolin has stock in uniQure, Inc.. Dr. Margolin has received intellectual property interests from a discovery or technology relating to health care.
	No disclosure on file
	No disclosure on file
	No disclosure on file
Darren P. Baker, PhD (Sanofi Genzyme)	Dr. Baker has received personal compensation for serving as an employee of Sanofi. Dr. Baker has received stock or an ownership interest from Sanofi.
Peter Senior	The institution of Peter Senior has received research support from Novo Nordisk. Peter Senior has received personal compensation in the range of $10,000-$49,999 for serving as a Guidelines Chair with Diabetes Canada (reg charity). Peter Senior has a non-compensated relationship as a Investigator (post hoc adjudication of thyroid AEs in MS trials) with Sanofi that is relevant to AAN interests or activities.

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