Abstract Details

Title Postpartum Relapse After First On-Study Pregnancy in RRMS Patients Treated With Alemtuzumab in the Phase 2 and 3 Clinical Development Program Over 8 Years

Topic Multiple Sclerosis

Presentation(s) P11 - Poster Session 11 (8:00 AM-9:00 AM)

Poster/Presentation
Number 9-020

Objective Examine relapse rates before, during, and after the first pregnancy in alemtuzumab-treated RRMS patients over 8 years.

Background In childbearing women with MS, relapses may increase in frequency and severity postpartum. Alemtuzumab significantly reduced relapse rates in RRMS patients versus subcutaneous interferon beta-1a and maintained efficacy over 8 years in phase 2 and 3 core clinical trials (CAMMS223 [NCT00050778]; CARE-MS I [NCT00530348]; CARE-MS II [NCT00548405]), and their extension studies (CAMMS03409 [NCT00930553]; TOPAZ [NCT02255656]).

Design/Methods Contraception was required for 4 months (M) after last alemtuzumab dose during the core trials, and for 6M after alemtuzumab in the extensions. Patients received 2 courses of alemtuzumab in the core phase 2 and 3 trials (12 mg/day; baseline: 5 days; 12M later: 3 days) and additional alemtuzumab as needed in the extensions (3 days; ≥12M apart). Patients could receive other disease-modifying therapy in the extensions. This analysis only considered a patient’s first pregnancy after alemtuzumab 12 mg, and pregnancies that occurred by M85 to allow for at least 1-year follow-up post pregnancy onset.

Results Over 8 years, 122 pregnancies met inclusion criteria; 72%, 18%, and 10% of pregnancies began >12M, >4 to 12M, and ≤4M after the last alemtuzumab dose, respectively. Annualized relapse rate (ARR) in the year before study entry was 1.8, and decreased to 0.10 and 0.12 in the 2 years before pregnancy. ARR fell to 0.02 during pregnancy, increased minimally in the first year after pregnancy (0.22), and returned to pre-pregnancy levels in the second and third years after pregnancy (0.12 each year). Safety will be presented.

Conclusions In alemtuzumab-treated patients, the increase in postpartum relapse rates in the first year after pregnancy was minimal and lower than postpartum exacerbations of relapse reported in the literature. Relapse rates returned to pre-pregnancy levels by the second year postpartum.

Authors/Disclosures
Elisabeth G. Celius, MD PRESENTER	Dr. Celius 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. Celius 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. Celius 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. Celius 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. Celius 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. Celius has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Sanofi. Dr. Celius has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Merck. Dr. Celius has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Biogen. Dr. Celius has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Novartis. Dr. Celius has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Roche.
Jiwon Oh, MD, FAAN (St Michael's Hospital)	Dr. Oh has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Roche. The institution of Dr. Oh has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biogen-Idec. Dr. Oh has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for EMD-Serono. Dr. Oh has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Sanofi-Genzyme. Dr. Oh has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Dr. Oh has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Amgen. Dr. Oh has received personal compensation in the range of $500-$4,999 for serving as a Consultant for BMS. Dr. Oh has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Astra Zeneca. Dr. Oh has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche. Dr. Oh has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biogen-Idec. Dr. Oh has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi-Genzyme. The institution of Dr. Oh has received research support from Biogen-Idec. The institution of Dr. Oh has received research support from Roche.
Anat Achiron, MD, PhD, FAAN (Sheba Medical Center, Tel-Hashomer)	Dr. Achiron has nothing to disclose.
Alastair Compston, PhD, FRCP	No disclosure on file
Virginia A. Devonshire, MD (UBC Hospital S126)	Dr. Devonshire has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Merck- Serono. Dr. Devonshire has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Novartis . Dr. Devonshire has received personal compensation in the range of $500-$4,999 for serving as a Consultant for biogen . Dr. Devonshire has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for novartis. Dr. Devonshire has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for roche. Dr. Devonshire has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for biogen .
Kerstin Hellwig (St. Josef Hospital Bochum)	Kerstin Hellwig has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Teva . Kerstin Hellwig has received personal compensation in the range of $500-$4,999 for serving as a Consultant for BMS. Kerstin Hellwig has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Novartis . Kerstin Hellwig has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Roche . Kerstin Hellwig has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Merck . Kerstin Hellwig has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sanofi Genzyme . Kerstin Hellwig has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Mylan . Kerstin Hellwig has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis . Kerstin Hellwig has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche . Kerstin Hellwig has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Merck . Kerstin Hellwig has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Novartis . Kerstin Hellwig has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Roche . The institution of Kerstin Hellwig has received research support from Roche . The institution of Kerstin Hellwig has received research support from Merck . The institution of Kerstin Hellwig has received research support from Biogen. The institution of Kerstin Hellwig has received research support from Genzyme . The institution of Kerstin Hellwig has received research support from Novartis . The institution of Kerstin Hellwig has received research support from BMS .
George J. Hutton, MD, FAAN (Baylor College of Medicine)	Dr. Hutton has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Autoimmunity Biologic Solutions, Inc.. The institution of Dr. Hutton has received research support from Biogen. The institution of Dr. Hutton has received research support from Genentech. The institution of Dr. Hutton has received research support from Genzyme.
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.
Marie M. Moore, NP	No disclosure on file
	No disclosure on file
Livia D. Sousa, MD (Centro Hospitalar E Universitario De Coimbra)	Dr. Sousa has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Bayer,Merck,Novartis,Biogen,Saniofi,Roche.
Stephen G. Vincent, MD, FAAN (Neurological Services, PLLC)	No disclosure on file
Luke Chung (Sanofi Genzyme)	Luke Chung has received personal compensation for serving as an employee of Sanofi Genzyme. Luke Chung has received stock or an ownership interest from Sanofi Genzyme.
	No disclosure on file
Colin Mitchell, PhD (Sanofi Genzyme)	No disclosure on file
David Rog, MBBS	Dr. Rog 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. Rog has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi Genzyme. Dr. Rog has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Novartis. Dr. Rog has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Roche. Dr. Rog has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Merck. Dr. Rog has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Neuraxpharm. Dr. Rog has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Teva. The institution of Dr. Rog has received research support from Merck. The institution of Dr. Rog has received research support from Novartis. The institution of Dr. Rog has received research support from TG Therapeutics. Dr. Rog has received research support from Janssen-Cilag.

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