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THUR 196 Pregnancy outcomes in alemtuzumab-treated rrms patients
  1. Rog David1,
  2. Oh Jiwon2,
  3. Chambers Christina3,
  4. Hellwig Kerstin4,
  5. McCombe Pamela5,
  6. Chung Luke6,
  7. Daizadeh Nadia6,
  8. Compston D Alastair S7
  1. 1Salford Royal NHS Foundation Trust, Salford, UK
  2. 2St Michael’s Hospital, University of Toronto, Toronto, Ontario, Canada
  3. 3University of California San Diego, La Jolla, CA, USA
  4. 4St Josef Hospital, Ruhr University Bochum, Bochum, Germany
  5. 5The University of Queensland, Brisbane, Australia
  6. 6Sanofi, Cambridge, MA, USA
  7. 7University of Cambridge, Cambridge, UK


Murine studies show no alemtuzumab-related teratogenicity, but no controlled human clinical studies of alemtuzumab in pregnancy exist. In phase 2 (CAMMS223 [NCT00050778]) and phase 3 (CARE-MS I [NCT00530348], CARE-MS II [NCT00548405]) studies, patients received 2 annual alemtuzumab courses. Two extension studies provided longer-term evaluation (NCT00930553; TOPAZ [NCT02255656]). Pregnant/lactating patients were ineligible for further treatment but were followed up for safety. As of 1 April 2017, 248 pregnancies occurred in 156/972 alemtuzumab-treated female patients (mean [SD] age at conception, 32.5 [4.4] years; mean [SD] time from last alemtuzumab dose to conception, 33.5 [22.6] months; 16 within 4 months of dosing), with 218 completed, 14 ongoing, and 16 with unknown outcomes. Of completed pregnancies with known outcomes, 147 (67%) were live births with no congenital abnormalities or birth defects. There were 48 (22%) spontaneous abortions, 22 (10%) elective abortions, and 1 (0.5%) stillbirth. To date, there has been no signal for teratogenicity. Incidence of spontaneous abortions was comparable with treatment-naive MS patients (5%–21%) and the general population (17%–22%). Real-world data are currently collected by the International Lemtrada Pregnancy Exposure Registry, a prospective, non-interventional, observational safety study enrolling patients in ≥19 countries who become pregnant within 4 months of alemtuzumab exposure.

Study Support: Sanofi.

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