Abstract Details

Title Pregnancy and Infant Outcomes in Females Receiving Ocrelizumab for the Treatment of Multiple Sclerosis: Analysis of over 3,000 Pregnancies to Date

Topic Multiple Sclerosis

Presentation(s) S7 - Multiple Sclerosis: Special Populations and Non-MS CNS Neuroinflammatory Disease (4:06 PM-4:18 PM)

Poster/Presentation
Number 004

Background

The US prescribing information advises contraception with OCR and for 6 months after the last infusion; however, pregnancies may occur in this interval.

Objective

To report pregnancy and infant outcomes among females with multiple sclerosis (MS) receiving ocrelizumab (OCR).

Design/Methods

Pregnancies from the Roche safety database were analyzed. Maternal OCR exposure was defined as ≥1 infusion; potential in utero exposure was defined as ≤3 months prior to the last menstrual period or during pregnancy. Fetal death was termed spontaneous abortion (SA) if <22 complete gestational weeks (GW), or stillbirth (SB) if later. Live births (LB) were preterm if <37 complete GW. Major congenital anomalies (MCAs) were classified via EUROCAT 1.5.

Results

As of July 12, 2023, 3,253 cumulative MS pregnancies were received; 2,446 were reported prospectively, 800 retrospectively, seven unspecified. Of the 2,446 prospective pregnancies, 855 (35.0%) had in utero exposure, 575 (23.5%) had no in utero exposure and 1,016 (41.5%) had unknown exposure. Outcomes were known for 1,145 prospective pregnancies: 957 (83.6%) were LB (586 [61.4%] full-term, 81 [8.5%] preterm, 288 [30.2%] unknown GW); 14 (1.2%) ectopic pregnancies (EP); 58 (5.1%) elective terminations (ET); 115 (10.0%) SA; 1 (<0.1%) SB. Of 855 prospective pregnancies exposed in utero, 512 had known outcomes: 431 (84.2%) LB; 4 (0.8%) EP; 38 (7.4%) ET; 38 (7.4%) SA; 1 (0.2%) SB. Twelve (1.3%) MCAs occurred in prospective LB; seven had in utero exposure. Infant outcomes, including 1-year outcomes (n=226), effect of potential breastmilk exposure (n=126) and known B cell levels (n=68) will also be presented.

Conclusions

This is the largest dataset of pregnancy outcomes for an anti-CD20 therapy in MS. In utero exposure to ocrelizumab did not increase the risk of adverse pregnancy or infant outcomes compared with previous reports as well as epidemiological background of both MS and general population.

Authors/Disclosures
Riley Bove, MD, FAAN (University of California, San Francisco) PRESENTER	Dr. Bove has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for NeurologyLive. Dr. Bove has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Horizon. Dr. Bove 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. Bove has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for TG Therapeutics. Dr. Bove has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Jansen. The institution of Dr. Bove has received research support from Biogen. The institution of Dr. Bove has received research support from Roche Genentech. The institution of Dr. Bove has received research support from Novartis. The institution of Dr. Bove has received research support from Eli Lilly.
Carlo Pietrasanta	No disclosure on file
Celia Oreja Guevara	Celia Oreja Guevara has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for merck. Celia Oreja Guevara has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for roche. Celia Oreja Guevara has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for sanofi. Celia Oreja Guevara has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for novartis.
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 Biogen . Kerstin Hellwig has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis . Kerstin Hellwig has received personal compensation in the range of $500-$4,999 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 Genzyme . Kerstin Hellwig has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Bayer . 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 $500-$4,999 for serving as a Consultant for Janssen . 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 INC research . 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 $500-$4,999 for serving on a Speakers Bureau for Biogen . Kerstin Hellwig has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Bayer . 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 TEVA.
Ruth Dobson (Queen Mary University London)	The institution of Ruth Dobson has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche. The institution of Ruth Dobson has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biogen. The institution of Ruth Dobson has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis . The institution of Ruth Dobson has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sandoz. The institution of Ruth Dobson has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Merck. The institution of Ruth Dobson has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Janssen. The institution of Ruth Dobson has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Merck. The institution of Ruth Dobson has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Janssen. The institution of Ruth Dobson has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Biogen . The institution of Ruth Dobson has received research support from NMSS. The institution of Ruth Dobson has received research support from MS Society UK . The institution of Ruth Dobson has received research support from BMA Foundation . The institution of Ruth Dobson has received research support from Biogen . The institution of Ruth Dobson has received research support from Merck . The institution of Ruth Dobson has received research support from Horne Family Charitable Trust .
Sandra Vukusic, MD (Hopital Neurologique Pierre Wertheimer)	The institution of Dr. Vukusic has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biogen. The institution of Dr. Vukusic has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Roche. The institution of Dr. Vukusic has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. The institution of Dr. Vukusic has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Merck. The institution of Dr. Vukusic has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Teva. The institution of Dr. Vukusic has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Celgene. The institution of Dr. Vukusic has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Janssen. The institution of Dr. Vukusic has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sandoz. Dr. Vukusic has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biogen.
Chien-Ju Lin	No disclosure on file
Daniela Alves (Hoffmann La Roche)	No disclosure on file
Dusanka Zecevic	No disclosure on file
Germano Ferreira	No disclosure on file
Licinio M. Craveiro, MD, PhD (Roche)	Dr. Craveiro has received personal compensation for serving as an employee of Hoffmann La-Roche. Dr. Craveiro has received stock or an ownership interest from Hoffmann La-Roche.
Noemi Pasquarelli	Noemi Pasquarelli has nothing to disclose.
Thomas McElrath, MD, PhD (Brigham and Women's Hospital)	Thomas McElrath, MD, PhD has received personal compensation for serving as an employee of NxPrenatal Inc, Louisville Ky. Research support to institution, equity.. Thomas McElrath, MD, PhD has received personal compensation for serving as an employee of Mirvie Inc, San Francisco, Ca. Service on scientific advisory board, equity. Thomas McElrath, MD, PhD has received personal compensation for serving as an employee of Hoffman – LaRoache, Basel SW. Service on scientific advisory board. Cash payment. Thomas McElrath, MD, PhD has received personal compensation for serving as an employee of Comanche Biopharma, Inc. Boston, MA Service on scientific advisory board. Cash payment..