Pregnancy Exposure to Anti-CD20 Monoclonal Antibodies in Patients With Multiple Sclerosis: Results From an Italian Multicenter Registry Study.

Authors

Irene Gattuso, Angela Genchi, Girolama Alessandra Marfia, Doriana Landi, Assunta Bianco, Massimiliano Mirabella, Giovanna Borriello, Antonio Gallo, Laura Brambilla, Valentina Gasparini, Lorena Lorefice, Maria Pia Amato, Francesca Rinaldi, Roberta Lanzillo, Elisabetta Signoriello, Maria Cellerino, Clara Grazia Chisari, Paola Cavalla, Carla Tortorella, Giovanna De Luca, Albulena Bajrami, Roberta Fantozzi, Damiano Paolicelli, Cristina Montomoli, Massimo Filippi, Lucia Moiola, CD20-Pregnancy Study Group

Published in

Neurology(R) neuroimmunology & neuroinflammation. Volume 13. Issue 6. Pages e200650. Epub Aug 28, 2026.

Abstract

Although anti-CD20 monoclonal antibodies (anti-CD20s) theoretically represent an ideal treatment option for women with multiple sclerosis (wwMS) planning a pregnancy, the paucity of real-world data still limits their use in this context. Through our Italian registry "CD20-PREGNANCY," we aim to report pregnancy, infant, and maternal outcomes in wwMS treated with anti-CD20s.
In this observational study, wwMS having received rituximab (RTX), ocrelizumab (OCR), or ofatumumab (OFA) before and/or during pregnancy (≤12 months for RTX/OCR, ≤6 months for OFA) were included. Considering drug pharmacokinetics and timings of immunoglobulin placental transfer, pregnancies were classified as "exposed" (last administration pre-pregnancy ≤2.3 months for RTX, ≤3 for OCR, ≤1.8 for OFA) and "not-exposed" (last administration beyond these intervals) for comparative analysis.
A total of 153 pregnancies (85 "not-exposed," 68 "exposed") across 27 Italian MS centers were collected. The median age at conception was 33.9 years (interquartile range 30.0-37.6) with 39.9% of women older than 35 years. Most pregnancies occurred in patients treated with OCR (77.1%). 80.4% of pregnancies ended in livebirth and 13.1% in spontaneous abortions (SA), without stillbirths/neonatal deaths. There was a significantly higher percentage of SA in "exposed" pregnancies than "not-exposed" (20.6% vs 7.1%, p = 0.014), but with values similar to those reported in general population. One serious perinatal infection ("exposed" group) and 2 major congenital anomalies (MCA) (one per group) were reported. Compared with the 12 months pre-pregnancy, annualized relapse rate remained stable during pregnancy but slightly increased postpregnancy (0.00 vs +0.09) in "not-exposed." Conversely, it decreased in both periods (-0.02 vs -0.13) among "exposed". Compared with pre-pregnancy, postpregnancy combined unique active lesions decreased in both groups (-0.15 in "not-exposed", -0.38 in "exposed"), while 2 confirmed disability worsening were observed ("not-exposed").
In conclusion, a good control of disease activity was observed without an increased risk of MCA or perinatal infections. Percentages of SA were overall in line with those of general population, although with a higher proportion in the "exposed" group. These findings support the use of anti-CD20 therapies in wwMS planning pregnancy, although further data are needed to better define their safety profile in this setting.

PMID:
42664474
Bibliographic data and abstract were imported from PubMed on 29 Aug 2026.

Read full publication at:
Please sign in to see all details.

Stats

1-terrible, 9-excellent. How would you rate this publication? Sign in in to submit your rating.

Post a comment

You need to be signed in to post comments. You can sign in here.

Comments

There are no comments yet.