Pregnancy Outcomes in the Ozanimod Clinical Development Program in Patients With Ulcerative Colitis, Crohn's Disease, and Relapsing Multiple Sclerosis

Marla C Dubinsky; Lorna Charles; Krzysztof W Selmaj; Giancarlo Comi; Anthony Krakovich; Melissa Rosen; C Janneke van der Woude; Uma Mahadevan

doi:10.1093/ibd/izae011

Pregnancy Outcomes in the Ozanimod Clinical Development Program in Patients With Ulcerative Colitis, Crohn's Disease, and Relapsing Multiple Sclerosis

Inflamm Bowel Dis. 2024 Dec 5;30(12):2512-2515. doi: 10.1093/ibd/izae011.

Authors

Marla C Dubinsky¹, Lorna Charles², Krzysztof W Selmaj^{3

4}, Giancarlo Comi⁵, Anthony Krakovich², Melissa Rosen², C Janneke van der Woude⁶, Uma Mahadevan⁷

Affiliations

¹ Susan and Leonard Feinstein Inflammatory Bowel Disease Clinical Center, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
² Bristol Myers Squibb, Princeton, NJ, USA.
³ Center for Neurology, Lodz, Poland.
⁴ Department of Neurology, Collegium Medicum, University of Warmia and Mazury, Olsztyn, Poland.
⁵ Department of Neurorehabilitation Sciences, Vita-Salute San Raffaele University and Casa di Cura Igea, Milan, Italy.
⁶ Department of Gastroenterology and Hepatology, Erasmus University Medical Center, Rotterdam, Netherlands.
⁷ Gastroenterology Division, Department of Medicine, University of California, San Francisco, San Francisco, CA, USA.

No abstract available

Keywords: Crohn’s disease; multiple sclerosis; ozanimod; pregnancy; ulcerative colitis.

Plain language summary

This study evaluated pregnancy outcomes in patients with ulcerative colitis, Crohn’s disease, or multiple sclerosis and in healthy volunteers treated with ozanimod. There was no increased incidence of fetal abnormalities or adverse pregnancy outcomes with ozanimod exposure during early pregnancy.

Grants and funding

Bristol Myers