Pregnancy and Infant Outcomes in Women With Multiple Sclerosis Treated With Ocrelizumab.

Background And Objectives: Ocrelizumab labeling advises contraception for women during treatment and for 6-12 months thereafter. Because pregnancies may occur during this time, it is critical to understand pregnancy and infant outcomes in women with multiple sclerosis (MS) after ocrelizumab exposure.

Methods: Pregnancy cases reported to Roche global pharmacovigilance until 12 July 2023 were analyzed.

Subcutaneous ocrelizumab in multiple sclerosis: Results of the Phase 1b OCARINA I study.

Objective: Subcutaneous ocrelizumab is being developed to provide treatment flexibility and additional choice to patients with multiple sclerosis. OCARINA I (NCT03972306) is an open-label, multicenter, Phase 1b, dose-finding study to investigate the pharmacokinetics, safety, tolerability, and immunogenicity of subcutaneous ocrelizumab and to select a dose for the Phase 3 OCARINA II study (NCT05232825).

Methods: Patients with relapsing or primary progressive multiple sclerosis (aged 18-65 years; Expanded Disability Status Scale score 0.

Ocrelizumab during pregnancy and lactation: Rationale and design of the MINORE and SOPRANINO studies in women with MS and their infants.

Background: Most disease-modifying therapies (DMTs) approved for the treatment of multiple sclerosis (MS) are not recommended during pregnancy, and discouraged while breastfeeding. However, discontinuation of some DMTs before pregnancy can leave women vulnerable to MS relapses. Although available data on ocrelizumab suggest no increased risk in terms of pregnancy or neonatal outcomes, it is unknown whether ocrelizumab transfers across the placenta or is absorbed through breastmilk; and if so, whether infant B cell development, immune responses or growth and development are affected.

Pregnancy outcomes of women with multiple sclerosis treated with ocrelizumab in Canada: A descriptive analysis of real-world data.

Objectives: To report and describe the real-world use of ocrelizumab in women with multiple sclerosis (MS) in Canada before and/or during pregnancy as well as their fetal outcomes.

Methods: We identified retrospective and prospective Canadian pregnancy exposure cases from the Roche Global Safety Database from November 5, 2008 until March 31, 2021, and linked these cases to information within the Canadian Roche Patient Support Program (COMPASS). The analysis only included spontaneous reports or those from a non-interventional program.