Real-world data supports ocrelizumab prior to conception

Women with MS receiving ocrelizumab before conception are likely at low risk for within-pregnancy relapse and not at increased risk of post-partum relapses. The treatment thus represents a good strategic option to control disease activity in the peri-pregnancy period. These were the main conclusions from a study based on real-world data from the international MSBase pregnancy, neonatal outcomes, and women’s health registry.

Dr Wei Yeh (Alfred Health and Monash University, Australia) and colleagues aimed to add data on disease activity during pregnancy and the post-partum period in women using ocrelizumab versus other disease-modifying therapies (DMTs) [1]. They included pregnancies between 2011 and 2023 in women with MS treated with ocrelizumab, natalizumab, dimethyl fumarate, or low-efficacy DMT (interferon beta or glatiramer acetate) before pregnancy.

Outcomes of 1,722 women with 1,985 pregnancies were analysed (ocrelizumab, n=73; natalizumab, n=419; dimethyl fumarate, n=164; low-efficacy DMT, n=1,329). Natalizumab users were further stratified into women who continued its use until the third trimester of pregnancy and restarted ≤1 month post-partum (natalizumab-early, n=82), and women who terminated natalizumab prior to 4 weeks’ gestation and restarted late after giving birth (natalizumab-late, n=82).

The main results show that MS disease activity was minimal in the first 3 months of the post-partum period among women treated with ocrelizumab (see Figure). Post-partum annualised relapse rate was 0.09 (95% CI 0.07–0.29) for ocrelizumab; 0.10 (95% CI 0.03–0.26) for natalizumab-early; 0.74 (95% CI 0.50–1.06) for natalizumab-late; 0.39 for dimethyl fumarate (95% CI 0.26–0.57); and 0.43 (95% CI 0.38–0.48) for low-efficacy DMT. A total of 3 women treated with ocrelizumab before conception had a post-partum relapse; none had relapses before conception or during pregnancy.

Figure: ARR for each 3-month period of the study [1]



ARR, annualised relapse rate; DMF, dimethyl fumarate; Low, low-efficacy therapy; NAT-E, natalizumab-early; NAT-L, natalizumab-late; OCR, ocrelizumab.

Dr Yeh concluded that women who used ocrelizumab prior to conception had the lowest relapse rate during pregnancy and post-partum compared with the other investigated DMTs. Pre-conception use of ocrelizumab, therefore, constitutes an option to effectively control disease activity during and around pregnancy.

1. Yeh W, et al. Disease activity during pre-conception, pregnancy and postpartum in women with MS receiving ocrelizumab or other disease-modifying therapies in a real-world cohort. O173, MSMilan 2023, 11–13 October, Milan, Italy.

 

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Posted on 4 December, 20234 December, 2023