Browsing by Author "Jokubaitis, Vilija G."

Now showing 1 - 4 of 4

Citation - WoS: 12
Citation - Scopus: 8
Disease Activity in Pregnant and Postpartum Women With Multiple Sclerosis Receiving Ocrelizumab or Other Disease-Modifying Therapies
(Lippincott Williams & Wilkins, 2024) Yeh, Wei Z.; van der Walt, Anneke; Skibina, Olga G.; Kalincik, Tomas; Alroughani, Raed; Kermode, Allan G.; Fabis-Pedrini, Marzena J.; Jokubaitis, Vilija G.; Cárdenas-Robledo, Simón
Background and Objectives Women with multiple sclerosis (MS) are at risk of disease reactivation in the early postpartum period. Ocrelizumab (OCR) is an anti-CD20 therapy highly effective at reducing MS disease activity. Data remain limited regarding use of disease-modifying therapies (DMTs), including OCR, and disease activity during peripregnancy periods. Methods We performed a retrospective cohort study using data from the MSBase Registry including pregnancies conceived after December 31, 2010, from women aged 18 years and older, with relapsing-remitting MS or clinically isolated syndrome. Women were classified by preconception exposure to DMTs, including OCR, rituximab (RTX), natalizumab (NAT), stratified into active (NAT-A; continued >= 28 weeks of gestation, restarted <= 1 month postpartum) or conservative (NAT-C; continued <= 4 weeks of gestation, restarted >1 month postpartum) strategies, dimethyl fumarate (DMF) or low-efficacy DMTs (interferon-beta, glatiramer acetate). Annualized relapse rates (ARRs) were calculated for 12-month prepregnancy, pregnancy, and 6-month postpartum periods. Results A total of 2,009 live births from 1,744 women were analyzed, including 73 live births from 69 women treated with preconception OCR. For OCR, no within-pregnancy relapse was observed and 3 women (4.1%) experienced 1 relapse in the postpartum period (ARR 0.09 [95% CI 0.02-0.27]). For NAT-A, 3 (3.7%) of 82 women relapsed during pregnancy (0.05 [0.01-0.15]) and 4 (4.9%) relapsed during postpartum (0.10 [0.03-0.26]). However, for NAT-C, 13 (15.9%) of 82 women relapsed within pregnancy (0.32 [0.20-0.51]) and 25 (30.5%) relapsed during postpartum (0.74 [0.50-1.06]). In the low-efficacy DMT group, 101 (7.6%) of 1,329 women experienced within-pregnancy relapse (0.12 [0.10-0.14]), followed by an increase in postpartum relapse activity with 234 women (17.6%) relapsing (0.43 [0.38-0.48]). This was similarly seen in the DMF group with 13 (7.9%) of 164 women experiencing within-pregnancy relapse (0.12 [0.06-0.20]) and 25 (15.2%) of 164 relapsing postpartum (0.39 [0.26-0.57]). Our RTX cohort had 0 of 24 women experiencing within-pregnancy relapse and 3 (12.5%) of 24 experiencing postpartum relapse. Discussion Women treated with OCR or NAT-A were observed to have low relapse rates during pregnancy and postpartum. NAT-C was associated with increased risk of relapses. There was no within-pregnancy relapse in our RTX cohort, although we caution overinterpretation due to our sample size. An effective DMT strategy with a favorable safety profile for the mother and infant should be discussed and implemented well in advance of planning a family. Classification of Evidence This study provides Class III evidence that for women with relapsing-remitting MS or clinically isolated syndrome who become pregnant, ocrelizumab, rituximab, and natalizumab (continued >= 28 weeks of gestation and restarted <= 1 month postpartum) were associated with reduced risk of relapses, compared with other therapeutic strategies.
Disease Course After Pregnancy in Women With Progressive Multiple Sclerosis Symptoms
(SAGE Publications Ltd, 2025) Shipley, J.; Beadnall, H.N.; Sanfilippo, P.G.; Horáková, D.; Boz, C.; Prat, A.; Özakbaş, S.; Jokubaitis, Vilija G.
Background: The impact of pregnancy on disease outcomes has not been characterised in women with progressive multiple sclerosis (MS) phenotypes. This study aimed to describe the clinical characteristics and disease course of women who experienced a pregnancy after a diagnosis of primary progressive MS (PPMS) or secondary progressive MS (SPMS). Methods: This multicentre observational cohort study utilised data from the international MSBase Registry extracted on 2 June 2024. Expanded Disability Status Scale (EDSS) scores of women with progressive MS were assessed up to 10 years postpartum and compared to those of propensity score–matched women with progressive MS without a pregnancy history. Results: In total, 138 women with 164 pregnancies were included in the study, comprising 75 women with PPMS and 63 with SPMS. Of these, 24 women with PPMS and 47 with SPMS had longitudinal peri-pregnancy EDSS assessments and were included in the analysis of disability scores. A history of pregnancy was not associated with a significant difference in long-term disability trajectories in women with either PPMS (estimate = −0.02; 95% confidence interval (CI) = −0.07 to 0.04) or SPMS (estimate = 0.00; 95% CI = −0.02 to 0.03). Conclusion: A history of pregnancy is not associated with a significant difference in long-term disability in women with progressive MS symptoms. © 2025 Elsevier B.V., All rights reserved.
Four Years On: Pregnancy and Birth Outcomes Reported in the MSBase Pregnancy, Neonatal Outcomes, and Women’s Health Registry (2020–2024)
(SAGE Publications Ltd, 2025) Jokubaitis, Vilija G.; Alroughani, Raed A.; Altintaş, Ayşe; Eichau, Sara; Hughes, Stella E.; Willekens, Barbara; Boz, Cavit; Kopchak, Oksana; Gray, Orla
Background: Family planning is an important aspect of multiple sclerosis (MS), and neuromyelitis optica spectrum disorder (NMOSD) management. Knowledge gaps remain, including optimal perinatal management strategies, and fetal risks associated with disease-modifying therapy (DMT) exposure. Objective: To describe perinatal DMT use, together with pregnancy and neonatal outcomes prospectively recorded in the International MSBase Pregnancy and Women’s Health Registry. Methods: We report summary statistics for data collected between May 2020 and August 2024. Results: A total of 1887 relapsing-remitting MS (RRMS), 12 primary-progressive MS (PPMS), 2 radiologically isolated syndrome (RIS) and 21 NMOSD completed pregnancies were recorded, including 1644 (85.5%) live births, 208 (10.8%) miscarriages, and 6 (0.3%) neonatal deaths. Most women had unassisted (53.8%) or assisted (7.4%) vaginal births. Seventy five percent of pregnancies had DMT exposures within 6 months preconception; 19% of NMOSD, and 62% of MS pregnancies were DMT-exposed during gestation; 18.1% of pregnancies reported in-pregnancy monoclonal antibody DMT exposure. No overt safety signals were seen. Conclusion: This first report from the newly launched MSBase pregnancy registry, establishes an increasing number of pregnancies being conceived on monoclonal antibody therapies. Although no safety signals were observed, it is important to continue monitoring for safety signals in real-world databases as the use of highly effective therapies continues to increase perinatally. © 2025 Elsevier B.V., All rights reserved.
Pregnancy-Related Disease Outcomes in Women with Moderate to Severe Multiple Sclerosis Disability
(Amer Medical Assoc, 2025) Shipley, Jessica; Beadnall, Heidi N.; Sanfilippo, Paul G.; Yeh, Wei Zhen; Horakova, Dana; Havrdova, Eva Kubala; Jokubaitis, Vilija G.
Importance: Understanding the association between pregnancy and clinical outcomes in women with moderate to severe multiple sclerosis (MS) disability is crucial for guiding family planning and management strategies. Objective: To assess peripregnancy relapse activity and disability progression in women with a preconception Expanded Disability Status Scale (EDSS) score of 3 or higher. Design, Setting, and Participants: This multicenter retrospective cohort study used data from the MSBase Registry, with clinical observations spanning 1984 through 2024. Study cohorts included pregnant women with MS with a preconception EDSS score of 3 or higher (range: 3-10, with higher scores indicating more severe MS-related disability) and propensity score-matched nonpregnant women with MS (controls). Main Outcomes and Measures: The main outcomes were peripregnancy annualized relapse rates (ARRs) and time to 6-month confirmed disability worsening (CDW). Results: A total of 1631 women with MS were included, of whom 575 were in the pregnant cohort (median [IQR] age at pregnancy, 32.5 [29.1-36.1] years) and 1056 were in the nonpregnant cohort (median [IQR] age, 32.6 [27.5-37.2] years). The median (range) preconception EDSS score was 3.5 (3.0-7.5). Relapse activity decreased during pregnancy, with a 75% reduction in ARR during the first trimester (rate ratio [RR], 0.25; 95% CI, 0.15-0.43), and increased to 36% above preconception levels in the first 3 months post partum (RR, 1.36; 95% CI, 1.06-1.75). Relapse during pregnancy was associated with a higher preconception ARR (odds ratio [OR], 1.56; 95% CI, 1.10-2.20) and preconception use of natalizumab (OR, 4.42; 95% CI, 1.24-23.57) or fingolimod (OR, 14.07; 95% CI, 2.81-91.30). Older age (OR, 0.92; 95% CI, 0.85-0.99) and continuation of disease-modifying therapy into pregnancy (OR, 0.42; 95% CI, 0.19-1.00) were associated with reduced risk. Disease-modifying therapy reinitiation within 1 month post partum was associated with lower odds of early postpartum relapse (OR, 0.45; 95% CI, 0.23-0.86). There was no significant difference in time to CDW between the pregnant and nonpregnant groups (hazard ratio [HR], 1.15; 95% CI, 0.96-1.38). However, ARR during pregnancy (HR, 1.37; 95% CI, 1.13-1.65) and postpartum EDSS score higher than 4 (HR, 2.69; 95% CI, 1.80-4.03) were associated with shorter time to CDW. Conclusions and Relevance: In this cohort study, women with moderate to severe MS disability exhibited a pattern of peripregnancy relapse activity similar to that reported in women with less disability. Pregnancy was not associated with worse long-term disability outcomes, although optimizing disease control in the peripregnancy period remained critical.