Browsing by Author "Boz, Cavit"

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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
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.
Real-World Effectiveness of Ocrelizumab in Multiple Sclerosis: A Multi-Registry Observational Cohort Study
(Sage Publications Ltd, 2025) Roos, Izanne; Sharmin, Sifat; Horakova, Dana; Ozakbas, Serkan; Libertinova, Jana; Boz, Cavit; Kalincik, Tomas
Real-World Effectiveness of Ocrelizumab in Relapsing Multiple Sclerosis: An Msbase Registry Sub-Study
(Elsevier Sci Ltd, 2026) Butzkueven, Helmut; Farr, Pamela; Ozakbas, Serkan; Boz, Cavit; Kalincik, Tomas; Taylor, Lisa; Spelman, Tim
Introduction: The MSOCR-R study evaluates the long-term effectiveness of ocrelizumab (OCR) in patients with relapsing multiple sclerosis (RMS) in real-world clinical settings. Methods: MSOCR-R is an ongoing, prospective, longitudinal, observational cohort study of people with RMS newly treated with OCR, using data from the international MSBase registry. The study started in July 2018, and data collected up to October 2023 were analyzed. Outcomes were confirmed disability worsening (CDW), progression independent of relapses (PIRA), and no evidence of disease activity (NEDA-3: absence of relapse, 24-week CDW, or imaging activity). Results: Overall, 1011 patients were enrolled (18.1% initiated OCR first-line therapy; 81.9% switched from previous treatment), with a median time of 3.4 years on OCR treatment. About 67% of patients were females. At OCR initiation, mean age was 41.9 years, median disease duration was 10.4 years, and median Expanded Disability Status Scale score was 3.0. The 4-year Kaplan-Meier probabilities of 24-week CDW or PIRA were 25.2% (95% CI 21.6-29.1) and 21.9% (95% CI 18.3-25.2), respectively. Annualized relapse rate substantially decreased from 0.58 (95% CI 0.53-0.63) before OCR to 0.05 (95% CI 0.04-0.06) after treatment initiation. NEDA-3 was assessed in 366 patients and the probability of achieving NEDA-3 was 39.7% (95% CI 36.0-43.5) at 4 years. Persistence on OCR was 88.0% (95% CI, 85.2-90.3) at 4 years. Better clinical outcomes were consistently observed among the first-line treatment cohort. Conclusion: The MSOCR-R study provides strong real-world evidence of OCR effectiveness in people with RMS.