Browsing by Author "Horakova, Dana"

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Cladribine as an Exit Strategy in People with MS Over the Age of 50
(Sage Publications Ltd, 2025) Roos, Izanne; Sharmin, Sifat; Mueller, Jannis; Horakova, Dana; Havrdova, Eva; Ozakbas, Serkan; Kalincik, Tomas
Comparative Effectiveness of Rituximab and Immunosuppressants in Neuromyelitis Optica Spectrum Disorder: a Retrospective Analysis of International Registry Data
(Sage Publications Ltd, 2025) Huang, Yishi; Engels, Daniel; Shaygannejad, Vahid; Horakova, Dana; Havrdova, Eva; Ozakbas, Serkan; Kalincik, Tomas
Disease-Modifying Treatment Cessation or Switch Due to Pregnancy Planning in Women With MS: Is It Safe
(Sage Publications Ltd, 2025) Hradilek, Pavel; Horakova, Dana; Drahota, Jiri; Mazouchova, Aneta; Havrdova, Eva; Vachova, Marta; Fistravec, Gregor
Late-Onset Multiple Sclerosis: Do High-Efficacy Treatments Deliver Better Outcomes
(Sage Publications Ltd, 2025) Foong, Yi Chao; Merlo, Daniel; Gresle, Melissa; Buzzard, Katherine; Horakova, Dana; Havrdova, Eva; Van der Walt, Anneke
Machine Learning-Generated Longitudinal Synthetic International Data in Multiple Sclerosis
(Sage Publications Ltd, 2025) Iqbal, Hassam; Qiang, Zhe; Sharmin, Sifat; Ball, Gareth; Brankovic, Aida; Horakova, Dana; Kalincik, Tomas
Managing Reactivation of Multiple Sclerosis During Treatment with Natalizumab
(Sage Publications Ltd, 2026) Lizak, Nathaniel; Sharmin, Sifat; Horakova, Dana; Havrdova, Eva Kubala; Eichau, Sara; Van Der Walt, Anneke; Kalincik, Tomas
Background: Following natalizumab failure, it is unknown whether switching to alternative high-efficacy therapies offers superior effectiveness over continuing natalizumab. Objective: To compare different treatment strategies following natalizumab failure. Methods: Patients suffering a relapse during natalizumab treatment with adequate follow-up were identified from the MSBase registry. Following natalizumab failure, natalizumab continuation was compared to switching to anti-CD20 therapies/alemtuzumab/lower-efficacy therapies and treatment discontinuation. The primary outcome was the risk of further relapses. Secondary outcomes included risk of subsequent magnetic resonance imaging (MRI) activity, confirmed disability worsening and disease-activity-free survival. Multivariable proportional hazards models compared outcomes during time-varying therapy exposures. Four sensitivity analyses were conducted with varied inclusion criteria and treatment failure definitions. Results: Of 1553 patients experiencing a relapse during natalizumab treatment, 1037 met the inclusion criteria. Following natalizumab failure, switch to anti-CD20 therapy was associated with a lower relapse risk (heart rate (HR) = 0.48, 95% confidence interval (CI) = 0.27-0.84) compared to continuing natalizumab; no differences were observed in MRI or disability outcomes. Treatment de-escalation or cessation was associated with increased relapse risk (HR = 1.46, 95% CI = 1.15-1.85; HR = 2.08, 95% CI = 1.22-3.55, respectively). We did not find evidence of a difference for switching to alemtuzumab. Sensitivity analyses replicated primary findings. Conclusion: This exploratory study indicates that switching to anti-CD20 therapies following natalizumab failure is associated with a >50% reduction in relapse risk. No differences were seen in secondary outcomes, despite consistent trends. Clinicians may consider anti-CD20 therapies following natalizumab failure, noting further research is needed to confirm differences in MRI and disability outcomes.
Practical Clinical Predictions: Msbase Validation of the Daae Score, a Clinical Tool for Estimating Risk of Conversion To Secondary Progressive Multiple Sclerosis
(Sage Publications Ltd, 2024) Fuchs, Tom; Schoonheim, Menno; Uher, Tomas; Horakova, Dana; Havrdova, Eva Kubala; Jelgerhuis, Julia; Weinstock-Guttman, Bianca
Predictors of Relapse and Disability Progression After Pregnancy in Women With Moderately Severe Multiple Sclerosis Disability
(Sage Publications Ltd, 2025) Shipley, Jessica; Beadnall, Heidi; Sanfilippo, Paul; Yeh, Wei; Horakova, Dana; Havrdova, Eva; Jokubaitis, Vilija
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.
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 Experience with Cladribine Tablets in the MSBase Registry 2025 Update
(Sage Publications Ltd, 2025) Spelman, Tim; van der Walt, Anneke; Ozakbas, Serkan; Horakova, Dana; Alroughani, Raed; Kalincik, Tomas; Butzkueven, Helmut; Jarvinen, Elina; Hodgkinson, Suzanne
A Standardised Definition of Progression Independent of Relapse Activity in Multiple Sclerosis
(Sage Publications Ltd, 2024) Mueller, Jannis; Sharmin, Sifat; Lorscheider, Johannes; Ozakbas, Serkan; Karabudak, Rana; Horakova, Dana; Kalincik, Tomas
Citation - WoS: 14
Citation - Scopus: 11
Standardized Definition of Progression Independent of Relapse Activity (Pira) in Relapsing-Remitting Multiple Sclerosis
(Amer Medical Assoc, 2025) Muller, Jannis; Sharmin, Sifat; Lorscheider, Johannes; Ozakbas, Serkan; Karabudak, Rana; Horakova, Dana; Kalincik, Tomas; Granziera, Cristina
Importance Progression independent of relapse activity (PIRA) is a significant contributor to long-term disability accumulation in relapsing-remitting multiple sclerosis (MS). Prior studies have used varying PIRA definitions, hampering the comparability of study results. Objective To compare various definitions of PIRA. Design, Setting, and Participants This cohort study involved a retrospective analysis of prospectively collected data from the MSBase registry from July 2004 to July 2023. The participants were patients with MS from 186 centers across 43 countries who had clinically definite relapsing-remitting MS, a complete minimal dataset, and 3 or more documented Expanded Disability Status Scale (EDSS) assessments. Exposure Three-hundred sixty definitions of PIRA as combinations of the following criteria: baseline disability (fixed baseline with re-baselining after PIRA, or plus re-baselining after relapses, or plus re-baselining after improvements), minimum confirmation period (6, 12, or 24 months), confirmation magnitude (EDSS score at/above worsening score or at/above threshold compared with baseline), freedom from relapse at EDSS score worsening (90 days prior, 90 days prior and 30 days after, 180 days prior and after, since previous EDSS assessment, or since baseline), and freedom from relapse at confirmation (30 days prior, 90 days prior, 30 days before and after, or between worsening and confirmation). Main Outcome and Measure For each definition, we quantified PIRA incidence and persistence (ie, absence of a 3-month confirmed EDSS improvement over >= 5 years). Results Among 87 239 patients with MS, 33 303 patients fulfilled the inclusion criteria; 24 152 (72.5%) were female and 9151 (27.5%) were male. At the first visits, the mean (SD) age was 36.4 (10.9) years; 28 052 patients (84.2%) had relapsing-remitting MS, and the median (IQR) EDSS score was 2.0 (1.0-3.0). Participants had a mean (SD) 15.1 (11.9) visits over 8.9 (5.2) years. PIRA incidence ranged from 0.141 to 0.658 events per decade and persistence from 0.753 to 0.919, depending on the definition. In particular, the baseline and confirmation period influenced PIRA detection. The following definition yielded balanced incidence and persistence: a significant disability worsening compared with a baseline (reset after each PIRA event, relapse, and EDSS score improvement), in absence of relapses since the last EDSS assessment, confirmed with EDSS scores (not preceded by relapses within 30 days) that remained above the worsening threshold for at least 12 months. Conclusion and Relevance Incidence and persistence of PIRA are determined by the definition used. The proposed standardized definition aims to enhance comparability among studies.
Treatment Strategies After Cell-Trafficking Agents in MS Patients Older Than 50 Years
(Sage Publications Ltd, 2025) Muller, Jannis; Benkert, Pascal; Horakova, Dana; Havrdova, Eva; Buzzard, Katherine; Skibina, Olga; Roos, Izanne