Long-term safety and effectiveness of natalizumab treatment in clinical practice: 10 years of real-world data from the Tysabri Observational Program (TOP)
| العنوان: | Long-term safety and effectiveness of natalizumab treatment in clinical practice: 10 years of real-world data from the Tysabri Observational Program (TOP) |
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| المؤلفون: | Helmut, Butzkueven, Ludwig, Kappos, Heinz, Wiendl, Maria, Trojano, Tim, Spelman, Ih, Chang, Rachna, Kasliwal, Seema, Jaitly, Nolan, Campbell, Pei-Ran, Ho, Stephanie, Licata, François, Ziegler |
| المساهمون: | Willekens, Barbara, Tysabri Observational Program (TOP) Investigators, Clinical sciences, Neuroprotection & Neuromodulation, Neurology |
| المصدر: | Journal of Neurology, Neurosurgery, and Psychiatry Journal of neurology, neurosurgery and psychiatry |
| سنة النشر: | 2020 |
| مصطلحات موضوعية: | Adult, Male, Pediatrics, medicine.medical_specialty, Multiple Sclerosis, 03 medical and health sciences, symbols.namesake, Disability Evaluation, 0302 clinical medicine, Natalizumab, Multiple Sclerosis, Relapsing-Remitting, medicine, Humans, Immunologic Factors, 030212 general & internal medicine, Poisson regression, ddc:610, Adverse effect, business.industry, Progressive multifocal leukoencephalopathy, Multiple sclerosis, Middle Aged, medicine.disease, Interim analysis, Psychiatry and Mental health, Treatment Outcome, symbols, Disease Progression, Surgery, Observational study, Female, Neurology (clinical), Human medicine, business, Real world data, 030217 neurology & neurosurgery, medicine.drug |
| الوصف: | ObjectiveThe Tysabri Observational Programme (TOP), which began >10 years ago, is an open-label, multinational, prospective observational study evaluating the long-term safety and effectiveness of natalizumab in relapsing-remitting multiple sclerosis patients.MethodsThese data provide a 10-year interim analysis of safety and effectiveness in TOP. Annualised relapse rates (ARRs) and disability progression/improvement were analysed using the Poisson model and the Kaplan-Meier method, respectively. Analyses included patients on natalizumab and those who discontinued natalizumab but remained in TOP.ResultsAs of November 2017, TOP included 6148 patients. Overall, 829 patients (13.5%) experienced ≥1 serious adverse event (SAE), with infection the most common (4.1%). Fifty-three patients (0.9%) had confirmed progressive multifocal leukoencephalopathy. SAE data were consistent with natalizumab’s known safety profile; no new safety signals were identified. A total of 3210 patients (52.2%) discontinued natalizumab; 2117 (34.4%) withdrew from TOP. Median time on natalizumab was 3.3 (range 0–11.6) years; median follow-up time was 5.2 (range 0–10.8) years. The on-natalizumab ARR was 0.15, a 92.5% reduction from the year before initiation. Ten-year cumulative probabilities of disability worsening and improvement were 27.8% and 33.1%, respectively. On-natalizumab ARRs were similar between patients who discontinued or remained on natalizumab, suggesting limited attrition bias.ConclusionsSince the TOP 5-year interim analysis (December 2012), cohort size (6148 vs 4821), median exposure (3.3 vs 1.8 years) and median follow-up time (62 vs 26 months) have increased. This 10-year interim analysis further supports the robust real-world effectiveness and well-established safety profile of natalizumab.Trial registration numberNCT00493298. |
| وصف الملف: | application/pdf |
| اللغة: | English |
| تدمد: | 0022-3050 |
| الوصول الحر: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::4c78b9aec3b2708caaa67d13d22053a5Test https://opus.bibliothek.uni-augsburg.de/opus4/frontdoor/index/index/docId/93019Test |
| حقوق: | OPEN |
| رقم الانضمام: | edsair.doi.dedup.....4c78b9aec3b2708caaa67d13d22053a5 |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 00223050 |
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