Observational studyBMC neurology2019
Outcomes of natalizumab treatment within 3 years of relapsing-remitting multiple sclerosis diagnosis: a prespecified 2-year interim analysis of STRIVE.
Observational study in BMC neurology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01485003 (A Multicenter, Observational, Open-Label, Single-Arm Study of Tysabri in Early Relapsing-Remitting Multiple Sclerosis in Anti-JCV Antibody Negative Patients), which is not on this map. Cited by 26 papers, 3 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Multicenter, Observational, Open-Label, Single-Arm Study of Tysabri in Early Relapsing-Remitting Multiple Sclerosis in Anti-JCV Antibody Negative Patients
Who cites it
26 citing papers in PubMed, 3 syntheses or guidelines pooled it.
- Adverse effects of immunotherapies for multiple sclerosis: a network meta-analysis.The Cochrane database of systematic reviews · 2023Pooled it
- Instruments measuring change in cognitive function in multiple sclerosis: A systematic review.Brain and behavior · 2023Pooled it
- Cognitive Efficacy of Pharmacologic Treatments in Multiple Sclerosis: A Systematic Review.CNS drugs · 2020Pooled it
- Stability in Cognition and Employment in People with Relapsing Multiple Sclerosis Treated with Cladribine Tablets: Two-year Phase IV CLARIFY-MS Study.Neurology and therapy · 2026Article
- Patient-reported outcomes of quality of life before and after autologous hematopoietic stem cell transplantation for multiple sclerosis.Multiple sclerosis (Houndmills, Basingstoke, England) · 2025Observational
- Homonymous Hemiatrophy of Macular Ganglion Cell Layer as a Marker of Retrograde Neurodegeneration in Multiple Sclerosis-A Narrative Review.Diagnostics (Basel, Switzerland) · 2024Review
- Long-term outcome of natalizumab-associated progressive multifocal leukoencephalopathy in Austria: a nationwide retrospective study.Journal of neurology · 2024Article
- No Evidence of Disease Activity (NEDA) as a Clinical Assessment Tool for Multiple Sclerosis: Clinician and Patient Perspectives [Narrative Review].Neurology and therapy · 2023Review
- Real-World Effectiveness of Natalizumab Extended Interval Dosing in a French Cohort.Neurology and therapy · 2023Article
- Correlation of disability with quality of life in patients with multiple sclerosis treated with natalizumab: primary results and post hoc analysis of the TYSabri ImPROvement study (PROTYS).BMJ neurology open · 2023Article
- The impact of disease modifying therapies on cognitive functions typically impaired in multiple sclerosis patients: a clinician's review.Frontiers in neurology · 2023Review
- Effects on cognition of DMTs in multiple sclerosis: moving beyond the prevention of inflammatory activity.Journal of neurology · 2022Review
- Investigating Serum sHLA-G Cooperation With MRI Activity and Disease-Modifying Treatment Outcome in Relapsing-Remitting Multiple Sclerosis.Frontiers in neurology · 2022Article
- Long-Term Effectiveness of Natalizumab in Patients with Relapsing-Remitting Multiple Sclerosis Treated in the Routine Care in Greece: Results from the Multicenter, Observational 5-Year Prospective Study 'TOPICS Greece'.Clinical drug investigation · 2021Observational
- Natalizumab is associated with early improvement of working ability in relapsing-remitting multiple sclerosis patients: WANT observational study results.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2021Observational
- Real-world effectiveness of natalizumab treatment in patients with relapsing multiple sclerosis in Argentina and Chile.Arquivos de neuro-psiquiatria · 2021Observational
- The Nerves to Conduct a Multiple Sclerosis Crime Investigation.International journal of molecular sciences · 2021Review
- No evidence for loss of natalizumab effectiveness with every-6-week dosing: a propensity score-matched comparison with every-4-week dosing in patients enrolled in the Tysabri Observational Program (TOP).Therapeutic advances in neurological disorders · 2021Article
- Common Peripheral Immunity Mechanisms in Multiple Sclerosis and Alzheimer's Disease.Frontiers in immunology · 2021Review
- Identifying Early Neuropsychological Indicators of Cognitive Involvement in Multiple Sclerosis.Neuropsychiatric disease and treatment · 2021Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors.
Funding
Abstract
backgroundSTRIVE is a multicenter, observational, open-label, single-arm study of natalizumab in anti-JC virus (JCV) seronegative patients with early relapsing-remitting multiple sclerosis (RRMS). The objective of this prespecified 2-year interim analysis was to determine the effectiveness of natalizumab in establishing and maintaining no evidence of disease activity (NEDA) in early RRMS.
methodsPatients aged 18-65 years had an RRMS diagnosis < 3 years prior to screening, an Expanded Disability Status Scale (EDSS) score ≤ 4.0, and anti-JCV antibody negative status. Magnetic resonance imaging was performed at baseline and yearly thereafter. Cumulative probabilities of 24-week-confirmed EDSS worsening and improvement were evaluated at 2 years. NEDA (no 24-week-confirmed EDSS worsening, no relapses, no gadolinium-enhancing lesions, and no new/newly enlarging T2-hyperintense lesions) was evaluated over 2 years. The Symbol Digit Modalities Test (SDMT) and Multiple Sclerosis Impact Score (MSIS-29) were assessed at baseline and 1 and 2 years. Statistical analysis used summary statistics and frequency distributions.
resultsThe study population (N = 222) had early RRMS, with mean (standard deviation [SD]) time since diagnosis of 1.6 (0.77) years and mean (SD) baseline EDSS score of 2.0 (1.13). NEDA was achieved in 105 of 187 patients (56.1%) during year 1 and 120 of 163 (73.6%) during year 2. Over 2 years, 76 of 171 patients (44.4%) attained overall NEDA. Probabilities of 24-week-confirmed EDSS worsening and improvement were 14.1% and 28.4%, respectively. After 2 years, patients exhibited significant improvements from baseline in SDMT (n = 158; mean [SD]: 4.3 [11.8]; p < 0.001) and MSIS-29 physical (n = 153; mean [SD]: - 3.9 [14.7]; p = 0.001), psychological (n = 152; mean [SD]: - 2.0 [7.9]; p < 0.001), and quality-of-life (n = 153; mean [SD]: - 6.0 [21.3]; p < 0.001) scores.
conclusionsThese results support natalizumab's effectiveness over 2 years, during which nearly half of early RRMS patients achieved NEDA. During year 2, nearly 75% of patients exhibited NEDA. Over 2 years, patients continued to experience significant cognitive and quality-of-life benefits. These results are limited by the lack of a comparator group to determine the extent of a placebo effect.
trial registrationclinicaltrials.gov, NCT01485003 , registered 5 December 2011.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.