dc.creator | Efthimios D., Georgios K., Antonia A., Rania G., Maria-Eleutheria E., TOPICS Study Group | en |
dc.date.accessioned | 2023-01-31T07:37:06Z | |
dc.date.available | 2023-01-31T07:37:06Z | |
dc.date.issued | 2021 | |
dc.identifier | 10.1007/s40261-021-01073-y | |
dc.identifier.issn | 11732563 | |
dc.identifier.uri | http://hdl.handle.net/11615/71277 | |
dc.description.abstract | Background and Objectives: For chronic diseases like multiple sclerosis (MS), real-world evidence on long-term treatment outcomes is essential. The study aimed to provide long-term data on the safety and effectiveness of natalizumab in patients with relapsing-remitting MS (RRMS) treated in a routine care setting in Greece. Methods: TOPICS Greece was a multicenter, single-country, prospective 5-year observational study. Results: Between 19-Apr-2012 and 18-Dec-2014, 304 eligible adults [females: 63.2%; median age at natalizumab initiation: 38.0 years; median disease duration: 6.2 years; median Expanded Disability Status Scale (EDSS) score at baseline: 3.5] were enrolled in the study by 20 hospital-based neurologists. The 1-year annualized relapse rate (ARR) before treatment initiation was 1.859, while the ARR during the first year of treatment was 0.131, representing a significant 93% reduction (p < 0.001). The ARR over the median treatment period of 59.4 months was 0.109. Patients with ≤1 relapse in the pre-natalizumab year (46.1%) and those having received ≤1 prior disease-modifying therapy (57.9%) displayed significantly lower on-natalizumab ARR. The 1-, 2-, 3-, 4- and 5-year cumulative probabilities of EDSS progression were 3.2, 6.2, 9.7, 13.4, and 17.4%, respectively; the respective probabilities of EDSS disability improvement were 18.3, 25.1, 27.4, 28.0, and 30.1%. Over a median safety data collection period of 48.7 months, 4.6% of the patients experienced ≥ 1 serious adverse event, with infections (reported in 1.0%) being the most common. Conclusion: In real-world settings in Greece, natalizumab displayed beneficial long-term effects on disease activity and disability progression consistent with previous studies with no new serious safety signals emerging. © 2021, The Author(s). | en |
dc.language.iso | en | en |
dc.source | Clinical Drug Investigation | en |
dc.source.uri | https://www.scopus.com/inward/record.uri?eid=2-s2.0-85113602625&doi=10.1007%2fs40261-021-01073-y&partnerID=40&md5=237327b5266822d75fdb6316d1cacd1f | |
dc.subject | immunoglobulin | en |
dc.subject | natalizumab | en |
dc.subject | steroid | en |
dc.subject | immunologic factor | en |
dc.subject | natalizumab | en |
dc.subject | adult | en |
dc.subject | Article | en |
dc.subject | disease activity | en |
dc.subject | disease duration | en |
dc.subject | disease exacerbation | en |
dc.subject | drug efficacy | en |
dc.subject | drug safety | en |
dc.subject | Expanded Disability Status Scale | en |
dc.subject | female | en |
dc.subject | Greece | en |
dc.subject | hospitalization | en |
dc.subject | human | en |
dc.subject | immunosuppressive treatment | en |
dc.subject | infection | en |
dc.subject | long term care | en |
dc.subject | major clinical study | en |
dc.subject | male | en |
dc.subject | multicenter study | en |
dc.subject | multiple sclerosis | en |
dc.subject | observational study | en |
dc.subject | opportunistic infection | en |
dc.subject | prospective study | en |
dc.subject | recurrence risk | en |
dc.subject | relapse | en |
dc.subject | survival rate | en |
dc.subject | treatment duration | en |
dc.subject | clinical trial | en |
dc.subject | multiple sclerosis | en |
dc.subject | treatment outcome | en |
dc.subject | Adult | en |
dc.subject | Female | en |
dc.subject | Greece | en |
dc.subject | Humans | en |
dc.subject | Immunologic Factors | en |
dc.subject | Multiple Sclerosis | en |
dc.subject | Multiple Sclerosis, Relapsing-Remitting | en |
dc.subject | Natalizumab | en |
dc.subject | Prospective Studies | en |
dc.subject | Treatment Outcome | en |
dc.subject | Adis | en |
dc.title | 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’ | en |
dc.type | journalArticle | en |