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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Fältnamn	Indikatorer	Metadata
000		03223naa a2200373 4500
001		oai:prod.swepub.kib.ki.se:143854951
003		SwePub
008		240701s2020 \| \|\|\|\|\|\|\|\|\|\|\|000 \|\|eng\|
024	7	a http://kipublications.ki.se/Default.aspx?queryparsed=id:1438549512 URI
024	7	a https://doi.org/10.1136/jnnp-2019-3223262 DOI
040		a (SwePub)ki
041		a engb eng
042		9 SwePub
072	7	a ref2 swepub-contenttype
072	7	a art2 swepub-publicationtype
100	1	a Butzkueven, H4 aut
245	1 0	a Long-term safety and effectiveness of natalizumab treatment in clinical practice: 10 years of real-world data from the Tysabri Observational Program (TOP)
264		c 2020-03-31
264	1	b BMJ,c 2020
520		a The 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.
700	1	a Kappos, L4 aut
700	1	a Wiendl, H4 aut
700	1	a Trojano, M4 aut
700	1	a Spelman, T4 aut
700	1	a Chang, I4 aut
700	1	a Kasliwal, R4 aut
700	1	a Jaitly, S4 aut
700	1	a Campbell, N4 aut
700	1	a Ho, PR4 aut
700	1	a Licata, S4 aut
773	0	t Journal of neurology, neurosurgery, and psychiatryd : BMJg 91:6, s. 660-668q 91:6<660-668x 1468-330Xx 0022-3050
856	4	u https://jnnp.bmj.com/content/jnnp/91/6/660.full.pdf
856	4 8	u http://kipublications.ki.se/Default.aspx?queryparsed=id:143854951
856	4 8	u https://doi.org/10.1136/jnnp-2019-322326

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Av författaren/redakt...: Butzkueven, H; Kappos, L; Wiendl, H; Trojano, M; Spelman, T; Chang, I; visa fler...; Kasliwal, R; Jaitly, S; Campbell, N; Ho, PR; Licata, S; visa färre...

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Av lärosätet: Karolinska Institutet

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