Journal
MULTIPLE SCLEROSIS JOURNAL
Volume 17, Issue 6, Pages 708-719Publisher
SAGE PUBLICATIONS LTD
DOI: 10.1177/1352458510394701
Keywords
disease-modifying therapies; multiple sclerosis; relapsing-remitting; Tysabri
Categories
Funding
- AFA Foundation
- Bayer-Schering Pharma
- Sanofi-Aventis
- Biogen Idec
- Swedish Research Council
- European Union [LSHM-CT-2005-018637]
- Soderbergs Foundation
- Bibbi and Nils Jensen's Foundation
- Montel Williams Foundation
- Swedish Brain Foundation
- national programme for quality registries in health care
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Background: A post marketing surveillance study was conducted to evaluate safety and efficacy of natalizumab in Swedish multiple sclerosis (MS) patients since its introduction in August 2006 until March 2010. Methods: Patients were registered in the web-based Swedish MS-registry at 40 locations and evaluated every 6 months. Adverse events and clinical outcomes were recorded. Results: One thousand one hundred and fifty-two patients were included (71.4% female) and 149 patients stopped treatment; the main reason was planned pregnancy. Anti-natalizumab antibodies were found in 4.5% (52 patients) of which 1.6% displayed persistent antibodies. Serious adverse events were rare, but included three cases with progressive multifocal leukoencephalopathy (PML). There were seven fatal cases, probably unrelated to the natalizumab treatment. For relapsing-remitting MS patients (n = 901), mean Expanded Disability Status Scale (EDSS, -10.7%), Multiple Sclerosis Severity Scale (MSSS, -20.4%), Multiple Sclerosis Impact Scale (MSIS-29, physical -9.9%, psychological -13.3%) and Symbol Digit Modalities Test (SDMT, +10.7%) all showed significant improvements during 24 months of treatment with natalizumab. The Swedish web-based MS quality registry proved to function as a platform for post-marketing MS drug surveillance, providing long-term data regarding drug effects and adverse events beyond clinical trials. Conclusions: Our results indicate that natalizumab is generally well tolerated and has sustained efficacy for patients with active MS, though the risk of PML is still an important concern.
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