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ArtikelQuantitative risk-benefit analysis of natalizumab  
Oleh: Thompson, J. P. ; Noyes, K. ; Dorsey, E. Ray
Jenis: Article from Journal - ilmiah internasional
Dalam koleksi: Neurology (Official Journal of The American Academy of Neurology) vol. 71 no. 05 (Jul. 2008), page 357-364.
  • Perpustakaan FK
    • Nomor Panggil: N11.K.2008.01
    • Non-tandon: 1 (dapat dipinjam: 0)
    • Tandon: tidak ada
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Isi artikelObjective: To model the long-term risks and benefits of natalizumab in individuals with relapsing multiple sclerosis (MS). Methods: We created a Markov model to evaluate treatment effects on reducing relapses and slowing disease progression using published natural history data and clinical trial results. Health changes, measured in quality-adjusted life-years (QALYs), were based on patient health preferences. Patient cohorts treated with no disease-modifying treatment, natalizumab, subcutaneous interferon ß-1a, and a theoretical "perfect" MS treatment were modeled. Sensitivity analysis was used to explore model uncertainty, including varying risks of developing progressive multifocal leukoencephalopathy (PML). Results: Treatment with natalizumab resulted in 9.50 QALYs over a 20-year time horizon, a gain of 0.80 QALYs over the untreated cohort and 0.38 QALYs over interferon ß-1a. The health loss due to PML was small (–0.06 QALYs). To offset natalizumab’s incremental health gain over interferon ß-1a, the risk had to increase from 1 to 7.6 PML per 1,000 patients treated over 17.9 months. The "perfect" MS treatment accumulated 10.59 QALYs over the 20-year time horizon, 1.89 QALYs above the untreated cohort. Interferon ß-1a resulted in greater QALY gains compared with natalizumab if natalizumab’s relative relapse reduction was reduced from 68% to 35% or if interferon ß-1a’s relative reduction was increased from 32% to 65%. Conclusions: A more than sevenfold increase in actual risk of progressive multifocal leukoencephalopathy was required to decrease natalizumab’s health gain below that of interferon ß-1a, and there remains considerable room for additional gains in health (>50%) beyond those already achieved with current therapies.
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