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Drug Evaluation

Use of natalizumab in multiple sclerosis: current perspectives

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Pages 1151-1162 | Received 20 Mar 2016, Accepted 23 Jun 2016, Published online: 27 Jul 2016

References

  • Noyes K, Weinstock-Guttman B. Impact of diagnosis and early treatment on the course of multiple sclerosis. Am J Manag Care. 2013 Nov;19(17 Suppl):s321–s331.
  • Pietrangelo A, Higuera V. Multiple sclerosis by the numbers: facts, statistics and you. 2015 [cited 2015 Mar 24]. Available from: http://www.healthline.com/health/multiple-sclerosis/facts-statistics-infographic.
  • Compston A, Coles A. Multiple sclerosis. Lancet. 2008 Oct 25;372(9648):1502–1517.
  • Dutta R, Trapp BD. Relapsing and progressive forms of multiple sclerosis: insights from pathology. Curr Opin Neurol. 2014 Jun;27(3):271–278. doi:10.1097/WCO.0000000000000094.
  • Trojano M, Paolicelli D, Bellacosa A, et al. The transition from relapsing-remitting MS to irreversible disability: clinical evaluation. Neurol Sci. 2003 Dec;24(Suppl 5):S268–S270. doi:10.1007/s10072-003-0171-6.
  • Comi G, Filippi M, Barkhof F, et al. Effect of early interferon treatment on conversion to definite multiple sclerosis: a randomised study. Lancet. 2001 May 19;357(9268):1576–1582.
  • Jacobs LD, Beck RW, Simon JH, et al. Intramuscular interferon beta-1a therapy initiated during a first demyelinating event in multiple sclerosis. CHAMPS Study Group. N Engl J Med. 2000 Sep 28;343(13):898–904.
  • Miller RM, Happe LE, Meyer KL, et al. Approaches to the management of agents used for the treatment of multiple sclerosis: consensus statements from a panel of U.S. managed care pharmacists and physicians. JMCP. 2012 Jan–Feb;18(1):54–62. doi:10.18553/jmcp.2012.18.1.54.
  • Goodin DS, Frohman EM, Garmany GP, et al. Disease modifying therapies in multiple sclerosis: report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology and the MS Council for Clinical Practice Guidelines. Neurology. 2002 Jan 22;58(2):169–178.
  • Mahad DH, Trapp BD, Lassmann H. Pathological mechanisms in progressive multiple sclerosis. Lancet Neurol. 2015 Feb;14(2):183–193. doi:10.1016/S1474-4422(14)70256-X.
  • Sellebjerg F, Cadavid D, Steiner D, et al. Exploring potential mechanisms of action of natalizumab in secondary progressive multiple sclerosis. Ther Adv Neurol Disord. 2016 Jan;9(1):31–43. doi:10.1177/1756285615615257.
  • Friese MA, Schattling B, Fugger L. Mechanisms of neurodegeneration and axonal dysfunction in multiple sclerosis. Nat Rev Neurol. 2014 Apr;10(4):225–238. doi:10.1038/nrneurol.2014.37.
  • Kutzelnigg A, Lucchinetti CF, Stadelmann C, et al. Cortical demyelination and diffuse white matter injury in multiple sclerosis. Brain. 2005 Nov;128(Pt 11):2705–2712. doi:10.1093/brain/awh641.
  • Fischer MT, Sharma R, Lim JL, et al. NADPH oxidase expression in active multiple sclerosis lesions in relation to oxidative tissue damage and mitochondrial injury. Brain. 2012 Mar;135(Pt 3):886–899. doi:10.1093/brain/aws012.
  • Fischer MT, Wimmer I, Höftberger R, et al. Disease-specific molecular events in cortical multiple sclerosis lesions. Brain. 2013 Jun;136(Pt 6):1799–1815. doi:10.1093/brain/awt110.
  • Haider L, Simeonidou C, Steinberger G, et al. Multiple sclerosis deep grey matter: the relation between demyelination, neurodegeneration, inflammation and iron. J Neurol Neurosurg Psychiatry. 2014 Dec;85(12):1386–1395. doi:10.1136/jnnp-2014-307712.
  • The use of natalizumab for the treatment of multiple sclerosis. AAN summary for evidence-based guideline for clinicians [Internet]. AAN; 2008. [cited 2016 May 19]. Available from: https://www.aan.com/Guidelines/home/GetGuidelineContent/306.
  • Hartung DM, Bourdette DN, Ahmed SM, et al. The cost of multiple sclerosis drugs in the US and the pharmaceutical industry: too big to fail? Neurology. 2015 May 26;84(21):2185–2192.
  • Brandes DW, Shaya FT, Pill MW. Quantifying the role of natalizumab in health and economic outcomes in multiple sclerosis. Am J Manag Care. 2010 Jun;16(6 Suppl):S171–S177.
  • Brett McQueen R, Nair KV, Vollmer TL, et al. Incorporating real-world clinical practice in multiple sclerosis economic evaluations. Expert Rev Pharmacoecon Outcomes Res. 2015 Dec;15(6):869–872. doi:10.1586/14737167.2015.1081060.
  • Schwab N, Schneider-Hohendorf T, Wiendl H. Therapeutic uses of anti-α4-integrin (anti-VLA-4) antibodies in multiple sclerosis. Int Immunol. 2015 Jan;27(1):47–53. doi:10.1093/intimm/dxu096.
  • Bielekova B, Becker BL. Monoclonal antibodies in MS: mechanisms of action. Neurology. 2010 Jan 5;74(Suppl 1):S31–S40.
  • Stüve O, Gold R, Chan A, et al. alpha4-integrin antagonism with natalizumab: effects and adverse effects. J Neurol. 2008 Dec;255(Suppl 6):58–65. doi:10.1007/s00415-008-6011-0.
  • Engelhardt B, Kappos L. Natalizumab: targeting alpha4-integrins in multiple sclerosis. Neurodegener Dis. 2008;5(1):16–22. doi:10.1159/000109933.
  • O’Connor P. Natalizumab and the role of alpha 4-integrin antagonism in the treatment of multiple sclerosis. Expert Opin Biol Ther. 2007 Jan;7(1):123–136. doi:10.1517/14712598.7.1.123.
  • Gupta S, Weinstock-Guttman B. Natalizumab for multiple sclerosis: appraising risk versus benefit, a seemingly demanding tango. Expert Opin Biol Ther. 2014 Jan;14(1):115–126. doi:10.1517/14712598.2014.864634.
  • Ode F Jr, Moore CS, Kennedy TE, et al. MicroRNA dysregulation in multiple sclerosis. Front Genet. 2012;3:311.
  • Meira M, Sievers C, Hoffmann F, et al. MiR-126: a novel route for natalizumab action? Mult Scler. 2014 Sep;20(10):1363–1370. doi:10.1177/1352458514524998.
  • Meira M, Sievers C, Hoffmann F, et al. Unraveling natalizumab effects on deregulated miR-17 expression in CD4+ T cells of patients with relapsing-remitting multiple sclerosis. J Immunol Res. 2014;2014:897249. doi:10.1155/2014/394127.
  • Ingwersen J, Menge T, Wingerath B, et al. Natalizumab restores aberrant miRNA expression profile in multiple sclerosis and reveals a critical role for miR-20b. Ann Clin Transl Neurol. 2015 Jan;2(1):43–55. doi:10.1002/acn3.152.
  • Deng R, Jin F, Prabhu S, et al. Monoclonal antibodies: what are the pharmacokinetic and pharmacodynamic considerations for drug development? Expert Opin Drug Metab Toxicol. 2012 Feb;8(2):141–160. doi:10.1517/17425255.2012.643868.
  • Research FCfDEa. Clinical pharmacology and biopharmaceutics review natalizumab. Available from: http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/125104s000_Natalizumab_Biopharmr.pdf.
  • Plavina T, Fox EJ, Lucas N, et al. A randomized trial evaluating various administration routes of natalizumab in multiple sclerosis. J Clin Pharmacol. 2016 Feb 2. doi:10.1002/jcph.707.
  • Harrer A, Pilz G, Wipfler P, et al. High interindividual variability in the CD4/CD8 T cell ratio and natalizumab concentration levels in the cerebrospinal fluid of patients with multiple sclerosis. Clin Exp Immunol. 2015 Jun;180(3):383–392. doi:10.1111/cei.12590.
  • Sheremata WA, Vollmer TL, Stone LA, et al. A safety and pharmacokinetic study of intravenous natalizumab in patients with MS. Neurology. 1999 Mar 23;52(5):1072–1074.
  • Miller DH, Khan OA, Sheremata WA, et al. A controlled trial of natalizumab for relapsing multiple sclerosis. N Engl J Med. 2003 Jan 2;348(1):15–23.
  • Polman CH, O’Connor PW, Havrdova E, et al. A randomized, placebo-controlled trial of natalizumab for relapsing multiple sclerosis. N Engl J Med. 2006 Mar 2;354(9):899–910. doi:10.1056/NEJMoa044397.
  • Rudick RA, Stuart WH, Calabresi PA, et al. Natalizumab plus interferon beta-1a for relapsing multiple sclerosis. N Engl J Med. 2006 Mar 2;354(9):911–923. doi:10.1056/NEJMoa044396.
  • Rudick R, Polman C, Clifford D, et al. Natalizumab: bench to bedside and beyond. JAMA Neurol. 2013 Feb;70(2):172–182. doi:10.1001/jamaneurol.2013.598.
  • Outteryck O, Ongagna JC, Brochet B, et al. A prospective observational post-marketing study of natalizumab-treated multiple sclerosis patients: clinical, radiological and biological features and adverse events. The BIONAT cohort. Eur J Neurol. 2014;21(1):40–48. doi:10.1111/ene.12204.
  • Piehl F, Holmén C, Hillert J, et al. Swedish natalizumab (Tysabri) multiple sclerosis surveillance study. Neurol Sci. 2011 Jan;31(Suppl 3):289–293. doi:10.1007/s10072-010-0345-y.
  • Oturai AB, Koch-Henriksen N, Petersen T, et al. Efficacy of natalizumab in multiple sclerosis patients with high disease activity: a Danish nationwide study. Eur J Neurol. 2009 Mar;16(3):420–423. doi:10.1111/j.1468-1331.2008.02517.x.
  • O’Connor P, Goodman A, Kappos L, et al. Long-term safety and effectiveness of natalizumab redosing and treatment in the STRATA MS Study. Neurology. 2014 Jul 1;83(1):78–86.
  • Vollmer TL, Phillips JT, Goodman AD, et al. An open-label safety and drug interaction study of natalizumab (Antegren) in combination with interferon-beta (Avonex) in patients with multiple sclerosis. Mult Scler. 2004 Oct;10(5):511–520.
  • Tubridy N, Behan PO, Capildeo R, et al. The effect of anti-alpha4 integrin antibody on brain lesion activity in MS. The UK Antegren Study Group. Neurology. 1999 Aug 11;53(3):466–472.
  • Goodman AD, Rossman H, Bar-Or A, et al. GLANCE: results of a phase 2, randomized, double-blind, placebo-controlled study. Neurology. 2009 Mar 3;72(9):806–812. doi:10.1212/01.wnl.0000343880.13764.69.
  • Hutchinson M, Kappos L, Calabresi PA, et al. The efficacy of natalizumab in patients with relapsing multiple sclerosis: subgroup analyses of AFFIRM and SENTINEL. J Neurol. 2009 Mar;256(3):405–415. doi:10.1007/s00415-009-0093-1.
  • Prosperini L, Borriello G, Fubelli F, et al. Natalizumab treatment in multiple sclerosis: the experience of S. Andrea MS Centre in Rome. Neurol Sci. 2011 Jan;31(Suppl 3):303–307. doi:10.1007/s10072-010-0348-8.
  • Sangalli F, Moiola L, Bucello S, et al. Efficacy and tolerability of natalizumab in relapsing-remitting multiple sclerosis patients: a post-marketing observational study. Neurol Sci. 2011 Jan;31(Suppl 3):299–302. doi:10.1007/s10072-010-0344-z.
  • Melin A, Outteryck O, Collongues N, et al. Effect of natalizumab on clinical and radiological disease activity in a French cohort of patients with relapsing-remitting multiple sclerosis. J Neurol. 2012 Jun;259(6):1215–1221. doi:10.1007/s00415-011-6339-8.
  • Zivadinov R, Dwyer MG, Hussein S, et al. Voxel-wise magnetization transfer imaging study of effects of natalizumab and IFNbeta-1a in multiple sclerosis. Mult Scler. 2012 Aug;18(8):1125–1134. doi:10.1177/1352458511433304.
  • Romme Christensen J, Ratzer R, Börnsen L, et al. Natalizumab in progressive MS: results of an open-label, phase 2A, proof-of-concept trial. Neurology. 2014 Apr 29;82(17):1499–1507.
  • Totaro R, Lugaresi A, Bellantonio P, et al. Natalizumab treatment in multiple sclerosis patients: a multicenter experience in clinical practice in Italy. Int J Immunopathol Pharmacol. 2014 Apr-Jun;27(2):147–154.
  • Van Pesch V, Bartholomé E, Bissay V, et al. Safety and efficacy of natalizumab in Belgian multiple sclerosis patients: subgroup analysis of the natalizumab observational program. Acta Neurol Belg. 2014 Sep;114(3):167–178. doi:10.1007/s13760-014-0308-9.
  • Zivadinov R, Hojnacki D, Bergsland N, et al. Effect of natalizumab on brain atrophy and disability progression in multiple sclerosis patients over 5 years. Eur J Neurol. 2016 Jun;23(6):1101–1109. doi:10.1111/ene.12992.
  • Dalton CM, Miszkiel KA, Barker GJ, et al. Effect of natalizumab on conversion of gadolinium enhancing lesions to T1 hypointense lesions in relapsing multiple sclerosis. J Neurol. 2004 Apr;251(4):407–413. doi:10.1007/s00415-004-0332-4.
  • Fox RJ, Cronin T, Lin J, et al. Measuring myelin repair and axonal loss with diffusion tensor imaging. AJNR. 2011 Jan;32(1):85–91. doi:10.3174/ajnr.A2238.
  • De Stefano N, Airas L, Grigoriadis N, et al. Clinical relevance of brain volume measures in multiple sclerosis. CNS Drugs. 2014 Feb;28(2):147–156. doi:10.1007/s40263-014-0140-z.
  • Zivadinov R, Reder AT, Filippi M, et al. Mechanisms of action of disease-modifying agents and brain volume changes in multiple sclerosis. Neurology. 2008 Jul 8;71(2):136–144.
  • Miller DH, Soon D, Fernando KT, et al. MRI outcomes in a placebo-controlled trial of natalizumab in relapsing MS. Neurology. 2007 Apr 24;68(17):1390–1401.
  • Magraner M, Coret F, Casanova B. The relationship between inflammatory activity and brain atrophy in natalizumab treated patients. Eur J Radiol. 2012 Nov;81(11):3485–3490. doi:10.1016/j.ejrad.2012.01.028.
  • Portaccio E, Stromillo ML, Goretti B, et al. Natalizumab may reduce cognitive changes and brain atrophy rate in relapsing-remitting multiple sclerosis – a prospective, non-randomized pilot study. Eur J Neurol. 2013 Jun;20(6):986–990. doi:10.1111/j.1468-1331.2012.03882.x.
  • Sastre-Garriga J, Tur C, Pareto D, et al. Brain atrophy in natalizumab-treated patients: a 3-year follow-up. Mult Scler. 2015 May;21(6):749–756. doi:10.1177/1352458514556300.
  • Vidal-Jordana A, Sastre-Garriga J, Pérez-Miralles F, et al. Early brain pseudoatrophy while on natalizumab therapy is due to white matter volume changes. Mult Scler. 2013 Aug;19(9):1175–1181. doi:10.1177/1352458512473190.
  • De Stefano N, Arnold DL. Towards a better understanding of pseudoatrophy in the brain of multiple sclerosis patients. Mult Scler. 2015 May;21(6):675–676. doi:10.1177/1352458514564494.
  • Sastre-Garriga J, Tur C, Pareto D, et al. Brain atrophy in natalizumab-treated patients: a 3-year follow-up. Mult Scler. 2015 May;21(6):749–756. doi:10.1177/1352458514556300.
  • Cadavid D, Tang Y, O’Neill G. [Responsiveness of the expanded disability status scale (EDSS) to disease progression and therapeutic intervention in progressive forms of multiple sclerosis]. Rev Neurol. 2010 Sep 16;51(6):321–329. Spanish.
  • Cadavid D, Jurgensen S, Lee S. Impact of natalizumab on ambulatory improvement in secondary progressive and disabled relapsing-remitting multiple sclerosis. PLoS One. 2013;8(1):e53297. doi:10.1371/journal.pone.0053297.
  • ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000 Feb 29. ClinicalTrials.gov identifier: NCT01416181. A clinical study of the efficacy of natalizumab on reducing disability progression in participants with secondary progressive multiple sclerosis (ASCEND in SPMS). Biogen 2015. Available from: https://clinicaltrials.gov/ct2/show/NCT01416181.
  • Steiner D, Arnold D, Freedman MS, et al. Natalizumab versus placebo in patients with secondary progressive multiple sclerosis (SPMS):resultsfrom ASCEND, a multicenter, double-blind, placebo-controlled, randomized phase 3 clinical trial. Vancouver (BC): AAN; 2016.
  • Rosa N, Lanza M, Borrelli M, et al. Intraocular pressure and corneal biomechanical properties in patients with myotonic dystrophy. Ophthalmology. 2009 2//;116(2):231–234. doi:10.1016/j.ophtha.2008.09.001.
  • Sørensen PS, Bertolotto A, Edan G, et al. Risk stratification for progressive multifocal leukoencephalopathy in patients treated with natalizumab. Mult Scler. 2012 Feb;18(2):143–152. doi:10.1177/1352458511435105.
  • Bozic C, Subramanyam M, Richman S, et al. Anti-JC virus (JCV) antibody prevalence in the JCV epidemiology in MS (JEMS) trial. Eur J Neurol. 2014 Feb;21(2):299–304. doi:10.1111/ene.12304.
  • Stolt A, Sasnauskas K, Koskela P, et al. Seroepidemiology of the human polyomaviruses. J Gen Virol. 2003 Jun;84(Pt 6):1499–1504. doi:10.1099/vir.0.18842-0.
  • Gossai A, Waterboer T, Nelson HH, et al. Seroepidemiology of human polyomaviruses in a US population. Am J Epidemiol. 2016 Jan 1;183(1):61–69.
  • Lee P, Plavina T, Castro A, et al. A second-generation ELISA (STRATIFY JCV DxSelect) for detection of JC virus antibodies in human serum and plasma to support progressive multifocal leukoencephalopathy risk stratification. J Clin Virol. 2013 Jun;57(2):141–146. doi:10.1016/j.jcv.2013.02.002.
  • Plavina T, Berman M, Njenga M, et al. Multi-site analytical validation of an assay to detect anti-JCV antibodies in human serum and plasma. J Clin Virol. 2012 Jan;53(1):65–71. doi:10.1016/j.jcv.2011.10.003.
  • Kardas P, Leboeuf C, Hirsch HH. Optimizing JC and BK polyomavirus IgG testing for seroepidemiology and patient counseling. J Clin Virol. 2015 Oct;71:28–33. doi:10.1016/j.jcv.2015.07.305.
  • Wenning W, Haghikia A, Laubenberger J, et al. Treatment of progressive multifocal leukoencephalopathy associated with natalizumab. N Engl J Med. 2009 Sep 10;361(11):1075–1080.
  • Clifford DB, De Luca A, Simpson DM, et al. Natalizumab-associated progressive multifocal leukoencephalopathy in patients with multiple sclerosis: lessons from 28 cases. Lancet Neurol. 2010 Apr;9(4):438–446. doi:10.1016/S1474-4422(10)70028-4.
  • Kornek B. An update on the use of natalizumab in the treatment of multiple sclerosis: appropriate patient selection and special considerations. Patient Prefer Adherence. 2015;9:675–684. doi:10.2147/PPA.S20791.
  • Yousry TA, Pelletier D, Cadavid D, et al. Magnetic resonance imaging pattern in natalizumab-associated progressive multifocal leukoencephalopathy. Ann Neurol. 2012 Nov;72(5):779–787. doi:10.1002/ana.23676.
  • Gorelik L, Lerner M, Bixler S, et al. Anti-JC virus antibodies: implications for PML risk stratification. Ann Neurol. 2010 Sep;68(3):295–303. doi:10.1002/ana.22128.
  • Bloomgren G, Richman S, Hotermans C, et al. Risk of natalizumab-associated progressive multifocal leukoencephalopathy. N Engl J Med. 2012 May 17;366(20):1870–1880. doi:10.1056/NEJMoa1107829.
  • Tur C, Montalban X. Natalizumab: risk stratification of individual patients with multiple sclerosis. CNS Drugs. 2014 Jul;28(7):641–648. doi:10.1007/s40263-014-0168-0.
  • Agency EM. EMA confirms recommendations to minimise risk of brain infection PML with Tysabri. 2016 [cited 2016 Feb 26]. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Press_release/2016/02/WC500202389.pdf.
  • Dong-Si T, Richman S, Wattjes MP, et al. Outcome and survival of asymptomatic PML in natalizumab-treated MS patients. Ann Clin Transl Neurol. 2014 Oct;1(10):755–764. doi:10.1002/acn3.114.
  • McGuigan C, Craner M, Guadagno J, et al. Stratification and monitoring of natalizumab-associated progressive multifocal leukoencephalopathy risk: recommendations from an expert group. J Neurol Neurosurg Psychiatry. 2016 Feb;87(2):117–125. doi:10.1136/jnnp-2015-311100
  • Vidal-Jordana A, Tintoré M, Tur C, et al. Significant clinical worsening after natalizumab withdrawal: predictive factors. Mult Scler. 2015 May;21(6):780–785. doi:10.1177/1352458514549401.
  • Schiess N, Calabresi PA. Natalizumab: bound to rebound? Neurology. 2009 Feb 3;72(5):392–393.
  • Fox RJ, Cree BA, DeSèze J, et al. MS disease activity in RESTORE: a randomized 24-week natalizumab treatment interruption study. Neurology. 2014 Apr 29;82(17):1491–1498.
  • Sorensen PS, Lisby S, Grove R, et al. Safety and efficacy of ofatumumab in relapsing-remitting multiple sclerosis: a phase 2 study. Neurology. 2014 Feb 18;82(7):573–581.
  • Clerico M, Schiavetti I, De Mercanti, et al. Treatment of relapsing-remitting multiple sclerosis after 24 doses of natalizumab: evidence from an Italian spontaneous, prospective, and observational study (the TY-STOP Study). JAMA Neurol. 2014 Aug;71(8):954–960. doi:10.1001/jamaneurol.2014.1200.
  • Capobianco M, di Sapio A, Malentacchi M, et al. No impact of current therapeutic strategies on disease reactivation after natalizumab discontinuation: a comparative analysis of different approaches during the first year of natalizumab discontinuation. Eur J Neurol. 2015 Mar;22(3):585–587. doi:10.1111/ene.12487.
  • Prosperini L, Annovazzi P, Capobianco M, et al. Natalizumab discontinuation in patients with multiple sclerosis: profiling risk and benefits at therapeutic crossroads. Mult Scler. 2015 Nov;21(13):1713–1722. doi:10.1177/1352458515570768.
  • Sangalli F, Moiola L, Ferrè L, et al. Long-term management of natalizumab discontinuation in a large monocentric cohort of multiple sclerosis patients. Mult Scler Relat Disord. 2014 Jul;3(4):520–526. doi:10.1016/j.msard.2014.04.003.
  • Sanai SA, Saini V, Benedict RH, et al. Aging and multiple sclerosis. Mult Scler J. 2016 Feb 19;22:717–725. doi:10.1177/1352458516634871.
  • Iaffaldano P, Lucisano G, Pozzilli C, et al. Fingolimod versus interferon beta/glatiramer acetate after natalizumab suspension in multiple sclerosis. Brain. 2015 Nov;138(Pt 11):3275–3286. doi:10.1093/brain/awv260.
  • Kappos L, Radue E-W, Comi G, et al. Switching from natalizumab to fingolimod: a randomized, placebo-controlled study in RRMS. Neurology. 2015 Jul 7;85(1):29–39. doi:10.1212/WNL.0000000000001706.
  • Alping P, Frisell T, Novakova L, et al. Rituximab versus fingolimod after natalizumab in multiple sclerosis patients. Ann Neurol. 2016 Mar 31. doi:10.1002/ana.24651.
  • Natalizumab: infections, hypersensitivity, etc. Prescrire Int. 2011 Dec;20(122):297.
  • Kohlmann R, Salmen A, Chan A, et al. Serological evidence of increased susceptibility to varicella-zoster virus reactivation or reinfection in natalizumab-treated patients with multiple sclerosis. Mult Scler. 2015 Dec;21(14):1823–1832. doi:10.1177/1352458515576984.
  • FDA US. Tysabri (natalizumab) injection full prescribing information [Internet]; 2012. [cited 2016 May 19]. Available from: http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125104s0576lbl.pdf
  • Fine AJ, Sorbello A, Kortepeter C, et al. Central nervous system herpes simplex and varicella zoster virus infections in natalizumab-treated patients. Clin Infect Dis. 2013 Sep;57(6):849–852. doi:10.1093/cid/cit376.
  • Antezana A, Sigal S, Herbert J, et al. Natalizumab-induced hepatic injury: a case report and review of literature. Mult Scler Relat Disord. 2015 Nov;4(6):495–498. doi:10.1016/j.msard.2015.08.008.
  • Natalizumab (TYSABRI) and multiple sclerosis. With longer follow-up: even more toxic than suspected. Prescrire Int. 2015 Mar;24(158):65–67.
  • Vukusic S, Confavreux C. Pregnancy and multiple sclerosis: the children of PRIMS. Clin Neurol Neurosurg. 2006 Mar;108(3):266–270. doi:10.1016/j.clineuro.2005.11.016.
  • Amato MP, Portaccio E. Fertility, pregnancy and childbirth in patients with multiple sclerosis: impact of disease-modifying drugs. CNS Drugs. 2015 Mar;29(3):207–220. doi:10.1007/s40263-015-0238-y.
  • Borisow N, Paul F, Dorr J. Optimal managment of multiple sclerosis during pregnancy: current perspectives. Dovepress. 2014;2014(4):111–120.
  • Cristiano L, Friend S, Bozic C, et al. Evaluation of pregnancy outcomes from the TYSABRI®(natalizumab) pregnancy exposure registry. Neurology. 2013;80 (Suppl 7) (Meeting Abstracts I)(P02.127).
  • Ebrahimi N, Herbstritt S, Gold R, et al. Pregnancy and fetal outcomes following natalizumab exposure in pregnancy. A prospective, controlled observational study. Mult Scler. 2015 Feb;21(2):198–205. doi:10.1177/1352458514546790.
  • Ciron J, Hautecoeur P, Mathis S, et al. Natalizumab throughout pregnancy: risk of low platelet count in the newborn at delivery. Rev Neurol. 2016 Feb;172(2):165–166. doi:10.1016/j.neurol.2015.07.007.
  • Haghikia A, Langer-Gould A, Rellensmann G, et al. Natalizumab use during the third trimester of pregnancy. JAMA Neurol. 2014 Jul 1;71(7):891–895.
  • De Giglio L, Gasperini C, Tortorella C, et al. Natalizumab discontinuation and disease restart in pregnancy: a case series. Acta Neurol Scand. 2015 May;131(5):336–340. doi:10.1111/ane.12364.
  • Vukusic S, Durand-Dubief F, Benoit A, et al. Natalizumab for the prevention of post-partum relapses in women with multiple sclerosis. Mult Scler. 2015 Jun;21(7):953–955. doi:10.1177/1352458514554056.
  • Cohen JA, Coles AJ, Arnold DL, et al. Alemtuzumab versus interferon beta 1a as first-line treatment for patients with relapsing-remitting multiple sclerosis: a randomised controlled phase 3 trial. Lancet. 2012 Nov 24;380(9856):1819–1828.
  • Coles AJ, Twyman CL, Arnold DL, et al. Alemtuzumab for patients with relapsing multiple sclerosis after disease-modifying therapy: a randomised controlled phase 3 trial. Lancet. 2012 Nov 24;380(9856):1829–1839.
  • Effect of daclizumab HYP versus intramuscular interferon beta-1a on no evidence of disease activity in patients with relapsing-remitting multiple sclerosis: analysis of the DECIDE Study. ECTRIMS; 2015; Barcelona, Spain. Abstract # 89, Parallel Session 2:89– Thursday, 8 October – 12:00 CEST.
  • Arnold DL, Kappos L, Wiendl H, et al. Benefits on brain MRI lesion activity with daclizumab HYP compared with interferon beta-1a are stable through 144 weeks‚ Äô treatment: results from the DECIDE Study. ECTRIMS; 2015 Oct 8; Barcelona, Spain.
  • Kappos L, Selmaj K, Arnold D, et al. Daclizumab HYP versus interferon beta-1a in relapsing-remitting multiple sclerosis: primary results of the DECIDE Study. Neurology. 2015;Supplement:S4.003.
  • Radue EW. Long-term efficacy of daclizumab HYP in relapsing-remitting multiple sclerosis: 3 year results from the SELECTED extension study. Neurology. 2015;84(14):Supplement:P7.226.
  • S.L. H. Efficacy and safety of ocrelizumab in relapsing multiple sclerosis – results of the interferon-beta-1a-controlled, double-blind, phase III OPERA I and II studies. ECTRIMS; 2015; Barcelona, Spain. Abstract#190; Poster Session Oct 9, 2015.
  • Montalban X. Baseline demographics and disease characteristics from ORATORIO, a phase III trial evaluating ocrelizumab in patients with primary progressive multiple sclerosis. Neurology. 2015;84(14):Supplement:P7.017.
  • Havrdova E, Galetta S, Hutchinson M, et al. Effect of natalizumab on clinical and radiological disease activity in multiple sclerosis: a retrospective analysis of the natalizumab safety and efficacy in relapsing-remitting multiple sclerosis (AFFIRM) study. Lancet Neurol. 2009 Mar;8(3):254–260. doi:10.1016/S1474-4422(09)70021-3.
  • Investigators CT, Coles AJ, Compston DA, et al. Alemtuzumab vs. interferon beta-1a in early multiple sclerosis. N Engl J Med. 2008 Oct 23;359(17):1786–1801.
  • Wynn D, Kaufman M, Montalban X, et al. Daclizumab in active relapsing multiple sclerosis (CHOICE study): a phase 2, randomised, double-blind, placebo-controlled, add-on trial with interferon beta. Lancet Neurol. 2010 Apr;9(4):381–390. doi:10.1016/S1474-4422(10)70033-8.
  • Goncalves A, Milea D, Gohier P, et al. Serum vitamin D status is associated with the presence but not the severity of primary open angle glaucoma. Maturitas. 2015 8//;81(4):470–474. doi:10.1016/j.maturitas.2015.05.008.
  • ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000 Feb 29. ClinicalTrials.gov identifier: NCT01462318. An immunogenicity and pharmacokinetics (PK) study of BIIB019 (daclizumab high yield process (DAC HYP)) prefilled syringe in relapsing remitting multiple sclerosis (RRMS) (OBSERVE). Biogen 2015. Available from: https://clinicaltrials.gov/ct2/show/NCT01462318.
  • ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000 Feb 29. ClinicalTrials.gov identifier: NCT01797965. Long-term extension study in participants with multiple sclerosis who have completed study 205MS301 (NCT01064401) to evaluate the safety and efficacy of BIIB019 (EXTEND). Biogen 2015. Available from: https://clinicaltrials.gov/ct2/show/NCT01797965.
  • ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000 Feb 29. ClinicalTrials.gov identifier: NCT01457924. Ofatumumab subcutaneous administration in subjects with relapsing-remitting multiple sclerosis (MIRROR). GlaxoSmithKline 2015. Available from: https://clinicaltrials.gov/ct2/show/study/NCT01457924.

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