Assessing the risk of multiple sclerosis disease-modifying therapies

References

• Rae-Grant A, Day GS, Marrie RA, et al. Practice guideline recommendations summary: disease-modifying therapies for adults with multiple sclerosis: report of the guideline development, dissemination, and implementation subcommittee of the American academy of neurology. Neurology. 2018;90:777–788.
   PubMed Web of Science ®Google Scholar
• Gerardi C, Bertele V, Rossi S, et al. Preapproval and postapproval evidence on drugs for multiple sclerosis. Neurology. 2018;90:964–973.
   PubMed Web of Science ®Google Scholar
• Soelberg Sorensen P. Safety concerns and risk management of multiple sclerosis therapies. Acta Neurol Scand. 2017;136:168–186.
   PubMed Web of Science ®Google Scholar
• Langer-Gould A, Atlas SW, Green AJ, et al. Progressive multifocal leukoencephalopathy in a patient treated with natalizumab. N Engl J Med. 2005;353:375–381.
   PubMed Web of Science ®Google Scholar
• Winkelmann A, Loebermann M, Reisinger EC, et al. Disease-modifying therapies and infectious risks in multiple sclerosis. Nat Rev Neurol. 2016;12:217–233.
   PubMed Web of Science ®Google Scholar
• Jacobs LD, Cookfair DL, Rudick RA, et al. Intramuscular interferon beta-1a for disease progression in relapsing multiple sclerosis. The multiple sclerosis collaborative research group (MSCRG). Ann Neurol. 1996;39:285–294.
   PubMed Web of Science ®Google Scholar
• Randomised double-blind placebo-controlled study of interferon beta-1a in relapsing/remitting multiple sclerosis. PRISMS (Prevention of Relapses and Disability by Interferon beta-1a Subcutaneously in Multiple Sclerosis) Study Group. Lancet. 1998; 352:1498–1504.
   PubMed Web of Science ®Google Scholar
• Interferon beta-1b is effective in relapsing-remitting multiple sclerosis. I. Clinical results of a multicenter, randomized, double-blind, placebo-controlled trial. The IFNB multiple sclerosis study group. Neurology. 1993; 43:655–661.
   PubMed Web of Science ®Google Scholar
• Clerico M, Barbero P, Contessa G, et al. Adherence to interferon-beta treatment and results of therapy switching. J Neurol Sci. 2007;259:104–108.
   PubMed Web of Science ®Google Scholar
• Villamil A, Mullen E, Casciato P, et al. Interferon beta 1a-induced severe autoimmune hepatitis in patients with multiple sclerosis: report of two cases and review of the literature. Ann Hepatol. 2015;14:273–280.
   PubMed Web of Science ®Google Scholar
• Ben-Amor AF, Trochanov A, Fischer TZ. Cumulative review of thrombotic microangiopathy, thrombotic thrombocytopenic purpura, and hemolytic uremic syndrome reports with subcutaneous interferon beta-1a. Adv Ther. 2015;32:445–454.
   PubMed Web of Science ®Google Scholar
• Gaetani L, Menduno PS, Cometa F, et al. Retinopathy during interferon-beta treatment for multiple sclerosis: case report and review of the literature. J Neurol. 2016;263:422–427.
   PubMed Web of Science ®Google Scholar
• de Jong HJI, Kingwell E, Shirani A, et al. Evaluating the safety of beta-interferons in MS: A series of nested case-control studies. Neurology. 2017;88:2310–2320.
   PubMed Web of Science ®Google Scholar
• Kim YJ, Lee HY, Lee JY, et al. Interferon beta‐1b‐induced Sweet’s syndrome in a patient with multiple sclerosis. Int J Dermatol. 2015;54:456–458.
   PubMed Web of Science ®Google Scholar
• Marrie RA, Horwitz RI. Emerging effects of comorbidities on multiple sclerosis. Lancet Neurol. 2010;9:820–828.
   PubMed Web of Science ®Google Scholar
• Johnson KP, Brooks B, Cohen J, et al. Copolymer 1 reduces relapse rate and improves disability in relapsing‐remitting multiple sclerosis Results of a phase III multicenter, double‐blind, placebo‐controlled trial. Neurology. 1995;45:1268–1276.
   PubMed Web of Science ®Google Scholar
• Khan O, Rieckmann P, Boyko A, et al. Three times weekly glatiramer acetate in relapsing-remitting multiple sclerosis. Ann Neurol. 2013;73:705–713.
   PubMed Web of Science ®Google Scholar
• Comi G, Martinelli V, Rodegher M, et al. Effect of glatiramer acetate on conversion to clinically definite multiple sclerosis in patients with clinically isolated syndrome (PreCISe study): a randomised, double-blind, placebo-controlled trial. Lancet. 2009;374:1503–1511.
   PubMed Web of Science ®Google Scholar
• Ziemssen T, Ashtamker N, Rubinchick S, et al. Long-term safety and tolerability of glatiramer acetate 20 mg/ml in the treatment of relapsing forms of multiple sclerosis. Expert Opin Drug Saf. 2017;16:247–255.
   PubMed Web of Science ®Google Scholar
• Zecca C, Mainetti C, Blum R, et al. Recurrent Nicolau syndrome associated with subcutaneous glatiramer acetate injection–a case report. BMC Neurol. 2015;15:249.
   PubMed Web of Science ®Google Scholar
• Almeida J, Sola-Valls N, Pose E, et al. Liver injury and glatiramer acetate, an uncommon association: case report and literature review. Ther Adv Neurol Disord. 2017;10:367–372.
   PubMed Web of Science ®Google Scholar
• Corominas M, Postigo I, Cardona V, et al. IgE-mediated allergic reactions after the first administration of glatiramer acetate in patients with multiple sclerosis. Int Arch Allergy Immunol. 2014;165:244–246.
   PubMed Web of Science ®Google Scholar
• Haas J, Firzlaff M. Twenty-four-month comparison of immunomodulatory treatments - a retrospective open label study in 308 RRMS patients treated with beta interferons or glatiramer acetate (Copaxone). Eur J Neurol. 2005;12:425–431.
   PubMed Web of Science ®Google Scholar
• Kappos L, Radue EW, O’Connor P, et al. A placebo-controlled trial of oral fingolimod in relapsing multiple sclerosis. N Engl J Med. 2010;362:387–401.
   PubMed Web of Science ®Google Scholar
• Calabresi PA, Radue EW, Goodin D, et al. Safety and efficacy of fingolimod in patients with relapsing-remitting multiple sclerosis (FREEDOMS II): a double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Neurol. 2014;13:545–556.
   PubMed Web of Science ®Google Scholar
• Cohen JA, Barkhof F, Comi G, et al. Oral fingolimod or intramuscular interferon for relapsing multiple sclerosis. N Engl J Med. 2010;362:402–415.
   PubMed Web of Science ®Google Scholar
• Limmroth V, Ziemssen T, Lang M, et al. Electrocardiographic assessments and cardiac events after fingolimod first dose - a comprehensive monitoring study. BMC Neurol. 2017;17:11.
   PubMed Web of Science ®Google Scholar
• Achiron A, Aref H, Inshasi J, et al. Effectiveness, safety and health-related quality of life of multiple sclerosis patients treated with fingolimod: results from a 12-month, real-world, observational PERFORMS study in the Middle East. BMC Neurol. 2017;17:150.
   PubMed Web of Science ®Google Scholar
• Jain N, Bhatti MT. Fingolimod-associated macular edema: incidence, detection, and management. Neurology. 2012;78:672–680.
   PubMed Web of Science ®Google Scholar
• Pfender N, Jelcic I, Linnebank M, et al. Reactivation of herpesvirus under fingolimod: A case of severe herpes simplex encephalitis. Neurology. 2015;84:2377–2378.
   PubMed Web of Science ®Google Scholar
• Arvin AM, Wolinsky JS, Kappos L, et al. Varicella-zoster virus infections in patients treated with fingolimod: risk assessment and consensus recommendations for management. JAMA Neurol. 2015;72:31–39.
   PubMed Web of Science ®Google Scholar
• Pham C, Bennett I, Jithoo R. Cryptococcal meningitis causing obstructive hydrocephalus in a patient on fingolimod. BMJ Case Rep. 2017 Jul 6;2017. pii: bcr-2017-220026. doi: 10.1136/bcr-2017-220026.
   Google Scholar
• Seto H, Nishimura M, Minamiji K, et al. Disseminated cryptococcosis in a 63-year-old patient with multiple sclerosis treated with fingolimod. Intern Med. 2016;55:3383–3386.
   PubMed Web of Science ®Google Scholar
• Francis G, Kappos L, O’Connor P, et al. Temporal profile of lymphocyte counts and relationship with infections with fingolimod therapy. Mult Scler. 2014;20:471–480.
   PubMed Web of Science ®Google Scholar
• Kappos L, Cohen J, Collins W, et al. Fingolimod in relapsing multiple sclerosis: an integrated analysis of safety findings. Mult Scler Relat Disord. 2014;3:494–504.
   PubMed Web of Science ®Google Scholar
• Kantor D, Johnson K, Vieira MC, et al. Real-world persistence with fingolimod for the treatment of multiple sclerosis: A systematic review and meta-analysis. J Neurol Sci. 2018;388:168–174.
   PubMed Web of Science ®Google Scholar
• Confavreux C, O’Connor P, Comi G, et al. Oral teriflunomide for patients with relapsing multiple sclerosis (TOWER): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Neurol. 2014;13:247–256.
   PubMed Web of Science ®Google Scholar
• O’Connor P, Wolinsky JS, Confavreux C, et al. Randomized trial of oral teriflunomide for relapsing multiple sclerosis. N Engl J Med. 2011;365:1293–1303.
   PubMed Web of Science ®Google Scholar
• Vermersch P, Czlonkowska A, Grimaldi LM, et al. Teriflunomide versus subcutaneous interferon beta-1a in patients with relapsing multiple sclerosis: a randomised, controlled phase 3 trial. Mult Scler. 2014;20:705–716.
   PubMed Web of Science ®Google Scholar
• Miller AE, Wolinsky JS, Kappos L, et al. Oral teriflunomide for patients with a first clinical episode suggestive of multiple sclerosis (TOPIC): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Neurol. 2014;13:977–986.
   PubMed Web of Science ®Google Scholar
• O’Connor P, Comi G, Freedman MS, et al. Long-term safety and efficacy of teriflunomide: nine-year follow-up of the randomized TEMSO study. Neurology. 2016;86:920–930.
   PubMed Web of Science ®Google Scholar
• Lorefice L, Fenu G, Gerevini S, et al. PML in a person with multiple sclerosis: is teriflunomide the felon? Neurology. 2018;90:83–85.
   PubMed Web of Science ®Google Scholar
• Elkjaer ML, Molnar T, Illes Z. Teriflunomide for multiple sclerosis in real-world setting. Acta Neurol Scand. 2017;136:447–453.
   PubMed Web of Science ®Google Scholar
• Coyle PK, Khatri B, Edwards KR, et al. Patient-reported outcomes in relapsing forms of MS: real-world, global treatment experience with teriflunomide from the Teri-PRO study. Mult Scler Relat Disord. 2017;17:107–115.
   PubMed Web of Science ®Google Scholar
• Gerschenfeld G, Servy A, Valeyrie-Allanore L, et al. Fatal toxic epidermal necrolysis in a patient on teriflunomide treatment for relapsing multiple sclerosis. Mult Scler. 2015;21:1476–1477.
   PubMed Web of Science ®Google Scholar
• Camara-Lemarroy CR, Castilló J, Sastre-Garriga J, et al. Severe hypertriglyceridemia associated with teriflunomide in a patient with multiple sclerosis: A case report. Mult Scler. 2018;24:1383–1385, 1352458518761185
   PubMed Web of Science ®Google Scholar
• Fox RJ, Miller DH, Phillips JT, et al. Placebo-controlled phase 3 study of oral BG-12 or glatiramer in multiple sclerosis. N Engl J Med. 2012;367:1087–1097.
   PubMed Web of Science ®Google Scholar
• Gold R, Kappos L, Arnold DL, et al. Placebo-controlled phase 3 study of oral BG-12 for relapsing multiple sclerosis. N Engl J Med. 2012;367:1098–1107.
   PubMed Web of Science ®Google Scholar
• Alroughani R, Ahmed SF, Behbehani R, et al. Effectiveness and safety of dimethyl fumarate treatment in relapsing multiple sclerosis patients: real-world evidence. Neurol Ther. 2017;6:189–196.
   PubMed Web of Science ®Google Scholar
• Muñoz MA, Kulick CG, Kortepeter CM, et al. Liver injury associated with dimethyl fumarate in multiple sclerosis patients. Mult Scler. 2017;23:1947–1949.
   PubMed Web of Science ®Google Scholar
• Brown W, Suksaranjit P, Khor LL. Eosinophil-mediated cardiac injury possibly due to dimethyl fumarate. JACC Cardiovasc Imaging. 2016;9:752–753.
   PubMed Web of Science ®Google Scholar
• Ma BB, Ostrow LW, Newsome SD. Disseminated zoster with paresis in a multiple sclerosis patient treated with dimethyl fumarate. Neurol Neuroimmunol Neuroinflamm. 2016;3:e203.
   PubMed Web of Science ®Google Scholar
• Perini P, Rinaldi F, Puthenparampil M, et al. Herpes simplex virus encephalitis temporally associated with dimethyl fumarate-induced lymphopenia in a multiple sclerosis patient. Mult Scler Relat Disord. 2018;26:68–70.
   PubMed Web of Science ®Google Scholar
• Ruggieri S, Logoteta A, Martini G, et al. Listeria monocytogenes-induced rhombencephalitis in a patient with multiple sclerosis treated with dimethyl fumarate. JAMA Neurol. 2018;75:762–763.
   PubMed Web of Science ®Google Scholar
• Berger JR. Classifying PML risk with disease modifying therapies. Mult Scler Relat Disord. 2017;12:59–63.
   PubMed Web of Science ®Google Scholar
• Fox RJ, Chan A, Gold R, et al. Characterizing absolute lymphocyte count profiles in dimethyl fumarate-treated patients with MS: patient management considerations. Neurol Clin Pract. 2016;6:220–229.
   PubMedGoogle Scholar
• Giovannoni G, Comi G, Cook S, et al. A placebo-controlled trial of oral cladribine for relapsing multiple sclerosis. N Engl J Med. 2010;362:416–426.
   PubMed Web of Science ®Google Scholar
• Giovannoni G, Soelberg Sorensen P, Cook S, et al. Safety and efficacy of cladribine tablets in patients with relapsing-remitting multiple sclerosis: results from the randomized extension trial of the clarity study. Mult Scler. 2018 Oct;24(12):1594-1604.
   Google Scholar
• Leist TP, Comi G, Cree BA, et al. Effect of oral cladribine on time to conversion to clinically definite multiple sclerosis in patients with a first demyelinating event (ORACLE MS): a phase 3 randomised trial. Lancet Neurol. 2014;13:257–267.
   PubMed Web of Science ®Google Scholar
• Pakpoor J, Disanto G, Altmann DR, et al. No evidence for higher risk of cancer in patients with multiple sclerosis taking cladribine. Neurol Neuroimmunol Neuroinflamm. 2015;2:e158.
   PubMed Web of Science ®Google Scholar
• Montalban X, Leist TP, Cohen BA, et al. Cladribine tablets added to IFN-β in active relapsing MS. Neurol Neuroimmunol Neuroinflamm. 2018;5:e477.
   Web of Science ®Google Scholar
• 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;354:899–910.
   PubMed Web of Science ®Google Scholar
• Rudick RA, Stuart WH, Calabresi PA, et al. Natalizumab plus interferon beta-1a for relapsing multiple sclerosis. N Engl J Med. 2006;354:911–923.
   PubMed Web of Science ®Google Scholar
• Kapoor R, Ho PR, Campbell N, et al. Effect of natalizumab on disease progression in secondary progressive multiple sclerosis (ASCEND): a phase 3, randomised, double-blind, placebo-controlled trial with an open-label extension. Lancet Neurol. 2018;17:405–415.
   PubMed Web of Science ®Google Scholar
• Ho PR, Koendgen H, Campbell N, et al. Risk of natalizumab-associated progressive multifocal leukoencephalopathy in patients with multiple sclerosis: a retrospective analysis of data from four clinical studies. Lancet Neurol. 2017;16:925–933.
   PubMed Web of Science ®Google Scholar
• Kamourieh S, Gananandan K, Raffel J, et al. Natalizumab granule cell neuronopathy: FDG-PET in diagnosis and immune reconstitution with G-CSF. Neurol Neuroimmunol Neuroinflamm. 2017;4:e384.
   PubMed Web of Science ®Google Scholar
• Mulero P, Auger C, Parolin L, et al. Varicella-zoster meningovasculitis in a multiple sclerosis patient treated with natalizumab. Mult Scler. 2018;24:358–360.
   PubMed Web of Science ®Google Scholar
• Valenzuela RM, Pula JH, Garwacki D, et al. Cryptococcal meningitis in a multiple sclerosis patient taking natalizumab. J Neurol Sci. 2014;340:109–111.
   PubMed Web of Science ®Google Scholar
• Wijnands JMA, Zhu F, Kingwell E, et al. Disease-modifying drugs for multiple sclerosis and infection risk: a cohort study. J Neurol Neurosurg Psychiatry. 2018;89:1050–1056.
   PubMed Web of Science ®Google Scholar
• Nixon M, Menger RP, Kalakoti P, et al. Natalizumab-associated primary central nervous system lymphoma. World Neurosurg. 2018;109:152–159.
   PubMed Web of Science ®Google Scholar
• Lukas RV, Stupp R, Gondi V, et al. Primary central nervous system lymphoma-PART 1: epidemiology, diagnosis, staging, and prognosis. Oncology (Williston Park). 2018;32:17–22.
   PubMed Web of Science ®Google Scholar
• Vavricka BM, Baumberger P, Russmann S, et al. Diagnosis of melanoma under concomitant natalizumab therapy. Mult Scler. 2011;17:255–256.
   PubMed Web of Science ®Google Scholar
• Castela E, Lebrun-Frenay C, Laffon M, et al. Evolution of nevi during treatment with natalizumab: A prospective follow-up of patients treated with natalizumab for multiple sclerosis. Arch Dermatol. 2011;147:72–76.
   PubMedGoogle Scholar
• Curto E, Munteis-Olivas E, Balcells E, et al. Pulmonary eosinophilia associated to treatment with natalizumab. Ann Thorac Med. 2016;11:224–226.
   PubMed Web of Science ®Google Scholar
• Stosic M, De Jesus P, McCarthy J, et al. Immune thrombocytopenic purpura in a patient with multiple sclerosis treated with natalizumab. Neurology. 2011;77:505–507.
   PubMed Web of Science ®Google Scholar
• Seibert JB, Alvarez E. Severe anemia in a patient with multiple sclerosis treated with natalizumab. Neurology. 2015;84:861.
   PubMed Web of Science ®Google Scholar
• Camacho-Halili M, George R, Gottesman M, et al. An approach to natalizumab hypersensitivity: a case series of induction of tolerance. Mult Scler. 2011;17:250–253.
   PubMed Web of Science ®Google Scholar
• Antezana A, Sigal S, Herbert J, et al. Natalizumab-induced hepatic injury: A case report and review of literature. Mult Scler Relat Disord. 2015;4:495–498.
   PubMed Web of Science ®Google Scholar
• 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;380:1829–1839.
   PubMed Web of Science ®Google Scholar
• Coles AJ, Fox E, Vladic A, et al. Alemtuzumab versus interferon β-1a in early relapsing-remitting multiple sclerosis: post-hoc and subset analyses of clinical efficacy outcomes. Lancet Neurol. 2011;10:338–348.
   PubMed Web of Science ®Google Scholar
• Haghikia A, Dendrou CA, Schneider R, et al. Severe B-cell-mediated CNS disease secondary to alemtuzumab therapy. Lancet Neurol. 2017;16:104–106.
   PubMed Web of Science ®Google Scholar
• Ferraro D, Camera V, Vitetta F, et al. Acute coronary syndrome associated with alemtuzumab infusion in multiple sclerosis. Neurology. 2018;90:852–854.
   PubMed Web of Science ®Google Scholar
• Holmøy T, von der Lippe H, Leegaard TM. Listeria monocytogenes infection associated with alemtuzumab - - a case for better preventive strategies. BMC Neurol. 2017;17:65.
   PubMed Web of Science ®Google Scholar
• Sheikh-Taha M, Corman LC. Pulmonary Nocardia beijingensis infection associated with the use of alemtuzumab in a patient with multiple sclerosis. Mult Scler. 2017;23:872–874.
   PubMed Web of Science ®Google Scholar
• Tuohy O, Costelloe L, Hill-Cawthorne G, et al. Alemtuzumab treatment of multiple sclerosis: long-term safety and efficacy. J Neurol Neurosurg Psychiatry. 2015;86:208–215.
   PubMed Web of Science ®Google Scholar
• Meunier B, Rico A, Seguier J, et al. Life-threatening autoimmune warm hemolytic anemia following treatment for multiple sclerosis with alemtuzumab. Mult Scler. 2018;24:811–813.
   PubMed Web of Science ®Google Scholar
• Willis MD, Hope-Gill B, Flood-Page P, et al. Sarcoidosis following alemtuzumab treatment for multiple sclerosis. Mult Scler. 2018;24:1779–1782.
   PubMed Web of Science ®Google Scholar
• Midaglia L, Gratacos M, Caronna E, et al. Myasthenia gravis following alemtuzumab therapy for multiple sclerosis. Neurology. 2018;91:622–624.
   PubMed Web of Science ®Google Scholar
• Hoffman BM, Zeid NA, Alam U, et al. Lambert-Eaton myasthenic syndrome associated with alemtuzumab administration. Mult Scler Relat Disord. 2019;27:131–132.
   PubMed Web of Science ®Google Scholar
• Giarola B, Massey J, Barnett Y, et al. Autoimmune encephalitis following alemtuzumab treatment of multiple sclerosis. Mult Scler Relat Disord. 2018;28:31–33.
   PubMed Web of Science ®Google Scholar
• Aouad P, Yiannikas C, Fernando SL, et al. A case of autoimmune myositis after treatment with alemtuzumab for multiple sclerosis. Mult Scler J Exp Transl Clin. 2018;4:2055217318819012.
   Google Scholar
• Ibitoye R, Wilkins A. Thyroid papillary carcinoma after alemtuzumab therapy for MS. J Neurol. 2014;261:1828–1829.
   PubMed Web of Science ®Google Scholar
• Hauser SL, Bar-Or A, Comi G, et al. Ocrelizumab versus interferon beta-1a in relapsing multiple sclerosis. N Engl J Med. 2017;376:221–234.
   PubMed Web of Science ®Google Scholar
• Montalban X, Hauser SL, Kappos L, et al. Ocrelizumab versus placebo in primary progressive multiple sclerosis. N Engl J Med. 2017;376:209–220.
   PubMed Web of Science ®Google Scholar
• Hawker K, O’Connor P, Freedman MS, et al. Rituximab in patients with primary progressive multiple sclerosis: results of a randomized double-blind placebo-controlled multicenter trial. Ann Neurol. 2009;66:460–471.
   PubMed Web of Science ®Google Scholar
• Boleto G, Avouac J, Wipff J, et al. Predictors of hypogammaglobulinemia during rituximab maintenance therapy in rheumatoid arthritis: A 12-year longitudinal multi-center study. Semin Arthritis Rheum. 2018;48:149–154.
   PubMed Web of Science ®Google Scholar
• Edan G, Miller D, Clanet M, et al. Therapeutic effect of mitoxantrone combined with methylprednisolone in multiple sclerosis: a randomised multicentre study of active disease using MRI and clinical criteria. J Neurol Neurosurg Psychiatry. 1997;62:112–118.
   PubMed Web of Science ®Google Scholar
• Hartung H-P, Gonsette R, König N, et al. Mitoxantrone in progressive multiple sclerosis: a placebo-controlled, double-blind, randomised, multicentre trial. Lancet. 2002;360:2018–2025.
   PubMed Web of Science ®Google Scholar
• Le Page E, Leray E, Edan G, et al. Long-term safety profile of mitoxantrone in a French cohort of 802 multiple sclerosis patients: a 5-year prospective study. Mul Scler. 2011;17:867–875.
   PubMed Web of Science ®Google Scholar
• Kingwell E, Koch M, Leung B, et al. Cardiotoxicity and other adverse events associated with mitoxantrone treatment for MS. Neurology. 2010;74:1822–1826.
   PubMed Web of Science ®Google Scholar
• Buttmann M, Seuffert L, Mäder U, et al. Malignancies after mitoxantrone for multiple sclerosis: A retrospective cohort study. Neurology. 2016;86:2203–2207.
   PubMed Web of Science ®Google Scholar
• Muraro PA, Martin R, Mancardi GL, et al. Autologous haematopoietic stem cell transplantation for treatment of multiple sclerosis. Nat Rev Neurol. 2017;13:391–405.
   PubMed Web of Science ®Google Scholar
• Atkins HL, Bowman M, Allan D, et al. Immunoablation and autologous haemopoietic stem-cell transplantation for aggressive multiple sclerosis: a multicentre single-group phase 2 trial. Lancet. 2016;388:576–585.
   PubMed Web of Science ®Google Scholar
• Nash RA, Hutton GJ, Racke MK, et al. High-dose immunosuppressive therapy and autologous hematopoietic cell transplantation for relapsing-remitting multiple sclerosis (HALT-MS): a 3-year interim report. JAMA Neurol. 2015;72:159–169.
   PubMed Web of Science ®Google Scholar
• Reich DS, Lucchinetti CF, Calabresi PA. Multiple Sclerosis. N Engl J Med. 2018;378:169–180.
   PubMed Web of Science ®Google Scholar
• Comi G, Radaelli M, Soelberg Sørensen P. Evolving concepts in the treatment of relapsing multiple sclerosis. Lancet. 2017;389:1347–1356.
   PubMed Web of Science ®Google Scholar
• Giovannoni G. Disease-modifying treatments for early and advanced multiple sclerosis: a new treatment paradigm. Curr Opin Neurol. 2018;31:233–243.
   PubMed Web of Science ®Google Scholar
• Bermel RA, You X, Foulds P, et al. Predictors of long-term outcome in multiple sclerosis patients treated with interferon β. Ann Neurol. 2013;73:95–103.
   PubMed Web of Science ®Google Scholar
• Schwab N, Schneider-Hohendorf T, Melzer N, et al. Natalizumab-associated PML: challenges with incidence, resulting risk, and risk stratification. Neurology. 2017;88:1197–1205.
   PubMed Web of Science ®Google Scholar
• Kowalec K, Wright GEB, Drogemoller BI, et al. Common variation near IRF6 is associated with IFN-beta-induced liver injury in multiple sclerosis. Nat Genet. 2018;50:1081–1085.
   PubMed Web of Science ®Google Scholar
• Ho P-R, Koendgen H, Campbell N, et al. Risk of natalizumab-associated progressive multifocal leukoencephalopathy in patients with multiple sclerosis: a retrospective analysis of data from four clinical studies. Lancet Neurol. 2017;16:925–933.
   PubMed Web of Science ®Google Scholar
• Emery P, Rigby W, Tak PP, et al. Safety with ocrelizumab in rheumatoid arthritis: results from the ocrelizumab phase III program. PLoS ONE. 2014;9:e87379.
   PubMed Web of Science ®Google Scholar
• European Medicines Agency [Internet]. Amsterdam: EMA; [ cited 2019 April 15]. Available from: https://www.ema.europa.eu/en/news/use-multiple-sclerosis-medicine-lemtrada-restricted-while-ema-review-ongoing
   Google Scholar