Advances in preventing adverse events during monoclonal antibody management of multiple sclerosis

References

• Ciccarelli O, Barkhof F, Bodini B, et al. Pathogenesis of multiple sclerosis: insights from molecular and metabolic imaging. Lancet Neurol. 2014;13:807–22.
   PubMed Web of Science ®Google Scholar
• Browne P, Chandraratna D, Angood C, et al. Atlas of multiple sclerosis 2013: A growing global problem with widespread inequity. Neurology. 2014;83:1022–24.
   PubMed Web of Science ®Google Scholar
• Tintore M, Vidal-Jordana A, Sastre-Garriga J. Treatment of multiple sclerosis - success from bench to bedside. Nat Rev Neurol. 2018. published online 2018 Oct 12. DOI:10.1038/s41582-018-0082-z
   Web of Science ®Google Scholar
• Rudick RA, Polman CH. Current approaches to the identification and management of breakthrough disease in patients with multiple sclerosis. Lancet Neurol. 2009;8:545–59.
   PubMed Web of Science ®Google Scholar
• Lucchetta RC, Tonin FS, Borba HHL, et al. Disease-modifying therapies for relapsing–remitting multiple sclerosis: a network meta-analysis. CNS Drugs. 2018;32:813–26.
   PubMed Web of Science ®Google Scholar
• Carlos TM, Schwartz BR, Kovach NL, et al. Vascular cell adhesion molecule-1 mediates lymphocyte adherence to cytokine-activated cultured human endothelial cells. Blood. 1990;76:965–70.
   PubMed Web of Science ®Google Scholar
• Davis LS, Oppenheimer-Marks N, Bednarczyk JL, et al. Fibronectin promotes proliferation of naive and memory T cells by signaling through both the VLA-4 and VLA-5 integrin molecules. J Immunol. 1990;145:785–93.
   PubMed 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;354:911–23.
   PubMed Web of Science ®Google Scholar
• EMA - Tysabri. (natalizumab) Summary of product characteristics. [cited 2018 Nov 18]. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Referrals_document/Tysabri_20/European_Commission_final_decision/WC500202392.pdf
   Google Scholar
• Ambrose LR, Morel AS, Warrens AN. Neutrophils express CD52 and exhibit complement-mediated lysis in the presence of alemtuzumab. Blood. 2009;114:3052–5.
   PubMed Web of Science ®Google Scholar
• Ruck T, Bittner S, Wiendl H, et al. Alemtuzumab in multiple sclerosis: mechanism of action and beyond. Int J Mol Sci. 2015;16:16414–39.
   PubMed Web of Science ®Google Scholar
• Rao SP, Sancho J, Campos-Rivera J, et al. Human peripheral blood mononuclear cells exhibit heterogeneous CD52 expression levels and show differential sensitivity to alemtuzumab mediated cytolysis. PLoS One. 2012;7:e39416.
   PubMed Web of Science ®Google Scholar
• Cossburn MD, Harding K, Ingram G, et al. Clinical relevance of differential lymphocyte recovery after alemtuzumab therapy for multiple sclerosis. Neurology. 2013;80:55–61.
   PubMed Web of Science ®Google Scholar
• Thompson SAJ, Jones JL, Cox AL, et al. B-Cell reconstitution and BAFF after alemtuzumab (Campath-1H) treatment of multiple sclerosis. J Clin Immunol. 2010;30:99–105.
   PubMed Web of Science ®Google Scholar
• Blinkenberg M, Soelberg Sørensen P. Monoclonal antibodies for relapsing multiple sclerosis: a review of recently marketed and late-stage agents. CNS Drugs. 2017;31:357–71.
   PubMed Web of Science ®Google Scholar
• Zhang X, Tao Y, Chopra M, et al. Differential reconstitution of T cell subsets following immunodepleting treatment with alemtuzumab (Anti-CD52 monoclonal antibody) in patients with relapsing-remitting multiple sclerosis. J Immunol. 2013;191:5867–74.
   PubMed Web of Science ®Google Scholar
• 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;380:1819–28.
   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;380:1829–39.
   PubMed Web of Science ®Google Scholar
• Menge T, Stüve O, Kieseier BC, et al. Alemtuzumab: the advantages and challenges of a novel therapy in MS. Neurology. 2014;83:87–97.
   PubMed Web of Science ®Google Scholar
• Greenfield AL, Hauser SL. B-cell therapy for multiple sclerosis: entering an era. Ann Neurol. 2018;83:13–26.
   PubMed Web of Science ®Google Scholar
• Rahmanzadeh R, Weber MS, Brück W, et al. B cells in multiple sclerosis therapy—A comprehensive review. Acta Neurol Scand. 2018;137:544–56.
   PubMed Web of Science ®Google Scholar
• Kappos L, Li D, Calabresi PA, et al. Ocrelizumab in relapsing-remitting multiple sclerosis: A phase 2, randomised, placebo-controlled, multicentre trial. Lancet. 2011;378:1779–87.
   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;376:221–34.
   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;376:209–20.
   PubMed Web of Science ®Google Scholar
• EMA - Lemtrada. (alemtuzumab) Summary of product characteristics. [cited 2018 Nov 18]. Available from: https://www.ema.europa.eu/documents/product-information/ocrevus-epar-product-information_en.pdf
   Google Scholar
• Bielekova B. Daclizumab therapy for multiple sclerosis. Neurotherapeutics. 2013;10:55–67.
   PubMed Web of Science ®Google Scholar
• Wynn D, Kaufman M, Montalban X, et al. Daclizumab in active relapsing multiple sclerosis (CHOICE study): a phase II, randomised, double-blind, placebo-controlled, add-on trial with interferon beta. Lancet Neurol. 2010;9:381–90.
   PubMed Web of Science ®Google Scholar
• Gold R, Giovannoni G, Selmaj K, et al. Daclizumab high-yield process in relapsing-remitting multiple sclerosis (SELECT): a randomised, double-blind, placebo-controlled trial. Lancet. 2013;381:2167–75.
   PubMed Web of Science ®Google Scholar
• Kappos L, Wiendl H, Selmaj K, et al. Daclizumab HYP versus interferon beta-1a in relapsing multiple sclerosis. N Engl J Med. 2015;373:1418–28.
   PubMed Web of Science ®Google Scholar
• Stettner M, Gross CC, Mausberg AK, et al. A fatal case of daclizumab-induced liver failure in a patient with MS. Neurol Neuroimmunol Neuroinflamm. 2019;6:e539.
   PubMedGoogle Scholar
• Luessi F, Engel S, Spreer A, et al. GFAPα IgG-associated encephalitis upon daclizumab treatment of MS. Neurol Neuroimmunol Neuroinflamm. 2018;5:e481.
   PubMed Web of Science ®Google Scholar
• Sweet BV. Natalizumab update. Am J Health Syst Pharm. 2007;64:705–16.
   Web of Science ®Google Scholar
• Calabresi PA, Giovannoni G, Confavreux C, et al. The incidence and significance of anti-natalizumab antibodies: results from AFFIRM and SENTINEL. Neurology. 2007;69:1391–403.
   PubMed Web of Science ®Google Scholar
• 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;83:78–86.
   PubMed Web of Science ®Google Scholar
• De La Hera B, Urcelay E, Brassat D, et al. Natalizumab-related anaphylactoid reactions in MS patients are associated with HLA class II alleles. Neurol Neuroimmunol Neuroinflamm. 2014;1:e47.
   PubMedGoogle Scholar
• Hellwig K, Schimrigk S, Fischer M, et al. Allergic and nonallergic delayed infusion reactions during natalizumab therapy. Arch Neurol. 2008;65:656–8.
   PubMedGoogle Scholar
• Maggi E, Vultaggio A, Matucci A. Acute infusion reactions induced by monoclonal antibody therapy. Expert Rev Clin Immunol. 2011;7:55–63.
   PubMed Web of Science ®Google Scholar
• FDA - Lemtrada. (alemtuzumab) Prescribing information. [cited 2018 Nov 18]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103948s5158lbl.pdf
   Google Scholar
• Caon C, Namey M, Meyer C, et al. Prevention and management of infusion-associated reactions in the comparison of alemtuzumab and rebif (®) efficacy in multiple sclerosis (CARE-MS) program. Int J MS Care. 2015;17:191–98.
   PubMedGoogle Scholar
• FDA - Tysabri. (natalizumab) Prescribing information. [cited 2018 Nov 18]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125104s0576lbl.pdf
   Google Scholar
• FDA - Ocrevus. (ocrelizumab) Prescribing information. [cited 2018 Nov 18]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761053lbl.pdf
   Google Scholar
• Dubuisson N, Baker D, Kang AS, et al. Alemtuzumab depletion failure can occur in multiple sclerosis. Immunology. 2018;154:253–60.
   PubMed Web of Science ®Google Scholar
• Van Der Kolk LE, Grillo-López AJ, Baars JW, et al. Complement activation plays a key role in the side-effects of rituximab treatment. Br J Haematol. 2001;115:807–11.
   PubMed Web of Science ®Google Scholar
• Butzkueven H, Kappos L, Pellegrini F, et al. Efficacy and safety of natalizumab in multiple sclerosis: interim observational programme results. J Neurol Neurosurg Psychiatry. 2014;85:1190–7.
   PubMed Web of Science ®Google Scholar
• Drgona L, Gudiol C, Lanini S, et al. ESCMID study group for infections in compromised hosts (ESGICH) consensus document on the safety of targeted and biological therapies: an infectious diseases perspective (Agents targeting lymphoid or myeloid cells surface antigens [II]: CD22, CD30, CD33, CD38, CD40, SLAMF-7 and CCR4). Clin Microbiol Infect. 2018;24(Suppl 2):S83–S94.
   PubMedGoogle 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;17:405–15.
   PubMed Web of Science ®Google Scholar
• CAMMS223 Trial Investigators, Coles AJ, Compston DA, et al. Alemtuzumab vs. interferon beta-1a in early multiple sclerosis. N Engl J Med. 2008;359:1786–801.
   PubMed Web of Science ®Google Scholar
• Horga A, Tintoré M. Natalizumab for relapsing-remitting multiple sclerosis. Neurologia. 2011;26:357–68.
   PubMed Web of Science ®Google Scholar
• Buonomo AR, Zappulo E, Viceconte G, et al. Risk of opportunistic infections in patients treated with alemtuzumab for multiple sclerosis. Expert Opin Drug Saf. 2018;17:709–17.
   PubMed Web of Science ®Google Scholar
• Jiang M, Abend JR, Johnson SF, et al. The role of polyomaviruses in human disease. Virology. 2009;384:266–73.
   PubMed Web of Science ®Google Scholar
• Williamson EML, Berger JR. Diagnosis and treatment of progressive multifocal leukoencephalopathy associated with multiple sclerosis therapies. Neurotherapeutics. 2017;14:961–73.
   PubMed Web of Science ®Google Scholar
• Kleinschmidt-DeMasters BK, Tyler KL. Progressive multifocal leukoencephalopathy complicating treatment with natalizumab and interferon beta-1a for multiple sclerosis. N Engl J Med. 2005;353:369–74.
   PubMed Web of Science ®Google Scholar
• Singer BA. The role of natalizumab in the treatment of multiple sclerosis: benefits and risks. Ther Adv Neurol Disord. 2017;10:327–36.
   PubMed Web of Science ®Google Scholar
• Pignolet B, Schwab N, Schneider-Hohendorf T, et al. CD62L test at 2 years of natalizumab predicts progressive multifocal leukoencephalopathy. Neurology. 2016;87:2491–4.
   PubMed Web of Science ®Google Scholar
• Prosperini L, De Rossi N, Scarpazza C, et al. Natalizumab-related progressive multifocal leukoencephalopathy in multiple sclerosis: findings from an Italian independent registry. PLoS One. 2016;11:e0168376.
   PubMed Web of Science ®Google Scholar
• Anton R, Haas M, Arlett P, et al. Drug-induced progressive multifocal leukoencephalopathy in multiple sclerosis: European regulators’ perspective. Clin Pharmacol Ther. 2017;102:283–9.
   PubMed Web of Science ®Google Scholar
• Scarpazza C, Signori A, Prosperini L, et al. Early diagnosis of progressive multifocal leucoencephalopathy: longitudinal lesion evolution. J Neurol Neurosurg Psychiatry. 2019;90:261-7.
   Google Scholar
• Berger JR, Aksamit AJ, Clifford DB, et al. PML diagnostic criteria: consensus statement from the AAN neuroinfectious disease section. Neurology. 2013;80:1430–38.
   PubMed Web of Science ®Google Scholar
• Wijburg MT, Warnke C, Barkhof F, et al. Performance of PML diagnostic criteria in natalizumab-associated PML: data from the Dutch-Belgian cohort. J Neurol Neurosurg Psychiatry. 2019 Jan;90:44-6.
   Web of Science ®Google Scholar
• Wijburg MT, Kleerekooper I, Lissenberg-Witte BI, et al. Association of progressive multifocal leukoencephalopathy lesion volume with JC virus polymerase chain reaction results in cerebrospinal fluid of natalizumab-treated patients with multiple sclerosis. JAMA Neurol. 2018;75:827–33.
   PubMed Web of Science ®Google Scholar
• Wijburg MT, Witte BI, Vennegoor A, et al. MRI criteria differentiating asymptomatic PML from new MS lesions during natalizumab pharmacovigilance. J Neurol Neurosurg Psychiatry. 2016;87:1138–45.
   PubMed Web of Science ®Google Scholar
• Sahraian MA, Radue EW, Eshaghi A, et al. Progressive multifocal leukoencephalopathy: A review of the neuroimaging features and differential diagnosis. Eur J Neurol. 2012;19:1060–9.
   PubMed Web of Science ®Google Scholar
• McNees AL, White ZS, Zanwar P, et al. Specific and quantitative detection of human polyomaviruses BKV, JCV, and SV40 by real time PCR. J Clin Virol. 2005;34:52–62.
   PubMed Web of Science ®Google Scholar
• Koralnik IJ, Boden D, Mai VX, et al. JC virus DNA load in patients with and without progressive multifocal leukoencephalopathy. Neurology. 1999;52:253–60.
   PubMed Web of Science ®Google Scholar
• Classen G, Classen C, Bernasconi C, et al. Quantitative electroencephalography supports diagnosis of natalizumab-associated progressive multifocal leukoencephalopathy. J Neurovirol. 2018. published online2018 Nov 9. DOI:10.1007/s13365-018-0689-2
   PubMed Web of Science ®Google Scholar
• Wattjes MP, Rovira À, Miller D, et al. Evidence-based guidelines: MAGNIMS consensus guidelines on the use of MRI in multiple sclerosis - Establishing disease prognosis and monitoring patients. Nat Rev Neurol. 2015;11:597–606.
   PubMed Web of Science ®Google Scholar
• Havrdova E, Horakova D, Kovarova I. Alemtuzumab in the treatment of multiple sclerosis: key clinical trial results and considerations for use. Ther Adv Neurol Disord. 2015;8:31–45.
   PubMed Web of Science ®Google Scholar
• Hauser SL, Kappos L, Montalban X, et al. Safety of ocrelizumab in multiple sclerosis: updated analysis in patients with relapsing and primary progressive multiple sclerosis. Presented at ECTRIMS 2018, Berlin (Poster number P1229)
   Google Scholar
• Chataway J, Miller DH. Natalizumab therapy for multiple sclerosis. Neurotherapeutics. 2013;10:19–28.
   PubMed Web of Science ®Google Scholar
• Sood AB, Kumar G, Robinson J. Bilateral acute retinal necrosis in a patient with multiple sclerosis on natalizumab. J Ophthalmic Inflamm Infect. 2016;6:26.
   PubMedGoogle Scholar
• Pawlitzki M, Teuber J, Campe C, et al. VZV-associated acute retinal necrosis in a patient with MS treated with natalizumab. Neurol Neuroimmunol Neuroinflamm. 2018;5:e475.
   PubMed Web of Science ®Google Scholar
• Sharma K, Ballham SA, Inglis KEA, et al. Does natalizumab treatment increase the risk of herpes simplex encephalitis in multiple sclerosis? Case and discussion. Mult Scler Relat Disord. 2013;2:385–7.
   PubMed Web of Science ®Google Scholar
• Yann K, Jackson F, Sharaf N, et al. Acute respiratory distress syndrome following alemtuzumab therapy for relapsing multiple sclerosis. Mult Scler Relat Disord. 2017;14:1–3.
   PubMed Web of Science ®Google Scholar
• Barone S, Scannapieco S, Torti C, et al. Hepatic microabscesses during CMV reactivation in a multiple sclerosis patient after alemtuzumab treatment. Mult Scler Relat Disord. 2018;20:6–8.
   PubMed Web of Science ®Google Scholar
• Clerico M, De Mercanti S, Artusi CA, et al. Active CMV infection in two patients with multiple sclerosis treated with alemtuzumab. Mult Scler. 2017;23:874–6.
   PubMed Web of Science ®Google Scholar
• Buonomo AR, Saccà F, Zappulo E, et al. Bacterial and CMV pneumonia in a patient treated with alemtuzumab for multiple sclerosis. Mult Scler Relat Disord. 2018. published online 2018 Oct 2. DOI:10.1016/j.msard.2018.09.031
   PubMed Web of Science ®Google Scholar
• Nesbitt C. Incidence of cervical dysplasia in females receiving Alemtuzumab: an australian single centre observational study. ECTRIMS Online Library. 2017. 199744.
   Google Scholar
• Olsen SJ, Patrick M, Hunter SB, et al. Multistate outbreak of Listeria monocytogenes infection linked to delicatessen turkey meat. Clin Infect Dis. 2005;40:962–67.
   PubMed Web of Science ®Google Scholar
• Rau D, Lang M, Harth A, et al. Listeria meningitis complicating alemtuzumab treatment in multiple sclerosis—report of two cases. Int J Mol Sci. 2015;16:14669–76.
   PubMed Web of Science ®Google Scholar
• Selmaj KW, Habek M, Bass AD, et al. Efficacy and safety of alemtuzumab in patients with RRMS is durable over 10 years: follow-up from the CAMMS223 study. Neurology;88(16), Supplement P5.338.
   Google Scholar
• Canham LJW, Manara A, Fawcett J, et al. Mortality from Listeria monocytogenes meningoencephalitis following escalation to alemtuzumab therapy for relapsing-remitting Multiple Sclerosis. Mult Scler Relat Disord. 2018;24:38–41.
   PubMed Web of Science ®Google Scholar
• Brouwer MC, Van De Beek D, Heckenberg SG, et al. Community-acquired Haemophilus influenzae meningitis in adults. Clin Microbiol Infect. 2007;13:439–42.
   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;4:495–8.
   PubMed Web of Science ®Google Scholar
• Baker D, Herrod SS, Alvarez-Gonzalez C, et al. Interpreting lymphocyte reconstitution data from the pivotal phase 3 trials of alemtuzumab. JAMA Neurol. 2017;74:961–9.
   PubMed Web of Science ®Google Scholar
• Steinman L. Induction of new autoimmune diseases after alemtuzumab therapy for multiple sclerosis: learning from adversity. JAMA Neurol. 2017;74:907–8.
   PubMed Web of Science ®Google Scholar
• Havrdova E, Arnold DL, Cohen JA, et al. Alemtuzumab CARE-MS I 5-year follow-up: durable efficacy in the absence of continuous MS therapy. Neurology. 2017;89:1107–16.
   PubMed Web of Science ®Google Scholar
• Coles AJ, Cohen JA, Fox EJ, et al. Alemtuzumab CARE-MS II 5-year follow-up: efficacy and safety findings. Neurology. 2017;89:1117–26.
   PubMed Web of Science ®Google Scholar
• Pariani N, Willis M, Muller I, et al. Alemtuzumab-induced thyroid dysfunction exhibits distinctive clinical and immunological features. J Clin Endocrinol Metab. 2018;103:3010–8.
   PubMed Web of Science ®Google Scholar
• Cuker A, Coles AJ, Sullivan H, et al. A distinctive form of immune thrombocytopenia in a phase 2 study of alemtuzumab for the treatment of relapsing-remitting multiple sclerosis. Blood. 2011;118:6299–305.
   PubMed Web of Science ®Google Scholar
• Lambert C, Dubois B, Dive D, et al. Management of immune thrombocytopenia in multiple sclerosis patients treated with alemtuzumab: a Belgian consensus. Acta Neurol Belg. 2018;118:7–11.
   PubMed Web of Science ®Google Scholar
• Neunert CE, Cooper N. Evidence-based management of immune thrombocytopenia: ASH guideline update. Hematology Am Soc Hematol Educ Program. 2018;2018:568–75.
   PubMed Web of Science ®Google Scholar
• Provan D, Newland AC. Current management of primary immune thrombocytopenia. Adv Ther. 2015;32:875–87.
   PubMed Web of Science ®Google Scholar
• Pisa M, Della Valle P, Coluccia A, et al. Acquired haemophilia A as a secondary autoimmune disease after alemtuzumab treatment in multiple sclerosis: A case report. Mult Scler Relat Disord. 2019;27:403–5.
   PubMed Web of Science ®Google Scholar
• Madeley J, Hodges G, Birchley A. Development of acquired haemophilia A in a patient treated with alemtuzumab for multiple sclerosis. BMJ Case Rep. 2018;2018:bcr-2018-226588.
   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
• Graf J, Ringelstein M, Lepka K, et al. Acute sarcoidosis in a multiple sclerosis patient after alemtuzumab treatment. Mult Scler. 2018;24:1776–8.
   PubMedGoogle Scholar
• Willis MD, Hope-Gill B, Flood-Page P, et al. Sarcoidosis following alemtuzumab treatment for multiple sclerosis. Mult Scler. 2018;24:1779–82.
   PubMed Web of Science ®Google Scholar
• Lapointe E, Moghaddam B, Barclay K, et al. Goodpasture’s syndrome following alemtuzumab therapy in multiple sclerosis. Can J Neurol Sci. 2018;45:712–4.
   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. 2018;27:131–2.
   PubMed Web of Science ®Google Scholar
• El Sankari S, Dahlqvist G, Monino L, et al. Auto-immune hepatitis in a patient with multiple sclerosis treated with alemtuzumab. Acta Neurol Belg. 2018;118:331–3.
   PubMed Web of Science ®Google Scholar
• VigiBase® - WHO. [cited2018 Nov 18]. Available from: http://www.vigiaccess.org
   Google Scholar
• Bergamaschi R, Montomoli C. Melanoma in multiple sclerosis treated with natalizumab: causal association or coincidence? Mult Scler. 2009;15:1532–3.
   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;147:72–6.
   PubMedGoogle Scholar
• Lebrun C, Rocher F. Cancer risk in patients with multiple sclerosis: potential impact of disease-modifying drugs. CNS Drugs. 2018;32:939–49.
   PubMed Web of Science ®Google Scholar
• Grundmark B. Natalizumab and rapidly evolving central nervous system lymphoma. In: WHO pharmaceuticals newsletter, no. 6. World Health Organization, Geneva. 2017. p. 14.
   Google Scholar
• Pace AA, Zajicek JP. Melanoma following treatment with alemtuzumab for multiple sclerosis. Eur J Neurol. 2009;16:e70–1.
   PubMed Web of Science ®Google Scholar
• Smith RA, Andrews KS, Brooks D, et al. Cancer screening in the United States, 2017: A review of current American Cancer Society guidelines and current issues in cancer screening. CA Cancer J Clin. 2018;68:297–316.
   PubMed Web of Science ®Google Scholar
• Signoriello E, Lanzillo R, Brescia Morra V, et al. Lymphocytosis as a response biomarker of natalizumab therapeutic efficacy in multiple sclerosis. Mult Scler. 2016;22:921–5.
   PubMed Web of Science ®Google Scholar
• Rossi S, Motta C, Studer V, et al. A genetic variant of the anti-apoptotic protein Akt predicts natalizumab-induced lymphocytosis and post-natalizumab multiple sclerosis reactivation. Mult Scler. 2013;19:59–68.
   PubMed Web of Science ®Google Scholar
• Baker D, Giovannoni G, Schmierer K. Marked neutropenia: significant but rare in people with multiple sclerosis after alemtuzumab treatment. Mult Scler Relat Disord. 2017;18:181–3.
   PubMed Web of Science ®Google Scholar
• Gaitán MI, Ysrraelit MC, Correale J. Neutropenia in patients with multiple sclerosis treated with alemtuzumab. JAMA Neurol. 2017;74:1143–4.
   PubMed Web of Science ®Google Scholar
• Puthenparampil F, Federle L, Cazzola C, et al. Decreased platelet number in multiple sclerosis during alemtuzumab infusion: a common, transient and clinically silent phenomenon. Ther Adv Neurol Disord. 2018;11:1756285617741056.
   Web of Science ®Google Scholar
• Yiannopoulou KG, Papadimitriou D, Anastasiou AI, et al. Neutropenia with fatal outcome in a multiple sclerosis patient 23 days after alemtuzumab infusion. Mult Scler Relat Disord. 2018;23:15–6.
   PubMed Web of Science ®Google Scholar
• Galgani S, Prosperini L, Haggiag S, et al. Early transient asymptomatic neutropenia associated with alemtuzumab treatment in multiple sclerosis: a case report. J Neurol. 2018;265:2152–3.
   PubMed Web of Science ®Google Scholar
• EMA - Ocrevus. (ocrelizumab) Summary of product characteristics. [cited 2018 Nov 18]. Available from: https://www.ema.europa.eu/documents/product-information/ocrevus-epar-product-information_it.pdf
   Google Scholar
• Friend S, Richman S, Bloomgren G, et al. Evaluation of pregnancy outcomes from the Tysabri® (natalizumab) pregnancy exposure registry: A global, observational, follow-up study. BMC Neurol. 2016;16:150.
   PubMed Web of Science ®Google Scholar
• De Giglio L, Gasperini C, Tortorella C, et al. Natalizumab discontinuation and disease restart in pregnancy: A case series. Acta Neurol Scand. 2015;131:336–40.
   PubMed Web of Science ®Google Scholar
• Haghikia A, Langer-Gould A, Rellensmann G, et al. Natalizumab use during the third trimester of pregnancy. JAMA Neurol. 2014;71:891–5.
   PubMed Web of Science ®Google Scholar
• Amato MP, Portaccio E. Fertility, pregnancy and childbirth in patients with multiple sclerosis: impact of disease-modifying drugs. CNS Drugs. 2015;29:207–20.
   PubMed Web of Science ®Google Scholar
• Havrdova E, Cohen JA, Horakova D, et al. Understanding the positive benefit: riskprofile of alemtuzumab in relapsing multiple sclerosis: perspectives from the alemtuzumab clinical development program. Ther Clin Risk Manag. 2017;13:1423–37.
   PubMed Web of Science ®Google Scholar
• Thiel S, Langer-Gould A, Rockhoff M, et al. Interferon-beta exposure during first trimester is safe in women with multiple sclerosis-A prospective cohort study from the German multiple sclerosis and pregnancy registry. Mult Scler. 2016;22:801–9.
   PubMed Web of Science ®Google Scholar