Vol 54, No 1 (2020)
Review Article
Published online: 2020-01-23
Monoclonal antibodies — a revolutionary therapy in multiple sclerosis
12
, 134, 56
, 134, 56
Abstract
Introduction. Multiple sclerosis (MS) has an increasing incidence and affects a young s egment of t he population, having a major impact on patients and consequently on society. The multifactorial aetiology and pathogenesis of this disease are incompletely known at present, but autoimmune aggression has a documented mechanism.
State of the art. Since the 1990s, immunomodulatory drugs of high efficacy and a good safety profile have been launched. But the concept of NEDA (No Evidence of Disease Activity) remains the target to achieve. Thus, the new revolutionary class of monoclonal antibodies (moAbs) used in multiple medical fields, from this perspective represents a challenge even for multiple sclerosis, including the primary progressive form, for which there has been no treatment until recently.
Clinical implications. In this article, we will review monoclonal antibodies’ use for MS, presenting their advantages and disadvantages, based on data accumulated since 2004 when the first monoclonal antibody was approved for active forms of the disease.
Future directions. There is still a need for personalised medicines, with a specific target, which should have fewer adverse effects and drug interactions.
Keywords: multiple sclerosismonoclonal antibodiessafetynatalizumabalemtuzumabocrelizumab
References
- Alonso A, Hernán MA. Temporal trends in the incidence of multiple sclerosis: a systematic review. Neurology. 2008; 71(2): 129–135.
- Sirbu CA, Plesa FC, Dragoi CM, et al. History of interferon treatments in multiple sclerosis–60 years of progress. Vols Farmacia. 2017; 65(1): 14–18.
- Kułakowska A, Drozdowski W. Does interferon beta therapy affect survival of multiple sclerosis patients? Neurol Neurochir Pol. 2014; 48(6): 436–441.
- Kułakowska A, Bartosik-Psujek H, Hożejowski R, et al. Selected aspects of the epidemiology of multiple sclerosis in Poland - a multicentre pilot study. Neurol Neurochir Pol. 2010; 44(5): 443–452.
- Río J, Tintoré M, Sastre-Garriga J, et al. Change in the clinical activity of multiple sclerosis after treatment switch for suboptimal response. Eur J Neurol. 2012; 19(6): 899–904.
- Sirbu CA, Furdu-Lungut E, Plesa CF, et al. et al.. M. Pharmacological treatment of relapsing remitting multiple sclerosis-where we are throw evidence based medicine? –review Farmacia. 2016; 64(5): 651–6.
- Arneth BM. Impact of B cells to the pathophysiology of multiple sclerosis. J Neuroinflammation. 2019; 16(1): 128.
- Derada Troletti C, Fontijn RD, Gowing E, et al. Inflammation-induced endothelial to mesenchymal transition promotes brain endothelial cell dysfunction and occurs during multiple sclerosis pathophysiology. Cell Death Dis. 2019; 10(2): 45.
- Dendrou CA, Fugger L, Friese MA. Immunopathology of multiple sclerosis. Nat Rev Immunol. 2015; 15(9): 545–558.
- Høglund RA, Maghazachi AA. Multiple sclerosis and the role of immune cells. World J Exp Med. 2014; 4(3): 27–37.
- Voge NV, Alvarez E. Monoclonal Antibodies in Multiple Sclerosis: Present and Future. Biomedicines. 2019; 7(1).
- Stüve O, Cepok S, Elias B, et al. Clinical stabilization and effective B-lymphocyte depletion in the cerebrospinal fluid and peripheral blood of a patient with fulminant relapsing-remitting multiple sclerosis. Arch Neurol. 2005; 62(10): 1620–1623.
- Veldhuijzen van Zanten SEM, De Witt Hamer PC, van Dongen GA. Brain Access of Monoclonal Antibodies as Imaged and Quantified by Zr-Antibody PET: Perspectives for Treatment of Brain Diseases. J Nucl Med. 2019; 60(5): 615–616.
- Preziosa P, Rocca MA, Filippi M. PET is necessary to make the next step forward in understanding MS pathophysiology - No. Mult Scler. 2019; 25(8): 1088–1090.
- Pieters T. Interferon: The Science and Selling of a Miracle Drug, 264 pp., illustrated. New York, Routledge, ISBN: 0-415-34246-5. 2005.
- Tovey MG, Lallemand C. Immunogenicity and other problems associated with the use of biopharmaceuticals. Ther Adv Drug Saf. 2011; 2(3): 113–128.
- Brown JW, Coles A, Horakova D, et al. MSBase Study Group. Association of Initial Disease-Modifying Therapy With Later Conversion to Secondary Progressive Multiple Sclerosis. JAMA. 2019; 321(2): 175–187.
- Harding K, Williams O, Willis M, et al. Clinical Outcomes of Escalation vs Early Intensive Disease-Modifying Therapy in Patients With Multiple Sclerosis. JAMA Neurol. 2019; 76(5): 536–541.
- Steinman L. The discovery of natalizumab, a potent therapeutic for multiple sclerosis. J Cell Biol. 2012; 199(3): 413–416.
- Shirani A, Stüve O. Natalizumab for Multiple Sclerosis: A Case in Point for the Impact of Translational Neuroimmunology. J Immunol. 2017; 198(4): 1381–1386.
- Ali R, Nicholas RS, Muraro PA. Drugs in development for relapsing multiple sclerosis. Drugs. 2013; 73(7): 625–650.
- Rice GPA, Hartung HP, Calabresi PA. Anti-alpha4 integrin therapy for multiple sclerosis: mechanisms and rationale. Neurology. 2005; 64(8): 1336–1342.
- Radue EW, Stuart WH, Calabresi PA, et al. SENTINEL Investigators, SENTINEL Investigators. Natalizumab plus interferon beta-1a for relapsing multiple sclerosis. N Engl J Med. 2006; 354(9): 911–923.
- Pietropaolo V, Prezioso C, Bagnato F, et al. John Cunningham virus: an overview on biology and disease of the etiological agent of the progressive multifocal leukoencephalopathy. New Microbiol. 2018; 41(3): 179–186.
- Graf J, Aktas O, Rejdak K, et al. Monoclonal Antibodies for Multiple Sclerosis: An Update. BioDrugs. 2019; 33(1): 61–78.
- Oshima Y, Tanimoto T, Yuji K, et al. Drug-associated progressive multifocal leukoencephalopathy in multiple sclerosis patients. Mult Scler. 2019; 25(8): 1141–1149.
- Kolcava J, Hulova M, Benesova Y, et al. The value of anti-JCV antibody index assessment in multiple sclerosis patients treated with natalizumab with respect to demographic, clinical and radiological findings. Mult Scler Relat Disord. 2019; 30: 187–191.
- Major EO, Yousry TA, Clifford DB. Pathogenesis of progressive multifocal leukoencephalopathy and risks associated with treatments for multiple sclerosis: a decade of lessons learned. Lancet Neurol. 2018; 17(5): 467–480.
- Kachuck NJ. Registries, research, and regrets: is the FDA's post-marketing REMS process not adequately protecting patients? Ther Adv Neurol Disord. 2011; 4(6): 339–347.
- Schwab N, Schneider-Hohendorf T, Melzer N, et al. Natalizumab-associated PML. Neurology. 2017; 88(12): 1197–1205.
- Fragoso YD, Adoni T, Brooks JB, et al. Practical Evidence-Based Recommendations for Patients with Multiple Sclerosis Who Want to Have Children. Neurol Ther. 2018; 7(2): 207–232.
- Scalfari A, Muraro P. Monoclonal Antibody Therapy and Long-term Outcomes in Multiple Sclerosis – The Challenge of Treatment Optimisation. European Neurological Review. 2018; 13(2): 78.
- De Angelis F, John NA, Brownlee WJ. Disease-modifying therapies for multiple sclerosis. BMJ. 2018; 363: k4674.
- Knier B, Hemmer B, Korn T. Novel monoclonal antibodies for therapy of multiple sclerosis. Expert Opin Biol Ther. 2014; 14(4): 503–513.
- 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(7): 14669–14676.
- Kappos L, Li D, Calabresi P, et al. Long-term safety and efficacy of ocrelizumase II, randomised, multicentre trial. Lancet. 2011; 378(9805): 1779–87.
- Havrdová E, Arnold DL, Bar-Or A, et al. No evidence of disease activity (NEDA) analysis by epochs in patients with relapsing multiple sclerosis treated with ocrelizumab vs interferon beta-1a. Mult Scler J Exp Transl Clin. 2018; 4(1): 2055217318760642.
- ICER Institute for Clinical and Economic Review. Disease-modifying therapies for relapsing-remitting and primary-progressive multiple sclerosis: effectiveness and value. Final evidence report. https://icer-review.org/wp-content/uploads/2016/08/CTAF_MS_Final_Report_030617.pdf. (2017).
- Dobson R, Dassan P, Roberts M, et al. UK consensus on pregnancy in multiple sclerosis: 'Association of British Neurologists' guidelines. Pract Neurol. 2019; 19(2): 106–114.
- Sorensen PS, Sellebjerg F. Pulsed immune reconstitution therapy in multiple sclerosis. Ther Adv Neurol Disord. 2019; 12: 1756286419836913.
- Li H, Hu F, Zhang Y, et al. Comparative efficacy and acceptability of disease-modifying therapies in patients with relapsing-remitting multiple sclerosis: a systematic review and network meta-analysis. J Neurol. 2019 [Epub ahead of print].
- Cree BAc. Rituximab is an acceptable alternative to ocrelizumab for treating multiple sclerosis - Commentary. Mult Scler. 2018; 24(9): 1161–1162.
- Piehl F, Hillert J. Rituximab is an acceptable alternative to ocrelizumab for treating multiple sclerosis - Yes. Mult Scler. 2018; 24(9): 1157–1159.
- Cohan SL, Lucassen EB, Romba MC, et al. Daclizumab: Mechanisms of Action, Therapeutic Efficacy, Adverse Events and Its Uncovering the Potential Role of Innate Immune System Recruitment as a Treatment Strategy for Relapsing Multiple Sclerosis. Biomedicines. 2019; 7(1).
- Bar-Or A, Grove RA, Austin DJ, et al. Subcutaneous ofatumumab in patients with relapsing-remitting multiple sclerosis: The MIRROR study. Neurology. 2018; 90(20): e1805–e1814.
- Hauser S. Efficacy and safety of ofatumumab versus teriflunomide in relapsing multiple sclerosis: results of the phase 3 ASCLEPIOS I and II trials. Oral presentation. : ECTRIMS.
- Long-term follow-up results from the phase 2 multicenter study of ublituximab (UTX), a novel glycoengineered anti-CD20 monoclonal antibody (mAb), in patients with relapsing multiple sclerosis (RMS), ECTRIMS Online Library. Fox E Sep. ; 12: 2019.
- Steinman L, et al. Study design and patient demographics of the ULTIMATE phase III trials evaluating Ublituximab (UTX), a novel glycoengineered anti-CD20 monoclonal antibody (mAb), in patients with relapsing multiple sclerosis (RMS). ECTRIMS Online Library.
- Cadavid Efficacy Analysis of the Anti-LINGO-1 Monoclonal Antibody BIIB033 in Acute Optic Neuritis: The RENEW Trial. AAN 2015: P7. ; 202.
- Cadavid D, Mellion M, Hupperts R, et al. SYNERGY study investigators. Safety and efficacy of opicinumab in patients with relapsing multiple sclerosis (SYNERGY): a randomised, placebo-controlled, phase 2 trial. Lancet Neurol. 2019; 18(9): 845–856.
