Applikationswege in der Therapie der Multiplen Sklerose – monoklonale Antikörper im Fokus
Literatur
Azevedo CJ, Kutz C, Dix A, et al. Intracerebral haemorrhage during alemtuzumab administration. Lancet Neurol 2019;18(4):329 – 31
Baker D, Giovannoni G und Schmierer K. Marked neutropenia: significant but rare in people with multiple sclerosis after alemtuzumab treatment. Mult Scler Relat Disord 2017a;18:181 – 3
Baker D, Herrod SS, Alvarez-Gonzalez C, et al. Interpreting lymphocyte reconstitution data from the pivotal phase 3 trials of alemtuzumab. JAMA Neurol 2017b;74(8):961 – 9
Baker D, Kang AS, Giovannoni G, et al. Neutropenia following immune-depletion, notably CD20 targeting, therapies in multiple sclerosis. Mult Scler Relat Disord 2024;82:105400
Baker D, Pryce G, James LK, et al. The ocrelizumab phase II extension trial suggests the potential to improve the risk: benefit balance in multiple sclerosis. Mult Scler Relat Disord 2020;44:102279
Bar-Or A, Calkwood JC, Chognot C, et al. Effect of ocrelizumab on vaccine responses in patients with multiple sclerosis: the VELOCE study. Neurology 2020;95(14):e1999 – e2008
Bar-Or A, Winthrop K, Wiendl H, et al. Effect of ofatumumab on lymphocytes and neutrophils in patients with relapsing multiple sclerosis up to 4 years. Annual meeting of the Consortium of Multiple Sclerosis Centers, National Harbor, USA, 2022
Bigaud M, Anthony D, Lutzenburg P, et al. Comparative pharmacology of ofatumumab versus ocrelizumab in humanised-CD20 transgenic mice. P298. ECTRIMS Congress, Amsterdam, Niederlande, 2022
Bigaud M, Anthony D, Zipfel G, et al. Comparative pharmacology of ofatumumab vs ocrelizumab in humanized CD20 transgenic mice. O007. AAN Annual Meeting, Boston, USA, 2023 Bsteh G, Hegen H, Traxler G, et al. Comparing humoral immune response to SARS-CoV-2 vaccines in people with multiple sclerosis and healthy controls: an Austrian prospective multicenter cohort study. Eur J Neurol 2022;29(5):1538 – 44
Butzkueven H, Kappos L, Spelman T, et al. No evidence for loss of natalizumab effectiveness with every-6-week dosing: a propensity score-matched comparison with every-4-week dosing in patients enrolled in the Tysabri Observational Program (TOP). Ther Adv Neurol Disord 2021;14:17562864211042458
Butzkueven H, Kappos L, Wiendl H, et al. Long-term safety and effectiveness of natalizumab treatment in clinical practice: 10 years of real-world data from the Tysabri Observational Program (TOP). J Neurol Neurosurg Psychiatry 2020;91(6):660 – 8
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(9856):1819 – 28
Cohen JA, Hauser SL, Cross AH, et al. Five-year safety of ofatumumab in people living with relapsing multiple sclerosis. P8-3.004. AAN Annual Meeting, Boston, USA, 2023
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(9856):1829 – 39
Comi G, Bar-Or A, Lassmann H, et al. Role of B cells in multiple sclerosis and related disorders. Ann Neurol 2021;89(1):13 – 23
de Sèze J, Maillart E, Gueguen A, et al. Anti-CD20 therapies in multiple sclerosis: from pathology to the clinic. Front Immunol 2023;14:1004795
Delgado SR, Faissner S, Linker RA, et al. Key characteristics of anti-CD20 monoclonal antibodies and clinical implications for multiple sclerosis treatment. J Neurol 2023; 10.1007/s00415-023-12007 – 3
Dendrou CA, Fugger L und Friese MA. Immunopathology of multiple sclerosis. Nat Rev Immunol 2015;15(9):545 – 58
Derfuss T, Weber M, Hughes R, et al. P36 Serum immunoglobulin levels and risk of serious infections in the pivotal phase III trials of ocrelizumab in multiple sclerosis and their open-label extensions. Clin Neurophysiol 2020;131:e196
Eckardt C, Vay SU, Warnke C, et al. Dysphagie bei Multipler Sklerose – ein unterschätztes Symptom? Fortschr Neurol Psychiatr 2021;89(04):168 – 77
EMA. Lemtrada – referral. 2019. https://www.ema.europa.eu/en/medicines/human/referrals/lemtrada. Abgerufen am 15.03.2024
EMA. European Public Assessment Report (EPAR) risk-management-plan summary. 2022. www.ema.europa.eu. Abgerufen am 09.02.2024
EMA. European Public Assessment Report (EPAR) product informations. 2024. www.ema.europa.eu. Abgerufen am 18.07.2024
Faissner S und Gold R. Efficacy and safety of the newer multiple sclerosis drugs approved since 2010. CNS Drugs 2018;32(3):269 – 87
Faissner S und Gold R. Efficacy and safety of multiple sclerosis drugs approved since 2018 and future developments. CNS Drugs 2022;36(8):803 – 17
Faissner S, Heitmann N, Plaza-Sirvent C, et al. Immune response in ofatumumab treated multiple sclerosis patients after SARS-CoV-2 vaccination. Front Immunol 2022;13:980526
Faissner S, Plemel JR, Gold R, et al. Progressive multiple sclerosis: from pathophysiology to therapeutic strategies. Nat Rev Drug Discov 2019;18(12):905 – 22
Fox EJ, Alvarez E, Bosco J, et al. Infusion-related reactions (IRRs) with ublituximab in patients with relapsing multiple sclerosis (RMS): post hoc analyses from the phase 3 ULTIMATE I and II studies. P6.4-010. AAN Annual Meeting, Seattle, USA, 2022
Frischer JM, Bramow S, Dal-Bianco A, et al. The relation between inflammation and neurodegeneration in multiple sclerosis brains. Brain 2009;132(Pt 5):1175 – 89
Gaitán MI, Ysrraelit MC und Correale J. Neutropenia in patients with multiple sclerosis treated with alemtuzumab. JAMA Neurology 2017;74(9):1143 – 4
Gibiansky E, Petry C, Mercier F, et al. Ocrelizumab in relapsing and primary progressive multiple sclerosis: pharmacokinetic and pharmacodynamic analyses of OPERA I, OPERA II and ORATORIO. Br J Clin Pharmacol 2021;87(6):2511 – 20
Haase S, Krickl A-L, Freudenstein D, et al. Subcutaneous anti-CD20 targeted B cell depletion preserves memory B cells and IgG serum levels in patients with relapsing remitting multiple sclerosis (P280). ECTRIMS, Mailand, Italien, 2023
Haghikia A, Dendrou CA, Schneider R, et al. Severe B-cell-mediated CNS disease secondary to alemtuzumab therapy. Lancet Neurol 2017;16(2):104 – 6
Hartung HP, Mares J und Barnett MH. Alemtuzumab: rare serious adverse events of a high-efficacy drug. Mult Scler 2020;26(6):737 – 40
Hauser SL, Bar-Or A, Cohen JA, et al. Ofatumumab versus teriflunomide in multiple sclerosis. N Engl J Med 2020a;383(6):546 – 57
Hauser SL, Bar-Or A, Comi G, et al. Ocrelizumab versus interferon beta-1a in relapsing multiple sclerosis. N Engl J Med 2017;376(3):221 – 34
Hauser SL, Kappos L, Arnold DL, et al. Five years of ocrelizumab in relapsing multiple sclerosis: OPERA studies open-label extension. Neurology 2020b;95(13):e1854 – e67
Hauser SL, Kappos L, Montalban X, et al. Safety of ocrelizumab in patients with relapsing and primary progressive multiple sclerosis. Neurology 2021;97(16):e1546 – e59
Hess F, Uibel P, Berthele A, et al. Ocrelizumab-assoziierte schwere Neutropenie: eine unterschätzte Komplikation der Therapie mit CD20-Antikörpern bei Multipler Sklerose? Nervenarzt 2023;94(12):1153 – 6
Hill-Cawthorne GA, Button T, Tuohy O, et al. Long term lymphocyte reconstitution after alemtuzumab treatment of multiple sclerosis. J Neurol Neurosurg Psychiatry 2012;83(3):298 – 304
Huck C, Leppert D, Wegert V, et al. Low-dose subcutaneous anti-CD20 treatment depletes disease relevant B cell subsets and attenuates neuroinflammation. J Neuroimmune Pharmacol 2019;14(4):709 – 19
IQVIA Incorporated. IQVIA National Prescription Audit (NPA). 2023a. https://www.iqvia.com
IQVIA Incorporated. IQVIA National Sales Perspectives (NSP). 2023b. https://www.iqvia.com
Kappos L, Wolinsky JS, Giovannoni G, et al. Contribution of relapse-independent progression vs relapse-associated worsening to overall confirmed disability accumulation in typical relapsing multiple sclerosis in a pooled analysis of 2 randomized clinical trials. JAMA Neurol 2020;77(9):1132 – 40
Kaufman M, Pardo G, Rossman H, et al. Natalizumab treatment shows no clinically meaningful effects on immunization responses in patients with relapsing- remitting multiple sclerosis. J Neurol Sci 2014;341(1-2):22 – 7
Kim J und De Jesus O. Medication routes of administration. 2023. https://www.ncbi.nlm.nih.gov/books/NBK568677/. Abgerufen am 26.09.2023
Klimas R, Karl AS, Poser PL, et al. Über ein Jahr B-Zell-gerichtete Therapie mit Ofatumumab s.c.: erste Ergebnisse einer prospektiven, patientenzentrierten Real-World-Beobachtungsstudie. Nervenarzt 2023;94(10):923 – 33
Krajnc N, Bsteh G, Berger T, et al. Monoclonal antibodies in the treatment of relapsing multiple sclerosis: an overview with emphasis on pregnancy, vaccination, and risk management. Neurotherapeutics 2022;19(3):753 – 73
Kutzelnigg A und Lassmann H. Pathology of multiple sclerosis and related inflammatory demyelinating diseases. Handb Clin Neurol 2014;122:15 – 58
Li Z, Richards S, Surks HK, et al. Clinical pharmacology of alemtuzumab, an anti-CD52 immunomodulator, in multiple sclerosis. Clin Exp Immunol 2018;194(3):295 – 314
Magliozzi R, Howell OW, Reeves C, et al. A gradient of neuronal loss and meningeal inflammation in multiple sclerosis. Ann Neurol 2010;68(4):477 – 93
Mayer L, Kappos L, Racke MK, et al. Ocrelizumab infusion experience in patients with relapsing and primary progressive multiple sclerosis: results from the phase 3 randomized OPERA I, OPERA II, and ORATORIO studies. Mult Scler Relat Disord 2019;30:236 – 43
McCarthy CL, Tuohy O, Compston DA, et al. Immune competence after alemtuzumab treatment of multiple sclerosis. Neurology 2013;81(10):872 – 6
Möhn N, Pfeuffer S, Ruck T, et al. Alemtuzumab therapy changes immunoglobulin levels in peripheral blood and CSF. Neurol Neuroimmunol Neuroinflamm 2020;7(2)
ms international federation. Atlas of MS. 2023. https://www.atlasofms.org. Abgerufen am 29.01.2024
Pang V, Seery N, Wesselingh R, et al. Neutropaenia complications from ocrelizumab and rituximab treatment. Multiple Sclerosis and Related Disorders 2024;81:105147
Pitiot A, Heuzé-Vourc‘h N und Sécher T. Alternative routes of administration for therapeutic antibodies-state of the art. Antibodies (Basel) 2022;11(3)
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(9):899 – 910
Pozzilli C, Pugliatti M, Vermersch P, et al. Diagnosis and treatment of progressive multiple sclerosis: a position paper. Eur J Neurol 2023;30(1):9 – 21
Räuber S, Korsen M, Huntemann N, et al. Immune response to SARS-CoV-2 vaccination in relation to peripheral immune cell profiles among patients with multiple sclerosis receiving ocrelizumab. J Neurol Neurosurg Psychiatry 2022;93(9):978 – 85
Reich DS, Lucchinetti CF und Calabresi PA. Multiple Sclerosis. N Engl J Med 2018;378(2):169 – 80
Richter WF und Jacobsen B. Subcutaneous absorption of biotherapeutics: knowns and unknowns. Drug Metab Dispos 2014;42(11):1881 – 9
Rossi L, Dinoto A, Bratina A, et al. Neutropenia complicating anti-CD20 treatment in patients with multiple sclerosis: a retrospective case series and a systematic review of reported cases. Multiple Sclerosis and Related Disorders 2022;68:104090
Rudick RA, Stuart WH, Calabresi PA, et al. Natalizumab plus interferon beta-1a for relapsing multiple sclerosis. N Engl J Med 2006;354(9):911 – 23
Selewski DT, Shah GV, Segal BM, et al. Natalizumab. AJNR Am J Neuroradiol 2010;31(9):1588 – 90
Steinman L, Fox E, Hartung HP, et al. Ublituximab versus teriflunomide in relapsing multiple sclerosis. N Engl J Med 2022;387(8):704 – 14
Szepanowski F, Warnke C, Meyer zu Hörste G, et al. Secondary immunodeficiency and risk of infection following immune therapies in neurology. CNS Drugs 2021;35(11):1173 – 88
Torres JB, Roodselaar J, Sealey M, et al. Distribution and efficacy of ofatumumab and ocrelizumab in humanized CD20 mice following subcutaneous or intravenous administration. Front Immunol 2022;13:814064
Trepel F. Number and distribution of lymphocytes in man. A critical analysis. Klin Wochenschr 1974;52(11):511 – 5
Westermann J und Pabst R. Distribution of lymphocyte subsets and natural killer cells in the human body. The clinical investigator 1992;70(7):539 – 44
Ziemssen T, Groth M, Ettle B, et al. Immune response to SARS-CoV-2 mRNA vaccines in an open-label multicenter study in participants with relapsing multiple sclerosis treated with ofatumumab. Vaccines (Basel) 2022;10(12):2167
Ziemssen T, Schlegel E, Groth M, et al. Results on SARS-CoV-2 mRNA vaccine booster from an open-label multicenter study in ofatumumab-treated participants with relapsing multiple sclerosis. Vaccines (Basel) 2023;11(5)