Ocrelizumab Extended Interval Dosing in Primary Progressive Multiple Sclerosis: An Italian Experience


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Аннотация

Background:The intervals between two courses of anti CD20 therapies in the COVID19 pandemic era provided the opportunity to individually delay therapy, known as extended interval dosing (EID).

Materials and Methods:We collect real-world data on patients with primary progressive MS (PPMS) treated with Ocrelizumab (OCR) during the COVID’19 pandemic. The observation period in which the standard interval dosing (SID) or EID occurred (always a maintenance cycle, 600 mg) was from January 2020 to June 2021. All patients had two infusions during the observation period. Our first aim was to compare confirmed disability progression (CDP) between SID and EID patients.

Results:From a total cohort of 410 patients treated with OCR, 96 patients fulfilled the inclusion criteria. All patients received two infusions during the index window, 71 received only SID infusions whilst 25 received at least one EID infusion throughout the entire follow-up. During the entire available follow-up (median 10 months, IQR 7-11), CDP was recorded in 5 patients (3/71, 4.2% SID and 2/25, 8% EID, V-Cramer = 0.141, p-value = 0.167). EID regimen did not influence the risk of CDP during the investigated follow up.

Conclusion:In our multicentre real-world cohort, the EID regimen in PPMS patients did not result in increased CDP during the available follow-up.

Об авторах

Aurora Zanghì

Department of Medical and Surgical Sciences, University of Foggia

Email: info@benthamscience.net

Diana Ferraro

, University of Modena and Reggio Emilia

Email: info@benthamscience.net

Graziella Callari

, IRCSS G.Giglio

Email: info@benthamscience.net

Paola Valentino

, Azienda Ospedaliera Universitaria "Mater Domini"

Email: info@benthamscience.net

Franco Granella

Unit of Neurosciences, Department of Medicine and Surgery, University of Parma

Email: info@benthamscience.net

Francesco Patti

Department "G.F. Ingrassia, MS center University of Catania

Email: info@benthamscience.net

Giacomo Lus

Multiple Sclerosis Center, II Division of Neurology, Department of Clinical and Experimental Medicine,, Second University of Naples

Email: info@benthamscience.net

Simona Bonavita

Dipartimento di Scienze Mediche e Chirurgiche Avanzate, Università della Campania Luigi Vanvitelli,

Email: info@benthamscience.net

Maria Moretti

Department of Medical and Surgical Sciences, University of Foggia

Email: info@benthamscience.net

Carlo Avolio

Department of Medical and Surgical Sciences, University of Foggia

Email: info@benthamscience.net

Emanuele D’Amico

Department of Medical and Surgical Sciences,, University of Foggia,

Автор, ответственный за переписку.
Email: info@benthamscience.net

Список литературы

  1. Rolfes, L.; Pawlitzki, M.; Pfeuffer, S.; Nelke, C.; Lux, A.; Pul, R. Ocrelizumab extended interval dosing in multiple sclerosis in times of COVID-19. Neurol. Neuroimmunol. Neuroinflamm., 2021, 8(5), e1035. doi: 10.1212/NXI.0000000000001035 PMID: 34261812
  2. Bar-Or, A.; Calabresi, P.A.J.; Arnold, D.; Markowitz, C.; Shafer, S.; Kasper, L.H.; Waubant, E.; Gazda, S.; Fox, R.J.; Panzara, M.; Sarkar, N.; Agarwal, S.; Smith, C.H. Rituximab in relapsing-remitting multiple sclerosis: A 72-week, open-label, phase I trial. Ann. Neurol., 2008, 63(3), 395-400. doi: 10.1002/ana.21363 PMID: 18383069
  3. D’Amico, E.; Zanghì, A.; Chisari, C.G.; Fermo, S.L.; Toscano, S.; Arena, S.; Patti, F.; Zappia, M. Effectiveness and safety of Rituximab in demyelinating diseases spectrum: An Italian experience. Mult. Scler. Relat. Disord., 2019, 27, 324-326. doi: 10.1016/j.msard.2018.09.041 PMID: 30471585
  4. Furlan, A.; Forner, G.; Cipriani, L.; Vian, E.; Rigoli, R.; Gherlinzoni, F.; Scotton, P. COVID-19 in B cell-depleted patients after rituximab: A diagnostic and therapeutic challenge. Front. Immunol., 2021, 12, 763412. doi: 10.3389/fimmu.2021.763412 PMID: 34804051
  5. D’Amico, E.; Zanghì, A.; Gastaldi, M.; Patti, F.; Zappia, M.; Franciotta, D. Placing CD20-targeted B cell depletion in multiple sclerosis therapeutic scenario: Present and future perspectives. Autoimmun. Rev., 2019, 18(7), 665-672. doi: 10.1016/j.autrev.2019.05.003 PMID: 31059839
  6. Schiavetti, I.; Ponzano, M.; Signori, A.; Bovis, F.; Carmisciano, L.; Sormani, M.P. Severe outcomes of COVID-19 among patients with multiple sclerosis under anti-CD-20 therapies: A systematic review and meta-analysis. Mult. Scler. Relat. Disord., 2022, 57, 103358. doi: 10.1016/j.msard.2021.103358 PMID: 35158467
  7. Simpson-Yap, S.; De Brouwer, E.; Kalincik, T.; Rijke, N.; Hillert, J.A.; Walton, C.; Edan, G.; Moreau, Y.; Spelman, T.; Geys, L.; Parciak, T.; Gautrais, C.; Lazovski, N.; Pirmani, A.; Ardeshirdavanai, A.; Forsberg, L.; Glaser, A.; McBurney, R.; Schmidt, H.; Bergmann, A.B.; Braune, S.; Stahmann, A.; Middleton, R.; Salter, A.; Fox, R.J.; van der Walt, A.; Butzkueven, H.; Alroughani, R.; Ozakbas, S.; Rojas, J.I.; van der Mei, I.; Nag, N.; Ivanov, R.; Sciascia do Olival, G.; Dias, A.E.; Magyari, M.; Brum, D.; Mendes, M.F.; Alonso, R.N.; Nicholas, R.S.; Bauer, J.; Chertcoff, A.S.; Zabalza, A.; Arrambide, G.; Fidao, A.; Comi, G.; Peeters, L. Associations of disease-modifying therapies with COVID-19 severity in multiple sclerosis. Neurology, 2021, 97(19), e1870-e1885. doi: 10.1212/WNL.0000000000012753 PMID: 34610987
  8. Sormani, M.P.; De Rossi, N.; Schiavetti, I.; Carmisciano, L.; Cordioli, C.; Moiola, L.; Radaelli, M.; Immovilli, P.; Capobianco, M.; Trojano, M.; Zaratin, P.; Tedeschi, G.; Comi, G.; Battaglia, M.A.; Patti, F.; Salvetti, M.; Nozzolillo, A.; Bellacosa, A.; Protti, A.; Di Sapio, A.; Signori, A.; Petrone, A.; Bisecco, A.; Iovino, A.; Dutto, A.; Repice, A.M.; Conte, A.; Bertolotto, A.; Bosco, A.; Gallo, A.; Zito, A.; Sartori, A.; Giometto, B.; Tortorella, C.; Antozzi, C.; Pozzilli, C.; Mancinelli, C.R.; Zanetta, C.; Cordano, C.; Cordioli, C.; Scandellari, C.; Guaschino, C.; Gasperini, C.; Solaro, C.; Fioretti, C.; Bezzini, D.; Marastoni, D.; Paolicelli, D.; Vecchio, D.; Landi, D.; Bucciantini, E.; Pedrazzoli, E.; Signoriello, E.; Sbragia, E.; Susani, E.L.; Curti, E.; Milano, E.; Marinelli, F.; Camilli, F.; Boneschi, F.M.; Govone, F.; Bovis, F.; Calabria, F.; Caleri, F.; Rinaldi, F.; Vitetta, F.; Corea, F.; Crescenzo, F.; Patti, F.; Teatini, F.; Tabiadon, G.; Granella, F.; Boffa, G.; Lus, G.; Brichetto, G.; Comi, G.; Tedeschi, G.; Maniscalco, G.T.; Borriello, G.; De Luca, G.; Konrad, G.; Vaula, G.; Marfia, G.A.; Mallucci, G.; Liberatore, G.; Salemi, G.; Miele, G.; Sibilia, G.; Pesci, I.; Schiavetti, I.; Brambilla, L.; Lopiano, L.; Sinisi, L.; Pasquali, L.; Saraceno, L.; Carmisciano, L.; Chiveri, L.; Mancinelli, L.; Moiola, L.; Grimaldi, L.M.E.; Caniatti, L.M.; Capobianco, M.; Cava, M.D.; Onofrj, M.; Rovaris, M.; Salvetti, M.; Vercellino, M.; Bragadin, M.M.; Buccafusca, M.; Buscarinu, M.C.; Celani, M.G.; Grasso, M.G.; Stromillo, M.L.; Petracca, M.; Amato, M.P.; Sormani, M.P.; L’Episcopo, M.R.; Sessa, M.; Ferrò, M.T.; Trojano, M.; Ercolani, M.V.; Bianco, M.; Re, M.L.; Vianello, M.; Clerico, M.; Battaglia, M.A.; Napoli, M.; Ponzano, M.; Radaelli, M.; Conti, M.Z.; Calabrese, M.; Mirabella, M.; Filippi, M.; Inglese, M.; Lucchini, M.; Pozzato, M.; Danni, M.C.; Zaffaroni, M.; Zampolini, M.; Ponzio, M.; De Riz, M.; De Rossi, N.; De Stefano, N.; Cavalla, P.; De Mitri, P.; Grossi, P.; Zaratin, P.; Confalonieri, P.; Gallo, P.; Immovilli, P.; Ragonese, P.; Sola, P.; Annovazzi, P.; Iaffaldano, P.; Nardone, R.; Cerqua, R.; Clerici, R.; Lanzillo, R.; Motta, R.; Balgera, R.; Bergamaschi, R.; Totaro, R.; Iodice, R.; Capra, R.; Marangoni, S.; Realmuto, S.; Cottone, S.; Montepietra, S.; Rasia, S.; Arena, S.; Bucello, S.; Banfi, S.; Bonavita, S.; Malucchi, S.; Tonietti, S.; Vollaro, S.; Cordera, S.; Aguglia, U.; Clerici, V.T.; Barcella, V.; Bergamaschi, V.; Morra, V.B.; Dattola, V.; Mantero, V. Disease-modifying therapies and coronavirus disease 2019 severity in multiple sclerosis. Ann. Neurol., 2021, 89(4), 780-789. doi: 10.1002/ana.26028 PMID: 33480077
  9. Giovannoni, G. Anti-CD20 immunosuppressive disease-modifying therapies and COVID-19. Mult. Scler. Relat. Disord., 2020, 41, 102135. doi: 10.1016/j.msard.2020.102135 PMID: 32339915
  10. Hada, M.; Mosholder, A.D.; Leishear, K.; Perez-Vilar, S. Systematic review of risk of SARS-CoV-2 infection and severity of COVID-19 with therapies approved to treat multiple sclerosis. Neurol. Sci., 2022, 43(3), 1557-1567. doi: 10.1007/s10072-021-05846-3 PMID: 35006442
  11. Sharifian-Dorche, M.; Sahraian, M.A.; Fadda, G.; Osherov, M.; Sharifian-Dorche, A.; Karaminia, M.; Saveriano, A.W.; La Piana, R.; Antel, J.P.; Giacomini, P.S. COVID-19 and disease-modifying therapies in patients with demyelinating diseases of the central nervous system: A systematic review. Mult. Scler. Relat. Disord., 2021, 50, 102800. doi: 10.1016/j.msard.2021.102800 PMID: 33578206
  12. Baba, C.; Yigit, P.; Dastan, S.; Hancer, P.; Sagici, O.; Ozakbas, S.; Abasiyanik, Z. Challenges of persons with multiple sclerosis on ocrelizumab treatment during COVID-19 pandemic. Neurol. Clin. Neurosci., 2022, 10(1), 3-8. doi: 10.1111/ncn3.12561 PMID: 34909197
  13. Silveira, C.; Guedes, R.; Maia, D.; Curral, R.; Coelho, R. Neuropsychiatric symptoms of multiple sclerosis: State of the art. Psychiatry Investig., 2019, 16(12), 877-888. doi: 10.30773/pi.2019.0106 PMID: 31805761
  14. Available from:https://www.aifa.gov.it/sites/default/files/Ocrevus.pdf
  15. Thompson, A.J.; Banwell, B.L.; Barkhof, F.; Carroll, W.M.; Coetzee, T.; Comi, G.; Correale, J.; Fazekas, F.; Filippi, M.; Freedman, M.S.; Fujihara, K.; Galetta, S.L.; Hartung, H.P.; Kappos, L.; Lublin, F.D.; Marrie, R.A.; Miller, A.E.; Miller, D.H.; Montalban, X.; Mowry, E.M.; Sorensen, P.S.; Tintoré, M.; Traboulsee, A.L.; Trojano, M.; Uitdehaag, B.M.J.; Vukusic, S.; Waubant, E.; Weinshenker, B.G.; Reingold, S.C.; Cohen, J.A. Diagnosis of multiple sclerosis: 2017 revisions of the McDonald criteria. Lancet Neurol., 2018, 17(2), 162-173. doi: 10.1016/S1474-4422(17)30470-2 PMID: 29275977
  16. Available from:https://www.neurostatus.net/
  17. Available from:https://www.salute.gov.it/portale/nuovocorona-virus/dettaglioFaqNuovoCoronavirus.jsp?lingua=english&id=230
  18. Sahi, N.K.; Abidi, S.M.A.; Salim, O.; Abraham, R.; Kalra, S.; Al-Araji, A. Clinical impact of Ocrelizumab extended interval dosing during the COVID-19 pandemic and associations with CD19+ B-cell repopulation. Mult. Scler. Relat. Disord., 2021, 56, 103287. doi: 10.1016/j.msard.2021.103287 PMID: 34627005
  19. van Lierop, Z.Y.G.J.; Toorop, A.A.; van Ballegoij, W.J.C.; Olde Dubbelink, T.B.G.; Strijbis, E.M.M.; de Jong, B.A.; van Oosten, B.W.; Moraal, B.; Teunissen, C.E.; Uitdehaag, B.M.J.; Killestein, J.; Kempen, Z.L.E. Personalized B-cell tailored dosing of ocrelizumab in patients with multiple sclerosis during the COVID-19 pandemic. Mult. Scler., 2022, 28(7), 1121-1125. doi: 10.1177/13524585211028833 PMID: 34240631
  20. Zanghì, A.; Avolio, C.; Signoriello, E.; Abbadessa, G.; Cellerino, M.; Ferraro, D.; Messina, C.; Barone, S.; Callari, G.; Tsantes, E.; Sola, P.; Valentino, P.; Granella, F.; Patti, F.; Lus, G.; Bonavita, S.; Inglese, M.; D’Amico, E. Is it time for ocrelizumab extended interval dosing in relapsing remitting MS? evidence from an italian multicenter experience during the COVID-19 pandemic. Neurotherapeutics, 2022, 19(5), 1535-1545. doi: 10.1007/s13311-022-01289-6 PMID: 36036858
  21. Montalban, X.; Hauser, S.L.; Kappos, L.; Arnold, D.L.; Bar-Or, A.; Comi, G.; de Seze, J.; Giovannoni, G.; Hartung, H.P.; Hemmer, B.; Lublin, F.; Rammohan, K.W.; Selmaj, K.; Traboulsee, A.; Sauter, A.; Masterman, D.; Fontoura, P.; Belachew, S.; Garren, H.; Mairon, N.; Chin, P.; Wolinsky, J.S. Ocrelizumab versus placebo in primary progressive multiple sclerosis. N. Engl. J. Med., 2017, 376(3), 209-220. doi: 10.1056/NEJMoa1606468 PMID: 28002688
  22. D’Amico, E.; Patti, F.; Zanghì, A.; Zappia, M. A personalized approach in progressive multiple sclerosis: the current status of disease modifying therapies (DMTs) and future perspectives. Int. J. Mol. Sci., 2016, 17(10), 1725. doi: 10.3390/ijms17101725 PMID: 27763513
  23. Zanghì, A.; D’Amico, E.; Luca, M.; Ciaorella, M.; Basile, L.; Patti, F. Mental health status of relapsing-remitting multiple sclerosis Italian patients returning to work soon after the easing of lockdown during COVID-19 pandemic: A monocentric experience. Mult. Scler. Relat. Disord., 2020, 46, 102561. doi: 10.1016/j.msard.2020.102561 PMID: 33045494
  24. van Kempen, Z.L.E.; Hoogervorst, E.L.J.; Wattjes, M.P.; Kalkers, N.F.; Mostert, J.P.; Lissenberg-Witte, B.I. Personalized extended interval dosing of natalizumab in MS: A prospective multicenter trial. Neurology, 2020, 95(6), e745-e754. doi: 10.1212/WNL.0000000000009995 PMID: 32690785
  25. Ellrichmann, G.; Bolz, J.; Peschke, M.; Duscha, A.; Hellwig, K.; Lee, D.H.; Linker, R.A.; Gold, R.; Haghikia, A. Peripheral CD19+ B-cell counts and infusion intervals as a surrogate for long-term B-cell depleting therapy in multiple sclerosis and neuromyelitis optica/neuromyelitis optica spectrum disorders. J. Neurol., 2019, 266(1), 57-67. doi: 10.1007/s00415-018-9092-4 PMID: 30377816
  26. Benkert, P.; Meier, S.; Schaedelin, S.; Manouchehrinia, A.; Yaldizli, Ö.; Maceski, A.; Oechtering, J.; Achtnichts, L.; Conen, D.; Derfuss, T.; Lalive, P.H.; Mueller, C.; Müller, S.; Naegelin, Y.; Oksenberg, J.R.; Pot, C.; Salmen, A.; Willemse, E.; Kockum, I.; Blennow, K.; Zetterberg, H.; Gobbi, C.; Kappos, L.; Wiendl, H.; Berger, K.; Sormani, M.P.; Granziera, C.; Piehl, F.; Leppert, D.; Kuhle, J.; Aeschbacher, S.; Barakovic, M.; Buser, A.; Chan, A.; Disanto, G.; D’Souza, M.; Du Pasquier, R.; Findling, O.; Galbusera, R.; Hrusovsky, K.; Khalil, M.; Lorscheider, J.; Mathias, A.; Orleth, A.; Radue, E-W.; Rahmanzadeh, R.; Sinnecker, T.; Subramaniam, S.; Vehoff, J.; Wellmann, S.; Wuerfel, J.; Zecca, C. Serum neurofilament light chain for individual prognostication of disease activity in people with multiple sclerosis: A retrospective modelling and validation study. Lancet Neurol., 2022, 21(3), 246-257. doi: 10.1016/S1474-4422(22)00009-6 PMID: 35182510

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