Ocrelizumab use in multiple sclerosis: a real-world experience in a changing therapeutic scenario.
Multiple sclerosis
NEDA-3
Ocrelizumab
Real-world experience
Journal
Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology
ISSN: 1590-3478
Titre abrégé: Neurol Sci
Pays: Italy
ID NLM: 100959175
Informations de publication
Date de publication:
12 Mar 2024
12 Mar 2024
Historique:
received:
29
01
2024
accepted:
03
03
2024
medline:
13
3
2024
pubmed:
13
3
2024
entrez:
13
3
2024
Statut:
aheadofprint
Résumé
CD20-depleting therapies are a real milestone in the treatment of multiple sclerosis (MS). This study examined the ocrelizumab (OCR) use in patients with primary progressive (PP) and relapsing remitting (RR) MS, also evaluating the predictors of treatment response. Patients with MS treated with OCR between 2017 and 2022 were included, and OCR use trends examined. The patients' characteristics were assessed at baseline and after 24 months of OCR to assess the NEDA-3 status. This study included 421 patients: 33 (7.9%) with PP and 388 (92.1%) with RR MS. Among these, 67 (17.3%) were naïve, while switchers from first- and second-line disease-modifying therapies (DMTs) were 199 (51.3%) and 122 (31.4%), respectively. An increasing trend in OCR use was reported. For six patients treated with rituximab, OCR was chosen to improve tolerability; for 390 switcher patients, the choice was due to ineffectiveness; and for 25, as an exit strategy from natalizumab due to JC virus positivity. NEDA-3 status was calculated for subjects exposed to 24 months of OCR and was achieved by 163/192 (84.9%) RR patients and 9/16 (56%) PP patients, with younger age (p = 0.048) and annualized relapse rate in the year previous to OCR (p = 0.005) emerging as determinants. For the 25 patients who switched to OCR after natalizumab, no clinical or MRI activity after 12 months was reported. OCR has been confirmed to be a highly efficacious option for patients with PP and RR MS, even proving to be a valid exit strategy for natalizumab.
Identifiants
pubmed: 38472551
doi: 10.1007/s10072-024-07449-0
pii: 10.1007/s10072-024-07449-0
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Informations de copyright
© 2024. Fondazione Società Italiana di Neurologia.
Références
Sellebjerg F, Blinkenberg M, Sorensen PS (2020) Anti-CD20 monoclonal antibodies for relapsing and progressive multiple sclerosis. CNS Drugs 34(3):269–280. https://doi.org/10.1007/s40263-020-00704-w
doi: 10.1007/s40263-020-00704-w
pubmed: 31994023
Montalban X, Hauser SL, Kappos L et al (2017) Ocrelizumab versus placebo in primary progressive multiple sclerosis. N Engl J Med 376(3):209–220. https://doi.org/10.1056/NEJMoa1606468
doi: 10.1056/NEJMoa1606468
pubmed: 28002688
Frampton JE (2017) Ocrelizumab: first global approval. Drugs 77:1035–1041
doi: 10.1007/s40265-017-0757-6
pubmed: 28523586
De Sèze J, Maillart E, Gueguen A et al (2023) Anti-CD20 therapies in multiple sclerosis: from pathology to the clinic. Front Immunol 23(14):1004795. https://doi.org/10.3389/fimmu.2023.1004795
doi: 10.3389/fimmu.2023.1004795
Klein C, Lammens A, Schäfer W et al (2013) Epitope interactions of monoclonal antibodies targeting CD20 and their relationship to functional properties. MAbs 5(1):22–33. https://doi.org/10.4161/mabs.22771
doi: 10.4161/mabs.22771
pubmed: 23211638
pmcid: 3564883
Hauser SL, Bar-Or A, Comi G et al (2017) Ocrelizumab versus interferon Beta-1a in relapsing multiple sclerosis. N Engl J Med 376(3):221–234. https://doi.org/10.1056/NEJMoa1601277
doi: 10.1056/NEJMoa1601277
pubmed: 28002679
Zecca C, Bovis F, Novi G et al (2020) Treatment of multiple sclerosis with rituximab: a multicentric Italian-Swiss experience. Mult Scler 26(12):1519–1531. https://doi.org/10.1177/1352458519872889
doi: 10.1177/1352458519872889
pubmed: 31573386
Montalban X (2011) Review of methodological issues of clinical trials in multiple sclerosis. J Neurol Sci 311(Suppl 1):S35-42. https://doi.org/10.1016/S0022-510X(11)70007-7
doi: 10.1016/S0022-510X(11)70007-7
pubmed: 22206765
Fernandez-Diaz E, Perez-Vicente JA et al (2021) Real-world experience of ocrelizumab in multiple sclerosis in a Spanish population. Ann Clin Transl Neurol 8(2):385–394. https://doi.org/10.1002/acn3.51282
doi: 10.1002/acn3.51282
pubmed: 33369288
Sempere AP, Berenguer-Ruiz L, Borrego-Soriano I et al (2021) Ocrelizumab in multiple sclerosis: a real-world study from Spain. Front Neurol 15(11):592304. https://doi.org/10.3389/fneur.2020.592304
doi: 10.3389/fneur.2020.592304
Garcia-Cañibano B, Ouanes S, Ganesan GS et al (2021) Real-world experience of ocrelizumab in multiple sclerosis in an Arab population. J Drug Assess 10(1):106–113. https://doi.org/10.1080/21556660.2021.1989193
doi: 10.1080/21556660.2021.1989193
pubmed: 34692185
pmcid: 8530478
Montalban X, Matthews PM, Simpson A et al (2023) Real-world evaluation of ocrelizumab in multiple sclerosis: a systematic review. Ann Clin Transl Neurol 10(3):302–311. https://doi.org/10.1002/acn3.51732
doi: 10.1002/acn3.51732
pubmed: 36728340
pmcid: 10014013
Thompson AJ, Banwell BL, Barkhof F et al (2018) Diagnosis of multiple sclerosis: 2017 revisions of the McDonald criteria. Lancet Neurol 17(2):162–173
doi: 10.1016/S1474-4422(17)30470-2
pubmed: 29275977
Kurtzke JF (1983) Rating neurologic impairment in multiple sclerosis: an expanded disability status scale (EDSS). Neurology 33(11):1444–1452
doi: 10.1212/WNL.33.11.1444
pubmed: 6685237
Lublin FD, Reingold SC, Cohen JA et al (2014) Defining the clinical course of multiple sclerosis: the 2013 revisions. Neurology 83(3):278–86. https://doi.org/10.1212/WNL.0000000000000560
doi: 10.1212/WNL.0000000000000560
pubmed: 24871874
pmcid: 4117366
Giovannoni G, Tomic D, Bright JR et al (2017) “No evident disease activity”: the use of combined assessments in the management of patients with multiple sclerosis. Mult Scler 23(9):1179–1187
doi: 10.1177/1352458517703193
pubmed: 28381105
pmcid: 5536258
Thompson AJ, Hobart JC (1998) Multiple sclerosis: assessment of disability and disability scales. J Neurol 245:189–196
doi: 10.1007/s004150050204
pubmed: 9591219
Amin M, Hersh CM (2023) Updates and advances in multiple sclerosis neurotherapeutics. Neurodegener Dis Manag 13(1):47–70. https://doi.org/10.2217/nmt-2021-0058
doi: 10.2217/nmt-2021-0058
pubmed: 36314777
Filippi M, Amato MP, Centonze D et al (2022) Early use of high-efficacy disease-modifying therapies makes the difference in people with multiple sclerosis: an expert opinion. J Neurol 269(10):5382–5394. https://doi.org/10.1007/s00415-022-11193-w
doi: 10.1007/s00415-022-11193-w
pubmed: 35608658
pmcid: 9489547
Bsteh G, Riedl K, Krajnc N et al (2022) Has the pandemic changed treatment strategy in multiple sclerosis? Mult Scler Relat Disord 63:103912
doi: 10.1016/j.msard.2022.103912
pubmed: 35636274
pmcid: 9125982
Chisari CG, Bianco A, Brescia Morra V et al (2023) Effectiveness of ocrelizumab in primary progressive multiple sclerosis: a multicenter, retrospective, real-world study (OPPORTUNITY). Neurotherapeutics. 20(6):1696–1706. https://doi.org/10.1007/s13311-023-01415-y
doi: 10.1007/s13311-023-01415-y
pubmed: 37610702
pmcid: 10684838
Zhu C, Kalincik T, Horakova D, MSBase Study Group et al (2023) Comparison between dimethyl fumarate, fingolimod, and ocrelizumab after natalizumab cessation. JAMA Neurol 80(7):739–748. https://doi.org/10.1001/jamaneurol.2023.1542
doi: 10.1001/jamaneurol.2023.1542
pubmed: 37273217
Zhu C, Zhou Z, Roos I, MSBase Study Group (2022) Comparing switch to ocrelizumab, cladribine or natalizumab after fingolimod treatment cessation in multiple sclerosis. J Neurol Neurosurg Psychiatry 93(12):1330–1337. https://doi.org/10.1136/jnnp-2022-330104
doi: 10.1136/jnnp-2022-330104
pubmed: 36261289
Zhong M, van der Walt A, Stankovich J et al (2022) Prediction of multiple sclerosis outcomes when switching to ocrelizumab. Mult Scler 28(6):958–969. https://doi.org/10.1177/13524585211049986
doi: 10.1177/13524585211049986
pubmed: 34623947
Sellner J, Rommer PS (2019) A review of the evidence for a natalizumab exitì strategy for patients with multiple sclerosis. Autoimmun Rev 18(3):255–261. https://doi.org/10.1016/j.autrev.2018.09.012
doi: 10.1016/j.autrev.2018.09.012
pubmed: 30639651
Alping P, Frisell T, Novakova L et al (2016) Rituximab versus fingolimod after natalizumab in multiple sclerosis patients. Ann Neurol 79(6):950–958. https://doi.org/10.1002/ana.24651
doi: 10.1002/ana.24651
pubmed: 27038238
Bigaut K, Kremer L, Fabacher T et al (2022) Ocrelizumab versus fingolimod after natalizumab cessation in multiple sclerosis: an observational study. J Neurol 269(6):3295–3300. https://doi.org/10.1007/s00415-021-10950-7
doi: 10.1007/s00415-021-10950-7
pubmed: 34982200
pmcid: 8725429
Cellerino M, Boffa G, Lapucci C et al (2021) Predictors of ocrelizumab effectiveness in patients with multiple sclerosis. Neurotherapeutics 18(4):2579–2588. https://doi.org/10.1007/s13311-021-01104-8
doi: 10.1007/s13311-021-01104-8
pubmed: 34553320
pmcid: 8457546
Weideman AM, Tapia-Maltos MA, Johnson K et al (2017) Meta- analysis of the age-dependent efficacy of multiple sclerosis treatments. Front Neurol 10(8):577. https://doi.org/10.3389/fneur.2017.00577
doi: 10.3389/fneur.2017.00577
Cocco E, Sardu C, Spinicci G et al (2015) Influence of treatments in multiple sclerosis disability: a cohort study. Mult Scler 21(4):433–441. https://doi.org/10.1177/1352458514546788
doi: 10.1177/1352458514546788
pubmed: 25257611
Mahad DH, Trapp BD, Lassmann H (2015) Pathological mechanisms in progressive multiple sclerosis. Lancet Neurol 14:183–193
doi: 10.1016/S1474-4422(14)70256-X
pubmed: 25772897
Sanai SA, Saini V, Benedict RH et al (2016) Aging and multiple sclerosis. Mult Scler 22(6):717–725
doi: 10.1177/1352458516634871
pubmed: 26895718
Giovannoni G, Popescu V, Wuerfel J, Hellwig K et al (2022) Smouldering multiple sclerosis: the “real MS.” Ther Adv Neurol Disord 25(15):17562864211066752. https://doi.org/10.1177/17562864211066751
doi: 10.1177/17562864211066751
Graves JS, Krysko KM, Hua LH et al (2023) Ageing and multiple sclerosis. Lancet Neurol 22(1):66–77
doi: 10.1016/S1474-4422(22)00184-3
pubmed: 36216015
Lynch S, Baker S, Nashatizadeh M et al (2021) Disability measurement in multiple sclerosis patients 55 years and older: what is the expanded disability status scale really telling clinicians? Mult Scler Relat Disord 49:102724
doi: 10.1016/j.msard.2020.102724
pubmed: 33609959
Lorefice L, Frau J, Coghe G et al (2019) Assessing the burden of vascular risk factors on brain atrophy in multiple sclerosis: a case- control MRI study. Mult Scler Relat Disord 27:74–78
doi: 10.1016/j.msard.2018.10.011
pubmed: 30343253
Lorefice L, Mellino P, Fenu G et al (2023) How to measure the treatment response in progressive multiple sclerosis: current perspectives and limitations in clinical settings’. Mult Scler Relat Disord 76:104826. https://doi.org/10.1016/j.msard.2023.104826
doi: 10.1016/j.msard.2023.104826
pubmed: 37327601
Smets I, Giovannoni G (2022) Derisking CD20-therapies for long-term use. Mult Scler Relat Disord 57:103418. https://doi.org/10.1016/j.msard.2021.103418
doi: 10.1016/j.msard.2021.103418
pubmed: 34902761
Bisecco A, Matrone F, Capobianco M, on behalf of the Italian MS Register et al (2024) COVID-19 outbreak in Italy: an opportunity to evaluate extended interval dosing of ocrelizumab in MS patients. J Neurol 271(2):699–710. https://doi.org/10.1007/s00415-023-12084-4
doi: 10.1007/s00415-023-12084-4
pubmed: 37982852
Zanghì A, Ferraro D, Callari G et al (2024) Ocrelizumab extended interval dosing in primary progressive multiple sclerosis: an Italian experience. Curr Neuropharmacol 22(2):339–345. https://doi.org/10.2174/1570159X22666231002142709
doi: 10.2174/1570159X22666231002142709
pubmed: 37876043
Zanghì A, Avolio C, Signoriello E et al (2022) Is it time for ocrelizumab extended interval dosing in relapsing remitting MS? Evidence from an Italian multicenter experience during the COVID-19 Pandemic. Neurotherapeutics 19(5):1535–1545. https://doi.org/10.1007/s13311-022-01289-6
doi: 10.1007/s13311-022-01289-6
pubmed: 36036858
pmcid: 9422942