Ocrelizumab in pediatric multiple sclerosis
Ocrelizumab is a recombinant humanized anti-CD20 monoclonal IgG1, approved by FDA and EMA for adult patients with multiple sclerosis (MS). The data on the efficacy and safety of Ocrelizumab for pediatric MS cases are limited. Here, we describe pediatric relapsing-remitting MS (P-RRMS) cases who were...
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Published in | European journal of paediatric neurology Vol. 43; pp. 1 - 5 |
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Main Authors | , , , , , , |
Format | Journal Article |
Language | English |
Published |
England
Elsevier Ltd
01.03.2023
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Subjects | |
Online Access | Get full text |
ISSN | 1090-3798 1532-2130 1532-2130 |
DOI | 10.1016/j.ejpn.2023.01.011 |
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Abstract | Ocrelizumab is a recombinant humanized anti-CD20 monoclonal IgG1, approved by FDA and EMA for adult patients with multiple sclerosis (MS). The data on the efficacy and safety of Ocrelizumab for pediatric MS cases are limited.
Here, we describe pediatric relapsing-remitting MS (P-RRMS) cases who were treated with Ocrelizumab as a disease-modifying drug.
P-RRMS cases who were started Ocrelizumab below 18 years-of-age and followed-up >12 months with Ocrelizumab treatment were included. The primary end-points were annualized relapse rate (ARR) and magnetic resonance imaging (MRI) activity (new/enlarging T2 lesions and new gadolinium (Gd) enhancing lesions). The secondary end-points were the percentage of patients who remain relapse-free and/or free from Gd enhancing lesions, Expanded Disability Status Scale (EDSS) score, and the safety profile of Ocrelizumab.
Of 18 P-RRMS cases receiving Ocrelizumab, 10 patients fulfilled the inclusion criteria for our study. The median duration of follow-up under Ocrelizumab was 28,3 months (min: 15 months, max: 46 months). Mean ARR decreased from 2.01 (±0.71) to 0 during the follow-up of Ocrelizumab treatment (P < 0.0001). None of the patients had MRI activity during the treatment. Mean EDSS decreased from 1.75 (±1.09) to 1.20 (±0.63) from the initiation of Ocrelizumab to the last follow-up of the patients (P = 0.024). None of the patients had serious side effects, except one patient who experienced anaphylaxis.
Ocrelizumab can be considered a safe and effective treatment option in highly active P-RRMS. |
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AbstractList | Ocrelizumab is a recombinant humanized anti-CD20 monoclonal IgG1, approved by FDA and EMA for adult patients with multiple sclerosis (MS). The data on the efficacy and safety of Ocrelizumab for pediatric MS cases are limited.
Here, we describe pediatric relapsing-remitting MS (P-RRMS) cases who were treated with Ocrelizumab as a disease-modifying drug.
P-RRMS cases who were started Ocrelizumab below 18 years-of-age and followed-up >12 months with Ocrelizumab treatment were included. The primary end-points were annualized relapse rate (ARR) and magnetic resonance imaging (MRI) activity (new/enlarging T2 lesions and new gadolinium (Gd) enhancing lesions). The secondary end-points were the percentage of patients who remain relapse-free and/or free from Gd enhancing lesions, Expanded Disability Status Scale (EDSS) score, and the safety profile of Ocrelizumab.
Of 18 P-RRMS cases receiving Ocrelizumab, 10 patients fulfilled the inclusion criteria for our study. The median duration of follow-up under Ocrelizumab was 28,3 months (min: 15 months, max: 46 months). Mean ARR decreased from 2.01 (±0.71) to 0 during the follow-up of Ocrelizumab treatment (P < 0.0001). None of the patients had MRI activity during the treatment. Mean EDSS decreased from 1.75 (±1.09) to 1.20 (±0.63) from the initiation of Ocrelizumab to the last follow-up of the patients (P = 0.024). None of the patients had serious side effects, except one patient who experienced anaphylaxis.
Ocrelizumab can be considered a safe and effective treatment option in highly active P-RRMS. Ocrelizumab is a recombinant humanized anti-CD20 monoclonal IgG1, approved by FDA and EMA for adult patients with multiple sclerosis (MS). The data on the efficacy and safety of Ocrelizumab for pediatric MS cases are limited.BACKGROUNDOcrelizumab is a recombinant humanized anti-CD20 monoclonal IgG1, approved by FDA and EMA for adult patients with multiple sclerosis (MS). The data on the efficacy and safety of Ocrelizumab for pediatric MS cases are limited.Here, we describe pediatric relapsing-remitting MS (P-RRMS) cases who were treated with Ocrelizumab as a disease-modifying drug.OBJECTIVEHere, we describe pediatric relapsing-remitting MS (P-RRMS) cases who were treated with Ocrelizumab as a disease-modifying drug.P-RRMS cases who were started Ocrelizumab below 18 years-of-age and followed-up >12 months with Ocrelizumab treatment were included. The primary end-points were annualized relapse rate (ARR) and magnetic resonance imaging (MRI) activity (new/enlarging T2 lesions and new gadolinium (Gd) enhancing lesions). The secondary end-points were the percentage of patients who remain relapse-free and/or free from Gd enhancing lesions, Expanded Disability Status Scale (EDSS) score, and the safety profile of Ocrelizumab.METHODP-RRMS cases who were started Ocrelizumab below 18 years-of-age and followed-up >12 months with Ocrelizumab treatment were included. The primary end-points were annualized relapse rate (ARR) and magnetic resonance imaging (MRI) activity (new/enlarging T2 lesions and new gadolinium (Gd) enhancing lesions). The secondary end-points were the percentage of patients who remain relapse-free and/or free from Gd enhancing lesions, Expanded Disability Status Scale (EDSS) score, and the safety profile of Ocrelizumab.Of 18 P-RRMS cases receiving Ocrelizumab, 10 patients fulfilled the inclusion criteria for our study. The median duration of follow-up under Ocrelizumab was 28,3 months (min: 15 months, max: 46 months). Mean ARR decreased from 2.01 (±0.71) to 0 during the follow-up of Ocrelizumab treatment (P < 0.0001). None of the patients had MRI activity during the treatment. Mean EDSS decreased from 1.75 (±1.09) to 1.20 (±0.63) from the initiation of Ocrelizumab to the last follow-up of the patients (P = 0.024). None of the patients had serious side effects, except one patient who experienced anaphylaxis.RESULTSOf 18 P-RRMS cases receiving Ocrelizumab, 10 patients fulfilled the inclusion criteria for our study. The median duration of follow-up under Ocrelizumab was 28,3 months (min: 15 months, max: 46 months). Mean ARR decreased from 2.01 (±0.71) to 0 during the follow-up of Ocrelizumab treatment (P < 0.0001). None of the patients had MRI activity during the treatment. Mean EDSS decreased from 1.75 (±1.09) to 1.20 (±0.63) from the initiation of Ocrelizumab to the last follow-up of the patients (P = 0.024). None of the patients had serious side effects, except one patient who experienced anaphylaxis.Ocrelizumab can be considered a safe and effective treatment option in highly active P-RRMS.CONCLUSIONOcrelizumab can be considered a safe and effective treatment option in highly active P-RRMS. |
Author | Bibinoğlu Amirov, Ceren Saltık, Sema Uygunoğlu, Uğur Yalçınkaya, Cengiz Siva, Aksel Saip, Sabahattin Tütüncü, Melih |
Author_xml | – sequence: 1 givenname: Ceren surname: Bibinoğlu Amirov fullname: Bibinoğlu Amirov, Ceren organization: Istanbul University-Cerrahpasa, Cerrahpasa Medical School, Department of Pediatrics, Division of Child Neurology, Istanbul, Turkey – sequence: 2 givenname: Sema surname: Saltık fullname: Saltık, Sema organization: Istanbul University-Cerrahpasa, Cerrahpasa Medical School, Department of Pediatrics, Division of Child Neurology, Istanbul, Turkey – sequence: 3 givenname: Cengiz orcidid: 0000-0002-3443-8524 surname: Yalçınkaya fullname: Yalçınkaya, Cengiz organization: Istanbul University-Cerrahpasa, Cerrahpasa Medical School, Department of Neurology, Istanbul, Turkey – sequence: 4 givenname: Melih surname: Tütüncü fullname: Tütüncü, Melih organization: Istanbul University-Cerrahpasa, Cerrahpasa Medical School, Department of Neurology, Istanbul, Turkey – sequence: 5 givenname: Sabahattin surname: Saip fullname: Saip, Sabahattin organization: Istanbul University-Cerrahpasa, Cerrahpasa Medical School, Department of Neurology, Istanbul, Turkey – sequence: 6 givenname: Aksel orcidid: 0000-0002-8340-6641 surname: Siva fullname: Siva, Aksel organization: Istanbul University-Cerrahpasa, Cerrahpasa Medical School, Department of Neurology, Istanbul, Turkey – sequence: 7 givenname: Uğur surname: Uygunoğlu fullname: Uygunoğlu, Uğur email: uguruygunoglu@gmail.com organization: Istanbul University-Cerrahpasa, Cerrahpasa Medical School, Department of Neurology, Istanbul, Turkey |
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CitedBy_id | crossref_primary_10_1016_j_msard_2024_105647 crossref_primary_10_1016_j_pediatrneurol_2024_12_015 crossref_primary_10_1007_s40278_023_45663_2 crossref_primary_10_46563_2686_8997_2023_4_1_43_51 crossref_primary_10_1080_17512433_2025_2481868 crossref_primary_10_1111_ene_16228 crossref_primary_10_1186_s41120_024_00098_9 crossref_primary_10_1016_j_ejpn_2023_03_003 crossref_primary_10_53126_MEB42220 crossref_primary_10_1007_s11910_023_01300_3 crossref_primary_10_1016_j_msard_2024_105849 crossref_primary_10_3390_sclerosis2020007 crossref_primary_10_1177_13524585241295554 crossref_primary_10_3390_children12030259 crossref_primary_10_1007_s40272_024_00675_1 crossref_primary_10_1016_j_spen_2023_101054 crossref_primary_10_1007_s40120_024_00633_6 |
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Scler. J doi: 10.1177/1352458517732843 – reference: 36990951 - Eur J Paediatr Neurol. 2023 Mar;43:A1 |
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SubjectTerms | Adult Antibodies, Monoclonal, Humanized - therapeutic use Child Humans Immunologic Factors - therapeutic use Multiple Sclerosis - diagnostic imaging Multiple Sclerosis - drug therapy Multiple Sclerosis, Relapsing-Remitting - chemically induced Multiple Sclerosis, Relapsing-Remitting - diagnostic imaging Multiple Sclerosis, Relapsing-Remitting - drug therapy Recurrence Treatment Outcome |
Title | Ocrelizumab in pediatric multiple sclerosis |
URI | https://www.clinicalkey.com/#!/content/1-s2.0-S1090379823000119 https://dx.doi.org/10.1016/j.ejpn.2023.01.011 https://www.ncbi.nlm.nih.gov/pubmed/36724688 https://www.proquest.com/docview/2771941436 |
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