The ocrelizumab phase II extension trial suggests the potential to improve the risk: Benefit balance in multiple sclerosis
•Ocrelizumab phase II trial extension data has 18-month post-drug follow-up.•Annualized relapse rate seems to remain low during the drug-free follow-up.•Infections and adverse events seem to be reduced during drug-free follow-up.•Extended interval dosing may be possible that maintains efficacy and a...
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| Veröffentlicht in: | Multiple sclerosis and related disorders Jg. 44; S. 102279 |
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Elsevier B.V
01.09.2020
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| ISSN: | 2211-0348, 2211-0356, 2211-0356 |
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| Abstract | •Ocrelizumab phase II trial extension data has 18-month post-drug follow-up.•Annualized relapse rate seems to remain low during the drug-free follow-up.•Infections and adverse events seem to be reduced during drug-free follow-up.•Extended interval dosing may be possible that maintains efficacy and allows for more successful vaccination to new infections.•Extended interval dosing may afford a drug-free pregnancy.
Ocrelizumab inhibits relapsing multiple sclerosis when administered every six months. Based on potential similar memory B cell depletion mechanisms with cladribine and alemtuzumab, we hypothesised that CD20-depletion of B cells by ocrelizumab may exhibit a duration of response exceeding the current licenced treatment interval.
Internet-located information from regulatory submissions and meeting reports relating to the unpublished open-label, phase II ocrelizumab extension trial (NCT00676715) were reviewed. This followed people (54–55/arm) with MS, who switched from placebo or interferon-beta to ocrelizumab for three 600 mg treatment cycles (week 24, 48, 72) or people treated with ocrelizumab for four 600 mg treatment cycles (week 0–72), followed by an 18 month treatment-free period.
CD19+ B cells were rapidly depleted within 2 weeks and slow CD19+ B cell repopulation began about 6 months after the last infusion with median-repletion of over 15 months. The reduced annualized relapse rate during the published efficacy study appeared to be maintained in the extension study and there were no new T1 gadolinium-enhancing or T2 lesions detected in the treatment-free period. Importantly, within these extension cohorts, there appeared to be fewer adverse events and infections events.
Ocrelizumab appears to induce durable relapsing disease inhibition, within 3 treatment cycles Therefore, it may be possible to reduce the frequency of dosing to maintain efficacy, whilst limiting infection and other risks associated with continuous immunosuppression and could allow more effective vaccination against new pathogens. Further studies are now clearly required to determine whether this data is robust. |
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| AbstractList | Highlights•Ocrelizumab phase II trial extension data has 18-month post-drug follow-up. •Annualized relapse rate seems to remain low during the drug-free follow-up. •Infections and adverse events seem to be reduced during drug-free follow-up. •Extended interval dosing may be possible that maintains efficacy and allows for more successful vaccination to new infections. •Extended interval dosing may afford a drug-free pregnancy. •Ocrelizumab phase II trial extension data has 18-month post-drug follow-up.•Annualized relapse rate seems to remain low during the drug-free follow-up.•Infections and adverse events seem to be reduced during drug-free follow-up.•Extended interval dosing may be possible that maintains efficacy and allows for more successful vaccination to new infections.•Extended interval dosing may afford a drug-free pregnancy. Ocrelizumab inhibits relapsing multiple sclerosis when administered every six months. Based on potential similar memory B cell depletion mechanisms with cladribine and alemtuzumab, we hypothesised that CD20-depletion of B cells by ocrelizumab may exhibit a duration of response exceeding the current licenced treatment interval. Internet-located information from regulatory submissions and meeting reports relating to the unpublished open-label, phase II ocrelizumab extension trial (NCT00676715) were reviewed. This followed people (54–55/arm) with MS, who switched from placebo or interferon-beta to ocrelizumab for three 600 mg treatment cycles (week 24, 48, 72) or people treated with ocrelizumab for four 600 mg treatment cycles (week 0–72), followed by an 18 month treatment-free period. CD19+ B cells were rapidly depleted within 2 weeks and slow CD19+ B cell repopulation began about 6 months after the last infusion with median-repletion of over 15 months. The reduced annualized relapse rate during the published efficacy study appeared to be maintained in the extension study and there were no new T1 gadolinium-enhancing or T2 lesions detected in the treatment-free period. Importantly, within these extension cohorts, there appeared to be fewer adverse events and infections events. Ocrelizumab appears to induce durable relapsing disease inhibition, within 3 treatment cycles Therefore, it may be possible to reduce the frequency of dosing to maintain efficacy, whilst limiting infection and other risks associated with continuous immunosuppression and could allow more effective vaccination against new pathogens. Further studies are now clearly required to determine whether this data is robust. Ocrelizumab inhibits relapsing multiple sclerosis when administered every six months. Based on potential similar memory B cell depletion mechanisms with cladribine and alemtuzumab, we hypothesised that CD20-depletion of B cells by ocrelizumab may exhibit a duration of response exceeding the current licenced treatment interval. Internet-located information from regulatory submissions and meeting reports relating to the unpublished open-label, phase II ocrelizumab extension trial (NCT00676715) were reviewed. This followed people (54-55/arm) with MS, who switched from placebo or interferon-beta to ocrelizumab for three 600 mg treatment cycles (week 24, 48, 72) or people treated with ocrelizumab for four 600 mg treatment cycles (week 0-72), followed by an 18 month treatment-free period. CD19+ B cells were rapidly depleted within 2 weeks and slow CD19+ B cell repopulation began about 6 months after the last infusion with median-repletion of over 15 months. The reduced annualized relapse rate during the published efficacy study appeared to be maintained in the extension study and there were no new T1 gadolinium-enhancing or T2 lesions detected in the treatment-free period. Importantly, within these extension cohorts, there appeared to be fewer adverse events and infections events. Ocrelizumab appears to induce durable relapsing disease inhibition, within 3 treatment cycles Therefore, it may be possible to reduce the frequency of dosing to maintain efficacy, whilst limiting infection and other risks associated with continuous immunosuppression and could allow more effective vaccination against new pathogens. Further studies are now clearly required to determine whether this data is robust. Ocrelizumab inhibits relapsing multiple sclerosis when administered every six months. Based on potential similar memory B cell depletion mechanisms with cladribine and alemtuzumab, we hypothesised that CD20-depletion of B cells by ocrelizumab may exhibit a duration of response exceeding the current licenced treatment interval.OBJECTIVEOcrelizumab inhibits relapsing multiple sclerosis when administered every six months. Based on potential similar memory B cell depletion mechanisms with cladribine and alemtuzumab, we hypothesised that CD20-depletion of B cells by ocrelizumab may exhibit a duration of response exceeding the current licenced treatment interval.Internet-located information from regulatory submissions and meeting reports relating to the unpublished open-label, phase II ocrelizumab extension trial (NCT00676715) were reviewed. This followed people (54-55/arm) with MS, who switched from placebo or interferon-beta to ocrelizumab for three 600 mg treatment cycles (week 24, 48, 72) or people treated with ocrelizumab for four 600 mg treatment cycles (week 0-72), followed by an 18 month treatment-free period.METHODSInternet-located information from regulatory submissions and meeting reports relating to the unpublished open-label, phase II ocrelizumab extension trial (NCT00676715) were reviewed. This followed people (54-55/arm) with MS, who switched from placebo or interferon-beta to ocrelizumab for three 600 mg treatment cycles (week 24, 48, 72) or people treated with ocrelizumab for four 600 mg treatment cycles (week 0-72), followed by an 18 month treatment-free period.CD19+ B cells were rapidly depleted within 2 weeks and slow CD19+ B cell repopulation began about 6 months after the last infusion with median-repletion of over 15 months. The reduced annualized relapse rate during the published efficacy study appeared to be maintained in the extension study and there were no new T1 gadolinium-enhancing or T2 lesions detected in the treatment-free period. Importantly, within these extension cohorts, there appeared to be fewer adverse events and infections events.RESULTSCD19+ B cells were rapidly depleted within 2 weeks and slow CD19+ B cell repopulation began about 6 months after the last infusion with median-repletion of over 15 months. The reduced annualized relapse rate during the published efficacy study appeared to be maintained in the extension study and there were no new T1 gadolinium-enhancing or T2 lesions detected in the treatment-free period. Importantly, within these extension cohorts, there appeared to be fewer adverse events and infections events.Ocrelizumab appears to induce durable relapsing disease inhibition, within 3 treatment cycles Therefore, it may be possible to reduce the frequency of dosing to maintain efficacy, whilst limiting infection and other risks associated with continuous immunosuppression and could allow more effective vaccination against new pathogens. Further studies are now clearly required to determine whether this data is robust.CONCLUSIONSOcrelizumab appears to induce durable relapsing disease inhibition, within 3 treatment cycles Therefore, it may be possible to reduce the frequency of dosing to maintain efficacy, whilst limiting infection and other risks associated with continuous immunosuppression and could allow more effective vaccination against new pathogens. Further studies are now clearly required to determine whether this data is robust. |
| ArticleNumber | 102279 |
| Author | Baker, David Pryce, Gareth James, Louisa K. Schmierer, Klaus Marta, Monica |
| Author_xml | – sequence: 1 givenname: David orcidid: 0000-0002-8872-8711 surname: Baker fullname: Baker, David email: david.baker@qmul.ac.uk organization: Blizard Institute, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London E1 2AT, United Kingdom – sequence: 2 givenname: Gareth surname: Pryce fullname: Pryce, Gareth organization: Blizard Institute, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London E1 2AT, United Kingdom – sequence: 3 givenname: Louisa K. surname: James fullname: James, Louisa K. organization: Blizard Institute, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London E1 2AT, United Kingdom – sequence: 4 givenname: Monica orcidid: 0000-0002-5464-9070 surname: Marta fullname: Marta, Monica organization: Blizard Institute, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London E1 2AT, United Kingdom – sequence: 5 givenname: Klaus orcidid: 0000-0002-9293-8893 surname: Schmierer fullname: Schmierer, Klaus organization: Blizard Institute, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London E1 2AT, United Kingdom |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/32645640$$D View this record in MEDLINE/PubMed |
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| Keywords | CD20 B cell Multiple sclerosis Ocrelizumab Immunotherapy |
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| Snippet | •Ocrelizumab phase II trial extension data has 18-month post-drug follow-up.•Annualized relapse rate seems to remain low during the drug-free... Highlights•Ocrelizumab phase II trial extension data has 18-month post-drug follow-up. •Annualized relapse rate seems to remain low during the drug-free... Ocrelizumab inhibits relapsing multiple sclerosis when administered every six months. Based on potential similar memory B cell depletion mechanisms with... |
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| SubjectTerms | Antibodies, Monoclonal, Humanized - therapeutic use B cell CD20 Clinical Trials, Phase II as Topic Humans Immunologic Factors - therapeutic use Immunotherapy Interferon-beta Multiple Sclerosis Multiple Sclerosis, Relapsing-Remitting - drug therapy Neurology Ocrelizumab |
| Title | The ocrelizumab phase II extension trial suggests the potential to improve the risk: Benefit balance in multiple sclerosis |
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