dc.contributor.author | Giovannoni, G | en_US |
dc.contributor.author | Wiendl, H | en_US |
dc.contributor.author | Turner, B | en_US |
dc.contributor.author | Umans, K | en_US |
dc.contributor.author | Mokliatchouk, O | en_US |
dc.contributor.author | Castro-Borrero, W | en_US |
dc.contributor.author | Greenberg, SJ | en_US |
dc.contributor.author | McCroskery, P | en_US |
dc.contributor.author | Giannattasio, G | en_US |
dc.date.accessioned | 2018-04-09T08:12:48Z | |
dc.date.issued | 2018-11 | en_US |
dc.date.submitted | 2017-10-12T14:18:01.215Z | |
dc.identifier.uri | http://qmro.qmul.ac.uk/xmlui/handle/123456789/36263 | |
dc.description.abstract | BACKGROUND:: Reversible lymphocyte count reductions have occurred following daclizumab beta treatment for relapsing-remitting multiple sclerosis. OBJECTIVE:: To analyse total and differential lymphocyte levels and relationship with infection status. METHODS:: In DECIDE, blood samples were collected at 12-week intervals from daclizumab beta- ( n = 919) or intramuscular interferon beta-1a-treated ( n = 922) patients. Infections/serious infections were assessed proximate to grade 2/3 lymphopenia or low CD4+/CD8+ T-cell counts. Total safety population (TSP) data were additionally analysed from the entire clinical development programme ( n = 2236). RESULTS:: Over 96 weeks in DECIDE, mean absolute lymphocyte count (ALC), CD4+ and CD8+ T-cell counts decreased <10% (7.1% vs 1.6%, 9.7% vs 2.0%, 9.3% vs 5.9%: daclizumab beta vs interferon beta-1a, respectively); shifts to ALC below lower limit of normal occurred in 13% versus 15%, respectively. Grade 3 lymphopenia was uncommon (TSP: <1%) and transient. Lymphocyte changes generally occurred within 24 weeks after treatment initiation and were reversible within 12 weeks of discontinuation. In DECIDE, mean CD4+/CD8+ T-cell counts were similar regardless of infection status. TSP data were consistent with DECIDE. CONCLUSION:: When observed, ALC and CD4+/CD8+ T-cell count decreases in daclizumab beta-treated patients were generally mild-to-modest, reversible upon treatment discontinuation and not associated with increased risk of infections, including opportunistic infections. | en_US |
dc.description.sponsorship | This study was funded by Biogen and AbbVie, Inc. Biogen and AbbVie, Inc. provided funding for medical writing support in the development of this paper. | en_US |
dc.format.extent | 1725 - 1736 | en_US |
dc.language | eng | en_US |
dc.relation.ispartof | Mult Scler | en_US |
dc.subject | Relapsing–remitting | en_US |
dc.subject | disease-modifying therapies | en_US |
dc.subject | immunology | en_US |
dc.subject | multiple sclerosis | en_US |
dc.title | Circulating lymphocyte levels and relationship with infection status in patients with relapsing-remitting multiple sclerosis treated with daclizumab beta. | en_US |
dc.type | Article | |
dc.rights.holder | © The Author(s), 2017. | |
dc.identifier.doi | 10.1177/1352458517729464 | en_US |
pubs.author-url | https://www.ncbi.nlm.nih.gov/pubmed/28914581 | en_US |
pubs.issue | 13 | en_US |
pubs.notes | No embargo | en_US |
pubs.publication-status | Published | en_US |
pubs.volume | 24 | en_US |