Matches in SemOpenAlex for { <https://semopenalex.org/work/W2487444883> ?p ?o ?g. }
Showing items 1 to 97 of
97
with 100 items per page.
- W2487444883 abstract "Daclizumab is a humanized monoclonal antibody against CD25 that modulates interleukin 2 signaling. The SELECT TRILOGY of clinical studies (SELECT/SELECTION/SELECTED) evaluated the safety and efficacy of daclizumab in patients with relapsing-remitting multiple sclerosis (RRMS). We report the long-term safety and efficacy of daclizumab 150 mg subcutaneous every 4 weeks in patients with RRMS in the SELECTED open-label extension study. An interim intent-to-treat analysis of all enrolled patients was performed in January 2014 for this ongoing study. The SELECTED study enrolled 90 % of patients who completed SELECTION. In the safety and efficacy analysis (N = 410), median treatment time in SELECTED was 25 months (range, <1–45). Adverse events (AEs) were reported in 76 % of patients, serious AEs (SAEs) excluding MS relapse in 16 %, and treatment discontinuation due to AEs including multiple sclerosis (MS) relapse in 12 %. AEs were primarily of mild to moderate severity, and common AEs (≥10 %), excluding MS relapse, were nasopharyngitis (12 %) and upper respiratory tract infection (12 %). Most commonly reported SAEs (in ≥3 patients), excluding MS relapses, were increased serum hepatic enzymes, pneumonia, ulcerative colitis, and urinary tract infection (<1 % each). Incidences of AE groups of interest include cutaneous events (28 %), cutaneous SAEs (2 %), gastrointestinal SAEs (2 %), hepatic SAEs, (1 %) and malignancies (1 %). The incidence of AEs, SAEs, and treatment-related study discontinuations did not increase over time and no deaths were reported. The adjusted annualized relapse rate (95 % confidence interval (CI)) analyzed at 6-month intervals was 0.15 (0.10–0.22) for weeks 97–120 and 0.15 (0.10–0.21) for weeks 121–144. In year 3, the adjusted mean (95 % CI) number of new/newly enlarging T2 hyperintense lesions was 1.26 (0.93–1.72) and the mean (median) annualized change in brain volume was −0.32 % (−0.34 %). The AE incidence did not increase with extension of therapy into year 3 in SELECTED; the safety profile was similar to that previously observed. The clinical efficacy of daclizumab was sustained over the 3 years comprising the SELECT TRILOGY, although potential selection bias cannot be excluded. Clinicaltrials.gov NCT01051349 ; first registered January 15, 2010." @default.
- W2487444883 created "2016-08-23" @default.
- W2487444883 creator A5004417493 @default.
- W2487444883 creator A5006041455 @default.
- W2487444883 creator A5008967786 @default.
- W2487444883 creator A5011944665 @default.
- W2487444883 creator A5015754502 @default.
- W2487444883 creator A5020016996 @default.
- W2487444883 creator A5031171090 @default.
- W2487444883 creator A5051313308 @default.
- W2487444883 creator A5056248102 @default.
- W2487444883 creator A5062220148 @default.
- W2487444883 creator A5067317369 @default.
- W2487444883 creator A5067994259 @default.
- W2487444883 creator A5078067575 @default.
- W2487444883 date "2016-07-26" @default.
- W2487444883 modified "2023-10-09" @default.
- W2487444883 title "Safety and efficacy of daclizumab in relapsing-remitting multiple sclerosis: 3-year results from the SELECTED open-label extension study" @default.
- W2487444883 cites W1970275143 @default.
- W2487444883 cites W2112079575 @default.
- W2487444883 cites W2128707151 @default.
- W2487444883 cites W2133613306 @default.
- W2487444883 cites W2167414238 @default.
- W2487444883 cites W2171375112 @default.
- W2487444883 cites W2330965779 @default.
- W2487444883 doi "https://doi.org/10.1186/s12883-016-0635-y" @default.
- W2487444883 hasPubMedCentralId "https://www.ncbi.nlm.nih.gov/pmc/articles/4962457" @default.
- W2487444883 hasPubMedId "https://pubmed.ncbi.nlm.nih.gov/27461166" @default.
- W2487444883 hasPublicationYear "2016" @default.
- W2487444883 type Work @default.
- W2487444883 sameAs 2487444883 @default.
- W2487444883 citedByCount "34" @default.
- W2487444883 countsByYear W24874448832016 @default.
- W2487444883 countsByYear W24874448832017 @default.
- W2487444883 countsByYear W24874448832018 @default.
- W2487444883 countsByYear W24874448832019 @default.
- W2487444883 countsByYear W24874448832020 @default.
- W2487444883 countsByYear W24874448832021 @default.
- W2487444883 crossrefType "journal-article" @default.
- W2487444883 hasAuthorship W2487444883A5004417493 @default.
- W2487444883 hasAuthorship W2487444883A5006041455 @default.
- W2487444883 hasAuthorship W2487444883A5008967786 @default.
- W2487444883 hasAuthorship W2487444883A5011944665 @default.
- W2487444883 hasAuthorship W2487444883A5015754502 @default.
- W2487444883 hasAuthorship W2487444883A5020016996 @default.
- W2487444883 hasAuthorship W2487444883A5031171090 @default.
- W2487444883 hasAuthorship W2487444883A5051313308 @default.
- W2487444883 hasAuthorship W2487444883A5056248102 @default.
- W2487444883 hasAuthorship W2487444883A5062220148 @default.
- W2487444883 hasAuthorship W2487444883A5067317369 @default.
- W2487444883 hasAuthorship W2487444883A5067994259 @default.
- W2487444883 hasAuthorship W2487444883A5078067575 @default.
- W2487444883 hasBestOaLocation W24874448831 @default.
- W2487444883 hasConcept C126322002 @default.
- W2487444883 hasConcept C197934379 @default.
- W2487444883 hasConcept C203014093 @default.
- W2487444883 hasConcept C2778715236 @default.
- W2487444883 hasConcept C2779719350 @default.
- W2487444883 hasConcept C2780640218 @default.
- W2487444883 hasConcept C2909675724 @default.
- W2487444883 hasConcept C2911091166 @default.
- W2487444883 hasConcept C71924100 @default.
- W2487444883 hasConcept C90924648 @default.
- W2487444883 hasConceptScore W2487444883C126322002 @default.
- W2487444883 hasConceptScore W2487444883C197934379 @default.
- W2487444883 hasConceptScore W2487444883C203014093 @default.
- W2487444883 hasConceptScore W2487444883C2778715236 @default.
- W2487444883 hasConceptScore W2487444883C2779719350 @default.
- W2487444883 hasConceptScore W2487444883C2780640218 @default.
- W2487444883 hasConceptScore W2487444883C2909675724 @default.
- W2487444883 hasConceptScore W2487444883C2911091166 @default.
- W2487444883 hasConceptScore W2487444883C71924100 @default.
- W2487444883 hasConceptScore W2487444883C90924648 @default.
- W2487444883 hasFunder F4320308604 @default.
- W2487444883 hasFunder F4320309117 @default.
- W2487444883 hasIssue "1" @default.
- W2487444883 hasLocation W24874448831 @default.
- W2487444883 hasLocation W24874448832 @default.
- W2487444883 hasLocation W24874448833 @default.
- W2487444883 hasLocation W24874448834 @default.
- W2487444883 hasOpenAccess W2487444883 @default.
- W2487444883 hasPrimaryLocation W24874448831 @default.
- W2487444883 hasRelatedWork W1532617462 @default.
- W2487444883 hasRelatedWork W1996481500 @default.
- W2487444883 hasRelatedWork W2053771050 @default.
- W2487444883 hasRelatedWork W2164991635 @default.
- W2487444883 hasRelatedWork W2260535563 @default.
- W2487444883 hasRelatedWork W2466043692 @default.
- W2487444883 hasRelatedWork W2596124090 @default.
- W2487444883 hasRelatedWork W2617222556 @default.
- W2487444883 hasRelatedWork W4386640344 @default.
- W2487444883 hasRelatedWork W958360590 @default.
- W2487444883 hasVolume "16" @default.
- W2487444883 isParatext "false" @default.
- W2487444883 isRetracted "false" @default.
- W2487444883 magId "2487444883" @default.
- W2487444883 workType "article" @default.