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Safety and efficacy of daclizumab in relapsing-remitting multiple sclerosis: 3-year results from the SELECTED open-label extension study

Overview of attention for article published in BMC Neurology, July 2016
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  • In the top 25% of all research outputs scored by Altmetric
  • High Attention Score compared to outputs of the same age (82nd percentile)
  • Good Attention Score compared to outputs of the same age and source (75th percentile)

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1 blog
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Citations

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43 Dimensions

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102 Mendeley
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Title
Safety and efficacy of daclizumab in relapsing-remitting multiple sclerosis: 3-year results from the SELECTED open-label extension study
Published in
BMC Neurology, July 2016
DOI 10.1186/s12883-016-0635-y
Pubmed ID
Authors

Ralf Gold, Ernst-Wilhelm Radue, Gavin Giovannoni, Krzysztof Selmaj, Eva Havrdova, Dusan Stefoski, Till Sprenger, Xavier Montalban, Stanley Cohan, Kimberly Umans, Steven J. Greenberg, Gulden Ozen, Jacob Elkins

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.

X Demographics

X Demographics

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Mendeley readers

Mendeley readers

The data shown below were compiled from readership statistics for 102 Mendeley readers of this research output. Click here to see the associated Mendeley record.

Geographical breakdown

Country Count As %
Spain 1 <1%
Unknown 101 99%

Demographic breakdown

Readers by professional status Count As %
Student > Master 14 14%
Student > Ph. D. Student 13 13%
Other 9 9%
Researcher 9 9%
Student > Bachelor 9 9%
Other 24 24%
Unknown 24 24%
Readers by discipline Count As %
Medicine and Dentistry 44 43%
Neuroscience 10 10%
Pharmacology, Toxicology and Pharmaceutical Science 4 4%
Nursing and Health Professions 3 3%
Biochemistry, Genetics and Molecular Biology 3 3%
Other 7 7%
Unknown 31 30%
Attention Score in Context

Attention Score in Context

This research output has an Altmetric Attention Score of 10. This is our high-level measure of the quality and quantity of online attention that it has received. This Attention Score, as well as the ranking and number of research outputs shown below, was calculated when the research output was last mentioned on 29 August 2016.
All research outputs
#3,279,678
of 22,881,154 outputs
Outputs from BMC Neurology
#417
of 2,440 outputs
Outputs of similar age
#63,112
of 365,298 outputs
Outputs of similar age from BMC Neurology
#14
of 56 outputs
Altmetric has tracked 22,881,154 research outputs across all sources so far. Compared to these this one has done well and is in the 85th percentile: it's in the top 25% of all research outputs ever tracked by Altmetric.
So far Altmetric has tracked 2,440 research outputs from this source. They typically receive a little more attention than average, with a mean Attention Score of 6.7. This one has done well, scoring higher than 82% of its peers.
Older research outputs will score higher simply because they've had more time to accumulate mentions. To account for age we can compare this Altmetric Attention Score to the 365,298 tracked outputs that were published within six weeks on either side of this one in any source. This one has done well, scoring higher than 82% of its contemporaries.
We're also able to compare this research output to 56 others from the same source and published within six weeks on either side of this one. This one has done well, scoring higher than 75% of its contemporaries.