Evidence map›Paper›PMID 27251051›Full record

Trial reportAdvances in therapy2016

Cutaneous Adverse Events in the Randomized, Double-Blind, Active-Comparator DECIDE Study of Daclizumab High-Yield Process Versus Intramuscular Interferon Beta-1a in Relapsing-Remitting Multiple Sclerosis.

James G Krueger, Leon Kircik, Firas Hougeir, Adam Friedman, Xiaojun You, Nisha Lucas, Steven J Greenberg, Marianne Sweetser, Wanda Castro-Borrero, Peter McCroskery and 1 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Advances in therapy, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01064401 (Multicenter, Double-blind, Randomized, Parallel-group, Monotherapy, Active-control Study to Determine the Efficacy and Safety of Daclizumab High Yield Process), which is not on this map. Cited by 15 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 3 pooled it
8.8field-weighted citation impact, top 2% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01064401 phase3completednot on this map

Multicenter, Double-blind, Randomized, Parallel-group, Monotherapy, Active-control Study to Determine the Efficacy and Safety of Daclizumab High Yield Process (DAC HYP) Versus Avonex® (Interferon β 1a) in Patients With Relapsing-Remitting Multiple Sclerosis

TypeinterventionalSponsorBiogenRan2010 to 2014Enrolled1,841ConditionsRelapsing-Remitting Multiple SclerosisArmsBIIB019 (Daclizumab High Yield Process), Interferon beta-1a Placebo, Interferon beta-1a, Daclizumab High Yield Process Placebo
3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 3 syntheses or guidelines pooled it, 35 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Trial
  5. Article
  6. Review
  7. Review
  8. Review
  9. Daclizumab: Development, Clinical Trials, and Practical Aspects of Use in Multiple Sclerosis.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2017
    Review
  10. Review
  11. Review
  12. Review
  13. Daclizumab.Hospital pharmacy · 2016
    Article
  14. Spotlight on daclizumab: its potential in the treatment of multiple sclerosis.Degenerative neurological and neuromuscular disease · 2016
    Review
  15. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 7 institutions in 1 country.

James G KruegerLaboratory for Investigative Dermatology, The Rockefeller University, 120 York Ave., New York, NY, 10065, USA. kruegej@mail.rockefeller.edu.
Leon KircikDepartment of Dermatology, Mount Sinai Hospital, One Gustave L. Levy Place, New York, NY, 10029, USA.
Firas HougeirDouglas Dermatology and Skin Cancer Specialists, LLC, 4645 Timber Ridge Drive, Douglasville, GA, 30135, USA.
Adam FriedmanDepartment of Dermatology, George Washington University School of Medicine and Health Sciences, 22nd & I Street NW, Washington, DC, 20037, USA.
Xiaojun YouBiogen, 225 Binney Street, Cambridge, MA, 02142, USA.
Nisha LucasBiogen, 225 Binney Street, Cambridge, MA, 02142, USA.
Steven J GreenbergAbbVie, 1 North Waukegan Road, North Chicago, IL, 60064, USA.
Marianne SweetserBiogen, 225 Binney Street, Cambridge, MA, 02142, USA.
Wanda Castro-BorreroBiogen, 225 Binney Street, Cambridge, MA, 02142, USA.
Peter McCroskeryBiogen, 225 Binney Street, Cambridge, MA, 02142, USA.
Jacob ElkinsBiogen, 225 Binney Street, Cambridge, MA, 02142, USA.
Biogen (United States) · USAbbVie (United States) · USAlnylam Pharmaceuticals (United States) · USGeorge Washington University · USGeorgia Cancer Specialists · USMount Sinai Hospital · USRockefeller University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionCutaneous adverse events (AEs) have been observed in clinical studies of daclizumab high-yield process (HYP) in relapsing-remitting multiple sclerosis (RRMS). Here, we report cutaneous AEs observed in the randomized, double-blind, active-comparator DECIDE study (ClinicalTrials.gov identifier, NCT01064401).

methodsDECIDE was a randomized, double-blind, active-controlled phase 3 study of daclizumab HYP 150 mg subcutaneous every 4 weeks versus interferon (IFN) beta-1a 30 mcg intramuscular (IM) once weekly in RRMS. Treatment-emergent AEs were classified and recorded by investigators. Investigators also assessed the severity of each AE, and whether it met the criteria for a serious AE. Cutaneous AEs were defined as AEs coded to the Medical Dictionary for Regulatory Activities System Organ Class of skin and subcutaneous tissue disorders. The incidence, severity, onset, resolution, and management of AEs were analyzed by treatment group.

resultsCutaneous AEs were reported in 37% of daclizumab HYP-treated patients and 19% of IFN beta-1a-treated patients. The most common investigator-reported cutaneous AEs with daclizumab HYP were rash (7%) and eczema (4%). Most patients with cutaneous AEs remained on treatment (daclizumab HYP, 81%; IM IFN beta-1a, 90%) and had events that were mild or moderate (94% and 98%) and subsequently resolved (78% and 82%). Most patients with cutaneous AEs did not require treatment with corticosteroids or were treated with topical corticosteroids (daclizumab HYP, 73%; IM IFN beta-1a, 81%). Serious cutaneous AEs were reported in 14 (2%) daclizumab HYP patients and one (<1%) IM IFN beta-1a patient.

conclusionThere was an increased risk of cutaneous AEs with daclizumab HYP. While physicians should be aware of the potential for serious cutaneous AEs, the typical cutaneous AEs were mild-to-moderate in severity, manageable, and resolved over time.

fundingBiogen and AbbVie Biotherapeutics Inc.

trial registrationClinicalTrials.gov identifier, NCT01064401.

Indexed as

AdultAntibodies, Monoclonal, HumanizedDaclizumabDouble-Blind MethodFemaleHumansImmunoglobulin GIncidenceInterferon beta-1aMaleMiddle AgedMultiple Sclerosis, Relapsing-RemittingSeverity of Illness IndexSkin DiseasesTreatment OutcomeAntibodies, Monoclonal, HumanizedDaclizumabdaclizumab HYPImmunoglobulin GInterferon beta-1aCutaneous eventsDaclizumab high-yield processDermatologyInterferon betaNeurologyRelapsing-remitting multiple sclerosisSafety

Identifiers

PMID27251051
PMCPMC4939160
OpenAlexW2412589957

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.