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The 11-year long-term follow-up study from the randomized BENEFIT CIS trial

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  • Source:
    Neurology 2016 87 10, 978 (978-987) Published by: Lippincott Williams and Wilkins (E-mail: [email protected]) United States00283878
  • Additional Information
    • Author(s):
      Kappos L, Edan G, Freedman MS, Montalbán X, Hartung HP, Hemmer B, Fox EJ, Barkhof F, Schippling S, Schulze A, Pleimes D, Pohl C, Sandbrink R, Suarez G, Wicklein EM, BENEFIT Study Group
    • Contact Information:
      L. Kappos, Neurology, Departments of Medicine, Clinical Research, Biomedicine and Biomedical Engineering, University Hospital Basel, Switzerland. E-mail: ludwig.kapp[email protected]
    • Language:
      English
    • Publication Type:
      Journal Article; Multicenter Study; Randomized Controlled Trial
    • Record Status:
      This record is updated this issue.
    • Abstract:
      OBJECTIVE: To assess outcomes for patients treated with interferon beta-1b immediately after clinically isolated syndrome (CIS) or after a short delay.METHODS: Participants in BENEFIT (Betaferon/Betaseron in Newly Emerging MS for Initial Treatment) were randomly assigned to receive interferon beta-1b (early treatment) or placebo (delayed treatment). After conversion to clinically definite multiple sclerosis (CDMS) or 2 years, patients on placebo could switch to interferon beta-1b or another treatment. Eleven years after randomization, patients were reassessed.RESULTS: Two hundred seventy-eight (59.4%) of the original 468 patients (71.3% of those eligible at participating sites) were enrolled (early: 167 [57.2%]; delayed: 111 [63.1%]). After 11 years, risk of CDMS remained lower in the early-treatment arm compared with the delayed-treatment arm (p = 0.0012), with longer time to first relapse (median [Q1, Q3] days: 1,888 [540, not reached] vs 931 [253, 3,296]; p = 0.0005) and lower overall annualized relapse rate (0.21 vs 0.26; p = 0.0018). Only 25 patients (5.9%, overall; early, 4.5%; delayed, 8.3%) converted to secondary progressive multiple sclerosis. Expanded Disability Status Scale scores remained low and stable, with no difference between treatment arms (median [Q1, Q3]: 2.0 [1.0, 3.0]). The early-treatment group had better Paced Auditory Serial Addition Task-3 total scores (p = 0.0070). Employment rates remained high, and health resource utilization tended to be low in both groups. MRI metrics did not differ between groups.CONCLUSIONS: Although the delay in treatment was relatively short, several clinical outcomes favored earlier treatment. Along with low rates of disability and disease progression in both groups, this supports the value of treatment at CIS.CLINICALTRIALSGOV IDENTIFIER: NCT01795872.CLASSIFICATION OF EVIDENCE: This study provides Class IV evidence that early compared to delayed treatment prolongs time to CDMS in CIS after 11 years.
    • EMBASE keywords:
      adult; article; brain size; *clinically definite multiple sclerosis; comparative study; contrast enhancement; controlled study; cross-sectional study; *demyelinating disease/dt [Drug Therapy]; demyelinating disease/dt [Drug Therapy]; double blind procedure; *early intervention; employment; Expanded Disability Status Scale; female; *follow up; health care utilization; human; major clinical study; male; multicenter study; *multiple sclerosis/dt [Drug Therapy]; multiple sclerosis/dt [Drug Therapy]; neuroimaging; nuclear magnetic resonance imaging; paced auditory serial addition test; phase 3 clinical trial; priority journal; prospective study; randomized controlled trial; recurrence risk; relapse; therapy delay; time to treatment; unspecified side effect/si [Side Effect]; gadolinium; *interferon beta serine/ae [Adverse Drug Reaction]; *interferon beta serine/ct [Clinical Trial]; *interferon beta serine/cm [Drug Comparison]; *interferon beta serine/dt [Drug Therapy]; *interferon beta serine/sc [Subcutaneous Drug Administration]; placebo; classification; clinical outcome; clinical trial; controlled clinical trial; genetic susceptibility; multiple sclerosis; randomization; interferon beta serine
      Adult
      Female
      Humans
      Male
      Young Adult
      Cross-Sectional Studies
      Demyelinating Diseases/diagnostic imaging
      Disability Evaluation
      Double-Blind Method
      Follow-Up Studies
      Kaplan-Meier Estimate
      Recurrence
      Time-to-Treatment
      Treatment Outcome
      Adjuvants, Immunologic/*administration & dosage
      Demyelinating Diseases/*drug therapy
      Interferon beta-1b/*administration & dosage
    • Accession Number:
      612077437
    • Source:
      This document should be cited as: Kappos L Edan G Freedman MS Montalbán X Hartung HP Hemmer B Fox EJ Barkhof F Schippling S Schulze A Pleimes D Pohl C Sandbrink R Suarez G Wicklein EM BENEFIT Study Group. The 11-year long-term follow-up study from the randomized BENEFIT CIS trial 2016 (The Cochrane Controlled Trials Register (CCTR/CENTRAL). DOI: 10.1212/WNL.0000000000003078. Oxford: Update Software. Updated quarterly.
    • Accession Number:
      CN-01210831
  • Citations
    • ABNT:
      KAPPOS L et al. The 11-year long-term follow-up study from the randomized BENEFIT CIS trial. Neurology, [s. l.], v. 87, n. 10, p. 978–987, 2016. DOI 10.1212/WNL.0000000000003078. Disponível em: http://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=cgh&AN=CN-01210831. Acesso em: 26 out. 2020.
    • AMA:
      Kappos L, Edan G, Freedman MS, et al. The 11-year long-term follow-up study from the randomized BENEFIT CIS trial. Neurology. 2016;87(10):978-987. doi:10.1212/WNL.0000000000003078
    • APA:
      Kappos L, Edan G, Freedman MS, Montalbán X, Hartung HP, Hemmer B, Fox EJ, Barkhof F, Schippling S, Schulze A, Pleimes D, Pohl C, Sandbrink R, Suarez G, Wicklein EM, & BENEFIT Study Group. (2016). The 11-year long-term follow-up study from the randomized BENEFIT CIS trial. Neurology, 87(10), 978–987. https://doi.org/10.1212/WNL.0000000000003078
    • Chicago/Turabian: Author-Date:
      Kappos L, Edan G, Freedman MS, Montalbán X, Hartung HP, Hemmer B, Fox EJ, et al. 2016. “The 11-Year Long-Term Follow-up Study from the Randomized BENEFIT CIS Trial.” Neurology 87 (10): 978–87. doi:10.1212/WNL.0000000000003078.
    • Harvard:
      Kappos L et al. (2016) ‘The 11-year long-term follow-up study from the randomized BENEFIT CIS trial’, Neurology, 87(10), pp. 978–987. doi: 10.1212/WNL.0000000000003078.
    • Harvard: Australian:
      Kappos L, Edan G, Freedman MS, Montalbán X, Hartung HP, Hemmer B, Fox EJ, Barkhof F, Schippling S, Schulze A, Pleimes D, Pohl C, Sandbrink R, Suarez G, Wicklein EM & BENEFIT Study Group 2016, ‘The 11-year long-term follow-up study from the randomized BENEFIT CIS trial’, Neurology, vol. 87, no. 10, pp. 978–987, viewed 26 October 2020, .
    • MLA:
      Kappos L, et al. “The 11-Year Long-Term Follow-up Study from the Randomized BENEFIT CIS Trial.” Neurology, vol. 87, no. 10, Jan. 2016, pp. 978–987. EBSCOhost, doi:10.1212/WNL.0000000000003078.
    • Chicago/Turabian: Humanities:
      Kappos L, Edan G, Freedman MS, Montalbán X, Hartung HP, Hemmer B, Fox EJ, et al. “The 11-Year Long-Term Follow-up Study from the Randomized BENEFIT CIS Trial.” Neurology 87, no. 10 (January 1, 2016): 978–87. doi:10.1212/WNL.0000000000003078.
    • Vancouver/ICMJE:
      Kappos L, Edan G, Freedman MS, Montalbán X, Hartung HP, Hemmer B, et al. The 11-year long-term follow-up study from the randomized BENEFIT CIS trial. Neurology [Internet]. 2016 Jan 1 [cited 2020 Oct 26];87(10):978–87. Available from: http://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=cgh&AN=CN-01210831