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

Autor: Kappos, Ludwig, Edan, Gilles, Freedman, Mark S., Montalbán, Xavier, Hartung, Hans-Peter, Hemmer, Bernhard, Fox, Edward J., Barkhof, Frederik, Schippling, Sven, Schulze, Andrea, Pleimes, Dirk, Pohl, Christoph, Sandbrink, Rupert, Suarez, Gustavo, Wicklein, Eva-Maria, Csiba, László, Csépány, Tünde
Přispěvatelé: University of Basel (Unibas), Vision, Action et Gestion d'informations en Santé (VisAGeS), Institut National de la Santé et de la Recherche Médicale (INSERM)-Inria Rennes – Bretagne Atlantique, Institut National de Recherche en Informatique et en Automatique (Inria)-Institut National de Recherche en Informatique et en Automatique (Inria)-SIGNAUX ET IMAGES NUMÉRIQUES, ROBOTIQUE (IRISA-D5), Institut de Recherche en Informatique et Systèmes Aléatoires (IRISA), Université de Rennes (UR)-Institut National des Sciences Appliquées - Rennes (INSA Rennes), Institut National des Sciences Appliquées (INSA)-Institut National des Sciences Appliquées (INSA)-Université de Bretagne Sud (UBS)-École normale supérieure - Rennes (ENS Rennes)-Institut National de Recherche en Informatique et en Automatique (Inria)-Télécom Bretagne-CentraleSupélec-Centre National de la Recherche Scientifique (CNRS)-Université de Rennes (UR)-Institut National des Sciences Appliquées - Rennes (INSA Rennes), Institut National des Sciences Appliquées (INSA)-Institut National des Sciences Appliquées (INSA)-Université de Bretagne Sud (UBS)-École normale supérieure - Rennes (ENS Rennes)-Institut National de Recherche en Informatique et en Automatique (Inria)-Télécom Bretagne-CentraleSupélec-Centre National de la Recherche Scientifique (CNRS)-Institut de Recherche en Informatique et Systèmes Aléatoires (IRISA), Institut National des Sciences Appliquées (INSA)-Institut National des Sciences Appliquées (INSA)-Université de Bretagne Sud (UBS)-École normale supérieure - Rennes (ENS Rennes)-Télécom Bretagne-CentraleSupélec-Centre National de la Recherche Scientifique (CNRS), Ottawa Hospital Research Institute [Ottawa] (OHRI), Vall d'Hebron University Hospital [Barcelona], Centre de résonance magnétique biologique et médicale (CRMBM), Aix Marseille Université (AMU)-Assistance Publique - Hôpitaux de Marseille (APHM)-Centre National de la Recherche Scientifique (CNRS), Munich Cluster for systems neurology [Munich] (SyNergy), Technische Universität Munchen - Université Technique de Munich [Munich, Allemagne] (TUM)-Ludwig-Maximilians-Universität München (LMU), Virginia Tech [Blacksburg], University hospital of Zurich [Zurich], PAREXEL International [Berlin], VU University Medical Center [Amsterdam], Heinrich Heine Universität Düsseldorf = Heinrich Heine University [Düsseldorf], Bayer HealthCare Pharmaceuticals Inc [Whippany], Bayer Pharma AG [Berlin], University of Zurich, Kappos, L, Edan, Gilles, CentraleSupélec-Télécom Bretagne-Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Institut National de Recherche en Informatique et en Automatique (Inria)-École normale supérieure - Rennes (ENS Rennes)-Université de Bretagne Sud (UBS)-Centre National de la Recherche Scientifique (CNRS)-Institut National des Sciences Appliquées - Rennes (INSA Rennes), Institut National des Sciences Appliquées (INSA)-Université de Rennes (UNIV-RENNES)-Institut National des Sciences Appliquées (INSA)-CentraleSupélec-Télécom Bretagne-Université de Rennes 1 (UR1), Institut National des Sciences Appliquées (INSA)-Université de Rennes (UNIV-RENNES)-Institut National des Sciences Appliquées (INSA)-Institut de Recherche en Informatique et Systèmes Aléatoires (IRISA), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-École normale supérieure - Rennes (ENS Rennes)-Université de Bretagne Sud (UBS)-Centre National de la Recherche Scientifique (CNRS)-Institut National des Sciences Appliquées - Rennes (INSA Rennes), Institut National des Sciences Appliquées (INSA)-Université de Rennes (UNIV-RENNES)-Institut National des Sciences Appliquées (INSA), Dubois, Bénédicte, Department of Neurology [Suisse], University Hospital Basel [Basel], Institut National des Sciences Appliquées - Rennes (INSA Rennes), Institut National des Sciences Appliquées (INSA)-Université de Rennes (UNIV-RENNES)-Institut National des Sciences Appliquées (INSA)-Université de Rennes (UNIV-RENNES)-Université de Bretagne Sud (UBS)-Centre National de la Recherche Scientifique (CNRS)-École normale supérieure - Rennes (ENS Rennes)-Institut National de Recherche en Informatique et en Automatique (Inria)-Télécom Bretagne-Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-CentraleSupélec-Institut National des Sciences Appliquées - Rennes (INSA Rennes), Université de Rennes (UNIV-RENNES)-CentraleSupélec-Institut de Recherche en Informatique et Systèmes Aléatoires (IRISA), Institut National des Sciences Appliquées (INSA)-Université de Rennes (UNIV-RENNES)-Institut National des Sciences Appliquées (INSA)-Université de Rennes (UNIV-RENNES)-Université de Bretagne Sud (UBS)-Centre National de la Recherche Scientifique (CNRS)-École normale supérieure - Rennes (ENS Rennes)-Télécom Bretagne-Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-CentraleSupélec, Service de Neurologie [Rennes], Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Hôpital Pontchaillou-CHU Pontchaillou [Rennes], The Ottawa Hospital, Medical Image Analysis Center (MIAC AG), Department of neurology, Heinrich-Heine-Universität Düsseldorf [Düsseldorf], Munich Cluster of Systems Neurology (SyNery), Department Neurology of the Klinikum rechts der Isar, Technische Universität München [München] (TUM), Myelo Therapeutics [Berlin], Consejo Nacional de Investigaciones Científicas y Técnicas [Buenos Aires] (CONICET), Klinische Neurowetenschappen, MUMC+: MA Med Staf Spec Neurologie (9), RS: MHeNs - R1 - Cognitive Neuropsychiatry and Clinical Neuroscience, Technische Universität München [München] (TUM)-Ludwig-Maximilians-Universität München (LMU), Radiology and nuclear medicine, Amsterdam Neuroscience - Neuroinfection & -inflammation
Předmět:
0301 basic medicine
Male
Cross-sectional study
MESH: Adjuvants
Immunologic
Kaplan-Meier Estimate
Disability Evaluation
0302 clinical medicine
Recurrence
Medicine
MESH: Double-Blind Method
Young adult
10. No inequality
MESH: Treatment Outcome
Clinically isolated syndrome
MESH: Disability Evaluation
Orvostudományok
MESH: Follow-Up Studies
3. Good health
Treatment Outcome
2728 Neurology (clinical)
MESH: Young Adult
Female
[SDV.NEU]Life Sciences [q-bio]/Neurons and Cognition [q-bio.NC]
Interferon beta-1b
Adult
medicine.medical_specialty
Randomization
MESH: Demyelinating Diseases
610 Medicine & health
MESH: Interferon beta-1b
Placebo
Klinikai orvostudományok
Article
Time-to-Treatment
03 medical and health sciences
Young Adult
MESH: Cross-Sectional Studies
Adjuvants
Immunologic
Double-Blind Method
Immunologic/administration & dosage* Adult Cross-Sectional Studies Demyelinating Diseases/diagnostic imaging Demyelinating Diseases/drug therapy* Disability Evaluation Double-Blind Method Female Follow-Up Studies Humans Interferon beta-1b/administration & dosage* Kaplan-Meier Estimate Male Recurrence Time-to-Treatment Treatment Outcome Young Adult
Internal medicine
Humans
Adjuvants
[SDV.NEU] Life Sciences [q-bio]/Neurons and Cognition [q-bio.NC]
MESH: Time-to-Treatment
MESH: Kaplan-Meier Estimate
Expanded Disability Status Scale
MESH: Humans
business.industry
Multiple sclerosis
MESH: Adult
medicine.disease
MESH: Male
Surgery
10040 Clinic for Neurology
MESH: Recurrence
030104 developmental biology
Cross-Sectional Studies
Neurology (clinical)
business
MESH: Female
030217 neurology & neurosurgery
Demyelinating Diseases
Follow-Up Studies
Zdroj: ResearcherID
Neurology
Neurology, 2016, 87 (10), pp.978-987. ⟨10.1212/WNL.0000000000003078⟩
Kappos, L, Edan, G, Freedman, M S, Montalbán, X, Hartung, H P, Hemmer, B, Fox, E J, Barkhof, F, Schippling, S, Schulze, A, Pleimes, D, Pohl, C, Sandbrink, R, Suarez, G & Wicklein, E M 2016, ' The 11-year long-term follow-up study from the randomized BENEFIT CIS trial ', Neurology, vol. 87, no. 10, pp. 978-987 . https://doi.org/10.1212/WNL.0000000000003078
Neurology, American Academy of Neurology, 2016, 87 (10), pp.978-987. ⟨10.1212/WNL.0000000000003078⟩
Neurology, American Academy of Neurology, 2016, 87 (10), pp.978-87. ⟨10.1212/WNL.0000000000003078⟩
Neurology, 87(10), 978-987. LIPPINCOTT WILLIAMS & WILKINS
Kappos, Ludwig; Edan, Gilles; Freedman, Mark S; Montalbán, Xavier; Hartung, Hans-Peter; Hemmer, Bernhard; Fox, Edward J; Barkhof, Frederik; Schippling, Sven; Schulze, Andrea; Pleimes, Dirk; Pohl, Christoph; Sandbrink, Rupert; Suarez, Gustavo; Wicklein, Eva-Maria; Mattle, Heinrich (2016). The 11-year long-term follow-up study from the randomized BENEFIT CIS trial. Neurology, 87(10), pp. 978-987. American Academy of Neurology 10.1212/WNL.0000000000003078
Neurology, 87(10), 978-987. Lippincott Williams and Wilkins
ISSN: 0179-5872
0028-3878
1526-632X
DOI: 10.1212/WNL.0000000000003078⟩
Popis: Objective: To assess outcomes for patients treated with interferon beta-1b immediately after clinicallyisolated 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 (delayedtreatment). After conversion to clinically definite multiple sclerosis (CDMS) or 2 years, patients onplacebo 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 atparticipating sites) were enrolled (early: 167 [57.2%]; delayed: 111 [63.1%]). After 11 years, risk ofCDMS remained lower in the early-treatment arm compared with the delayed-treatment arm (p 50.0012), with longer time to first relapse (median [Q1, Q3] days: 1,888 [540, not reached] vs 931[253, 3,296]; p50.0005) and lower overall annualized relapse rate (0.21 vs 0.26; p50.0018). Only25 patients (5.9%, overall; early, 4.5%; delayed, 8.3%) converted to secondary progressive multiplesclerosis. Expanded Disability Status Scale scores remained low and stable, with no differencebetween treatment arms (median [Q1,Q3]: 2.0 [1.0, 3.0]). The early-treatment group had better PacedAuditory Serial Addition Task–3 total scores (p 5 0.0070). Employment rates remained high, andhealth 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 outcomesfavored earlier treatment. Along with low rates of disability and disease progression in bothgroups, this supports the value of treatment at CIS.
NCT01795872.
Databáze: OpenAIRE
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