Long-term impact of interferon beta-1b in patients with CIS: 8-year follow-up of BENEFIT.
OBJECTIVE
To examine the long-term impact of early treatment initiation of interferon beta-1b (IFNB1b, Betaferon/Betaseron) in patients with a first event suggestive of multiple sclerosis (MS).


METHODS
In the original placebo-controlled phase of BENEFIT, patients were randomised to IFNB1b 250 μg or placebo subcutaneously every other day. After 2 years or diagnosis of clinically definite MS (CDMS), all patients were offered open-label IFNB1b treatment for a maximum duration of 5 years. Thereafter, patients were enrolled in an observational extension study for up to 8.7 years.


RESULTS
Of the initial 468 patients, 284 (60.7%; IFNB1b: 178 (61.0% of the original arm), placebo: 106 (60.2% of original arm)) were enrolled in the extension study. 94.2% of patients were receiving IFNB1b. Patients originally randomised to IFNB1b had a reduced risk of developing CDMS by 32.2% over the 8-year observation period (HR 0.678; 95% CI 0.525 to 0.875; p=0.0030), a longer median time to CDMS by 1345 days (95% CI 389 to 2301), and a lower annualised relapse rate (0.196 (95% CI 0.176 to 0.218) versus 0.255 (95% CI 0.226 to 0.287), p=0.0012), with differences mainly emerging in the first year of the study. Cognitive outcomes remained higher in the early treated patients. EDSS remained low over time with a median of 1.5 in both arms.


CONCLUSIONS
These 8-year results provide further evidence supporting early initiation of treatment with IFNB1b in patients with a first event suggestive of MS.
University of Rennes, Rennes, France.
G
G
Edan
University of Basel and University Hospital, Basel, Switzerland.
L
L
Kappos
Department of Clinical Neuroimmunology, Hospital Vall d'Hebron, Barcelona, Spain.
X
X
Montalbán
VU University Medical Center, Amsterdam, The Netherlands.
C H
CH
Polman
Ottawa Hospital Research Institute, Ottawa, Canada.
M S
MS
Freedman
Heinrich-Heine University, Düsseldorf, Germany.
H-P
HP
Hartung
National Hospital for Neurology and Neurosurgery, London, UK.
D
D
Miller
MS MRI Centre-Free University Hospital, Amsterdam, The Netherlands.
F
F
Barkhof
PAREXEL International GmbH, Berlin, Germany.
J
J
Herrmann
Bayer Pharma AG, Berlin, Germany.
V
V
Lanius
Bayer Pharma AG, Berlin, Germany.
B
B
Stemper
Bayer Pharma AG, Berlin, Germany Department of Neurology, University Hospital of Bonn, Bonn, Germany.
C
C
Pohl
Heinrich-Heine University, Düsseldorf, Germany Bayer Pharma AG, Berlin, Germany.
R
R
Sandbrink
Bayer HealthCare Pharmaceuticals Inc, Whippany, New Jersey, USA.
D
D
Pleimes
D000328:Adult; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D000068576:Interferon beta-1b; D016899:Interferon-beta / Q000008:administration & dosage / Q000627:therapeutic use*; D008297:Male; D009103:Multiple Sclerosis / Q000188:drug therapy*; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
D000068576:Interferon beta-1b; D016899:Interferon-beta
INTERFERON; INTERVENTIONAL; MULTIPLE SCLEROSIS; RANDOMISED TRIALS