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001-es BibID:BIBFORM067748
Első szerző:Kappos, Ludwig
Cím:The 11-year long-term follow-up study from the randomized BENEFIT CIS trial / Ludwig Kappos, Gilles Edan, Mark S. Freedman, Xavier Montalbán, Hans-Peter Hartung, Bernhard Hemmer, Edward J. Fox, Frederik Barkhof, Sven Schippling, Andrea Schulze, Dirk Pleimes, Christoph Pohl, Rupert Sandbrink, Gustavo Suarez, Eva-Maria Wicklein, BENEFIT Study Group
Dátum:2016
ISSN:0028-3878
Megjegyzések: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 atparticipating 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 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 multiple sclerosis. 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 Paced Auditory Serial Addition Task?3 total scores (p 5 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 bothgroups, this supports the value of treatment at CIS.
Tárgyszavak:Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban
Megjelenés:Neurology 87 : 10 (2016), p. 978-987. -
További szerzők: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 (1952-) (neurológus, pszichiáter) Csépány Tünde (1956-) (neurológus, pszichiáter) BENEFIT Study Group
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