TY - JOUR
T1 - A randomized study of two interferon-beta treatments in relapsing-remitting multiple sclerosis
AU - Koch-Henriksen, N
AU - Sørensen, P S
AU - Christensen, T
AU - Frederiksen, J
AU - Ravnborg, M
AU - Jensen, K
AU - Heltberg, A
AU - Kristensen, O
AU - Stenager, E
AU - Petersen, T
AU - Hansen, T
AU - Danish Multiple Sclerosis Group
PY - 2006/4/11
Y1 - 2006/4/11
N2 - OBJECTIVE: To investigate whether the efficacy of interferon-beta (IFNbeta) treatment of relapsing-remitting MS (RR-MS) was influenced by type, dose, and frequency of administration.METHODS: From June 1996 through October 1997, the authors offered participation to all Danish RR-MS patients who met the following criteria: definite MS, at least two relapses within 2 years, age 18 to 55, and an Expanded Disability Status Scale (EDSS) score of < or = 5.5. The study was multicenter, controlled, open-label, randomized, head-to-head comparing IFNbeta-1a 22 microg once a week (n = 143) with IFNbeta-1b 250 microg every other day (n = 158), both subcutaneously, for 24 months. Patients who declined randomization were offered treatment with IFNbeta-1b 250 microg every other day (n = 120). The primary end-points were the annualized relapse rate, the time to first relapse, and neutralizing antibody formation. The secondary endpoint was time to sustained progression.RESULTS: The annual relapse rates were virtually equal in the two arms of the randomized study (IFNbeta-1a: 0.70; IFNbeta-1b: 0.71); so were the time to first relapse and the time to sustained progression. In the nonrandomized patients (IFNbeta-1b), the annual relapse rate was not significantly different, but the time to progression was shorter.CONCLUSION: In this study, 250 microg interferon-beta-1b administered every other day did not prove clinically superior to once-a-week administration of 22 microg interferon-beta-1a.
AB - OBJECTIVE: To investigate whether the efficacy of interferon-beta (IFNbeta) treatment of relapsing-remitting MS (RR-MS) was influenced by type, dose, and frequency of administration.METHODS: From June 1996 through October 1997, the authors offered participation to all Danish RR-MS patients who met the following criteria: definite MS, at least two relapses within 2 years, age 18 to 55, and an Expanded Disability Status Scale (EDSS) score of < or = 5.5. The study was multicenter, controlled, open-label, randomized, head-to-head comparing IFNbeta-1a 22 microg once a week (n = 143) with IFNbeta-1b 250 microg every other day (n = 158), both subcutaneously, for 24 months. Patients who declined randomization were offered treatment with IFNbeta-1b 250 microg every other day (n = 120). The primary end-points were the annualized relapse rate, the time to first relapse, and neutralizing antibody formation. The secondary endpoint was time to sustained progression.RESULTS: The annual relapse rates were virtually equal in the two arms of the randomized study (IFNbeta-1a: 0.70; IFNbeta-1b: 0.71); so were the time to first relapse and the time to sustained progression. In the nonrandomized patients (IFNbeta-1b), the annual relapse rate was not significantly different, but the time to progression was shorter.CONCLUSION: In this study, 250 microg interferon-beta-1b administered every other day did not prove clinically superior to once-a-week administration of 22 microg interferon-beta-1a.
KW - Adjuvants, Immunologic/therapeutic use
KW - Adolescent
KW - Adult
KW - Disease-Free Survival
KW - Female
KW - Humans
KW - Interferon beta-1a
KW - Interferon beta-1b
KW - Interferon-beta/therapeutic use
KW - Male
KW - Middle Aged
KW - Multiple Sclerosis, Relapsing-Remitting/drug therapy
KW - Probability
U2 - 10.1212/01.wnl.0000204018.52311.ec
DO - 10.1212/01.wnl.0000204018.52311.ec
M3 - Journal article
C2 - 16510769
SN - 0028-3878
VL - 66
SP - 1056
EP - 1060
JO - Neurology
JF - Neurology
IS - 7
ER -