A prospective, open-label treatment trial to compare the effect of IFN beta-1a (Avonex), IFN beta-1b (Betaseron), and glatiramer acetate (Copaxone) on the relapse rate in relapsing-remitting multiple sclerosis

A prospective, non-randomized, open-label treatment trial was performed in patients with relapsing-remitting multiple sclerosis (RRMS), with follow up for 12 months. Our primary objective was to prospectively compare the effe ct of IFN beta -1a (Avonex), IFN beta -1b (Betaseron), and glatiramer aceta te (GA, Copaxone) on the relapse rate in patients with RRMS. Between August 1996 and September 1999, 156 consecutive patients with clinically definite RRMS with a Kurtzke scale (EDSS) score of 4 or less were followed for 12 m onths, from the time of initiating therapy or electing to remain untreated. Prior 2-year relapse history and available chart information was carefully reviewed at the time of enrolment. Thirty-three of 156 elected no treatmen t (mean age 32.5 years; mean EDSS 2.64) at enrolment; 40 elected IFN beta - 1a (mean age 32.4 years; mean EDSS 2.69), 41 IFN beta -1b (mean age 32.1 ye ars; mean EDSS 2.56), and 42 chose GA (mean age 31.5 years; mean EDSS 2.57) . Annual relapse rate based upon the 2 years prior to enrolment was 1.08 in the untreated group, 1.20 in the AV group, 1.21 in the BE group, and 1.10 in the GA group. There were no statistically significant differences among the four groups at enrolment. After 12 months of treatment, patients in the untreated groups had a relapse rate of 0.97, whereas patients in the IFN b eta -1a, IFN beta -1b, and GA groups had relapse rate of 0.85, 0.61, and 0. 62, respectively. Compared to the untreated group, reduction in the relapse rate was statistically significant only in the GA (P = 0.003) and IFN beta -1b (P = 0.002) groups, in contrast to the IFN beta -1a treated patients, who did not show a significant reduction (P = 0.309). Compared to the untre ated patients, mean EDSS was significantly reduced only in the GA (P = 0.00 1) and IFN beta -1b (P = 0.01), in contrast to IFN beta -1a treated patient s (P = 0.51). In this prospective, controlled, open-label, non-randomized 1 2-month study, treatment with only GA and IFN beta -1b significantly reduce d the relapse rate compared to untreated patients, supporting early treatme nt in RRMS. Our results are similar to the observations made after 12 month s of therapy in phase III studies of IFN beta -1a, IFN beta -1b, and GA. De spite some limitations of the study design, the results provide helpful cli nical information regarding the relative efficacy of each therapy in mildly affected treatment-naive RRMS patients.