"Comparison of glatiramer acetate (Copaxone) and interferon beta-1b
(Betaferon) in multiple sclerosis patients: an open-label 2-year
follow-up"
Flechter S, Vardi J, Pollak L, Rabey
JM.
The MS Clinical Research and Therapy Service, Department of
Neurology, Assaf Harofeh Medical Center,, Zerifin 70300 Israel.
OBJECTIVE: To compare the
clinical efficacy, as expressed by relapse rate and disability
accumulation, and safety profile of glatiramer acetate (Copaxone;
COP-1) and Interferon beta-1b (Betaferon; IFN beta - 1b)
administered to multiple sclerosis patients during a 2-year
follow-up on an open-label parallel design, as compared to their
clinical condition in the 2-year period prior to treatment.
BACKGROUND: Copaxone and IFN beta
- 1b have been recently introduced for the treatment of relapsing
forms of MS. Both medications have been proven to have a relatively
safe profile and are used extensively world-wide.
METHODS: 58 consecutive patients
with relapsing forms of MS were enrolled from the MS out-patient
clinic, during three months.
After being informed in detail of the
two approved treatment options existing at the time in Israel, the
patients chose by themselves to receive either: (a) Copaxone 20 mg
subcutaneously (sc) daily (Copaxone dly, 20 patients), or (b)
Copaxone 20 mg sc alternate-day (Copaxone alt, 18 patients) or (c)
IFN beta-1b 8 MIU sc in alternate day (20 patients).
Mean relapse rate/year and mean EDSS/year
were calculated for each group of patients during the 2 years prior
to the onset of treatment, and during the year prior to the onset of
treatment.
Statistical significance was observed in
the relapse rate in the year prior to the onset of treatment between
the IFN beta -1b group and the two Copaxone groups (p = 0.05). This
statistical difference has no effect on the overall data of the 2
years prior to starting the treatment and on the results.
No statistical significance was observed
in the total number of relapses, and on the 2-year relapse rate,
prior to the onset of treatment. Mean relapse rate/year and mean
EDSS/year were calculated for each group during the first and second
year of treatment.
Wilcoxon analysis for clinical data and
chi-square for adverse events were applied.
RESULTS: The three groups were
statistically comparable concerning mean relapse/year in the 2 years
before the trial started and no statistical significance was
observed among the three groups.
A statistically significant reduction in
the mean relapse rate in the 2 years after onset of treatment was
observed in the three group of patients: Copaxone daily (dly) 1.1
+/- 0.6 (p = 0.0001); Copaxone alternate (alt) 0.9 +/- 0.6 (p =
0.0004) and IFN beta -1b 1.2 +/- 0.7 (p = 0.0001).
Disability as expressed by EDSS score
prior to the onset of treatment and after 2 years of treatment
showed deterioration in the three groups although more significant
in the Copaxone groups: Copaxone dly 3.3 +/- 1.4 to 3.8 +/- 1.6 (p =
0.007); Copaxone alt 2.4 +/- 1.1 to 2.8 +/- 1.3 (p=0.04); IFN beta -
1b 3.1 +/- 1.3 to 3.3 +/- 2.0 (N.S.).
The most common adverse events reported
were: (1) flu-like symptoms 7 pts (35%) in the IFN beta -1b group;
10 pts (26%) of the two Copaxone groups; (2) increased spasticity of
lower limbs 3 pts (15%), only in the IFN beta -1b group; (3) site
injection reaction (SIR): 16 SIR (80%) in the IFN beta -1b group; 12
SIR (67%) in the Copaxone alt group; 14 SIR (70%) in the Copaxone
dly group; and (4) systemic reaction 3 pts (15%) in the IFN beta -1b
group; 4 pts (22%) in the Copaxone alt group; 6 pts (30%) in the
Copaxone dly group.
Premature termination occurred in five
patients treated with Copaxone (3 in the alternate group and 2 in
the daily group).
CONCLUSION: The present study,
despite the limitations of an open-label study, shows that Copaxone
dly, Copaxone alt and IFN beta -1b treatment seem to be equally
effective for the control of exacerbations in MS.
The adverse event profile, as reported
by the patients, was also similar. However, the adverse events
profile registered indicated that Copaxone is somewhat less
detrimental, whereas disability as measured by EDSS accumulation
showed that the interferon beta - 1b patients demonstrated a slower
progression of the disability.
J Neurol Sci 2002 May
15;197(1-2):51-5
PMID: 11997066 [PubMed
link] |
