tinkershaw,
There have been numerious head to head trials in the past, but each trial has been set-up in favor of the sponsoring party.
Here's Teva's latest head to head. Of course the population could have favored Teva from the getgo.
Glatiramer acetate and interferon beta-1a for intramuscular administration: a study of outcomes among multiple sclerosis intent-to-treat and persistent-use cohorts.
Castelli-Haley J, Oleen-Burkey MA, Lage MJ, Johnson K.
Teva Neuroscience, Kansas City, MO, USA.
Abstract
OBJECTIVE: To study outcomes of multiple sclerosis (MS) patients treated with either glatiramer acetate (Copaxone) or interferon beta-1a for once-weekly, intramuscular administration (Avonex).
METHODS: An 'intent-to-treat' (ITT) cohort (n=1282) was established, consisting of patients diagnosed with MS who began therapy on either glatiramer acetate (GA) or intramuscular interferon beta-1a (IFN beta-1a-IM) and had continuous insurance coverage from 6 months before to 24 months after the date when they began taking the medication. A 'persistent use' (PU) cohort (n=639) was also constructed, consisting of individuals who, in addition to the criteria listed above, had a claim for GA or IFN beta-1a-IM within 28 days of the end of the 2-year post-period. Data were obtained from the i3 InVision Data Mart Database from July 2001 to June 2006. Multivariate regressions were used to examine both the 2-year total direct medical costs and the likelihood of relapse associated with the use of each of these alternative MS medications. A relapse was defined as either being hospitalized with a principal diagnosis of MS or having an outpatient visit with a MS diagnosis followed within 7 days by a claim for a corticosteroid. All regressions controlled a wide range of factors that may potentially affect outcomes.
RESULTS: In the ITT cohort, patients who started therapy on GA had a significantly lower 2-year risk of relapse (10.01 vs. 5.18%; p=0.0034) as well as significantly lower 2-year total medical costs ($44,201 vs. $41,121; p=0.0294). In the PU cohort, patients who used GA also had a significantly lower 2-year risk of relapse (7.25 vs. 2.16%; p=0.0048) as well as significantly lower total medical costs ($67,744 vs. 63,714; p=0.0445). Limitations: The analyses relies on an administrative claims database of an insured population and hence, may not be generalizeable to other populations. In addition, such a database precludes measurement of lost work time, unemployment, caregiver burden or other costs associated with MS.
CONCLUSIONS: Results from this study indicate that the use of GA is associated with significantly lower probability of relapse as well as significantly lower 2-year total direct medical costs than IFN beta-1a-IM.
And then here's the MS Society writeup.....
One of the difficulties of interpreting results of clinical trials is that they are mostly drug-company sponsored, are often conducted in ‘ideal’ populations and conditions that don’t necessarily reflect the real world, and often avoid direct head-to-head comparisons of rival drugs. So, studies that follow up people in real world situations taking the tested medications can often provide very useful insights into how effective these drugs really are.
One such recently published study examined administrative records from a large database of insured US patients taking either glatiramer (Copaxone) or interferon beta-1a (Avonex). The study had the advantage of large numbers of patients, and used an intention to treat analysis (that is, analyzing outcomes based on whether people started treatment on the drug, not whether they kept it going) as well as a persistent use analysis (that is, analyzing outcomes based on whether people stayed on the drug). It had the drawback of being drug company-sponsored.
The findings were strongly in favour of Copaxone. In the intention to treat analysis, those on Copaxone (5%) had half the two year relapse rate of those on Avonex (10%); for those who stayed on the drug, the difference was even larger in favour of Copaxone (2% vs 7%). In both forms of analysis, those on Copaxone had significantly lower medical costs, implying less illness requiring treatment.
The randomized controlled trials have not shown much difference between the various disease-modifying drugs in terms of relapse rate reduction. This real world study should provide confidence to those taking Copaxone, who are often told the drug is inferior to the interferons, that they have made a sensible choice in opting for this drug, particularly given its better safety and tolerability
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