Key result
Once-weekly beta interferon trial analysis suggests early termination and attrition bias skew reported efficacy.
Why the study?
One marketed beta interferon for relapsing-remitting multiple sclerosis showed impressive efficacy in its pivotal trial, but later head-to-head studies and reviews questioned its superiority due to potential biases.
Does a once-weekly beta interferon regimen improve outcomes in relapsing-remitting multiple sclerosis?
Does a once-weekly beta interferon regimen improve outcomes in relapsing-remitting multiple sclerosis?
The reported superiority of a once-weekly beta interferon for multiple sclerosis may be confounded by attrition bias, highlighting the need for raw data transparency to confirm its efficacy.
Urges caution with once-weekly beta interferon in RRMS; leaves open true efficacy pending raw data reanalysis.
Three interferons are marketed for the treatment of relapsing-remitting multiple sclerosis. In its pivotal trial, one of them demonstrated impressive efficacy as a once-weekly regimen, but later head-to-head studies and reviews questioned its superiority. Analysis of this pivotal trial in publications and health authority reviews has shown that its early termination might have caused attrition bias. Censored patients were different from those completing the study on magnetic resonance imaging parameters and benefited from placebo in terms of relapse rate. Early progression of disability and differences in follow-up duration could have favored the benefit observed for the progression of disability outcome. Only the raw data could be of help to confirm or refute doubts about this trial. Raw data should be made available to the scientific community.
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Alexis Clapin (2012) conducted a review in Relapsing-remitting multiple sclerosis. Beta Interferons vs. Placebo was evaluated on Relapse rate and progression of disability. Analysis of a pivotal trial for a once-weekly beta interferon in relapsing-remitting multiple sclerosis suggests that early termination and attrition bias may have skewed the reported efficacy.
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