Saturday, 28 January 2012

Bad Science:Interferons after Mitoxantrone

Today is our research day and I have to deliver Bad Science. When you read papers you have to digest whether they actually tell us anything. You do not always believe things you read. Importantly is it worth reading them in the first place?

Todays story is an an example. NO LINK PROVIDED, READING VALUE IS LOW

Objective: The objective of this study was to assess the effect of treatment with interferon (IFN) β-1a, 44 µg subcutaneously (sc) three times weekly (tiw), on clinical and magnetic resonance imaging (MRI) outcomes in patients with relapsing multiple sclerosis (MS) following mitoxantrone therapy.

Methods: This was an open-label, randomized, multicentre, rater-blinded, 96-week observational study. Clinically stable patients with relapsing forms of MS, who had discontinued mitoxantrone treatment 1-6 months before study entry, were randomized to IFN β-1a sc 44 µg tiw, or no treatment. The primary endpoint was time to first relapse. Secondary endpoints included the number of relapse-free patients, disease activity assessed by MRI and time to 3-month confirmed Expanded Disability Status Scale (EDSS) progression, all at week 96.

Results: A total of 30 patients were randomized (intent-to-treat population: 14 IFN β-1a, 15 untreated; one patient from the safety population discontinued the study after 25 days owing to an adverse event and without providing any postbaseline efficacy data, and was thus excluded from the intent-to-treat population). Overall, 71.4% (10/14) of patients in the IFN β-1a group remained relapse free over 96 weeks, versus 46.7% (7/15) in the untreated group (p = 0.26 THIS ACTUALLY MEANS THERE WAS NO DIFFERENCE DESPITE THE INFERENCE). IFN β-1a delayed the time to first relapse versus no treatment (p = 0.14. THIS ACTUALLY MEANS THERE WAS NO DIFFERENCE IN TIME TO RELAPSE DESPITE THE INFERENCE); time to first relapse (25th percentile) was 95.4 (IFN β-1a) versus 46.0 weeks (no treatment). Confirmed EDSS progression was observed in five patients in each treatment group. Mean change in EDSS score was 0.3 in both groups (p = 0.79 THIS ACTUALLY MEANS THERE WAS NO DIFFERENCE). Changes in the number or volume of T1 and T2 lesions at week 96 were not significantly different between treatment groups (THEY ACTUALLY TELLL US THAT THERE WAS NO DIFFERENCE). There were no new or unexpected adverse events related to IFN β-1a treatment.

Conclusions: Several endpoints appeared to show a benefit of IFN β-1a treatment, but no significant differences could be detected owing to the small sample. THEY TELL US NOTHING WAS SHOWN Therefore, these data only permit, at best, tentative conclusions (THEY DO NOT PERMIT CONCLUSIONS AS THE DATA COULD EASILY BE DUE TO CHANCE AND MEAN NOTHING) about the disease course in patients with MS after de-escalation from mitoxantrone and continuation with or without IFN β-1a. Larger confirmatory studies are required.

While we want to know if after you stop mitoxantrone (you can only have so many doses because of risks to the heart) can beta interferon be of benefit in halting relapses. But we have to digest the information and ask, is there anything of real importance occuring here?

If one looked at more people would there be benefit to be seen? However, as the results stand you have to conclude that they show nothing concrete. This is a reason why it is important that studies are properly powered (that is contain a lare enough number of samples to provide meaningful information) so that you get a result that informs otherwise you have to do it all again. The authours should have waitied until they had enough data to say something.