Comparison of treatments
 

From the Ectrims site:

http://www.akm.ch/ectrims2006/


An open label trial comparing the effects of IFNB-1a (Rebif®), (Avonex®), IFNB-1b (Betaferon®) and glatiramer acetate (Copaxone®) on the relapse rate, lesion load on MRI and disease progression in patients with relapsing-remitting multiple sclerosisN.S. Oztekin, M.F. Oztekin, O. Yilmaz, R. Polat (Ankara, TR)

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Objective: We previously reported the results of 24 months of treatmentwith 3 interferons in patients with relapsing-remitting multiple sclerosis.

We now report the results of four immunomodulatory therapies after 6 years of follow up, on relapse rate, progression in disability in EDSS and disease activity measured by Gd enhanced MRI.

Method: 316 consecutive patients , with definite R-R MS and EDSS less than 5.5 were randomly assigned to receive one of the four immunomodulatory therapies.

40 age and EDSS matched patients with RRMS who did not receive any treatment were used as control group.
26 patients in the treatment group used 22 micrograms, 62 patients used 44 microgms of Rebif, 71 patients used Avonex,102 patients received Betaferon and 52 patients used glatiramer acetate(Copaxone),.

All the patients in the treatment and control groups were evaluated before treatment and every 3 months by clinical and EDSS assesments.MRI scans with gadolinium enhancement were obtained at baseline and every three months both in the four arms of the treatment group and in the control group.

Results: After 6 years of treatment 271 patients remained in their original treatment group.Compared to the untreated group(1.02) mean annualized number of relapses was significantly reduced in all the treatment groups:IFNB-1a, Rebif (22 microgms=0.69, p=0.001), 44 microgms 0.57(p<0.005),Avonex (0.61p=0.005), IFNB-1b(0.574, p<0.005), Copaxone (0.55, p<0.005). Exacerbation frequency was mean 0.472 in the treatment groups whereas it was 0.91 in the control group(p<0.01).

There was a reduction in MRI disease activity up to 45% reduction in the number of active lesions per petient per MRI scan after 6 years of treatment, while the reduction was 20% in the control group.

There was no statistically significant difference in terms of annual execerbation rate(p=0.5), exacerbation frequency (p=0.05) and MRI disease activity in (p>0.05) between the groups receiving Rebif, Avonex , Betaferon and Copaxone after 6 years of treatment.

Conclusion: The results of this 6 year open labeled study comparing the immunomodulating effects of these four therapies in R-R MS patients has shown no statistically significant difference in terms of annual exacerbation rate, execerbation frequency and MRI disease activity.

My completely non-statistical but minutiae obsessed brain reads the above quote as "up to 45% reduction" in active lesions of patients on CRABs, meaning that the best result in the treated patients was 45%, with no average listed. And that the average lesion reduction in patients receiving nothing at all was still 20%.

I'd always hoped that at least some people were doing better than that on the meds.

Anyone want to comment or clarify? With the same percentages for all the meds, it always seems to me that the CRABs work (modestly) on the same subset of patients and the rest of us maybe have a different form of the disease. I'd rather they'd spend more time on figuring out what we've got. :)

Wannabe,

Conclusion: The results of this 6 year open labeled study comparing the immunomodulating effects of these four therapies in R-R MS patients has shown no statistically significant difference in terms of annual exacerbation rate, execerbation frequency and MRI disease activity.[/QUOTE]

I guess this means that the company who has the best marketing/sales group of the "big four" pharmas in MS drugs is going to get the largest market share of the business!!

Harry

Yep! SSDD!! Nothing new or promising in this study.:(

That's what my completely non-statistical but minutiae obsessed brain reads as well. :)

And how much of that 25% difference could be attributed to placebo effect. And how much do these 'treatments' cost us?

It seems that the crabs are superior to no treatment, but not hugely superior to risk the side effects and money. Now I can see why Mayo does not recommend treatment for mild MS.

BBS1951-
You wrote that Mayo doesn't not recommend treatment for mild m.s. Did you read that somewhere? If so please respond so I can go check it out. Thanks, m

Hi Wayleaf. I always keep a copy of their report handy. Here's a link.

http://www.mayoclinic.org/news2004-rst/2401.html

I could be the Poster Child for the Wait and See Approach. :)

Thanks for posting the link euphonia. I was also at Mayo and the MS Neuro directly said it to me.

No, I am a poster chlid for MS Mild!

Frankly guys, this study is not terribly interesting.

A) It's open label.

B) There's no placebo cohort but rather an age and disease matched control group.

C) About 45 people dropped out. Maybe because they were doing well. Or poorly. Or became pregnant. Or?

On the positive side there appeared to be a 40%-50% reduction in relapse rate in the treated group vs. controls.

I think "up to a 45% reduction" means that that was the best result of any of the four therapies, but the other three must have been close, since the differences between the four were not statistically significant.

But again, because of the methodological problems, I think we shouldn't make too much of this study.

Mark