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Posted: Wed Jan 23, 2008 10:13 am Post subject: Copaxone long-term study
Now that's some long-term follow up!
Long-term (up to 22 years), open-label,compassionate-use study of glatiramer acetatein relapsingremitting multiple sclerosis.
Mult Scler. 2008 Jan 21 [Epub ahead of print]
Miller A, Spada V, Beerkircher D, Kreitman RR.
Mount Sinai School of Medicine, New York, NY, USA.
To evaluate the safety and efficacy of long-term glatiramer acetate (GA) therapy, 46 patients with relapsingremitting multiple sclerosis (RRMS) were treated for up to 22 years in an ongoing, open-label study. Kurtzke expanded disability status scale (EDSS) was measured every six months, relapses were reported at occurrence and patients self-reported adverse events (AEs). At GA initiation, disease durations ranged from 020 years (median 6.0 years) and at data cut-off (October 2004), GA therapy duration ranged from 122 years (median 12.0 years). Mean EDSS score increased 0.9 +/-1.9 from the pretreatment score (3.0 +/- 1.8; P =0.076). Only 10/28 (36%) patients with baseline EDSS <4.0 had a last observed value >/=4.0 and 8/34 (24%) with entry EDSS <6.0 reached EDSS >/=6.0. A majority (57%) maintained improved or unchanged EDSS scores. Annualized relapse rate decreased to 0.1 +/- 0.2 from 2.9 +/- 1.4 prestudy (P <0.0001). Of the 18 remaining patients in October 2004 (average disease duration 23 years), 17% with baseline EDSS scores <4.0 reached EDSS >/=4.0 and 28% with baseline scores <6.0 reached EDSS >/=6.0. Adverse events were similar to those reported in short-term clinical trials. This study shows a low rate of relapses and EDSS progression in RRMS patients on GA for up to 22 years.
Actually I wouldn't be so cynical. I think that this is a fairly significant data point showing copaxone really does slow the disease down even over the long haul. The reduction in relapses to 0.1 (1 per 10 years) has a VERY impressive level of significance (p < 0.0001). Copaxone really struggled with measures of statistical significance in their original FDA approval studies.
I can't help but wonder - "how did you get 22 years of data on a drug that's only been FDA approved for 11?". Many in the medical community have always been a bit skeptical of copaxone's lengthy time to approval. Has to do with those p-values...
Another question...how did this study control for survivor bias...e.g. only those for whom the medicine worked well (and was tolerable) would stay on it for a long period of time. Hence the study tends to not include those who migrated to other treatments.
I confess I like seeing studies like this 'cause I take the stuff and want it to work well for me!
Actually I wouldn't be so cynical. I think that this is a fairly significant data point showing copaxone really does slow the disease down even over the long haul. The reduction in relapses to 0.1 (1 per 10 years) has a VERY impressive level of significance (p < 0.0001). Copaxone really struggled with measures of statistical significance in their original FDA approval studies.
I can't help but wonder - "how did you get 22 years of data on a drug that's only been FDA approved for 11?". Many in the medical community have always been a bit skeptical of copaxone's lengthy time to approval. Has to do with those p-values...
Another question...how did this study control for survivor bias...e.g. only those for whom the medicine worked well (and was tolerable) would stay on it for a long period of time. Hence the study tends to not include those who migrated to other treatments.
I confess I like seeing studies like this 'cause I take the stuff and want it to work well for me!
Bingo! This is nice and all but there are only 46 patients left and those happen to be the patients who were doing well on Copaxone. Let's see the data on all those that dropped out.
Joined: Sep 11, 2007 Posts: 667 Location: southern California
Posted: Fri Mar 07, 2008 11:27 am Post subject:
Actually, it says only 18 patients of the original 46 remain active in the study. I also wonder what happened to the other 28 people.
Husband just had one year MRI since dx and starting copax. No new lesions, no enhancing lesions, and no exacerbations. We're hoping the copax will keep him stable for awhile.
-AC
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