383 people were recruited for the Avonex CHAMPS study in the late 90s, randomized into placebo-taking or drug-taking groups. After two years, results showed a benefit to people on the drug versus those on placebo, so everyone in the study was put on the drug. At 5 years numbers showed a benefit for long term drug use. This was the CHAMPS study.
A study was then constructed to look at even longer term results. This was deemed the CHAMPIONS study. Results were released last week in Seattle. First glance suggests good things about getting on a disease modifying therapy early and sticking with it. I say first glance because the number of participants was low. In the initial study there were 383 participants. In the second, 155. How did they lose over half the initial study's participants? Are 383 and 155 enough participants?
They lost participants partly due to compliance issues. I know one woman personally who couldn't tolerate the side effects of the drug so went off it. Some folks just couldn't handle the needle every week. I've heard of others who had adverse effects, so had to go off it. Whatever the reason they stopped Avonex, they were out of the second part of the study, and probably some dropped out of the first. I wonder if the company followed them anyway. It would be interesting to find out what, if any, changes there are in their health. As to the question of the number of participants, I don't know the answer.
I was on placebo in the CHAMPS study. For 18 months I injected myself with water, not knowing if it was water or Avonex (though secretly I thought it was placebo). I had a relapse and was determined to be clinically diagnosed MS at that point (before I had only the clinically isolated syndrome). After a year on Avonex I called their help line at 3 in the morning in tears wondering if the side effects would ever wear off. I took my shot in the evening along with two extra strength tylenol and would go to bed. And wake up four hours later in agony. The person on the other end of the phone assured me the side effects would lessen with time. The next time I saw my family doc, I told her about the side effects waking me up in pain. She gave me a new product, 8 hour arthritis tylenol. Hallelujah! So I used the samples she gave me, slept through the nights I took my shot and was able to get up in the morning and take more regular tylenol before the side effects arose again, thus keeping them at bay. I understand completely why some people opted out of the study. Again, I'm one of the lucky ones who was able to tolerate the side effects.
I have also been a part of the CHAMPIONS study. I'm one in 155. Almost 10 years after starting Avonex, I have a pretty good routine and the side effects have lessened considerably. I have almost no side effect hangover the day after my shot and I have had only one relapse since beginning the medication. So it appears to be working for me.
There are criticisms of both studies for valid reasons. The first study was to determine if Avonex was effective in delaying the onset of CDMS after one CIS event. After showing that it did, a second study was constructed to follow those on Avonex and see if relapse rates were significantly reduced. One of the problems is that the researchers could cherry pick the participants - though in reality they were just following a group of people who had already showed a positive result (as a group) to the drug. I am going to be asking these questions at the MS Clinic in days to come to see what I can find out. I still believe that early treatment is the best option we have right now.
The main idea of this post is to encourage those that can, to get on a treatment early. People are being diagnosed earlier in the course of their illness, so they qualify for these drugs. Until recently many people had to wait years before getting a diagnosis and because of the delay in beginning treatment, may have suffered irreversable damage and/or disability. These drugs are not the be all and end all. They are a way for us at this point in time to delay the onset and progression of this disease. They are a stepping stone to a better treatment or *gasp* a cure.