Hi, wow, there's rarely any activity in the Campath discussions! I never quite know how to feel about that.
I just signed the extension too. It's not necessarily yearly infusions though. For sure it's continuing the same tests; the blood, urine, neuro & physical exams, quality of life questionnaires, etc. for 3 more years.
For those in the study that received the two fixed annual cycles of Alemtuzumab infusions they may or may not receive more infusions. There has to be evidence of MS activity in the form of clinical relapses or new lesions on MRI. More of a wait and see approach. Also another infusion is only offered if it's been at least 12 months since the last infusion and there's no current or ongoing infection. Infusions can be received during this extension until month 35, one month before the 3 year study extension is over. Tthough if received that late some extended monitoring may be necessary.
For those that received Rebif in the previous trial, they're now eligible for the "standard" 2 yearly Campath infusions that the others in the trial received. Monitoring after to see if more is needed.
Given the current fasttrack status Alemtuzumab for MS therapy could be approved by the FDA before this extendend study is over. So it's not endless yearly infusions until it's approved. Drug approval doesn't end a drug trial, for many drugs we're still researching long after approval comes.
There's also a sub-study for those in this genzyme study, blood collection for DNA sampling. They're looking for genetic biomarkers to see if there are DNA sequences that are associated with and would also help predict how well alemtuzumab works on one's MS symptoms and side effects from the treatment. Campath might trigger a genetic precursor someone has to develop ITP or thyroid issues. If that were the case it would certainly help someone make a more informed choice about medication and associated risks.
Had my end of study MRI the other week, haven't heard back how it looked. Last year Campath was doing the trick and my MRI had no changes. If it's clear this year I was told there would be no third infusion for me...at this time...and we just wait over the next 3 years for any negative changes. So far I do feel more energetic. Just before the second infusion I was really starting to drag and I don't seem to have that this year.
I was newly diagnosed before I started the trial, haven't had many "episodes." Today beneath my left eye, top of the baggy area, it has been visibly twitching for about 8 hours straight. Few dozen times a minute. During this twice now my entire left cheek has felt really hot, sorta radiating heat towards my neck, beneath ear. Does this mean something's starting? My coordinator said to call anytime something weird happens for 24 hours straight, even if it's 2 am. The eye twitch thing isn't painful, though the cheek thing was sorta uncomfortable. It's really minor and I don't know if its one of those weird brief things that will go away quickly and be ignored or if it lasts the 24 hours + making it something to consider as an exacerbation.
I hate to complain about it, I know this could be so much worse. It's starting to drive me bonkers in a Chinese water torture sort of way! I videotaped it on my phone and if it's still going on tomorrow I guess I'll email the coordinator my stink eye footage. LOL
Hope everyone is doing well, keep on...keeping on!