ASCEND trial, week 72
Three quarters of the way there
On Wednesday 22 Jan I had another infusion for the ASCEND trial, week 72, my 18th infusion of tysabri. Its a 96 week trial, so 24 weeks to go, 6 more infusions. Am I on a placebo? Nobody knows, this is because it is a double blinded trial. I certainly feel good but hey it was a nice day and I met up with someone who I have got to know through the trial.
This visit was one where I am assessed. The blinded doctor thought I looked very well, he did an Expanded Disability Status Scale (EDSS) test and I was given a score of 6.
The description for EDSS score of 6
- Requires a walking aid – cane, crutch, etc – to walk about 100m with or without resting
In fact I walked over 130 metres in the assessment and in the six minute timed walk I managed to walk 230 metres, this is not a part of the EDSS assessment. OK I will never win a gold medal but I’m told that I’m getting better each time. When I started the trial in September 2012 my EDSS score was 6, so no change in 18 months.
This is a Phase 3 trial for SPMS sufferers to reduce the rate of disease progresion. When the trial has been completed everyone’s results are collated, 2015 is when the results will be published. If the national drug agencies give their approval the drug will then become commercially available. Biogen Idec hope that Tysabri will reduce the rate of progresion and even improve the ability to walk for patients who suffer SPMS. At the moment the drug is only available for people who suffer RRMS.
On the positive side my walking has not changed significantly. On the other hand I know that my balance has deteriorated, my double vision is more pronounced and I have noticed a deterioration in fine control such as writing, using a screw driver and accuracy of my typing. These affect my quality of life.
So I know my MS has deteriorated but my EDSS score has remained the same. Another important consideration is the time of day that the EDSS test is done, for the ASCEND trial it is always done between 9.30 and 10.30 in the morning. As the day progresses I do get more tired, less able to do anything and my ability depends upon what I have done that day. If I have been very busy and been on my feet for a long time then my EDSS score could easily rise to 7. Also my ability to do things will vary from day to day, I am reasonably consistent but I do have bad days.
The description for an EDSS score of 7
- Unable to walk beyond approximately 5m even with aid. Essentially restricted to wheelchair; though wheels self in standard wheelchair and transfers alone. Up and about in wheelchair some 12 hours a day
The EDSS test measures the disability of an MSer but is it consistemt and is it accurate. Optic neuritis, tremor, incontinence, fatigue and cognitive ability can often be totally disabling for an MSer but only mobility is considered with advanced MS. This cannot be right.
Write in and tell me your views on the EDSS scale, do you think it is an accurate measurement of MS disability. What do you think could be used instead?