Over 3 years ago I was in a phase 3 study for Adacolumn Apheresis here in Toronto. The study was conducted at many
locations throughout Canada and the USA. At that time it was already approved in Europe and Japan. I had 10 treatments of the original study and later found out I was on the placebo with no change in my symptoms. After that I had 15 treatments of the real treatment with no improvement in symptoms. After the entire study was over I received a letter saying that the efficiency of the treatment was only slightly better than placebo and as a result it would not be approved for use in Canada or the US at that time.
After talking to my GI he thought there could be several possible reasons for the differences in North America compared to results in Europe and Japan as follows:
a) The test criteria in North America could be far more stringent.
b) The Adacolumn was manufactured at a different factory located in the USA. There may be manufacturing problems.
c) The disease itself could have different variants in different parts of the world and the treatment doesn’t work as well on the North American variant.
My GI said if they find the reason and they can correct it, they may re-test it in North America.
Diagnosed in 2000 at age 43 with UC. Colon removed October 20/08.
Bad reaction to Asacol, Pentasa and Dipentum - can’t take any more 5ASAs.
Prednisone - worked well for 1 month, then side effects became unbearable.
6-MP - blood tests showed not metabolizing properly.
Corticosteroid enema, Flagyl, Ciprofloxin, VSL#3, Adacolumn Apheresis – no effect
Methotrexate with Remicade - 7 infusions with no improvement
Folic Acid and B12 injections.
Abatacept trial - no effect
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