Speaking of Targretin for CTCL, here's the text of the first patient to address the FDA advisory committee:
MR. KUPSCH: Good morning. I am Barry Kupsch, a sufferer of CTCL. I'm voluntarily appearing this morning to share my experience with Targretin capsules. Ligand is not paying me to speak but are reimbursing for necessary expenses.
Several years ago, I was afflicted with an unusual skin disorder and was seen by several dermatologists. Not one of them could come up with the diagnosis, just a guess. My body was covered with a very raised, red, itchy rash, accompanied by the enlargement of the lymph nodes in my neck and groin. The itchiness progressively worsened and I started getting large cracks in my hands, heels, and soles of my feet. Walking was an experience in pain every day with every step I took. The only way I could walk was to use crazy glue and glue the cracks together, hoping none would end up in the crevices. When I did walk, I would shuffle along at the same speed as an elderly person.
During the following months, I was started on PUVA treatments in Edmonton. This was a trip twice a week and a drive of 2 hours one way. At first there seemed to be some improvement, then suddenly I reacted to it. My skin became very reddened as if I was severely sunburnt. After this, I was unable to tolerate the sun at all. The only way I could be outside was to cover my body with sunscreen and wear sun protective clothing.
Shortly thereafter, I was admitted to the hospital twice with generalized swelling due to fluid retention. My skin started weeping fluid, especially from my legs and ears. At this time I was sloughing skin and my face looked like it was dipped in water, then oatmeal. The pain was very severe.
Some of the medications which I was on were methotrexate and soralen which made my skin even more sun sensitive. The itchiness worsened, which was one of the side effects of this drug, and the pain remained constant.
In March of 1996, I was started on interferon injections and a positive diagnosis of CTCL was made. I did start having some improvement in my hands and feet, but the itchiness remained. I took the interferon for a year and a half. The major side effects for me were depression, irritability, and constant flu-like symptoms. My arms and thighs were sore from all the needles.
My condition was not improving and the itch was so bad I took a wire brush to my hands, desperate for some relief from the itch. Instead of sleeping at night, I would scratch till the early morning hours, and our bed sheets would be constantly covered with blood.
Since my occupation is farming, I spend many hours outside. While doing my field work, I thought I was protected from the sun by the tractor cab. Much to my surprise, the sun rays were magnified by the glass, burning me even more severity. Thus, I was unable to do my farm work outside in the daytime. So, when other people were sleeping, I was out working. My condition was to the point of being unable to work, so I hired people to help me farm.
There were many times I hated being around people, and people did not like being around me because I was constantly scratching. My sleep habits were messed up and my family was having a hard time coping with the miserable person I became. Since I could not see any light at the end of my tunnel, suicide did cross my mind just to end the constant itch and pain.
In September of 1997, I was given the opportunity to partake in this Targretin study which was the only thing left for me to do. I found the Targretin easy to take and I noticed a change in my skin within a few days. I started shedding layer after layer of skin. The cracks all healed and my skin slowly started to look normal. After being on the Targretin for a year and a half, the itchiness had finally subsided. My skin is now a normal texture and color. My lymph nodes have decreased dramatically in size.
The only side effects I have had are higher levels of cholesterol and triglycerides. I have been taking Lipidor to counteract this. I finally can live a normal life, work, and have fun outdoors, and feel there is a future for me and my family.
In October, I decided to come off the Targretin temporarily just to give my body a rest from all the drugs, but plan to resume the treatment should any problems arise.
Thank you. |
