Wanted to report on my visit to the Cedars Sinai IBD research center in Los Angeles.
After having failed Humira and Entyvio my GI was looking for consultative advice from the Crohn researchers as to what to do next.
For Cedars Sinai my case was on special interest since I had Crohns for 45 years and later they found I had participated in Stelara research 9 years ago.
http://www.cedars-sinai.edu/Patient...mmatory-Bowel-Disease-Center/Expert-Team.aspx
This place is a treasure trove of Crohns statistics, I had to fill out dozens of pages of questionaires, when I got there had two more nurses to answer even more questionaires.
When I got to talk extensively with the Center director Dr Gil Melmed he was constantly typing in the keyboard collecting more data which centered around:
The progression over the 45 years of my Crohns and where the surgeries took place: Bowel resections and where the next bowel resection took place (usually on the Anastomosis), where were the fistulas and strictures, where did Crohns go next: the different parts of the colon primarily ulcers (e.g. the Secum was removed back in 95), progression to the rectum and now the anus which is the worst of all.
He was interested in all the drugs I had taken over the years (the ones that did not work: Azulfidine, Pentasa, Asacol, Prednisone) and in the last 10 years Humira (which worked wonderfully for 3 years, needed to be cranked up from once every two weeks to every week, eventually stopped), and this year Entyvio which after 7 infusions it had not worked at all. All of these were mono-therapies and he was surprised that I did not try combo therapies (e.g. Imuran) The industry kept saying that Entyvio was slow, that you need to wait until infusion 5 or 6. I waited and waited and by infusion 6 I had scheduled Dr Melmed which took two months to arrive at the appointment, by then I had infusion 7 and still no results. $34,000 spent on Entyvio by the insurance company.
They were very interested in what anti-inflammatory supplements I was taking: Fish Oil, Curcumin/Turmeric and Boswelia.These have been helpful. Not effective: Colostrum, Peppermint Oil, Aloe Vera, and Flax Seed Oil. I tried them because others were showing benefits but not for me.
\
Now we get to the real reason why I was there:
I wanted to get a recommendation for off-label use of Stelara which is currently approved for Psoriasis via injection four times a year.
This center is part of the Uniti-2 study for Stelara with 612 Crohns patients on the program. They have all kinds of statistics on the response rates for the different dosages and frequency of administration.
I had participated in 2006 on the CNTO 1275 which was the name for Stelara while it was not yet in the marketplace. They were extremely careful in administering increasing dosages to humans, I was the first in California to receive it and they kept monitoring my blood and particularly the liver for any toxicity. I received 80 mg on week 1, 80 mg on week 2, 80 mg on week 3 (my Crohn symptoms dramatically decreased at this point). I was given one more 80 mg on week 4, they stopped for a month, then I got 4 more injections on the final month. Went into remission for about 5 months, but unfortunately these clinical trials are not a form of treatment so I did not get no more. Stelara was then marketed as a Psoriasis drug, been waiting for nine years for the release as a Crohns drug.
The problem with Stelara is this: the psoriasis dosage is very light: 45 mg via injection four times a year. That will not do it for Crohns. Dr Melmed had tried many dosages over the control groups and gone as high as 400 mg with a lesser dose 6 times a year. At these levels it has to be administered via infusion. The positive clinical response rate was 69% and 41% for remission.
http://www.streetinsider.com/Corpor...TI-2+Study+Met+Primary+Endpoint/10981026.html
http://www.ccfa.org/news/stelara.html?referrer=https://www.bing.com/
This center maintains extensive statistics on the sequencing of successes and failures with other drugs. He said that people who had responded to anti-TNF medications (in my case Humira) will probably do well with Stelara. People who did not respond do better with Entyvio.
I know that statistics is not the final truth. People respond differently to the same drug. But it is impressive when a doctor knows what the previous 612 Crohns patients success have been. That is a far cry than a GI that may have 15 patients on the drug. (and no experience with Stelara).
So when do I get Stelara ? Unfortunately need to wait another year until the FDA approves it and the manufacturer releases it. Then it will most likely be an infusion so the Psoriasis injection dosage will not do it.
What do I do in the meantime ? He suggested combo therapy with Remicade and Imuran. But I asked: I failed Humira, don't I have now antibodies for anti-TNF agents? He said that the anti bodies are chemical specific to each medicine, e.g. Humira, and he has statistically found that you can still do well with Remicade.
Stelara works differently than the anti-TNF drugs by since it is directed against interleukin 12 and interleukin 23, naturally occurring proteins that regulate the immune system and immune-mediated inflammatory disorders.
The doctors report will be sent to my GI, one of four GIs at my home office. They treat with Humira, Remicade and Entyvio. With Entyvio they have 15 patients, 10 which Entyvio has worked and 5 where it has not worked, I am one of the last 5. For now I will probably go with Remicade and Imuran and we will see what happens.
Dr Melmed ordered an MRE which is very different and much more expensive than the traditional CTE which we all have had. The MRE can display internal fistulas which are not visible with other tests.
Dr Melmed is by physician referral only, he takes long periods where he is more of a scientist and does not see patients at all. If I wanted another appointment I have to wait 3 months until March.
I hope that all this information is useful. I feel that from 1970-2005 the progress of Crohns drugs was dismal. The last 10 years have seen an acceleration of new drugs (anti-TNF and protein inhibitors) and observations on combo therapies like Remicade and Imuran.
Combo therapy has its risks (lymphoma) see article on its risks and the difference between clinical vs transmural remission:
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3380260/
After having failed Humira and Entyvio my GI was looking for consultative advice from the Crohn researchers as to what to do next.
For Cedars Sinai my case was on special interest since I had Crohns for 45 years and later they found I had participated in Stelara research 9 years ago.
http://www.cedars-sinai.edu/Patient...mmatory-Bowel-Disease-Center/Expert-Team.aspx
This place is a treasure trove of Crohns statistics, I had to fill out dozens of pages of questionaires, when I got there had two more nurses to answer even more questionaires.
When I got to talk extensively with the Center director Dr Gil Melmed he was constantly typing in the keyboard collecting more data which centered around:
The progression over the 45 years of my Crohns and where the surgeries took place: Bowel resections and where the next bowel resection took place (usually on the Anastomosis), where were the fistulas and strictures, where did Crohns go next: the different parts of the colon primarily ulcers (e.g. the Secum was removed back in 95), progression to the rectum and now the anus which is the worst of all.
He was interested in all the drugs I had taken over the years (the ones that did not work: Azulfidine, Pentasa, Asacol, Prednisone) and in the last 10 years Humira (which worked wonderfully for 3 years, needed to be cranked up from once every two weeks to every week, eventually stopped), and this year Entyvio which after 7 infusions it had not worked at all. All of these were mono-therapies and he was surprised that I did not try combo therapies (e.g. Imuran) The industry kept saying that Entyvio was slow, that you need to wait until infusion 5 or 6. I waited and waited and by infusion 6 I had scheduled Dr Melmed which took two months to arrive at the appointment, by then I had infusion 7 and still no results. $34,000 spent on Entyvio by the insurance company.
They were very interested in what anti-inflammatory supplements I was taking: Fish Oil, Curcumin/Turmeric and Boswelia.These have been helpful. Not effective: Colostrum, Peppermint Oil, Aloe Vera, and Flax Seed Oil. I tried them because others were showing benefits but not for me.
\
Now we get to the real reason why I was there:
I wanted to get a recommendation for off-label use of Stelara which is currently approved for Psoriasis via injection four times a year.
This center is part of the Uniti-2 study for Stelara with 612 Crohns patients on the program. They have all kinds of statistics on the response rates for the different dosages and frequency of administration.
I had participated in 2006 on the CNTO 1275 which was the name for Stelara while it was not yet in the marketplace. They were extremely careful in administering increasing dosages to humans, I was the first in California to receive it and they kept monitoring my blood and particularly the liver for any toxicity. I received 80 mg on week 1, 80 mg on week 2, 80 mg on week 3 (my Crohn symptoms dramatically decreased at this point). I was given one more 80 mg on week 4, they stopped for a month, then I got 4 more injections on the final month. Went into remission for about 5 months, but unfortunately these clinical trials are not a form of treatment so I did not get no more. Stelara was then marketed as a Psoriasis drug, been waiting for nine years for the release as a Crohns drug.
The problem with Stelara is this: the psoriasis dosage is very light: 45 mg via injection four times a year. That will not do it for Crohns. Dr Melmed had tried many dosages over the control groups and gone as high as 400 mg with a lesser dose 6 times a year. At these levels it has to be administered via infusion. The positive clinical response rate was 69% and 41% for remission.
http://www.streetinsider.com/Corpor...TI-2+Study+Met+Primary+Endpoint/10981026.html
http://www.ccfa.org/news/stelara.html?referrer=https://www.bing.com/
This center maintains extensive statistics on the sequencing of successes and failures with other drugs. He said that people who had responded to anti-TNF medications (in my case Humira) will probably do well with Stelara. People who did not respond do better with Entyvio.
I know that statistics is not the final truth. People respond differently to the same drug. But it is impressive when a doctor knows what the previous 612 Crohns patients success have been. That is a far cry than a GI that may have 15 patients on the drug. (and no experience with Stelara).
So when do I get Stelara ? Unfortunately need to wait another year until the FDA approves it and the manufacturer releases it. Then it will most likely be an infusion so the Psoriasis injection dosage will not do it.
What do I do in the meantime ? He suggested combo therapy with Remicade and Imuran. But I asked: I failed Humira, don't I have now antibodies for anti-TNF agents? He said that the anti bodies are chemical specific to each medicine, e.g. Humira, and he has statistically found that you can still do well with Remicade.
Stelara works differently than the anti-TNF drugs by since it is directed against interleukin 12 and interleukin 23, naturally occurring proteins that regulate the immune system and immune-mediated inflammatory disorders.
The doctors report will be sent to my GI, one of four GIs at my home office. They treat with Humira, Remicade and Entyvio. With Entyvio they have 15 patients, 10 which Entyvio has worked and 5 where it has not worked, I am one of the last 5. For now I will probably go with Remicade and Imuran and we will see what happens.
Dr Melmed ordered an MRE which is very different and much more expensive than the traditional CTE which we all have had. The MRE can display internal fistulas which are not visible with other tests.
Dr Melmed is by physician referral only, he takes long periods where he is more of a scientist and does not see patients at all. If I wanted another appointment I have to wait 3 months until March.
I hope that all this information is useful. I feel that from 1970-2005 the progress of Crohns drugs was dismal. The last 10 years have seen an acceleration of new drugs (anti-TNF and protein inhibitors) and observations on combo therapies like Remicade and Imuran.
Combo therapy has its risks (lymphoma) see article on its risks and the difference between clinical vs transmural remission:
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3380260/
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