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The most impressive results of a UC study to date?

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Ulcerative Colitis
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Posted 9/29/2013 12:04 PM (GMT 0)
Tofacitnib (xeljanz) is an oral biologic. Specifically it is an janus-associated kinase (JAK) inhibitor.

http://www.nejm.org/doi/full/10.1056/NEJMoa1112168   ---> Click pdf in the upper right to access the complete article.

Posted 9/29/2013 12:46 PM (GMT 0)
This is on my list to talk to my GI about for sure.
Posted 9/29/2013 1:41 PM (GMT 0)
I always find it amazing how well the placebo category scores. In this study a clinical response at 8 weeks was 42%. What's up with that?
Posted 9/29/2013 3:16 PM (GMT 0)
What do you find 'impressive' in this study? This was a clinical trial so without these results, they would have faced hard time with FDA approval process.
Posted 9/29/2013 4:51 PM (GMT 0)
I think Gary means that there is a strong possibility that your mind and mental state could be a significant factor in this disease. It varies for each person but the flare ups I've had have come after prolonged times of stress.
Posted 9/29/2013 10:47 PM (GMT 0)
deltaforce,

The response rates are impressive. 78% of people on the highest dosage of the medicine showed clinical improvement over 8 wks. I have never seen a number so high. And yes, obviously it is a clinical trial that needed statistically significant results to gain FDA approval.
Posted 9/29/2013 10:49 PM (GMT 0)
Yeah, Gary, the high placebo rates surprise me too. I guess this disease waxes and wanes for most people. For me, I've yet to achieve remission in two years.
Posted 9/29/2013 10:54 PM (GMT 0)
I find it amazing that 42% of patients in the study had a clinical response to a placebo. Although, more than likely, those on the "placebo" were probably on steroids and 5ASA's, which would mean that technically they did not get better by placebo alone.
Posted 9/30/2013 4:49 AM (GMT 0)
small study, only 194 adults involved. that's likely part of the reason the placebo group is so high. It would be good to see a second study with a higher # of participants. that said, the clinical response rates and remission rates are in the realm of remicade, not too shabby. high cholesterol is the biggest side effect, weird? at least there is no mention of malignancy here; no lymphoma.
Posted 9/30/2013 11:52 AM (GMT 0)
Lymphoma/malignancy takes more than 8 weeks to develop.
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