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Xeljanz Trial Update

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Ulcerative Colitis
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Posted 5/16/2017 12:47 PM (GMT 0)
http://www.businesswire.com/news/home/20160728006530/en/Pfizer-Announces-Positive-Top-Line-Results-Pivotal-Phase

As you know, we are a big fan of Xeljanz which has put my husband in remission after the other FDA-approved biologics didn't. I hope it gets approved by FDA this year. That should make it less of a fight with insurance for coverage.
Posted 5/16/2017 1:46 PM (GMT 0)
Seems like good results with the 41 percent that maintained remission after 52 weeks. Still wonder what level of UC the patients had at the commencement of the trial.
Posted 5/16/2017 3:28 PM (GMT 0)
Any idea when it will be an officially approved UC treatment? Still off-label that I know of.

Interesting but that article is from July 28, 2016. The latest news is the Phase 3 trial was posted in NJMA.

press.pfizer.com/press-release/phase-3-octave-studies-oral-tofacitinib-ulcerative-colitis-results-published-new-engla

www.nejm.org/doi/full/10.1056/NEJMoa1606910

The OCTAVE Sustain study evaluated the efficacy of tofacitinib as maintenance therapy compared to placebo in adult patients with moderate to severe UC. It included patients who had completed one of the OCTAVE Induction studies and had achieved at least clinical response

In OCTAVE Sustain, 34.3% and 40.6% of patients achieved remission at Week 52 with tofacitinib 5 mg BID and tofacitinib 10 mg BID, respectively, compared to 11.1% taking placebo
Posted 5/17/2017 4:22 AM (GMT 0)
from phase 3 to market can be 18 to 24 month, and to get preferred status on insurance formularies would take longer

but this is already on market, so, hard to know how long for uc approval
Posted 5/17/2017 8:15 AM (GMT 0)
DB,

Like you said, xeljanz is already on formularies so it should be easier to get approval.

Patients maybe a be able to get off label approval easier now that the phase-3 study has come out. This was the case with me and Stelara, the phase-3 study came out and was submitted for approval for CD and my insurance company approved it for me without too much difficulty.
Posted 5/24/2018 5:30 AM (GMT 0)
Hello suzy, I am also on xeljanz for 2 months now but only 5 mg twice a day. Although it worked like magic the first month its appeared to have become less effective in the past month and scope today showed mild- moderate inflammation still. Like your husband I only responded to steroids also. My question for you is, did your husband every flare while one Xeljanz? Did he ever try lowed dose at 5 mg twice a day (thats all i am approved for right now unfortunately...) How long was he on steroids before he developed osteoporosis? I have been on them for the greater part of a year ( I was diagnosed 1.5 year ago). I thought it wud be the miracle and it was for a while but now I'm worried again about possibly needing surgery. Im surprised it lost effectiveness since it shouldn't produce antibodies to it unlike the tnf drugs...
Posted 5/25/2018 2:50 PM (GMT 0)
I responded to your question re dosage in your other post. Your insurance should cover the higher dose. It's what our GI typically prescribes and I think it is consistent with the Phase 3 results. Husband takes 10 mg in the morning and 10 mg at night.

He had some very minor setbacks in the first few months, like blood, but nothing like a flare. Six months in he was in full remission and has been good ever since.

He was first tested for osteoporosis about 3 years on steroids. He has been on prolia for the past 18 months to address the osteroporosis -- sometimes steroid-induced osteoporosis supposedly responds to those drugs.
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