Xeljanz Update

My husband was scheduled to have first step of 3-step j pouch surgery today.

Ten days ago, to everyone's surprise, our insurance agreed to pay for Xeljanz even though it is not yet approved for UC. Delaying the surgery was not an easy or obvious decision. After having such high hopes for Entyvio and then suffering through it for 6 months with no response other than extreme fatigue, he was not eager to delay surgery for another experiment with drugs. However, the clinical trial measured effects after 8 weeks and 48% of people (very small group, admittedly) had improvements. So we are giving it 8 weeks.

His regular GI did not have a protocol in their office to prescribe the drug, but our second opinion doctor at Johns Hopkins was able to do it. We are his first patient to use it. Our pharmacist has never dispensed it. Definitely feel like a guinea pig.

He takes two pills in the morning and two at night (so much better than infusion). One week in -- no side effects; definitely feels better but it is too early to tell if it is the drug or just the ups and downs of UC. The big test will be in a few weeks when he starts to taper off the prednisone. Needs to get monthly bloodwork to check lipid levels.

Very little info from IBD sufferers using this drug in the cyberworld. I do note that there is someone on the Crohns page who got this off label and reports to be doing well.

I will update regarding progress, or lack thereof.

Thank you for the information. Since Xeljanz was in the pipeline, I have an eye on it. Since its debut in the market, I am hoping that it will be approved for UC. I personally have high hopes from Xeljanz. I hope it works with your husband. Please keep us updated.

Tried getting this in Canada but they wont budge

Just starting week 7 on Xeljanz, and so far cautiously optimistic it is working. Doc had said to start tapering off prednisone at week 4. Husband started tapering off of prednisone (22.5mg seemed to be the magic dose for keeping symptoms in check) at week 3. Had terrible symptoms for a week but they subsided. Now down to 10 mg prednisone, which he hasn't been able to do since the remicade worked briefly two years ago. Feels better than he has in a long time, and no apparent side effects. Big test will be in a few weeks as he completes tapering off the prednisone.

Keith,

The prednisone withdrawal is the next hurdle, perhaps. How long after you were off did it take before the symptoms subsided. Husband is going down 2.5mg every 6 days.

-Suzy

I've had it a few times, it is brutal. Once time I remember my hands just wouldn't stop shaking from it.

I had to go back on steroids once just to get the withdrawal to subside.

I think the last time I had withdrawal it took about 6-8 weeks to fully go away.

That sounds like amazing progress!!! I am so excited for you guys. I think the key is going to be going SLOW. I had to go at .5 a week when I was trying to get from pred to stable on 6mp. It took a long time but it got me a 1.5 or 2 year remission. Take it slow. I really hope his GI is able to help him work to get off slowly and keep things managed. :)

This report was from 2015. I was impressed with the study cited for xeljanz. If I'm not mistaken, it has the highest clinical response rate (in studies that I've seen) of all biologics. I'm not great at reading clinical trial results so feel free to correct me if I'm wrong on this.

This phase two study was for moderate/severe UC patients who failed other biologics...see below.

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4282853/

"1. Tofacitinib

Tofacitinib represents a new class of JAK inhibitor that inhibits JAK1, JAK2, and JAK3 to modulate the signaling of IL-2, IL-4, IL-7, IL-9, IL-15, and IL-21 receptors that are associated with six types of cytokine functions that integrate lymphocyte activation, function, and proliferation. In addition, by inhibiting JAK1, tofacitinib blocks the activities of proinflammatory cytokines including IL-6 and interferon γ, and by inhibiting JAK2, it blocks the signaling to erythropoietin. Because of its varied anti-inflammatory actions, tofacitinib is currently used in allograft rejection prevention, rheumatoid arthritis, and psoriasis.

Recently, a phase II, double-blind, placebo-controlled study evaluated the effects of tofacitinib administration for 8 weeks in 194 moderate-to-severe ulcerative colitis patients who did not respond to steroids, immunosuppressives, or anti-TNF agents.6 Patients were assigned to one of five treatment groups: tofacitinib 0.5 mg, 3 mg, 10 mg, 15 mg, or placebo in a 2:2:2:3:3 ratio. For 8 weeks, medications were taken twice daily, and the patients were followed for another 4 weeks.

The primary endpoint of clinical response rate at week 8 was 42% in the placebo group and 32%, 48%, 61%, and 78% in the tofacitinib 0.5 mg, 3 mg, 10 mg, and 15 mg twice daily groups, respectively (p=0.39, p=0.55, p=0.10, and p<0.001), showing a statistically significant difference only for the 15 mg twice daily group. The clinical remission rate at week 8 was 10% in the placebo group and 13%, 33%, 48%, and 41% in the tofacitinib groups, respectively, in order of increasing dosage, with the 10 mg and 15 mg twice daily groups showing statistically significant differences (all p<0.001). Tofacitinib dose-dependent increases in low-density lipoprotein cholesterol and high-density lipoprotein cholesterol were observed, and neutropenia which means absolute neutrophil count less than 1,500 per cubic mm was detected in three patients. In terms of serious adverse events, a single case each of postoperative abscess and anal abscess occurred in the 10 mg group. In conclusion, this study confirmed that tofacitinib was more effective than placebo in bringing about clinical response and clinical remission in moderate-to-severe ulcerative colitis patients.

In patients with active ulcerative colitis who do not respond to anti-TNF agents, tofacitinib shows clinical importance in that it can easily induce clinical response and clinical remission. However, since there have been no reports to date on remission maintenance with tofacitinib and only short-term side effects have been investigated, additional large-scale studies will be needed in the future to gather evidence regarding high remission maintenance and safety. Through this process, the role of tofacitinib in treating ulcerative colitis patients who do not respond to anti-TNF agents will be determined."

So buy stocks in this company then ?

;)

Husband just had colonoscopy which confirmed what we already knew -- he is in remission. No evidence of colitis anywhere. Mucosa totally normal. We still need to await biopsy results, however, doc was pretty confident they would come back normal.

So, Xeljanz seems to be doing the job. 4 small pills a day and so far no side effects. It is in Phase III trials in US and I have seen some news reports that Pfizer is hoping to get FDA approval for use in UC by 2017.

For what it's worth, GI has one patient in the Stelara UC study. Patient was like my husband in that remicade, humira, entyvio didn't work. Stelara is working great for this guy -- completely clean colon 8 weeks or so into the study.

Awesome, congrats.

Interesting, I wonder how many other AI diseases that Xeljanz will work for.

www.cnn.com/2016/10/18/health/experimental-drugs-restore-hair-loss/index.html

Drug reverses one baldness type; is male pattern next?

In his mid 40s, Mike Thomas went bald. Not a "little bald spot in the back" kind of bald or "receding hairline" kind of bald, but almost totally and completely bald. He was diagnosed with alopecia areata, an autoimmune disease, and he was devastated.

As part of a study conducted at Stanford and Yale, Thomas and 65 other alopecia areata patients took the pill, called Xeljanz, which is prescribed for people with rheumatoid arthritis, another autoimmune disease.
More than half of the study subjects saw hair regrowth. A third recovered more than 50% of their lost hair. In a separate study, nine of 12 patients with alopecia areata recovered more than 50% of hair regrowth using a similar drug, Jakafi, which is approved for cancer treatment

Sent you an email.