FDA Arthritis Advisory Committee Hearing for Pfizer’s RA JAK: Tofacitinb

Kelly & Katie Beth by White House

Advisory Committee hearing feed link

My daughter Katie Beth and I are in Washington, DC for the final FDA Arthritis Advisory Committee (AAC) hearing about Pfizer’s JAK, tofacitinib. Early in the morning, Katie Beth and I will be en route to the meeting.

The AAC meeting will be broadcast online with a live feed. We’ve been told I may speak between 12:30 and 2 pm EDT, depending on how long the morning session takes. Here is the link that should lead to the feed. (Thanks for getting it for me, Angie.)

My time will be limited to five minutes. So I feel like I’ve condensed six years of experience and my whole 650 page website into 1.5 typed pages. As my sons say, “Dude. Really?”

Yes.

Sweetness in between pain

Kelly by Washington MonumentThis afternoon, when it stopped raining we decided to walk down to the White House and take some pictures for Roo. It’s the one souvenir he really wants – the photos. (I still bought him something else, of course.) We made it there, and got some tourist photos. But getting back was seriously tough. I sat on every bench we passed, but there are no words for how bad my feet and hips and back hurt… Those of you who know don’t need to hear more.

Anyway, we somehow made it back for more meds. I’m sitting on the bed now with hot tea and piles of pillows. Feeling better except for the cramping of my feet which are still quite angry. Since I grew up in the DC area, the sweet smell of the spring trees adds a deep contentment. And I was so glad to have made it down there! This seems amplified if one has RA, but that’s life isn’t it? A lot of pain, with sweetness in between.

We’ll fly home Thursday and Katie Beth’s graduation from community college is that afternoon. This will be extra sweet since we didn’t hold a graduation from high school (homeschool)! It will be tight timing, but what kid going to pharmacy school would pass up an FDA hearing?

It has been tough, but we also can know we’re supposed to be here. Yesterday, we were assigned middle seats at the back of the plane – on separate rows and no one wanted to move so I could have Katie Beth with me. Where we finally ended up, the woman next to me just happened to work at the FDA and prayed for me to be well and for success of RA research! We even got to see a couple of special friends while we’re here. Watch for the sweetness. Even if it’s between the pain.

Kelly by White House

Recommended reading

Kelly Young

Kelly Young is an advocate providing ways for patients to be better informed and have a greater voice in their healthcare. She is the president of the Rheumatoid Patient Foundation. Kelly received national acknowledgement with the 2011 WebMD Health Hero award. Through her writing, speaking, and use of social media, she is building a more accurate awareness of Rheumatoid disease aka Rheumatoid Arthritis (RA) geared toward the public and medical community; creating ways to empower patients to advocate for improved diagnosis and treatment; and bringing recognition and visibility to the Rheumatoid patient journey. In 2009, Kelly created Rheumatoid Arthritis Warrior, a comprehensive website about RA of about 950 pages and writes periodically for other newsletters and websites. Kelly served on the Mayo Clinic Center for Social Media Advisory Board. There are over 42,000 connections of her highly interactive Facebook Fan page. She created the hashtag: #rheum. Kelly is the mother of five, a home-schooler, Bible teacher, NASA enthusiast, and NFL fan. You can also connect with Kelly by on Twitter or YouTube, or LinkedIn. She has lived over nine years with unrelenting Rheumatoid disease. See also http://www.rawarrior.com/kelly-young-press/

27 thoughts on “FDA Arthritis Advisory Committee Hearing for Pfizer’s RA JAK: Tofacitinb

  • May 9, 2012 at 1:44 am
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    My thoughts and prayers will be with you tomorrow. You will do what you have always done, represent us professionally. Thank you for what you do.
    God Bless You,
    David

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  • May 9, 2012 at 3:15 am
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    I wish I had known about this site and you coming to DC. I am an RA warrior, 24 and live in DC. Thank you for representing us. I have always wanted to get to know people who could be able to understand what I go through. I hope all goes well tomorrow and can’t wait to read what happens.

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    • May 11, 2012 at 1:30 pm
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      Hi Ruth! Can you send me an email if you’re interested? If you’d like to help, we have something coming up in your area. kelly AT rawarrior.com

      I’ll try to post an update asap about the meeting. It seems that tofa may get approved later this year.

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  • May 9, 2012 at 9:25 am
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    Kelly. I’m so excited for you and today and for all RA Warriors out there! Love you!

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      • May 9, 2012 at 1:51 pm
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        Oh, Kelly! I hope you have some heating pads with you to warm up after you return to the hotel.

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        • May 11, 2012 at 1:19 pm
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          Elizabeth, I was so cold & in so much pain & yawning, groggy from meds – when the hearing was over, I rode back to the hotel & went to sleep under blankets with my dress & hose still on! I sometimes wear a heating pad so I can speak without shivering – I wish I’d worn a pantsuit & heating pad as usual. Several mistakes on my part by not anticipating the situation I guess. You live & learn.

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  • May 9, 2012 at 1:35 pm
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    Tried to get in on the meeting but it says it was full! Yeah! That means alot of people are interested in this,thank you Kelly! Your truly an inspiration for us.

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  • May 9, 2012 at 1:47 pm
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    Well, drat! the computer “room” was too full for me to access. But I’m praying for you the whole time! You are our hero, Kelly! Go get ’em, Tiger!

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  • May 9, 2012 at 2:03 pm
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    Love you and praying your impact will be powerful and productive. Mom

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  • May 9, 2012 at 6:23 pm
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    Hi Kelly and Katie Beth,
    Kelly, I feel pain for you when you talked about your back, feet, and hip pain. I recently had left foot surgery from OA damage to some toe joints and I was scheduled for low back surgery last week but it is on hold for now. All RA/OA related. I read your article about being assigned middle seats in the plane. I have flown since diagnosed with RA and do to this disability, my RA doctor and Podiatrist both wrote a letter for me to give the airline attendant at the gate asking them if they could allow me to pre board and be seated in the front bulk head seats. The airlines do not require you to have a note nor disclose your disability but I bring it just in case any one thinks I’m pulling a fast one. I fly Southwest and whoever is with me is allowed to pre board and be seated with leg room especially for the stiffness. If you fly again somewhere, you might want to ask to pre board like with Katie Beth and this way you won’t be split up and be comfortable at the same time. The airlines are very accommodating with those with disabilities. Hope this helps you and the others reading this. Take care Steve P

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  • May 9, 2012 at 7:09 pm
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    Kelly thank you for all you do for all of us. Boy do I understand about your feet! Praying for you in my daily prayers.

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  • May 9, 2012 at 7:56 pm
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    Just heard that the FDA approved the drug—hooray! (They probably heard that you were coming to town and started shaking in their boots! And rightly so, since you had all of us cheering behind you!!) One Boston news channel had the announcement an hour ago, and perhaps the others also reported this news. Tomorrow’s newspapers may also have updates on this…..You may be tired and hurting today, Kelly, but the day was successful! Obviously, we don’t know all that went on, and we’ll look forward to your report, but we hope you received hope and validation today that what you are doing is so important to so many people!

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    • May 11, 2012 at 12:46 pm
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      I’ll try to type up a more detailed report today, Vi. The committee did recommend approval – with several caveats. The decision will be made by the FDA during the summer probably & we’ll know in a few months the final decision. But it’s likely yes after the votes this week. The last 3 weeks have been incredibly hard w/ lots of time on heavy meds or ice & pillows. Hopefully some rest & seeing the spine docs will ease it a bit – but I’ve numerous deadlines, etc. ugh…. I know you get it. Send Kaitlyn my love.

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  • May 9, 2012 at 8:21 pm
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    I knew that you were in DC but I forgot why. Someone on my friend’s list on FB posted an article about this Tofacitinb, and I started checking around. Since you’re able to get out and enjoy life in an area that you remember fondly, you may not have seen this? http://www.nytimes.com/2012/05/10/health/panel-supports-arthritis-pill.html?_r=1&smid=fb-share

    As always, they are worried about the cancer rate but doesn’t that go without saying with the RA crowd? I hope you have a great time! Thanks for being there and fighting for us. 🙂 I hope that Katie Beth has a wonderful time, too! And congratulations to her on her graduation!!!

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  • May 9, 2012 at 8:25 pm
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    One more article! I frequent the “Medical Prescribing Reference” website, eMPR. They also have a blurb on it, and they say, “The tofacitinib group showed statistically significant changes versus placebo in reducing signs and symptoms of RA, as measured by ACR20 response rates at six months. It also reduced the progression of structural damage and improved physical function. As for the 5mg twice-daily dose, the study only demonstrated statistically significant improvements versus placebo in ACR20 response rates at six months, but no differences elsewhere.” That sounds pretty significant to me!
    http://www.empr.com/phase-3-study-of-tofacitinib-for-rheumatoid-arthritis/article/200768/

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    • May 11, 2012 at 12:17 am
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      But the new drug which is a pill will be more expensive than the injections. That is a shame and I think the patent being up on lipitor plays into it.

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      • May 11, 2012 at 12:19 pm
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        Hey, Jenn, can you tell me where you heard that please? Everything I’ve read & everyone I’ve spoken with at Pfizer says the price has not been set yet. There are many factors which will affect it – like the 10+ years of research & clinical trials that went into developing the drug. I sure hope it would not be more, but hopefully we’ll find out later this year.

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  • May 10, 2012 at 1:11 am
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    hi kelly & katie beth:)
    all the best wishes for tomorrow!! no wonder you will do amazing as always. I’m so proud of you, Kelly AND you Katie Beth; we SO APPRECIATE your work!!
    I happened to have just made a flight from WA to WA DC~I also grew up DC area. now, I’m here to spend time with my Dad as he is fighting cancer and has been hospitalized receiving radiation treatments.
    I too had a middle seat and had no idea how bad my legs would feel by the end of the trip. when I switched planes in Chicago I just went up to the gate when they were doing all the preboarding and told her I was disabled and she let me right through…at least that made the boarding easier.
    also I brought my own pillow and blanket on the plane and that helped. I didn’t think about a bulkhead seat; thanks Steve:) that’s what I’ll do for my return trip!
    I’ll be thinking of you both tomorrow and sending you all the best! xojen

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  • May 11, 2012 at 7:02 pm
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    how very, very cool! Thanks for doing this for all of us – your presentation was wonderful!

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  • May 12, 2012 at 9:46 pm
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    Kelly, your written statement for the hearing is amazing. Perfect in every way. Thank you thank you thank you!

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  • May 26, 2012 at 10:23 pm
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    I did the Jak study and am at the tail end of 4 years for the different variences required. I am thrilled to hear it was approved, and sorry I hadn’t found this blog sooner!. first hand knowledge and being tested with this, I can tell you I literally went from steroid and 8 methyltrexate a week to the Jak. I had the placebo for the first three months, and could tell, literally within 48 hours when I had the real deal. I do battle many moment sof pain and fatigueas always, but my life improved 100%; from literally not being able to walk for more than a few steps or bend my knees to sit, to being able to move much more easily. I am working with the fatigue now, trying to understand when I have it and how to cope without becming distressed or depressed. God Bless You All.

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    • May 27, 2012 at 7:30 am
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      Thanks, Robin. I hope it will be made available & will work for a lot of people as well as it did for you. So many of us have been stuck where you were, having a hard time sitting or walking or using our other joints. I’ve become convinced that we need much more research and possibly other types of therapies so that we can all experience that reprieve.

      Reply

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