I agreed to participate in a clinical trial for a new biologic drug and they just called me and I will start my trials Tuesday.
This new biologic is taken orally and the doctor told me that this is part 2 of the trials and they had wonderful results with part 1, the drug has a very high efficacy rate and less than 1% of the patients had any side-effects and the ones that showed up were very mild, the name of the drug is Apremilast, I'll keep yall posted on my results as I go along!
I'm so excited and I pray it works, I think this is a very good time for me to do a clinical trial because I'm in a flare, it's a moderate one but it's been getting slowly worse for the last month or so.
Hi Michelle,
That's so exciting! Keep us posted and I hope it helps!
~Molly B (Seattle)
Thanks Molly and I will definitely keep yall posted! They actually do a lot of clinical trials here, I was in the Enbrel clinical trials too, I was a little nervous for that one, it was one of the first biologics and the risks seemed so high because I wasn't used to hearing about such serious side-effects like Leukemia, Cancer, Sepsis, etc. but everything worked out fine.
wow, an oral biologic
here's hoping two things:
1. it works well for you and
2. it may possibly be cheaper (for everyone) than the others out there now.
do you know anything about that last point?
even if its not cheaper, it would be more convenient.
do you know if its safer (in regards to the suppression of the immune system and those kinds of side effects)? or are the risks similar? is it a TNF inhibitor?
so many questions LOL
sue
Sue, I don't know the answer to the cost question but per the immune system suppression...Biologics are specifically designed to suppress targeted parts of the immune system. I will ask about the cost for you though and share any information that I'm allowed to.
hi michelle,
i got some of my questions answered here:
http://www.mskreport.com/articles.cfm?articleID=2811satisfied my curiosity about what part(s) of the immune system it went after.
i should probably hunt first, then ask my questions.......
that's what i expect my students to do LOL
the cost question is probably something everyone would be interested in.
thanks,
sue
Hi Michelle,
That sounds great. I hope it works out well for you. I wonder that since it's oral, if it is less potent, but yet just as effective as other biologics. Very interesting trial.
Take care,
James.
Hi James and thanks, how are you feeling today, any improvement? I certainly hope so, you've had a rough go of it...I'm not sure if Apermilast has a different potency than the other biologics but I'm sure when I get the trial packet it'll have that info in it, when I did the clinical trials for Enbrel, we were supplied with a library of info on it...I am wondering if there's a different absorption rate since it's going through the stomach, that may somehow make it more effective and I know it targets IL23 (the Interleukin 23 gene) that we've been hearing about so much lately.
Hi Michelle,
Yes, I am doing much better today. Thanks for asking. I started to feel better as I was replying to everyone yesterday, and then I got caught up on my sleep which helped alot too. My stomach isn't feeling too bad either.
I was always wondering when they were going to start making these types of meds in a pill/oral form. I'm glad they are working on that now. It's something to look forward to.
take care,
James.
Is the trial for AS or Psoriasis? It looks like a IL 23 blocker WAY cool
My bet is that it works
Wow. That's cool a pill. I hope you have great success on the new medication Michelle. Please keep us posted on how it's working for you!
Kim
Michelle, I'm so excited for you! I'll be checking in for your updates. Fingers crossed that this gets you out of your flare. Mind if I ask what indication this trial is for? Psoriasis?
Michelle.
That's great. I'm so excited for you. Definitely keep us updated, as I know you will!
Hopefully this will get you out of your flare.
Michelle... How great!!! Do they give you the option of dropping out if you find you are in the placebo group, or if everything stops working? I was offered to go into a trial once, and turned it down because I was in a particularly nasty flare and didn't want to take the chance of getting a placebo. Keep up the fight.
Hi Drizz...I'm beginning in Phase 2 of the clinicals, Phase 1 was targeted at psoriasis and Phase 2 will be an increase in dosage and will target inflammatory diseases. I agree with you, I think it will work!
I will definitely keep yall posted Kim, I think this drug is going to have a huge impact on AS, to date, I'm the only participant that has AS.
Hi Megan, I will be in Phase 2 which targets inflammatory diseases, I'm the AS guinea pig but they had amazing results with Phase 1, which targeted psoriasis and I'm sure it will help mine, my psoriasis gets crazy when I'm going into a flare.
Oh, I will Sarah...
Hi Dean, I would complete the study even if I found out that I was getting the placebo, just so the study data would be reliable but I'm pretty sure that I'm going to get the real thing and I'll tell you why...the doctor told me that she was very happy to find someone who has AS to participate in her study.
Hey James, I'm glad to hear that you're feeling a little better today, I just got back from doing my labs and x-rays for the clinical trials....YEA!!!
Thanks Ben, I'm keeping my fingers crossed that this will be the one! I hope all is well with you, it's always nice to see you when you drop in...
Wow Michelle... this is exciting news! I am so grateful to those who participate in these trials to further the research that has such potential to help our community.
Gee that is one small sample size for AS so far, lol, I hope they'll be able to recruit a few more ASers ... I'd try not to get your hopes up too high though, as most often these trials are blinded, meaning that even your doctor won't know whether you're getting the placebo or not. Errr, but maybe that's not the case for phase II trials???
Yay - it will be so interesting to read your updates and I'll be keeping my fingers crossed that this new med will work wonderfully for you! I heard they've been working furiously on pill versions of these meds and if they have the same positive effects they'll be such a blessing.
So cool that this one targets IL23 + TNFa.
from Celdene.com:
"Apremilast is a member of a proprietary pipeline of novel small molecules with anti-inflammatory activities that impedes the production of multiple pro-inflammatory mediators by inhibiting PDE4 resulting in reductions in TNF-alpha as well as interleukin-2 (IL-2), IL-17 and IL23, interferon-gamma, leukotrienes, and nitric oxide synthase. Apremilast is our lead investigational drug in this class of anti-inflammatory compounds. Based on promising results from proof-of-mechanism and clinical studies, Celgene is accelerating clinical and regulatory strategies for apremilast in psoriasis and psoriatic arthritis, as well as embarking on exploratory clinical trials in rheumatoid arthritis and additional rheumatic, dermatologic and inflammatory diseases to determine the potential of apremilast across a broad range of debilitating inflammatory diseases."
Hugs and best of luck!!
mig
Hey Mig, I just called the doctor's office, Shondra was gone for the day but her assistant answered the phone so I asked her if it was a blind or double-blind study and she said that she didn't think it was either....I hope she's right but I will find out everything Tuesday...
Oh wow that is great for you Michelle!!!
And thanks for checking for me.
I was rather curious to know.
More hugs,
mig
Michelle!!!! I'm keeping my fingers crossed for you!! Please do keep us posted.
Warm hugs,
Well, I'm not totally sure yet Mig but I'm so hoping that she's right!
But even if it is a blind study, my chances of getting the drug are way better than if I don't participate at all....
Hey Kat...I will keep yall posted and I'm going to share every bit of information that I'm legally allowed to on this....
How cool! I can't wait to hear your updates!
Thanks Gardengirl, I'm pretty excited about it....it will be wonderful if it works!!
Wow, just read your post Michelle, and this is exciting news! Look forward to hearing updates from you.
Brad
While I know nothing about this drug, I think it has one thing going for it that should almost guarantee it is cheaper than all the other biologics, and that is the pill delivery. Every insurance company I've ever dealt with seems to keep all "injectable drugs" in a special class all their own. Don't know if this arose due to the injection delivery of insulin for diabetics, but I'd be surprised if that didn't somehow play a part. I think injection is always the least desirable form of delivery for drug companies, as it costs more to produce, has more side effects due exculsively to the injection itself (ie, infection and/or sepsis), and it is frowned upon by insurance companies. Therefore, it would seem that any drug that can be delivered in a pill instead of an injection (or, as in the case of Remicade, IV infusion) almost HAS to be cheaper. I would be happy to be shown to be wrong about this--well, happy isn't the right word, as that would mean there is a chance the pill will cost as much or more than the injectables, but you know what I mean!
And, if I am right and it is cheaper, how much cheaper remains to be seen and will likely not be known until just before they are ready to release this drug (assuming all trials go ok, knock wood).
Brad
Well, one thing is for sure Brad, it'll be more popular with the patients! I think production costs will be less given the pill form and I think we'll see generics popping up after the three year exclusive....the trials look great so far, from everything I've been told...so I'll just keep my fingers crossed!
i agree with you brad, that's exactly what i was thinking, that's why i asked.
sue
I'm hoping it will be less $ than the injectables.
But my bf made a good point - wouldn't you pay a few bucks more for the convenience of a non-injectable, non-refrigerated medication?
I certainly hope the drug company doesn't try to take advantage of patients because they know this will be a first choice over injectable meds.
Nonetheless, I'm pretty excited there is a new on one the horizon. I seem to have gone through nearly everything else available on the market!
I hope so too Megan and I really don't see why it wouldn't be cheaper, it would really be great if Walmart would add it to the $4 list....hah! Seriously though Megan, I hope this drug continues to show so much promise, it would be absolutely wonderful if it delivers all that they hope it will....I know you've been through a lot at such a young age, it would be nice if you could find something that really works for you...I told my children about it tonight and they were pretty excited. Erica & Kristen both have been Dxed with Fibro since they were 15 and Erica also has a Dx of Rheumatoid Arthritis and her rheumy suspects Lupus, she had a really rough couple of years but when she turned 19, she went into remission and she only has pain occassionally but I reminded her tonight that given our family link there's a very good chance that one of them or one of their children will have problems at some point and it would just be great if we can find something that works before that happens. Well Megan, let's keep our fingers crossed on this one...
Michelle,
This sounds exciting and I hope it works!
Keep us all updated and let us know if you are feeling any side effects ect...
Hugs,
Lisa
I hope it works, and that it will not also work for MS. That is what I am looking for something that will treat all the diseases that end in 's'.
I hope so too Orch, I have two sisters with MS and the only medication that they're prescribed is Prednisone, one of them has been on it for over 20 years and the same for my Mother, she has Systemic Lupus...
Michelle,
The doctor put me on Avonex (interferon beta-1a) for the MS. She said it is proven to slow MS down. It does not stop it, but it will spread the attacks farther apart. I am surprised that your sisters have not been put on a similar drug. I am scared of prednisone. I do have to use the drops for iritis. The gave me three day dose of solumedrol when I was having an MS attach.
Hi Orch, it may be that Sandy is taking something besides prednisone, her MS is further advanced than Pam's but I'd have to say that Sandy has been doing pretty good for the last 10 years or so, she was diagnosed in the late 1980s, she was sitting at her desk and went blind in one eye, totally without warning and she was rushed to Houston and until the late 90s, she had an awful time with it! I came across a study, if memory serves me right, it was done by Princeton, anyway some grad students got the names of 1,000 people who'd had Mononucleosis when they were young, all of them were in their teens when they had it and this was 20 years later, those were the parameters the students chose, anyway, they asked them hundreds of questions and the results showed that a very high percentage of them had developed MS within the 20 years since they'd had Mono, I just thought that might be of interest to you....tomorrow is the big day!!
Good luck tomorrow! Do you have any idea yet how frequently you will take this drug?
The Mono connection is interesting I had mono when I was 10.
Hi Janet and thanks, no, I don't know how long I'll be taking it, I was so excited to get in on this one that I really didn't ask many questions...
...but I'll find out tomorrow and I'll post everything I know, I'm so excited to get started..
Wow, Orch! I'm going to try to find that study, it's been awhile since I came across that, I don't even think the internet was around then!
Good luck. I have been taking Enbrel for 3 months. But I started the NSD 3 weeks ago and have been able to do O.K. without it. I am working through my NSD which has been a LSD (low starch diet) on the week-ends. Anyways, I hope it works.
Thanks Jorg...I love Enbrel, it did a world of good for me when I was on it and the benefits from it lasted a year after I quit was off it! Good luck with your NSD and LSD...
Well, I'm off to see the wizard....
Thanks for the information Michelle
You're so welcome Orch, I know there are more articles on the web but I was in a hurry this morning..so I posted the first decent one I came across.
Okay...I went to the start day of the clinical trials and guess what?! She told me that I can share every single detail with yall...I have all the info on the study, she gave me a big packet after I told her about yall and told me to knock myself out, it wouldn't compromise the study or break any rules!
I asked her a couple of questions that I know yall really wanted answered....Yes, this drug is expected to cost a fraction of all the other biologics, that is the main goal of the manufacturers, this will be the first drug of it's kind that this particular manufacturer will produce, all of their other drugs are cancer drugs(she used another term but you get the jist), also, all of the participants will recieve the drug!
We will be split into 4 groups...the first group will recieve 10 mg. the second group 20 mg., the third group 30 mg. and the fourth group placebo(but only for the first 3 weeks), after that EVERYBODY gets the drug!!
She even drew us a flow chart!! And the study will last 9 months for most participants and up to 2 years for others! I've been dying to get to the computer to update yall but it's been a crazy day! I had a squirrel jump on my head this morning, literally, he was so hungry, he was panhandling...so now he lives in the house, I'm posting about it next, I got a couple of pictures ...he's just a baby, no bigger than my hand!
Erica is sick and I've got the baby and it's been a crazy day! I haven't even had a chance to read the packet but I'll get to it later and I'll share info and scan pages and if anyone has any questions...feel free to let me know!
A squirrel!??!!?! Oh, I can't wait to see the post!
Isn't he a doll!!
That's awesome Michelle. Keep us updated on everything and I can't wait to see what this drug is about, so to speak.
I absolutely, positively, will keep yall posted!
I'm so excited!
A squirrel on your head!
now i've heard of everything!
that sounds like the seinfeld episode where a bird flew into Elaine's head;
http://www.youtube.com/watch?v=wYMtielZN24and for the record, i'm not insinuating anything
sue
Too funny Sue!
I posted pictures of the little stinker on "Rocky Rescue", he's really cute...
I've been so busy the past few days that I pop in & out quickly throughout the day...but it seems like I haven't seen you posting as often as usual, are you feeling okay?
hi michelle,
thanks for asking about me.
i'm OK, just busy at work.
sue
Well it's good to hear that you're alright but sorry that you're having to work so hard.
don't worry about me, i'm just doing more of what i should be doing and less goofing off
i'm lucky to have a job that i like, and mostly the hours are self imposed.
sue
I bet you are excited Michelle! I can't wait to hear how you do on this!
Hey yall, I took my first dose of Apremilast this morning!
I was sent home with 10 days worth, 2x daily, so far, I feel the same. I hope I'm getting the real thing, that would be great but I've got a 75% chance of getting meds and a 25% of getting placebo and after 8 weeks everybody will be getting the medicine, so I can wait.
Well, Day 2...
I noticed maybe a slight improvement in my stiffness this morning, maybe a coincidence but duly noted, my pain levels are still the same but my skin looks much better, most of the redness is gone.
Yes! Michelle I am keeping my fingers and toes crossed for you! Great to hear what is happening and that so far, all is well!
Woohoooo!
I am also crossing my fingers! But not my toes. I don't want them to fuse that way.
Lol ... I am lucky that way, my toes are unaffected!
(mig quickly knocks on wood)
Well, week two...so far, so good...my inflammation levels are down and my energy levels are up, I think because I'm sleeping better due to less pain...also, stiffness levels are down significantly!
I kind of tricked my study doc today....I was chatting her up while she was a little distracted.... I asked her what they make the placebo out of and she told me it was basically nothing and I asked her if there was anything in it that could possibly cause a little stomach upset about 20 minutes after taking it...and she said no....
You are sneaky!!! LOL Glad it's helping!!
Michelle, I'm keeping my fingers crossed for you. You are pretty sneaky.
Warm hugs,
Hi Kat and Molly, thanks for rooting for me, I hope it turns out to be all we've hoped for....the expectations on this are pretty high and so far, so good...I'm off to see the wizard...
Today marks the beginning of the third week in the clinical trials, my skin is completely clear now, it's amazing, to say the least!
However, my pain levels are way up there, we have a cold front moving through and the temp went from the low 80s to the mid 30s(at night) in a little over 24 hours, so I've been experiencing terrible pain the last few days. It could be that I'm on the low dose, or maybe even on placebo, I'm thinking that maybe the higher doses would be for treating inflammatory diseases and I really don't think I'm on placebo because I'm seeing the same wonderful results in my skin as I did with Enbrel, it's basically 100% clear and the color of the skin in those areas is the same as the rest of my skin, it's usually really red from the inflammation.
That is awesome that this new drug shows promise!! I hope that this goes to market soon. i have been on humeira for 3 months with decent results, and noticed that my skin and psoratic areas disappeared. I understand about the effect of weather on pain levels, hang in there!
S
Hi Sal, I hope this drug hits the market soon too, that would be great! I'm glad to hear that the Humira is working for you....take care...
Hi Everyone...I just wanted to drop in and update everyone on the clinical trials....I'm in week four now and the results have been fantastic!
My skin is 100% clear now and my energy levels are the highest they've been in a few years! I've been traveling to meetings about the Doctor Fish Spa, doing presentations and have been putting in 16 hour days between that, the fish keep me hopping too and I've been catching up on things around here and I'm able to keep up without a problem, I'm doing things that I haven't been able to do for quite awhile now...I'm still having morning pain and stiffness and muscle and joint pain at night but I think that may be due to all of this activity and it goes away after I'm up for about an hour and I'm able to sleep at night...it's good rest too because I'm worn out after a long day....also, my stomach is healing up nicely! I hope it continues to go this well and that it becomes available to everyone soon, it is really making a difference!
I've been swamped lately and I miss everyone but I have been dropping in and keeping up with yall....
Thats wonderful. I am so glad its working for you. I too hope it becomes available soon. But keep up the good work being a trail blazer for the rest of us and thank you.
Thanks Patty....I know the results from the first phase of the study were very favorable, so I don't think there will be any problems getting it out there...I was amazed that everyone around me caught a virus and I managed to escape it, when I was Enbrel, I had a lot of problems with viruses, not to say that I didn't get wonderful results with it though, it worked great for me but I do like that Apremilast is a gene specific biologic. Take care...
fantastic! hope it continues!
thanks for letting us know,
sue
THanks for the updates Michelle. I'm always wondering how you're doing.
So glad to hear you're doing terrific on the new med!
You are already at Superwoman status, I can't imagine all you can do if you are feeling better....YEA!
Your never far from my thoughts, Im glad you are doing so well.
Hugs,
Lisa
Thanks Sue, I'm keeping my fingers crossed too!
Hi Megan...thanks for the support, I'm not sure, but I don't think I'm on the maximum dose, if I'm not, I will be soon as the doses are raised after 8 weeks for all study participants, I hope all is well with you....Take care....
That sounds great, now if it will work for MS also then I would be set. I hate the shots I have to take for MS, but the AS is what really causes me more problems.
Hi and how is it going so far? Sounds very promising, and you are a trail blazer!
Jan
Hi Orch...I really don't know if it would help your MS symptoms but I will pick the study doctors brain and try to get an answer for you on that but it would be great if you could get some relief in the AS area, I can't imagine trying to cope with MS too....you are definitely an inspiration....I was telling my sister about you last week, she was amazed at your accomplishments!
She's been having a rough go of it with her MS symptoms lately and I felt like she could really benefit from the site, so I directed her here and she's been "lurking" ...hopefully she'll be part of the gang soon....
It's going great Jan and thanks for the support, I hope all is well with you....
Just an update...I had an accident Thurs. afternoon, I didn't think it was too bad but that night, it became apparent that I needed to get checked out. The ER doctor sent me to a surgeon and I'll have surgery Monday morning so I called the clinical trial doctor to let her know and I told her that I don't want to have to drop out of the trials, she contacted the surgeon to check the medications that he anticipates having to put me on, there's no contradiction there and the hospital agreed to let me keep on with the trial drug while under their care, the only thing they said of course was that the hospital staff can't dispense the medicine, so that worked out well.
Aw Michelle... I am so sorry to hear you had an accident and are in need surgery too.
I am glad to know it won't mess up your trial on this new med but more than anything I hope you will have a speedy recovery and that they will take great care of you. How long will you have to be in hospital for, do you know yet?
Please take very good care and know that I'm thinking of you.
mig
Michelle I am so sorry you had this happen and extremely sorry you need surgery. I am glad you are able to stay on the meds. Please let us know how you are doing when you can. I be praying for you.
Hi Mig, I shouldn't be in the hospital for more than two days, I would already have it behind me, but my surgeon is out of town and won't be back until Monday and since he's familiar with my medical history, i'd prefer to wait. I'm glad that I can stay on the Apremilast but am disappointed by the set-back elsewhere, everything was shaping up nicely but there's nothing I can do about it, so...I might as well take advantage of the down time and get some much needed rest, post-op, I can delegate tasks to get this spa up and running, I'm confident that I'll be able to put time in, just no lifting until the ribs, clavical and shoulder heal. Take care and I'll be thinking of you too, my friend....
Hi Patty, thank you so much, I appreciate the prayers and I will be checking in....
oh dear micelle, so sorry to hear the news
here's wishing you a quick recovery.
sue
Thank you so much Sue...I really appreciate your well wishes...
I had no idea that I was going to need surgery, I expected to hear that I had serious bruising....
Hey Michelle, just wanted to wish you luck. I'm sorry you have to deal with all of this, but glad that you don't have to discontinue the trial.
How's it working for you, by the way?
Warm hugs,
Hi Kat, thanks, it realy wasn't a serious accident but I broke some ribs in my chest in an equestrian accident, years ago and they had to be wired because they broke close to the sternum and were unstable, since then, I've been having a lot of pain and inflammation in that area and I suspect some fusion, for the past six months or so, I've been feeling like that area was out of misaligned and I've had to stretch several times a day until it "goes back into place", I can actually feel it kind of pop back into place but since the accident, I can't pop it back and the doc told me that the whole upper left quadrant is in a bind, putting pressure on my clavical, scapula, shoulder and ribs....so, off to surgery I go. The clinical drug has been working wonders for me, I feel almost like my old self, my skin is 100% clear, although I still have pain, my energy levels are through the roof....I feel like a sping chicken....or at least a summer one.....
....take care....
Michelle I know you won't read this today but I am thinking about you. And I hope surgery is successful.
Michelle, I'm so happy for you. I know what a miracle these meds can feel like. And, boy, do I hear you on the energy levels!
As for the other, I'm sending tons of white light and love your way that the surgery does what it's supposed to do.
Warm hugs,
Thanks Kat, oh yeah, the energy levels are way up, I've been wanting to catch up on everything....all at once!
Of course, I feel like I've been hit by a train in the morning, my body's not used to this anymore, but it feels good to do it....
My surgeon has postponed surgery until Weds., he has requested more info about potential interactions between the clinical trial drug and the anesthesia....I'm glad he's being so thorough and I guess that would be good documentation for future reference on the drug safety....
Hi there, B-Day girl!
Surgery has been postponed for a couple of days...
Just my weekly update...I just got back from my weekly appt. with my clinical trial doctor, my test results have continued to be good, my skin is still 100% clear and my energy levels are soaring, despite my new injury, I still have pain but I'm not sure if some of it can be attributed to all the recently introduced physical activity after being nearly stagnant for so long. At every visit, my blood is drawn, an EKG is done, a skin scoring test is performed and a three page pain questionaire is done, they're very thorough.
thanks for the b'day wish. is it a good or bad thing they put it off?
Michelle, I'm keeping my fingers crossed for you. It sounds so very promising! And exciting!!
Warm hugs,
Well Patty...from the view-point that I'm ready to get this behind me and I'm in pain, bad but it's best that the doctor is being safe and looking into the possibility of a drug interaction....
Thanks Kat...
I am glad that the clinical trial people are looking after you so well Michelle!
And now I will be busy hoping that all goes well for you in surgery tomorrow!!
Best of luck and wishes for smooth and speedy healing.
Hugs!!
mig
Thanks Mig....I'm sure everything will be fine, even if not, I'll be oblivious to the fact....they put me on some pretty heavy meds this afternoon, I'm feeling no pain...
Ahhh, no pain is good!
It's great and to top it all off, Erica and Ali came and spent the day with me and then she fried pork chops with mashed potatoes, corn and gravy....Adam came over after work and then when Mike got home, we all ate and the kids cleaned up the kitchen....
It was really nice to kick back and relax....
Hey, now that you definitely deserved! What a good daughter to pitch in like that... who knows what sort of mess you would've made of the kitchen in that state.
lol
More hugs for a good sleep and smooth sailing tomorrow!
Let us know how you faired as soon as you're feeling up to it, please Michelle!
Too funny....and so true!
I probably would've had flour from head to toe and then some!
And I agree, that was very sweet of Erica...
Hi Yall...I'm now in week six and doing great on the medicine, Apremilast may be the way to go for me, it's hard to say if my pain levels are down because of the surgery but we've had a cold snap come through the last few days and that usually kills my hips and back but it doesn't seem to be bothering me as much as usual, of course I'm on pain meds from surgery but I'm sleeping through the night and have noticed that I'm not hurting as bad when I first wake up and I try not to take any medicine for the first couple of hours after I wake. So far, so good....
fingers crossed......
for you......
and........
everyone that may benefit from this drug!
sue
Thanks Sue, I have noticed the clinical doctor's office is buzzing with a lot of excitement over the great results they are seeing in the study patients, they've been bringing in outside medical personnel during the visits and they've been observing very intently and taking notes, the generic explanation is..."This is Brad, he's my shadow today, just for the day though and then he'll be gone..." or, "This is Jill...", honestly though, the results in me are almost unbelievable...it's not a cure-all but just the energy level improvement is helping tons but I am still having to take something for pain, I really can't make it through the whole day at this pace without it. I can't wait to see what happens in two weeks when the meds are increased....
you may have addressed this before, but either i missed it or don't remember..... any idea how long before it gets to market if the trial is a success?
and glad you're feeling an improvement,
i know for me, every little bit helps,
sue
I don't know Sue, I would think within a couple of years. Let's hope so anyway....
Week 7 update...Okay, the good news, my skin is not only 100% clear but it seems to be rehydrated as well...keeping the moisture in my skin has been a big problem for me the last few years, no matter how much water I drink, or how much moisturizer I use, my skin always feels very dry....now, the bad news, my pain levels are still very high and my morning stiffness went back to being severe, so, based on that info, I can only conclude the following....(1)either I'm on placebo or a low dose of Apremilast (2)it's not effective on pain (3)it's not effective on my pain (4)the recent surgery I've gone through is interfering with the results...again, I want to emphasize that I may be on the low dose or placebo, I want to be fair to the maufacturer and keep everyone informed of the clinical trial results that I'm experiencing at the same time but until we know what strength of drug, if any at all, we won't have any idea of the effecacy of this new and promising drug....
1 week ago you mentioned things were going well michelle! im sorry for the downturn, perhaps the stress of surgery does have something to do with it.
would they have switched you over to the placebo arm?
Hi doh...I'm glad you posed that question, I'm wondering if the surgery has has something to do with it too...maybe too much of an overload on my immune system...I'm still seeing benefits from the drug in other areas though and that makes me think that the reason that it's not helping my pain is that I'm probably on the low dose....after reading the results from the first phase of the clinical trials again, I realised that the improvement that I've seen from the drug is consistent with the improvement seen in the patients on the 10mg dose which is targeted at psoriasis, the second phase is to see if higher doses of the drug can help people with inflammatory diseases...so, considering that, I'm hopeful that when the doses are raised, in just a couple of weeks, that I'll get relief from my pain...I will have to be careful though to differentiate between the benefit of the heavy pain meds that I'll be on post-op and the drug....also doh, I think the reason my stiffness is an issue again is due to the lack of activity and the amount of time I spend in bed while recovering from surgery...I had seen an improvement in my morning stiffness and energy levels initially....but no, they would not have switched me to placebo, after you pose the question, I went back and reviewed the program outline and they up the dose on everyone in the study at planned intervals, but no dose lowering at any phase....just a note, with a lot of the other medications a lot of patients go into a flare when the medication is discontinued, follow up studies on the first phase subjects, there was no rebound reported on any of the subjects, which is fantastic because rebound flares are usually worse that regular flares, so this is great news.....
Happy Thanksgiving!!
WOW! I am supposed to "start wrapping my brain around" the possibility of starting biologics. You are so brave, thank you for being a part of this.
cc
Thanks CC....Yep, AS is going to have to take the rest of my life with me kicking and screaming....I'll try anything....I hope that doesn't come back and bite me from behind....
couldn't help but notice your mention of dry skin being cleared up by this drug trial......i have really dry skin.....do you think this is just a "positive" side effect of the drug? or is your dry skin related to your psoriasis?
just to clarify: i don't have anything remotely similar to psoriasis, but my skin will get so dry in the winter that it will start to scab (around my hips and stomach) if i don't put aloe and eucerin on it after every shower. i mostly can keep it all under control by using only dove as my soap and only a nondetergent shampoo as my shampoo ( i mean no detergent, i have no idea how it cleans, the ingredients are things like chammamoile water, etc....ok, there is some clay in it, i think that's how it works), bath in oatmeal bath when i take a bath, etc.
i might think the surgery has you hurting more? hope the flare settles down soon.
sue
No, I'm talking about dry skin almost as is I'm dehydrated but I'm definitely not dehydrated, my psoriasis is limited to my elbows and a couple of toe joints and is very easily controlled with a medicated ointment applied daily, I'm in the clinical trials to see if my inflammation will be helped by the clinical drug. I know there have been several posts about AS and night-time dehydration and that's what I am referring to here....take care....
Hi Yall, I'm going into week 15 of the clinical trials and things are looking great! I've rebounded since surgery and I feel wonderful, I'm working out twice a day and I have an abundance of energy....life is good!
Michelle, I'm so pleased to hear this! Keeping my fingers crossed that the positive results continue!!
Warm hugs,
I am so happy you are having good results. It is also good to hear from you again. Keep doing good. You are an encouragement to us all.
Way to go!
I am glad for you!!
what is the difference between the breed of dog in the two pictures?
I hope you just keep getting better and better!
Thanks Kat, it's always good to know that you're in my corner!
Hi Patty and thank you....I've been totally engrossed in my new workout and diet program, it was hard the first few weeks, but now my body has adjusted and I'm so glad I chose to do this, it helps me manage the pain and gives me a sense of empowerment over the AS monster....for now, I'm winning the war....
Thanks Lon! The difference between the two dogs...I'll try to keep it short, I tend to get lengthy when it comes to talking about German Shepherds, so here goes....there are basically two types of GSDs(the official name of the breed is German Shepherd Dog)...there are German imports and there are American Bred...the Germans breed differently than the Americans...imports are lower to the ground, bulkier and shorter coupled than Am breds and of course the Am breds have longer front reach, longer body and a more severe rear-end angulation...there's an ongoing HUGE debate about which dog is better...you can't show an import in a conformation show and the Am breds lack the drive to participate in the Schutzhund trials....I have an appreciation for both and I own both but what I find is that the imports are over-the-top with drive and the American bred GSDs are lacking the herding instinct as well as the prey drive that they should have in order to perform as they were intended to, so....I out-cross the two and I'm very pleased with the out-come...the black and tan dog, Sampson, in the smaller picture is an out-cross that I bred...he has excellent movement, perfect conformation, temperment, prey-drive and herding instinct and he earned his championship points by the age of two(in AKC sanctioned American Conformation Am Bred Class) and he is Schutzhund I titled as well...the mostly black dog, Windyhill's Corleone of Elkins(AKA Corey)is 100% Am bred, the product of two National Champions, he earned his championship points in American Conformation in both All-Breed and Specialty shows, at a very early age, he won a major in a puppy class, which is very unusual and he has won Best of Breed several times and has also won a couple of Best in Shows, he handled very well in the ring and moved out nicely, clean coming & going, but I found him to be lacking the drive that I love...both are excellent representations of the breed and are well within the breed standard and their hips are OFA certified....YEA! I kept it short, for once!
Michelle, that is very cool. I hadn't realized there are two distinct breeds of German Shepherd. There's a long-haired one, too, isn't there? I think a lady at the bottom of my street has one.
Warm hugs,
Hi Kat...Yes, there are long-haired shepherds, they're referred to as "coats", they are not allowed to compete in shows, as they are considered "undesireable" by the German Shepherd Dog Club of America(GSDCA) because it is a recessive gene that causes a GSD to be long-coated, therefore it is a "fault", the same thing applies to a white German Shepherd Dog. Now, they can compete in the agility classes but both "whites" and "coats" are prohibited from competing in the conformation classes...and just a footnote, there is no class or breed distinction in registering puppies that are coated or white, they are all registered simply under German Shepherd Dogs, as long as both parents are AKC registered and there aren't any violations or flags on the breeders record. And the breed standard in America is written by the GSDCA, there are veternarians of different specialties sitting on that board and make decisions about changes to the breed standard, of course these changes are made only to improve the breed, for instance, an attempt to eliminate hip dysplasia, mega-esophagous or some other imbalance. Once the changes are made in the breed standard, breeders then adjust their breeding program with the new goal in mind, in other words, it's never just for aesthetic purposes, it's always for mechanical reasons....
here's to winning the war........
sue
Michelle
It's great to see you posting again!!!! and then posting with such wonderful news-double yea!!!
Hope things continue to go your way.
P.S. My Shepard-Huskie is quite the furry kid. She is 9 years old and her name is Skully. She is very vocal and loves to have me let her out at 3 in the morning so she can sit on a snow pile and sniff the cold fresh air.
Hey Michelle, you're a hero!!! So..., what do you mean you'll tell us "what you're allowed to"... what are you saying...
Yes we can!
Thanks Jeffery and nice to be back, I hope all is well with you!
Skully sounds awesome, isn't it amazing how much joy our pets bring us! I bet your baby is beautiful!
Hi C.C., how ya doin?
I gotta tell ya, I'm a big fan!
And to answer your question...at first I wasn't sure what the confidentiality clause would say but as it turns out, I'm allowed to tell anything & everything...it's a good thing too, because I think that I would've gone crazy trying to keep this secret!
Hi,
Can you give a brief about the result of the oral biological. How it worked on you? etc.,
Thank you.
P.D. Jayaram
HI Jay, I'd be more than happy to....I noticed an improvement in my skin within the first week of taking the clinical trial drug, I have mild psoriasis, it is no longer visible at all, I also noticed an improvement in my energy levels and that has continued to improve, I haven't felt this energetic in many years. My pain levels were not impacted at all at first but that could be because of the dose, being a clinical trial, I have no idea what dose I'm on but it's due to be increased in the next couple of weeks...it's set up to increase in 10 mg. increments every 8 weeks until eventually every study participant will be on the highest dose which is 30 mg.....this medication has improved the quality of my daily life immeasurably.....
Hi Michelle:
Thanks for all your postings on Apremilast, I will ask my Rheumy about it next week, it will at least be a way to see if he is up on the latest news. Very excited that you are having good results!
Also following the dog sub-thread of this, we have four American Eskimos (well three and a half) and only recently learned that the original name for the breed was German Spitz, renamed after WWII. We call 'em the white monkeys
Wow, Michelle, that is amazing news! I'm so happy for you!
Do they have any update on if/when this will be available to the general public?
Cool. Not a huge surprise since it inhibts IL 23 and TNF. This helps confirm the IL 23 connection to me
Hi Dow, I'm familiar with the German Spitz story, they used to call German Shepherds by the name Alsatian...and I think the name is still used in parts of Europe. The American Eskimo is a beautiful dog! And I like the white monkey nick-name...very cute!
Hi Megan, I haven't heard anything about a potential release date, maybe the manufacturers website may have that info, I'll check on that and get back to you on it...
Hi Drizz...I couldn't agree with you more and what was it...a little over a year ago that they announced the discovery of the connection between IL-23 and the ARTS1 gene and inflammation? and they had a drug in clinical trials within 6 months?! Boy....we've come a long way! Now if I could just convince my Primary Care Doctor that AS isn't "a men's only" disease!
HI Michelle
We got lucky
IL23 is associated with more widespread diseases like Crohn's and psoriasis and the drug research was well underway in those areas. We are riding those coattails but that is OK as long as it gets done
Steve
Yeah Steve, that probably happened when I wasn't looking! I lost faith in new medicines after a miracle cure almost killed me, back in the nineties, had I not already known and trusted the judgement of Cindi and Shondra, I probably wouldn't have participated in their clinical trial....
Thank you for the information.
Jayaram
My Dear Friend,
I think our police depart. uses the black dog, the Corleone.
I did see two pure white dogs a few months ago in the back of a truck at the gas station. He said they were just a hobby, but they were sure pretty.
How much do they shed?
I am gone some nights. And I am working with convicted felons;so I would like a dog that could come inside and be a comfort to my wife. Yet would be hardy enough to stay out, with shelter of course.
I have enjoyed hearing about your dogs.
Years ago we had a decendant of rin tin tin. But she was so timid, I did not take the time to teach her.....
Thanks again
Lon
Hi Lon...I owned a huge, white male when I was a teenager...he was awesome and beautiful! Okay, the shedding...they do shed a lot, they "blow coat" twice a year, in late fall, they blow their summer coat so that their winter coat can come in and then in the late spring, they blow their winter coat so that they can get their summer coat, which is lighter than the winter coat..so it happens twice a year and very little in between....also, it depends on the dog to some degree, believe it or not, good coat retention is a breeding target...and they are definitely hardy enough to stay outside and they're wonderful protectors, I'm sure yall heard all the horror stories on the news after Katrina about armed bandits taking over everything down here...the stories are true...anyway, Mike tried to get home before it hit but he didn't make it...I had absolutely no trouble what so ever, none of those thugs would come near me and the kids with the dogs there, we took them everywhere with us as that saga unfolded and we had no trouble...we came across some thugs trying to drag a handicapped woman out of her car so they could carjack her, I opened my truck door and hollered to them that if they didn't let her go and get away from her I was going to let the dogs go on them....they let her go and ran off....I've looked at a couple of pups for yall and I like the lineage on them, they all come from parents with good, sound temperments and they'll make good dogs. Talk to you soon, hugs to Lin...
YEA!!! My dose was raised at my appointment yesterday, so everyone in the study group is now on Apremilast, if you were on placebo, they bumped you to 20 mg., if you were on 10 mg., they bumped you to 20 mg., if you were on 20 mg., you were bumped to 30 mg., and those already on 30 mg. were left on the 30 mg. dose. So now, I can't to see if the higher dose will impact my pain levels, I've been anxiously awaiting this leg of the study! This is the actual purpose of the study, to see if Apremilast is an effective treatment for inflammatory diseases if taken in higher doses....
Good luck with it, Michelle!!
Warm hugs,
Thanks Kat! It's been 3 days since my dose was raised and I'm experiencing quite a bit of nausea nausea. The first day it was pretty bad but it's getting better now, I'm sure by next week, this'll be behind me...on the flip side, I woke up an hour earlier than usual this morning and I actually felt rested! WooHoo!
I can't wait to see my lab results next week!
Keep it up, Michelle!!
ACK, maybe, under the circumstances, I should say, "Keep it down???"
I'm so glad this has been working so well for you.
Warm hugs,
so how are you feeling?
is your life getting back to normal?
Thanks so much Kat...you're my favorite cheerleader!
I'm telling you though, this nausea is debilitating....UGH! It's over by noon though, I hope it doesn't last too long....
Hi Lon...four words...PLOP, PLOP, FIZZ, FIZZ....
Until noon or so, anyway...other than that, I am feeling like I'm 20 again but ir only lasts for about 8 hours and then I'm done, just worn out. I'm thinking that it's just a matter of building up my endurance levels because I'm on the go the whoole eight hours...a little fine-tuning and this'll be awesome!!!
HI.
I have trouble keeping track and finding my way around this site at times. I am wondering how you are doing with all this activity and how you are feeling!?
Bit of a tough patch for me, but some blessings and good things along the way.
Lin is hanging in there.
Lon
I seem to have hadtoo many crisis to think about a dog right now. How much would it cost to ship a dog?
hmm. I did visit you site. I enjoyed it. LS
Hi Lon, I'm doing well actually, I have muscle fatigue sometimes but I'm sure that once my muscles get used to be worked again, that'll pass, just trading a pain for a pain.
I know what you mean about bringing a puppy into a chaotic situation...
You shouldn't have to pay any shipping charges on your dog though, I've been looking in your area...I know some wonderful breeders from back in my show days and if you decide on one that's not in your area, I'll get in touch with other GSDCA members and find out who's going to shows in your area and your pup can just hitch a ride, we do that a lot, it's no biggie and don't feel pressured to jump in, there are always opportunities to get a good dog when yall are ready.
I hope Lin is doing well, my hugs to the both of you, Lon....
Hi Michelle:
i have been following this thread with hope for you and all of us. Let me add to the chorus here of people thanking your both for undergoing this trial, and FOR SHARING/REPORTING here so regularly!!
Every time i read or hear of this medicine, i silently thank you; your efforts put a "face on"/personalize these studies.
The most recent report i've seen is here:
http://www.mskreport.com/articles.cfm?articleID=2811Of course the question we all have, that you cannot answer is
WHEN WILL THIS BE RELEASED ???
Hi
i hope you get stronger and stronger
i pray this medication works great for you for along time
we got sunshine i just spent 3 hours with a guy who had not seen the sun for several years. wow we take things for granted
lon
you are a buswy girl. have a good weekend?
i get so tired i almost stumble but all in all i am so very thankful for the blessings i enjoy i will keepin miind what you have said i owuld like a partner for when i walk and hike. also for when lin is home alone at night a well behave dog would get ther thorugh some lonesome times
thaks for all your encouragment
lon
Hi swim2...thank you so much for the words of encouragement and for posting the Celgene article!
I can honestly say that my pain levels seem to be a little better since my dose was raised last week, let's just keep our fingers crossed that the progress continues!
I really wish I knew when the release date is, I'm going to pick the doc's brain at my appointment tomorrow, if I find out anything, I'll post it as soon as I get in from the appointment...
I had a great weekend Lon...all the kids and grandbabies were here, we cooked, played boardgames and passed a really good time...this morning we all attended services together, I just love it when we can all be together and you're so right Lon, we take so many things for granted...life is good!
hi michelle,
any idea if others are doing as well as you are with the drug?
hope so,
an oral biologic, that would be wonderful,
sue
Hi Sue...the other study subjects are also doing great, swim2lakes posted the link to the study results above, very promising, the side-effects reported are almost non-existent and the dosage increase last week was across the board, the reason for the increase is to see if higher doses of the drug can provide relief to patients suffering from the inflammatory diseases, the manufacturer seems pretty confident that it will....
I've been on the higher dose for one week now and tomorrow my labs will be run to see if it has reduced my inflammation levels...
please let us know what your Lab results show ??
And also, wondering if the nausea has subsided since the dose increase.. here's HOPING.
Hi
It sounds like a good old fashioned family get together. I have had a lot of huge weeks, but we have had some real good life decisions. One man had about 12 family members come to see his baptism. It was really great!
We miss our family, so far away.
Lon
Hi Swim2...the nausea is improving but I have to make sure and eat a little something before taking it...
I promise that as soon as I get my lab results I'll post them, I'm really looking forward to that!
Oh Lon, I know it must be hard to be so far away from your family, I can't imagine, I'm very fortunate in that regard...that's why I can't leave, even after all the devestation that Mother Nature has thrown our way, unless everyone goes with me, I'm not going!
I do admire you for all that you and Lin have had to give up in order to serve others, you're wonderful!
Well...a small bump in the road....it's been a week and a half since my dose was increased and I've been so sick the last week that I lost 8 pounds, I can barely keep anything on my stomach...clear liquids only and I was so sick Wednesday morning that I considered going to the ER, I can't believe that I'm about to say this but.....I hope it's the flu...
I am glad you are having "some" good results. I wish your pain was better. I have been thinking of you.
My husband was put on Methotrexate a couple of years ago and it did nothing for him except clear up his eczema. It hasn't come back at all and he has been off of the MTX for 18 months at least.
I hope it really kicks in for you soon.
Blessings.
Possi
even if its not the flu, maybe the lower dose is better for you,
if it was helping with the AS and not causing side effects.....
i know a little bit of medicine seems to go a long way for me,
a little does exactly what its supposed to do,
and a little more can cause pretty nasty side effects,
i almost never take the recommended amount of anything,
i know this is a trial and you can't do that,
and i know you want to keep taking this med,
so hope it all settles down.
sue
Awww Michelle-belle, I wish this new dose wasn't making you feel so ill. That's just rotten. I will be keeping my fingers crossed that you'll start feeling better very very soon.
I have to say, I love every story your write about your doggies. Even when I don't have time to post you can be sure I am reading and with a smile!
mig
Thanks Possi...how are you feeling? I hope things are looking up....
I really hope that I can keep this dose down, the higher dose is to see if the drug is effective against inflammatory diseases, it would be to all of our benefit if it works....
Oh Mig, I hope that my body adjusts pretty soon....but again, I'm not certain that the medicine is causing this problem, I don't want to give it a bad rap, it could be a virus.....the dogs are great, I've been having a blast watching them do the "spring is coming dance"....my Azaleas are in bloom and it's been spring-like the last couple of weeks, that always makes them silly....
Oh, this nausea and I'm supposed to be riding in the Krewe of Merchants Parade tomorrow, I hope I can make it, I may have to carry my bucket onto the float with me....
The girls attended the Mardi Gras Ball of a young new krewe last weekend....Erica & Adam presented the Duke & Duchess on stage at the ball, they're thinking about joining up, they'll be with the Krewe of Chaos...
Week 20 Update!
I woke up yesterday with no back pain!! Woo-Hoo!!
I stayed that way until late afternoon, I'm serious, no pain!!!
I got so much done, it was great!!
I have no idea why I had no pain, but I'm not complaining!!
The nausea has completely subsided and I really DON'T think that it was related to the Apremilast and if it was, it only lasted a week...no biggie...this phase of the clinical trial ends in 4 weeks, I've been invited into the next phase, which is long-term and I've decided that I'm going to do it....
good news
are they calling the next phase a phase 3 trial yet?
Hi Steve....I'm not sure about that but I'll ask at my next visit, she's really good about sharing info...at each visit they do 2 EKGs on me and draw blood(which is always a hassle with me because I have deep veins) but anyway, they always fill up 7 vials to be sent to Celgene...well yesterday, I saw that one of them was labeled ANA and when I asked Cindi about it, she said she would gladly share all of my results with me.....I forgot to get them before I left though but I'll get them when I go back, I'd be interesred in seeing if they've changed any since I've been on the medicine...of course I'll probably have to get you to interpret them for me....
Hi Sweetheart,
Sounds like this could really be promising I am sure hoping so for your sake as well as ALL of os out here.
I hope by the time you get this the nausea has subsided...Im just getting over an apparent stomach bug that has decided to set off an ENTIRE flare..I woke up yesterday and I swear I have Iritis in both eyes so trying to figure out what I should do there..wondering if my regular Dr. will prescribe some Pred Forte or if I have to go to an eye Dr....my body feels like I have been ran over by a truck so I have basically been in bed since sunday. I don't know I kind of feel like I am giving up, Im just so sick and tired of being sick and tired..lol
Of course there is ALWAYS something going on at The Hancocks..even when I was at my sickest I could look out the window and see Chevy (our cocker) trying to get romantic with Ella except he has been fixed...so go figure. The kids got a hoot out of it although I would shut the curtains and say STOOOOOOP..lol
Hope things continue to go well for you, please keep me in your thoughts..I went for the TB test yesterday now I have to go back thursday and friday and have it read...Im not sure Im going to make it to Remicade or until they figure out if they are going to pay for it or not...all the paperwork, info and acceptance probly looking at another 3 to 4 weeks easy peasy.
Hope your family is well.
Lots of hugs,
Lisa
Hi Lisa...I'm so sorry to hear that you're having to go through this, I hope it clears out soon...rotten flares...and you're always in my thoughts and now in prayers too....yes, the nausea has passed and for 2 days in a row now, I wake up pain-free, yesterday it lasted until mid-afternoon...toady it lasted only until noon, but hey....I'm not complaining that it doesn't last all day though, getting even a few hours break from the pain makes it easier to cope with, I wish everyone could get at least that....
BTW...very funny story about Chevy & Ella...
glad to hear that the medicine is working for you.
it gives the rest of us hope.
sue
Hi Sue, there's definitely a lot of hope for the future....we've come a long way, baby!!
I hope the Apremi
lasts!
Good one, Dow!!
Well, here it is week 24 already, I went to my regular poke & prod this morning and I was told that the clinical trial has been extended so, I'll enter into Phase 3 next week...
Hi Michelle,
Can you give the update / status of Oral Biologic as on today.
Regards.
Jay
