Xolair trials in Seattle

Posted on: Tue, 06/29/2004 - 12:27pm
skanb's picture
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DS went to the doc's today. She offered to have him involved in the study they are currently conducting for kids 6-11 who have severe asthma. They are also trying to get FDA approval to trial Xolair in children with PA.

My question...does anyone know any reasons NOT to seriously look at joining this study? Thanks for your input. Kristi

Posted on: Tue, 06/29/2004 - 1:59pm
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Thanks for the heads-up e-mail [img]http://uumor.pair.com/nutalle2/peanutallergy/biggrin.gif[/img]
Is this a trial for asthma kids or PA kids? I thought Xolair was already approved for kids under 12 with severe asthma. DS is only 7 and our insurance has approved treatment with Xolair - thought they wouldn't do that if it was considered "experimental"?
I wonder if the Xolair people would be interested in tracking my son's allergic reactions or whatever even without him specifically being in the trial (since his pulmo doesn't want to run the risk of getting the placebo). The nurse who called with info for us did ask very specific questions about allergies but not PA. She seemed to be trying to determine if DS was atopic. She didn't seem to be very on the ball though - she insisted on explaining to me what a subcutaneous (sp?) injection was even though I told her that I give DS sub-q injections every night (grrr) - so who knows if DS's allergy info will get to anyone who might actually be interested in it...
Keep us posted...
Rebekah

Posted on: Wed, 06/30/2004 - 3:47pm
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Bumping. I want to make this decision soon. To clarify what rebekahc asked...
This study is to determine the safety and effectiveness of Xolair for use in children with severe asthma ages 6-11. (I think you are lucky the insurance is paying for it.) This has been approved for children ages 12+.
He has a 2/3 chance of getting Xolair rather than the placebo. I am thinking this is worth it. Your thoughts?
The same organization is still waiting for FDA permission to try Xolair on children under 18 with regards to PA.
I'll keep you posted. Kristi

Posted on: Fri, 07/09/2004 - 1:03pm
rebekahc's picture
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Kristi ~
DS had his first injections of Xolair today. Although I'm excited for the possible results of these injections it was not a pleasant experience for him poor guy! [img]http://uumor.pair.com/nutalle2/peanutallergy/frown.gif[/img]
He is on the once per 4 week dosing schedule and as a result he had to have two HUGE injections. A total of almost 3 cc (which is a heck of a lot!) The Xolair is very thick and so they have to use a very large needle for the injection (23 gauge or larger - picture a needle used to draw blood). They also have to inject it very slowly because of the thickness. DS was a real trooper though and only shed a few tears - no screaming.
The pulmonologist did say that since I am willing and qualified to give DS injections and also equipped to recognize and treat anaphylaxis or other allergic reactions that after the first 3 or 4 doses he will probably let me administer the injections to DS at home. I will probably see if we could use smaller more frequent doses instead of the huge dose (there is a 2 week dosing schedule, too).
Hopefully by December the anti-IgE will be in full effect and we can get him a puppy for Christmas! Lord knows he deserves it!!
Rebekah
P.S. My cost is $25/month for the Xolair and $15 for the doctor's office. Not too bad for such a wonder drug!

Posted on: Fri, 07/09/2004 - 1:29pm
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Rebekah,skanb
Please keep us posted.
Good Luck!!!
Love this site
Synthia

Posted on: Fri, 07/09/2004 - 2:03pm
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Rebekah, Thanks for the update. Sounds like your ds was a real trooper. I'm hoping it won't be too traumatic for my ds. He's been getting allergy shots for two years+. I know that the needle is bigger, but I hope these have prepared him for this.
We've decided to go ahead with the trial. He goes in Monday for his initial intake and then will be monitored for nine weeks before they start the injections. From everything I've heard, if I'm observant I will be able to tell if he is getting the Xolair or the placebo. I will keep you posted.
Thanks again for the update. [img]http://uumor.pair.com/nutalle2/peanutallergy/smile.gif[/img] Kristi

Posted on: Fri, 07/09/2004 - 4:31pm
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GENENTECH Announces Second Quarter 2004 Results
Scroll down to where it says immunology and specialty biotherapeutics.
Basically, it says that the first patient was enrolled for Phase II trials using Xolair for peanut allergy. There will be 150 patients.
[url="http://www.prnewswire.com/cgi-bin/stories.pl?AC"]http://www.prnewswire.com/cgi-bin/stories.pl?AC[/url]
CT=SVBIZINK3.story&STORY=/www/story/07-07-2004/0002206308&EDATE=WED+Jul+07+2004,+04:29+PM
Another item says the trial will last 38 weeks.
[url="http://www.thestreet.com/markets/stocksinmotion/10169948.html"]http://www.thestreet.com/markets/stocksinmotion/10169948.html[/url]

Posted on: Sun, 07/11/2004 - 11:20am
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Any ideas on how long before they might see the effects of this study and if the trials go well, when do they think it will come to market for the general public?

Posted on: Mon, 11/08/2004 - 2:43pm
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I am curious to see if anyone knows of a patient as young as 4 to take xolair. Aidan is being recommended for it & he turns 4 in Jan. We are exhausting our options with asthma meds & this is the next "step" I am trying to read up on this miracle drug, but have not seen how young they have gone. If anyone has any info I would appreciate it.
Thanks!!!
Mandi

Posted on: Wed, 11/10/2004 - 5:57am
skanb's picture
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Mandi,
Haven't heard how young a child they are using this drug for. Sorry. I wish I had more answers for you.
It turns out that ds is not eligible for the drug trial, as his scores are too high. They drew blood in March 2800+, June 1600, and October 2100+. This is in spite of his allergy shots for more than two years! He gets them for cats, dogs, dustmites, grass, weeds, etc. We go in next week to talk with his physician and see if we're going to do it with the insurance company paying instead of through the study.
Good luck to all. Kristi

Posted on: Wed, 11/10/2004 - 7:29am
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Thanks Kristi, I am still seeking info if anyone has ??anything?? He is a big boy and on adult doses for his asthma. I sometimes say he is allergic to air. Not funny, but sometimes it does fill like that. So I appreciate any info.
Mandi

Posted on: Wed, 11/10/2004 - 2:02pm
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Mandi ~
Your son is probably not much smaller than my DS. Although Logan is 8, (started Xolair at age 7) he's only about 56 pounds.
Xolair has been a miracle for us. Since July, Logan has used his inhaler only a handful of times and is currently taking NO preventatives!!!!! This is his bad time of year, and we've usually had at least one round of steroids and an er visit. Not to mention breathing treatments every 2 hours for weeks on end just to keep him out of his red zone.
In fact, he's doing so well we got him a puppy for Halloween instead of Christmas! The last time he played with a puppy (5 minutes total) he reacted so badly we had to stop on the way home and buy him new clothes. Now he plays with his puppy all day and not a single sneeze, hive or wheeze [img]http://uumor.pair.com/nutalle2/peanutallergy/biggrin.gif[/img]
I've heard Xolair is only approved for children 12 and over, but if your insurance will pay for it and you think DS can handle the really big shots, I would go for it. According to our pulminologist, it's a lifelong commitment - also something to consider.
Rebekah

Posted on: Thu, 11/11/2004 - 10:00am
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Rebekah, that really helps. Aidan is 57lbs & 43inches. So he is a big boy. His allergist wants to try two more weeks on his current meds. Then we do the blood test. I can't even imagine Aidan having a pet. He once had a reaction to a cat. He put his face on a pillow a cat slept on & his eyes swole shut & he was wheezing. You gave me some hope so thanks a whole lot. :>
Mandi

Posted on: Thu, 11/11/2004 - 1:25pm
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Genentech and Novartis are sponsoring an "Advances in Asthma Series". Undoubtedly Xolair will be mentioned! See if there's one in your area:
[url="http://www.healthtalk.com/asthma/programs/1_168_S/index.cfm?pview=SPI"]http://www.healthtalk.com/asthma/programs/1_168_S/index.cfm?pview=SPI[/url]
(I'm going to the Bellevue one)
------------------
Jana
[url="http://www.seattlefoodallergy.org"]www.seattlefoodallergy.org[/url]

Posted on: Fri, 01/21/2005 - 5:54am
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Rebekah ~ how is your son and the puppy doing? ~ Is the xolair trials still ongoing with your son? Hope all is well.

Posted on: Fri, 01/21/2005 - 1:27pm
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Hi! Thanks for asking! We're still doing well. Logan did finally get some sort of upper resp. infection this week (his first sick day all school year!!!!) but even so, his peak flows are doing okay. He's able to cough everything out and is using his inhaler just a few times a day.
The puppy is also doing fine and growing like a weed [img]http://uumor.pair.com/nutalle2/peanutallergy/smile.gif[/img]. Logan is still not reacting to him. YEA!! In fact, the other night, I couldn't find Logan; he turned up asleep in the cage with the dog LOL!
Since starting Xolair, Logan has had no eczema, no hives, no mystery reactions, and I've really loosened up on letting him eat his non-anaphylactic foods.
The only down side to the Xolair is the huge needles - poor Logan worries more and more each time [img]http://uumor.pair.com/nutalle2/peanutallergy/frown.gif[/img].
Even so, I am sooo glad he's on it!
Rebekah

Posted on: Sat, 01/29/2005 - 2:55pm
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Could someone please tell me what "lifelong commitment" means in terms of Xolair. My son is 3.5 yrs. old and his allergist said that if approved for his age group..he is a candidate for this drug. He is HIGHLY allergic to wheat, egg, milk and nuts AND has asthma, mystery hives, etc. Do you mean that once you start this drug you HAVE to continue your whole life? What if you do it a few years and then stop? I am a bit confused and would love some clarification. Thank you so much!

Posted on: Sun, 01/30/2005 - 5:15am
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I have worried about this too. What if someone changes jobs, and the new insurance company won't cover the shots? Will the peanut allergy recur? Will it be even worse?
Anne

Posted on: Sun, 01/30/2005 - 8:34am
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i am not worried about job changes, etc. I am wondering...why do people keep refering to this as a life long comittment. If you chose to stop, what would happen? I assume you would go back to having the allergies/asthma that you had previous to taking the shots.

Posted on: Sun, 01/30/2005 - 1:05pm
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The pulmonologist told me the Xolair was a lifelong commitment because of the possibility of a life threatening reaction to stopping the meds. Since the drug blocks the IgE from being reacted to and doesn't stop the IgE from being produced, the theory is that if Xolair was stopped, the system could be flooded with all the IgE in the bloodstream. I'm sure Xolair could be tapered off somehow.
Not sure I really totally buy that explanation, but it's a paraphrase of what I was told by Logan's doctor.
Rebekah

Posted on: Sat, 09/08/2007 - 2:57pm
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It's been a while, but I wanted to update you on several things about Xolair that have occured in our lives.
The insurance company initially refused to pay for it since DS was only 11 and they won't pay for less than 12. The doctor's office appealed and the insurance company agreed to pay for it.
DS started Xolair in late January/early Feb this year. What a MIRACLE drug this has been for him! He has dropped to lower doses of preventer meds, has had cross contaminated food (accidentally) without any reaction - another miracle for him.
The end of June we passed a respiratory virus around the house. DS was the only one (except DH who doesn't have asthma) who managed to get through it without nebs! In spite of lower preventers!!!
As for the "lifelong" commitment of Xolair,
the studies have been conducted as though that were the case. When we discussed this with his doc in November he suggested we try it and if it didn't work, DS could come off it. I asked about the "Lifelong commitment" and he stated that it shouldn't be stopped suddenly, but that he could certainly come off it if needed/wanted...
Fast forward to May...we took a one month vacation so he missed a dose (on 2 week dosing cycle) and nothing happened. He was fine, even tolerating the two dogs at my friends house where we were staying.
Dr. Becker at NW Allergy and Asthma stated that additional studies are being done to see what happens if the Xolair dose is decreased after someone is on it for a while. I'm waiting to hear the results of that study.
My nephew is 6 and I think is more allergic and asthmatic than DS. His allergist/ asthma specialist is trying to get him on Xolair too. I'll keep you posted if it works. He is small for his age, but I don't know off hand how much he weighs. I'll find out and post that.

Posted on: Sat, 09/08/2007 - 4:41pm
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I'm so glad Xolair is as much a miracle for your DS as it has been for mine! Logan is still taking it monthly (over 3 years now WOW!) and no asthma in sight - yea!! He also rarely gets sick anymore - I guess he's better able to fight off the germs.
Logan's IgE levels put him into the twice montly dosing and when it came up for reapproval our insurance actually fought the doctor to try and get Logan more Xolair LOL. The pulmo finally convinced them it was working fine with once a month, so why mess with it. Logan did have to miss one dose this summer because of an insurance change, so it was 8 weeks between shots. He finally got his shot last week but has since broken out with horrible eczema. He hasn't had skin problems since he was 3 or 4 years old, so I'm not sure what's going on. I'm hoping it's just because the Xolair isn't fully back into his system yet.
Thanks for the update!
Rebekah

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