Well, I had an interesting visit with my Rheumy (who is 2 hrs away) - he has just moved his practice next to Dr. Daniel Wallace, who wrote the ...Sjogrens Book. I have been feeling worse; my rheumy asked me to consider participating in a clinical trial - a drug specifically for sjogrens. He is emailing me the info, because Dr Wallace was not 'in' & he has the specifics (it was Fri afternoon). I do not remember the name of the drug! I will know more next week & I will decide within 2 weeks. I have been wanting to do something to help others, & hopefully, I will help myself, as well. I will post more when I have the info. My decision will not be hasty - I plan to consult with a few other drs, as well as friends, family, and you! Sorry I am being vague, at this point. I will share as this unfolds.
Looking forward to hearing about this!
Styx
I think it is good you are taking your time.
susanep :)
Sounds interesting! Looking forward to hearing about it :)
Sounds interesting and well done you for agreeing to go ahead! :)
Good on you girl!
Will be keeping my fingers crossed that something very good will come out of your efforts Trish.
It's always heartening to hear that someone somewhere is trying to get to the bottom of this curse.
Every little helps, Good luck, and keep us informed, Dolly X
I find it very exciting to know there is a new drug in the making. Let us know what you decide, I'll be grateful for the information no matter what you do. Good Luck!
mebog
Trish, Take it carefully but keep us posted on the new med. It is exciting to know there may be something out there for us.
Any news yet? Do you know the name of the drug they are using in the trial? Will you get the drug? Or is it one of those where some get the drug and some get placebo?
Can you tell I am all kinds of excited about sjogren's trials? Good luck and take care. CK
The drug is baminercept. Go on the website (and it'll show you which research hospitals are participating) http://clinicaltrials.gov/ct2/show/NCT01552681
I meet with the doctors on Fri, Mar 8th for a consult. Currently, I have a very bad cold - dang it - and this week is busy, includes a huge Memorial service that I must attend: funeral, reception & dinner at the family's home; about 7 hrs - eeek
I alternate between hopefulness and fear, but if I meet the criteria, it is most likely going to be 'yes'. I am kinda' concerned about how often I must make the 2 hour drive for the treatment. I am hoping to give you an update sometime on Friday
It is so brave that you are considering doing this. I thank you. I have thought that I would want to participate in a trial and had the lip biopsy done in hopes I would qualify but my ENT said my results were negative. From the study, it looks like you will be having one done at some point if you are not on the placebo. I had my done in November and I still have pain and numbness from it. I understand it can take up to 6 months to heal. I don't tell you this to scare you but just so you know that I would do it for us too if I could. And like you, it would be for myself too. I know I am just so tired of dealing with the symptoms. They affect every part of my life, making simple things like talking on the phone a monumental task at times. And doing things I use to love like running or taking a step class a huge effort with a long recovery time. So thank you for what you are about to do for me and others like me. A new medication could be just what the doctor ordered!
I did have a lip biopsy, with no complications (about 1 yr ago) It was borderline, but along with my other symptons, the dr dx'd sjogrens. If I fit the other criteria and move forward, I know I will have another biopsy - somewhere down the line. I completely agree with you about being absolutely weary of living with these symptons and the fighter in me really wants do something for all of us. Thanks for the words of encouragement. Cross your fingers about Friday.
Quote from: P.Trish on March 04, 2013, 02:03:56 PM
The drug is baminercept.
You lucky dog :)
If I was going in for a clinical trial, that's one of the drugs I would prefer to try. The putative mechanism of action makes me hopeful that it will be effective in Sjogren's.
Best of luck, and do keep us advised.
Styx
... though you might get the placebo ;)
Keeping my fingers crossed for you and hoping you get the drug and NOT the placebo if that is what you decide to do. :) Let us know how it goes. CK
I've heard that "Placebo" stuff is great for almost anything that ails you...but I can't seem to get my doc to prescribe it! ;) :P ;D
Ha! Sleepy, I am thinking that if I get the 'placebo drug', I'll feel better because this whole disease fiasco must surely be in my head (not) :P
Good luck girl.
susanep :)
Hope you get the drug and qualify too. Finger's crossed!
*#@" this cold virus! Yesterday, I had a fever - started a 'Z" pack - still planning to go for the clinical trial consult - on Friday - wish me luck - bought some elderberry syrup, which I took last night - really helped me sleep, despite the runny nose
Stay in bed and rest. Give your body time to fight off the virus. Good luck on Friday. Hoping all goes well for you. CK
I'm about to ask my rheumy if she thinks this clinical trial is worth a try. I'm located near Stanford, which is another of the research sites.
Of course the down side is that you may be in the placebo group, in which case you are not getting treatment.
Best of luck!
Yep, I understand about the placebo, but I have a lot of questions for the drs., this Friday. One of them is "Will I be taking the same drugs - that I am currently on - during the trial?" ex: plaquenil. Please let me know what your rheumy says. Also, I would really appreciate any questions that you, and others on this site, think I should ask. One of the drs is Daniel Wallace - he should know somethin' :). Thank you for the good luck wish!
Quote from: P.Trish on March 04, 2013, 06:39:20 PM
I did have a lip biopsy, with no complications (about 1 yr ago) It was borderline, but along with my other symptons, the dr dx'd sjogrens. If I fit the other criteria and move forward, I know I will have another biopsy - somewhere down the line. I completely agree with you about being absolutely weary of living with these symptons and the fighter in me really wants do something for all of us. Thanks for the words of encouragement. Cross your fingers about Friday.
Good luck and keep us informed!
I wanted to ask you about your borderline lip biopsy, if you don't mind, what were your borderline results?
Cheers,
Ana
Good luck and keep us posted. The clinical trial at UCSF hasn't begun enrolling yet, but I'm on the contact list when it does.
Anxiously awaiting to hear about your experience. I really hope it went well. CK
Hello everybody - thanks you again for your support, advice and good wishes - here is the update on my Friday, Mar 8 appt. at Cedars Sinai.
The drug company - running the clinical trial - has excluded me for now, because my lip biopsy - taken about a yr ago, was inconclusive. Their criteria is very strict; one has to be positively dx'd with Primary Sjogrens to participate & they definitely want a positive result on the biopsy. Ana, I think my dr said my lip biopsy was 3.4. Another concern is my IGg level, which is 1760 from Sept (high normal). Dr took another test yesterday. In the pursuit of the clinical trial, my dr is suggesting that I get another lip biopsy, since it has been a year. He thinks the clinical co. might cover the cost. So, I truly wish I had some helpful news for ya'll. I did learn that the infusions are once a month, which is do-able for me. The doctors said that it is extremely hard to find recruits for this trial. warmwaters and suslew - please let us know about what you find - meanwhile, I (and my doctor) haven't given up - it's just not happening tomorrow - and I'm not getting any younger people! Have a good weekend everbody. My pred pack has helped me feel better - and company is coming.
Hi Trish :)
I also failed to get on a trial because results were not conclusive enough. I think they have settled on me having lupus with sicca symptoms.
I;m sure you're disappoined because you will have got geared up to participating.
Take care - Scottie :)
Scottie - you read me well; I am disappointed, but as you know we just keep on tryin' & staying as productive as possible. I wonder if I wil ever adjust to these ups and downs (physically and mentally:P). Have a good weekend.
P. Trish,
So sorry but I know how you feel. Keep your head up! At least you tried :)
Quote from: P.Trish on March 09, 2013, 12:27:01 PM
Hello everybody - thanks you again for your support, advice and good wishes - here is the update on my Friday, Mar 8 appt. at Cedars Sinai.
The drug company - running the clinical trial - has excluded me for now, because my lip biopsy - taken about a yr ago, was inconclusive. Their criteria is very strict; one has to be positively dx'd with Primary Sjogrens to participate & they definitely want a positive result on the biopsy. Ana, I think my dr said my lip biopsy was 3.4. Another concern is my IGg level, which is 1760 from Sept (high normal). Dr took another test yesterday. In the pursuit of the clinical trial, my dr is suggesting that I get another lip biopsy, since it has been a year. He thinks the clinical co. might cover the cost. So, I truly wish I had some helpful news for ya'll. I did learn that the infusions are once a month, which is do-able for me. The doctors said that it is extremely hard to find recruits for this trial. warmwaters and suslew - please let us know about what you find - meanwhile, I (and my doctor) haven't given up - it's just not happening tomorrow - and I'm not getting any younger people! Have a good weekend everbody. My pred pack has helped me feel better - and company is coming.
Hi Trish, I am shocked that they excluded you in the trial, doesn't a focus score of greater than 1.0 with lymphocytic infiltrates qualify as a positive for Primary Sjogrens...?
I guess I am confused, because certainly the criteria states greater than 1, and you have 3.4, I just don't understand how they could call that inconclusive?
Are you seronegative but with all the typical dry eyes, mouth, etc?
Cheers,
Ana
Ana - I will double-check with my dr - next week - he answers email; maybe I heard number. wrong
Ptrish
I am disappointed for you. Keep your chin up. Just does not seem fair. Take care. CK
Some info on baminercept:
http://clinicaltrials.gov/ct2/show/NCT01552681
Hi Trish, I am shocked that they excluded you in the trial, doesn't a focus score of greater than 1.0 with lymphocytic infiltrates qualify as a positive for Primary Sjogrens...?
I guess I am confused, because certainly the criteria states greater than 1, and you have 3.4, I just don't understand how they could call that inconclusive?
Are you seronegative but with all the typical dry eyes, mouth, etc?
Cheers,
Ana
[/quote]
This made me think about mine. I was told it was negative but never actually saw the report so I went and got a copy today and it shows I had exactly 1 focus which indicates Sjogren's is possible.
>1 is positive and <1 is negative. I am exactly 1 so I am neither positive nor negative but a possibility!
And strangely this make me feel better about still having numbness from the biopsy 4 months later I guess it was not totally done in vain!
I'm always cautiously optimistic that they will find a drug to help us. It was brave of you to try to participate and I appreciate you and others who done so for other drug trials. They do have strict criteria enrolling patients because they don't want critics dismissing their results later because they didn't select patients unequivocally diagnosed with Sjogren's.
I had never heard of this drug and did a google search to see what the potential side effects were - and I found this instead, a business report from the company dated 2008. Looks like it was tried in rheumatoid arthritis patients without any success.
http://www.fiercebiotech.com/story/biogen-idec-drops-baminercept-ra/2008-10-09
I & my rheumy haven't given up; rheumo talking about a 2nd lip biopsy, since it 's been a yr - we'll see... He did mention, earlier on, that baminercept was used for RA & didn't work.
Thanks everyone - it is great honor & blessing to be in a group of smart & compassionate people.
Quote from: P.Trish on March 11, 2013, 10:12:29 PM
I & my rheumy haven't given up; rheumo talking about a 2nd lip biopsy, since it 's been a yr - we'll see... He did mention, earlier on, that baminercept was used for RA & didn't work.
Thanks everyone - it is great honor & blessing to be in a group of smart & compassionate people.
Hi,
Did you ever find out what your focus score was, 1.0 being the minimum for Sjogrens DX criteria?
I emailed him on Mon - hope to know by today
Ana, How are you? I finally heard from my rhuemy - he usually answers email within 24 hours, but he has been on vacation. Here is the result from my lip biopsy (one yr ago). When he said (at my last appt) that it was a 3 or 4, he was talking about the amount of 'tissue fragments' (glands) that were tested, not the level. Silly me. He also said that they should have tested more glands - now he tells me. Anyway, here's what it says:
*benign minor salivary with mild chronic inflammation
*no neoplasm identified
So, you can see why I do not qualify for the trial. My rheumo is suggesting I get a new biopsy - hmmm - we'll see. I hope everyone is having a good week. Springtime brings hope.
Quote from: P.Trish on March 19, 2013, 10:54:15 AM
Ana, How are you? I finally heard from my rhuemy - he usually answers email within 24 hours, but he has been on vacation. Here is the result from my lip biopsy (one yr ago). When he said (at my last appt) that it was a 3 or 4, he was talking about the amount of 'tissue fragments' (glands) that were tested, not the level. Silly me. He also said that they should have tested more glands - now he tells me. Anyway, here's what it says:
*benign minor salivary with mild chronic inflammation
*no neoplasm identified
So, you can see why I do not qualify for the trial. My rheumo is suggesting I get a new biopsy - hmmm - we'll see. I hope everyone is having a good week. Springtime brings hope.
Hi Trish, oh hanging in there...
So it seems that in your biopsy, you were not given a focus score at all, by the results you posted?
Perhaps pathologists only give a score when they are certain it is FLS.
It's hard, because even if you did have "focal lymphocytic sialadenitis (FLS)" the study wanted people with a very high score it seems...
I have "FLS" on my biopsy, but less than 1 focus score...
On tissue fragments, during my biopsy, I was told that the ideal amount is to get 3-4 viable samples.
Thanks for the info Ana - I am learning. There is no 'focus score' on the lab result page, but now I am noticing it is only a page 1 out of page 2 (pg 2 is missing). Regardless, I'll ask the rheumo about it - appt is in a month. Keep hangin' :)
Well, the trial is not going to be held at UCSF, so I contacted Dr. Genovese at Stanford and now have an appt on May 20th. I've sent him my results which are not straightforward ( seriously, are any of us clear cut???). He said it looks like I could be a good candidate, so I'll go down and see. I'll post back here and let you know how it goes.
If you're interested let me explain the not clear cut, 1 of 3 SS-A tests have been positive, 2 of 3 ANA's have been positive, my lip biopsy showed chronic sclerosing sialadenitis for which there was no focus score. This was explained to me as the lymphocytes have come, damaged everything at their little party and moved on, doc said if I had biopsies earlier there would likely have been a focal score. My eyes sometimes decide to make tears (during schimer's test), usually not, but my tear break up time is less than 2 seconds (lousy). I do show damage with the lisamine green staining test, and my unstimulated saliva is 0.64/5min, more than the cutoff of 0.5ml/5min to qualify (which I was told is about 20% of normal.
So we'll see, I'm not going to hope too much after reading how stringent they are being. My husband will be driving me down and it's about 1.5-2hrs for me each way. So even if I am accepted, we'll have to discuss logistics.
Quote from: P.Trish on March 19, 2013, 12:59:24 PM
Thanks for the info Ana - I am learning. There is no 'focus score' on the lab result page, but now I am noticing it is only a page 1 out of page 2 (pg 2 is missing). Regardless, I'll ask the rheumo about it - appt is in a month. Keep hangin' :)
Did you ever find that second page and what your FOCUS SCORE is?
Hi all, I viewed the clinical trial article and was hoping I would find my hospital, Lahey Clinic in Burlington, Ma to be participant...they are not, I am disappointed. I would have called my rheumy to see if I could qualify for the trial. Although I would be a little hesitant, I am all for trying something that may be approved specifically for sjs...I have so many bad days that trying something that may be proven effective for many of the symptoms that we all have would be something that I (personally) would sign up for.
Those who may be able to participate - keep us all posted and good luck!
Anabanana, I just had my Rheumy appt today - my focus score from the lip biopsy is .9
I am sorry it that it took so long to reply! Truthfully, I kept forgetting between flares & other fun health issues. My rheumy asked if I wanted another lip biopsy, since it has been well over a year. He subtly discouraged me, which was surprising because he is usually supportive of clinical trials. My current condition is 'status quo', meaning not any worse than 8 wks ago. For the fatigue, my insurance just approved nuvigil after 3 rejections. Now that I have it, I'm nervous about trying it.
I hope you are having a good weekend. I haven't given up on clinical trials or anything else that will help us all feel better; I am just 'brain-fogged' after the 5 hr trip (both ways) to see the Rheumy.
.
Back from Stanford today. I will go in for pre screening on June 11th. It looks like I qualify with my past SS-A and lip biopsy, but there are some exclusions that can come up with the bloodwork tests. I've reviewed the exclusions, and I don't see any surprises.
So clinical trial of baminercept for 6 months which may be drug or placebo. drug therapy will not be continued after trial; so if it works wonders I'll be sad and cold turkey
Or
start on cellcept in July as previously planned
??????
Quote from: P.Trish on April 19, 2013, 09:26:56 PM
Anabanana, I just had my Rheumy appt today - my focus score from the lip biopsy is .9
I am sorry it that it took so long to reply! Truthfully, I kept forgetting between flares & other fun health issues. My rheumy asked if I wanted another lip biopsy, since it has been well over a year. He subtly discouraged me, which was surprising because he is usually supportive of clinical trials. My current condition is 'status quo', meaning not any worse than 8 wks ago. For the fatigue, my insurance just approved nuvigil after 3 rejections. Now that I have it, I'm nervous about trying it.
I hope you are having a good weekend. I haven't given up on clinical trials or anything else that will help us all feel better; I am just 'brain-fogged' after the 5 hr trip (both ways) to see the Rheumy.
.
Oh, I understand. I am glad that you posted it. My focus score was about half of yours, but lymphocytic infiltrates, very specific to sjogrens...somewhere I read here...that in light of the lymphocytic infiltrates existing (not necessarily about diagnosing sjogrens), you either have the inflammatory cells specific to sjogrens, or you dont...even if you dont meet the 1 focus, we still have the process happening, but at the time of biopsy, thats what it showed...milder than 1 focus....that could have easily changed 1 month later, 3 months, 6 months, a year...it doesn't reflect the dryness at all.
Many doctors may want to dismiss this as soft finding, but come on, if you have a precancerous state (cells) for example, you have early cancer...just like if you have inflammatory cells, you have sjogrens (or if there are any other autoimmune diseases that could cause this?).
I met a person on another board who had a muscle biopsy and came back with mild myopathy/myositis, and still some doctors tried to say these might be soft findings...the person fired back at them...the muscle weakness presentation with the muscle biopsy findings should have been enough..these medical people, don't they understand that disease takes time to show the worst case scenario on a biopsy...by the time its very bad, it may be too late to help someone, but in the early stages when the damage on paper is mild, that is the time to take it seriously...its like they don't understand that a disease will be negative or mild(on paper) before it becomes severe, well, thats why and where medicine is failing...treat before it becomes worse...