I have not posted here in a very long time altho I have much appreciated all the support and information I gained from the members of this group, ESPECIALLY when I was first diagnosed with possible cerebritis or vasculitis and feeling very frightened. Johns Hopkins and U of Maryland still disagree about my final neuro SLE diagnosis but I have been on prednisone, plaquenil and cellcept for the last two years. Since the major flare-up in 2005/2006, with the onset of seizures and psychosis, I have had them controlled with Keppra and the other drugs and the occasional steroid infusions. I have just decided not to worry about the "label" and just know that there is definitely inflammation that is "waxing and waning" that causes problems with balance, visions and sometimes speech.
I have some mild kidney protein even with the cellcept (2 mg) and just today started the BLys clinical trial and that is the primary reason for my post. I'm wondering if anyone else here has been in the study or has considered it or decided against it? I had a mild reaction during the infusion so I think I am getting the drug instead of the placebo, which I won't know since the study is double blind for the 76 weeks. This is phase III and the enrollment is for over 800 worldwide and is about to close any day, depending on the number of people screened who are accepted.
The study parameters insist on positive ANAs TWICE so for those of us with maddening floating ANAs (and I have been one from non-reactive to 1:640) the screening can weed people out. The study only allows 2 chances to draw blood for "re-screening" so there is a high failure rate for admission to the study because of the lab requirements. I know my own rheumie had 12 people who "flunked" over the last year and I was positively shocked that I made it, sure that my ANA would be non-reactive.
The positive thing about the study, other than the possibility of a new drug to help, is clinicians are using THREE different scores to measure pain/inflammation etc...those "subjective" measures that are so difficult to quantify and describe, the Selena SLEDAI, BILAG, and PGA (Physician Global Assessment) so the data gathered from all of these lupus patients will be VERY detailed from BOTH PATIENT AND DOCTOR.
I also had to fill out a very detailed survey about my ability to do things for myself, which was very disheartening and somewhat embarrassing for me personnally, but also a valuable assessment tool for the study.
Anyway, I would love to hear from anyone who is participating in the study. I hope the info I posted is helpful to others. Having been on up to 60 mg of prednisone this past year, I just could not face continuing on that path without looking at some other option.
Also, some one commented about Rituxan and lupus in another thread that may be very old... My rheumie advised against because of the PMD deaths...altho that could also be because of the already neuro complications that I have. I could tell that it was a closed subject as far as he was concerned.
As far as this BLyS trial, I know this drug has been used for other things and have tried on my own to find side effect info and of course can't find it...If anyone sees it, pls lmk. Alternate names, BAFF, Belimumab and I believe APRIL may also be the same drug.
I have committed to myself to take this one step at a time and see how it goes, and if I have difficult side effects that are too much or concerns that cannot be answered that I will withdraw.
Thanks for listening and I look forward to hearing from you.
vickie
I have some mild kidney protein even with the cellcept (2 mg) and just today started the BLys clinical trial and that is the primary reason for my post. I'm wondering if anyone else here has been in the study or has considered it or decided against it? I had a mild reaction during the infusion so I think I am getting the drug instead of the placebo, which I won't know since the study is double blind for the 76 weeks. This is phase III and the enrollment is for over 800 worldwide and is about to close any day, depending on the number of people screened who are accepted.
The study parameters insist on positive ANAs TWICE so for those of us with maddening floating ANAs (and I have been one from non-reactive to 1:640) the screening can weed people out. The study only allows 2 chances to draw blood for "re-screening" so there is a high failure rate for admission to the study because of the lab requirements. I know my own rheumie had 12 people who "flunked" over the last year and I was positively shocked that I made it, sure that my ANA would be non-reactive.
The positive thing about the study, other than the possibility of a new drug to help, is clinicians are using THREE different scores to measure pain/inflammation etc...those "subjective" measures that are so difficult to quantify and describe, the Selena SLEDAI, BILAG, and PGA (Physician Global Assessment) so the data gathered from all of these lupus patients will be VERY detailed from BOTH PATIENT AND DOCTOR.
I also had to fill out a very detailed survey about my ability to do things for myself, which was very disheartening and somewhat embarrassing for me personnally, but also a valuable assessment tool for the study.
Anyway, I would love to hear from anyone who is participating in the study. I hope the info I posted is helpful to others. Having been on up to 60 mg of prednisone this past year, I just could not face continuing on that path without looking at some other option.
Also, some one commented about Rituxan and lupus in another thread that may be very old... My rheumie advised against because of the PMD deaths...altho that could also be because of the already neuro complications that I have. I could tell that it was a closed subject as far as he was concerned.
As far as this BLyS trial, I know this drug has been used for other things and have tried on my own to find side effect info and of course can't find it...If anyone sees it, pls lmk. Alternate names, BAFF, Belimumab and I believe APRIL may also be the same drug.
I have committed to myself to take this one step at a time and see how it goes, and if I have difficult side effects that are too much or concerns that cannot be answered that I will withdraw.
Thanks for listening and I look forward to hearing from you.
vickie