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Sangye
03-11-2011, 03:51 AM
Today they announced that for the first time in 56 years there is a new drug that's been FDA-approved for Lupus. Here's (http://www.npr.org/blogs/health/2011/03/10/134417435/fda-approves-benlysta-first-new-lupus-drug-in-more-than-50-years) an article on it. Here's (http://hgsi.com/latest/human-genome-sciences-and-glaxosmithkline-announce-fda-approval-of-benlysta-belimumab-for-treatment-of-systemic-lupus-erythema-2.html) the detailed info on the study, from a link in that article.

The drug works by killing off B cells, similar to rtx and cellcept. I have NO idea if it would be something considered for Wegs or if it even affects the same subpopulation of B cells that are the problem with Wegs. Dr Seo didn't mention it yesterday so my guess is that it's not a potential drug for us.

(On a sad note: one of the drug's side effects is depression, and two of the study participants committed suicide during the trial. I wonder how that will impact its use in the larger lupus community. I hope they can control that side effect.)

Anyway, I wanted to post it to give us all hope that there is always something new coming down the pike to help. Maybe someday there will be an FDA-approved drug for Wegs, too. That would sure make it easier to get insurance approvals for pricey drugs like rtx and cellcept. Keep your chin(s) up fellow Weggies! :smile1:

Brooke
03-11-2011, 04:45 AM
Very interesting, thanks Sangye.

Palmyra
03-11-2011, 05:46 AM
I saw similar reports on several web sites, regarding the FDA's approval. I think any and all research into the myriad of autoimmune disease is always a good thing for Weggies, as that pipeline really does funnel down meds for consideration. Didn't you mention that Dr Seo said some other possibilities were on the drug horizon, but were a couple of years off?

(Wow, the depression side effect is not good at all. As if these unfortunates need anything remotely like that! Ugh!)

freakyschizogirl
03-11-2011, 05:52 AM
Very said about the two patients who committed suicide :crying:

Psyborg
03-11-2011, 06:19 AM
Do they know for certain the drug caused the depresson. Anyone with these diseases could be prone to depression I'd think. Not that I doubt it couldn't just curious how they really track those things.

drz
03-11-2011, 07:46 AM
Do they know for certain the drug caused the depresson. Anyone with these diseases could be prone to depression I'd think. Not that I doubt it couldn't just curious how they really track those things.

Here is what the study said: There was only a 4% difference between treatment group and control group. It is uncertain that the psychiatric symptoms were a risk due to small difference. That small difference could happen by chance.

Psychiatric events (primarily depression, insomnia, and anxiety) were reported more frequently with belimumab (16%) than with placebo (12%). Serious psychiatric events, serious depression and two suicides were also reported (0.8% for belimumab and 0.4% for placebo). It is unknown if belimumab treatment is associated with increased risk for these events.
The most commonly reported adverse reactions (5%) with BENLYSTA were nausea, diarrhea, pyrexia, nasopharyngitis, bronchitis, insomnia, pain in extremity, depression, migraine, and pharyngitis.