New athritis drug gets approval recommendation | Arthritis Information

 

 A government advisory panel Tuesday recommended approval of the drug Actemra, promoted as a new type of treatment for rheumatoid arthritis, a painful and disabling swelling of the joints generally kept in check with medication.

The Hoffmann-La Roche, Inc. drug is already being used in Japan, and the Food and Drug Administration must now decide whether to give its approval for patients in the United States. Actemra's effectiveness was not in dispute, but some of its side effects raised questions. Nonetheless, the vote was 10-1 in favor of approval, and the agency generally follows the recommendations of its advisors.

While the most common form of arthritis comes from wear and tear on the joints as people age, rheumatoid arthritis is an immune system disorder in which the body turns on itself, attacking the joints. Known as "RA," it affects about 2.5 million Americans and usually strikes in early adulthood or middle age. Women are much more likely to suffer from the condition, which can lead to disability and an early death if untreated.

Actemra works by blocking the effect of a certain protein associated with inflammation. In clinical trials, patients with moderate to severe disease given Actemra showed an easing of symptoms and improvement on lab test results. One trial also showed that Actemra worked in some patients who had not seen improvement with a different type of treatment. In another trial, the drug was shown to help prevent damage to the joints.

http://news.yahoo.com/s/ap/20080729/ap_on_go_ot/fda_arthritis_drug;_ylt=AgNaNJ4XA27aX5CmwLcbRU_VJRIF Lynn492008-07-29 13:39:15Thanks, this part of the post is really interesting (and a reminder how serious this disease is). "In RA, you have a nearly 100 percent chance of being totally disabled and dying early, "

But since Actemra acts to suppress the immune system, it can also have serious side effects. These can include severe infections, liver abnormalities and damage to digestive organs.

"It's always good to have new options for treating patients, but with a new drug, you don't know what the side-effect profile is," said Dr. Patience White, chief public health officer at the Arthritis Foundation. "In RA, you have a nearly 100 percent chance of being totally disabled and dying early, and you have a small chance of the side effects we're talking about." The group does not generally take a position on whether a medication should be approved.
From the FDA site:
http://www.fda.gov/ohrms/dockets/ac/08/briefing/2008-4371b1-01-FDA.pdf

Had to scroll and scroll for what I was looking for - ACR numbers like were discussed in the 'remission' thread recently.  I only saw them once in this particular document, on the Risk/Benefit Overview.

For the overview, it said they used the patient group on 8 mg/kg + DMARD, so these would be the responses for that group only:
ACR20   58%
ACR50   36%
ACR70   18%

Which equals 112%, so let me look at that again!  Unless that is fuzzy math, so if they had an ACR70, they still went in the ACR20 total as well because it was 'at least'?   I've seen that phrasing - 'patients who had at least...'

Anyway, that should give some idea in relation to what was discussed on the other thread!

Suzanne2008-07-29 14:50:48Page 32, Table 29.  Wouldn't copy, sorry, but that is what is the numbers say.   http://www.medicalnewstoday.com/articles/56570.php [QUOTE=Suzanne] From the FDA site:
http://www.fda.gov/ohrms/dockets/ac/08/briefing/2008-4371b1-01-FDA.pdf

Had to scroll and scroll for what I was looking for - ACR numbers like were discussed in the 'remission' thread recently.  I only saw them once in this particular document, on the Risk/Benefit Overview.

For the overview, it said they used the patient group on 8 mg/kg + DMARD, so these would be the responses for that group only:
ACR20   58%
ACR50   36%
ACR70   18%

Which equals 112%, so let me look at that again!  Unless that is fuzzy math, so if they had an ACR70, they still went in the ACR20 total as well because it was 'at least'?   I've seen that phrasing - 'patients who had at least...'

Anyway, that should give some idea in relation to what was discussed on the other thread!

[/QUOTE]

58% achieved the ACR20 criteria.
36% achieved the ACR50 criteria (which, by definition means they meet the ACR20 criteria)
18% achieved the ACR70 criteria (which, by definition means they meet the ACR20 and ACR50 criteria)

JR you explained what i was thinking that the % numbers given were percentages of the percentages

I hope no one takes offense at what I'm about to type.

If you're going to read and interpret scientific research, do yourself a favor and study up on statistics.  There are many good textbooks and studyguides available on amazon.com and at your local bookstore. [QUOTE=JasmineRain]I hope no one takes offense at what I'm about to type.

If you're going to read and interpret scientific research, do yourself a favor and study up on statistics.  There are many good textbooks and studyguides available on amazon.com and at your local bookstore. [/QUOTE]

No offense taken.  I posted where to find the numbers AND in the same post came to the same conclusion you did, I just worded it differently.  I guess you missed that.

I think it is unfortunate that we can't get a study that says, "In this study of these patients on these meds over this amount of time, we had these results" and everything added up.  I know people drop out, etc.  But statistics came be used to prove anything, right or wrong.  It makes me uncomfortable on studies when the 'good news' is in statistic form and the 'bad' news isn't, if that make sense.
[QUOTE=Suzanne] [QUOTE=JasmineRain]I hope no one takes offense at what I'm about to type.

If you're going to read and interpret scientific research, do yourself a favor and study up on statistics.  There are many good textbooks and studyguides available on amazon.com and at your local bookstore. [/QUOTE]

No offense taken.  I posted where to find the numbers AND in the same post came to the same conclusion you did, I just worded it differently.  I guess you missed that.

I think it is unfortunate that we can't get a study that says, "In this study of these patients on these meds over this amount of time, we had these results" and everything added up.  I know people drop out, etc.  But statistics came be used to prove anything, right or wrong.  It makes me uncomfortable on studies when the 'good news' is in statistic form and the 'bad' news isn't, if that make sense.
[/QUOTE]

Suzanne - the numbers on Page 32, in Table 29 are not meant to be added up to achieve a total of 112%.

I urge you to study up on statistics.  Perhaps your local community college has a course.
Bottom line Jas - only 18% reached ACR70 and none reached 100% - correct. [QUOTE=Pip!]Bottom line Jas - only 18% reached ACR70 and none reached 100% - correct. [QUOTE=JasmineRain]
Suzanne - the numbers on Page 32, in Table 29 are not meant to be added up to achieve a total of 112%.

I urge you to study up on statistics.  Perhaps your local community college has a course.
[/QUOTE]

Again, I sorted that out in my original post, whether it was to your liking or not. I also said in my original post I was trying to find something to pertain to what had been discussed in the remission thread - that was the goal, not to showcase what you keep ragging on as my need for continuing education.

I'm sorry if you still mad that I don't like cellphone headsets!  They are recommended now, less cancer risk they say, I'm going to have to change my stance!
Pip, looks like they had a MTX group and a DMARD group.  Slog through, maybe they specify which DMARDS somewhere.  [QUOTE=Suzanne] From the FDA site:
http://www.fda.gov/ohrms/dockets/ac/08/briefing/2008-4371b1-01-FDA.pdf

Had to scroll and scroll for what I was looking for - ACR numbers like were discussed in the 'remission' thread recently.  I only saw them once in this particular document, on the Risk/Benefit Overview.

For the overview, it said they used the patient group on 8 mg/kg + DMARD, so these would be the responses for that group only:
ACR20   58%
ACR50   36%
ACR70   18%

Which equals 112%, so let me look at that again!  Unless that is fuzzy math, so if they had an ACR70, they still went in the ACR20 total as well because it was 'at least'?   I've seen that phrasing - 'patients who had at least...'

Anyway, that should give some idea in relation to what was discussed on the other thread!

[/QUOTE]

Is this the original post where you "sorted it all out"?
Jas - this is why we have you!  You can decipher. Also, this is the only place with ACR numbers, and they chose to use study + DMARD; other groups would have had different responses.  Maybe the size of the group was why they chose it, or that it would be the most likely representation of the population on it? [QUOTE=JasmineRain] [QUOTE=Suzanne] From the FDA site:
http://www.fda.gov/ohrms/dockets/ac/08/briefing/2008-4371b1-01-FDA.pdf

Had to scroll and scroll for what I was looking for - ACR numbers like were discussed in the 'remission' thread recently.  I only saw them once in this particular document, on the Risk/Benefit Overview.

For the overview, it said they used the patient group on 8 mg/kg + DMARD, so these would be the responses for that group only:
ACR20   58%
ACR50   36%
ACR70   18%

Which equals 112%, so let me look at that again!  Unless that is fuzzy math, so if they had an ACR70, they still went in the ACR20 total as well because it was 'at least'?   I've seen that phrasing - 'patients who had at least...'

Anyway, that should give some idea in relation to what was discussed on the other thread!

[/QUOTE]

Is this the original post where you "sorted it all out"?
[/QUOTE]

Yep LOL.   I knew what I meant!
Suzanne2008-07-30 09:16:58 [QUOTE=Pip!]Jas - this is why we have you!  You can decipher.
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