[Natalie8]

This article came out yesterday. Very interesting -- I've never heard of this drug--efalizumab for psoriasis. About 46,000 people are on it worldwide. 3 PML cases (2 recent) causing concern. After 3 years on the drug the risk of getting PML is 1:1100. Some doctors are now calling for people to get off it because they don't view that as a risk worth taking.


http://www.medpagetoday.com/MeetingCoverage/SDEF/12849

[Harry Z]

Originally Posted by Natalie8

This article came out yesterday. Very interesting -- I've never heard of this drug--efalizumab for psoriasis. About 46,000 people are on it worldwide. 3 PML cases (2 recent) causing concern. After 3 years on the drug the risk of getting PML is 1:1100. Some doctors are now calling for people to get off it because they don't view that as a risk worth taking.


http://www.medpagetoday.com/MeetingCoverage/SDEF/12849

Efalizumab is another one of the monoclonal antibody drugs that has surfaced in the last number of years. These drugs play with the immune system and as we very well know, contracting PML is a nasty side effect.

I'm guessing one would have to think long and hard about using this kind of drug for something like psoriasis, especially after these recent PML cases.

Harry

[lady_express_44]

Originally Posted by Harry Z

I'm guessing one would have to think long and hard about using this kind of drug for something like psoriasis, especially after these recent PML cases.

Harry

I really can't imagine why anyone with (just) psoriasis would even consider a drug that could potentially maim or kill them . . . then again, I don't know how severe of a medical issue this can be for some people. I always thought it was just an uncomfortable (sometimes painful) and unsightly skin condition.

I think the dermatologist in the article raises a very valid point that some people don't seem to consider when evaluating the risk associated with these new drugs:

The timing of the PML onset was especially troubling because of what it suggests about the true risk, said Craig L. Leonardi, M.D., a dermatologist at Saint Louis University in St. Louis.

He noted that efalizumab exposure is often estimated at 46,000 worldwide, but he said that only about 400 patients have been treated with efalizumab for four years and the number treated for three years is about 1,100.

"If you are talking about three out of 1,100 that is a very different number than three out of 46,000," Dr. Leonardi said.

Risk needs to be calculated on the mean amount of time people have been on the drug, NOT simply on the basis of how many people have tried the drug (for 15 minutes or more).

Both Dr. Leonardi and Dr. Koo said it was time to get proactive in advising patients to get off efalizumab rather than simply "giving them the choice."

While this might be a good "recommendation", I still think it should be up to the patient to make the decision for themselves.

Cherie

[FinLady]

Thinking I need to call my bro to check what med he's on. He has a rare and severe form of psoriasis.

[Riverwild]

Efalizumab is Raptiva.
Harry is correct in that it is one of a number of monoclonal antibodies developed in the past few years (some in development for 20 years +- before reaching market) to treat autoimmune diseases.

As I see it, the problems arising from monoclonal antibodies is that they are used as last resort medications for the most part, when nothing else available has worked to slow whatever autoimmune disease they are being used to treat. That usually means forms of chemotherapy and other VERY strong immune suppressing drugs. As we are seeing now with Tysabri, it's use after the patient being on methotrexate, azathioprine, mitoxantrone, etc, seems to be a trend and creates a stronger chance of PML because the immune system is still not reconstituted from the use of those other agents.

Unfortunately, the news about PML and Tysabri has been trumpeted and kept in the news since it's return to market. What we don't hear about is the PML associated with these other MABs. They have them. It's just not trumpeted the way it is with Tysabri.

Look it up for yourself. http://www.fda.gov/cder/aers/default.htm

Does that make them bad medicines if a known side effect is possibility of PML? Should they be withdrawn from market because they MIGHT cause a patient to be more susceptible to PML? Should the patient not have their choice? Should one drug be singled out because of PML when it's a known side effect of MABs? Maybe they need to be tried first instead of after other drugs?

[lady_express_44]

Originally Posted by Riverwild

Does that make them bad medicines if a known side effect is possibility of PML? Should they be withdrawn from market because they MIGHT cause a patient to be more susceptible to PML? Should the patient not have their choice? Should one drug be singled out because of PML when it's a known side effect of MABs? Maybe they need to be tried first instead of after other drugs?

One of the leading causes of the death in the US is prescription medications, due to deadly combinations, overdose, allergic reactions, etc. or simply as a "side-effect" of the med. I think most people accept there is risk with everything we take, and that the risk must be weighed up against the potential benefit.

For instance Chemo can kill, but leaving the cancer untreated is MORE likely to cause death. That choice isn't so difficult ...

Psoriasis is very unlikely to reduce life expectancy or kill the patient, so the risk/benefit considerations for using this kind of med are quite a different scenario. Then again, if the patient is suffering to the point that life is hardly worth living, and the drug can potentially change that substantially, that is an important consideration too.

Unfortunately, it is not ONLY the "last resort" patients that are recommended these very risky meds. The goal of any company is to get as many people as possible on their med, and they do this by down-playing any deadly "side-effects". They direct their marketing efforts to focusing on the potential advantages (over other drugs), and human nature being what it is, we will often choose the "best bang for our buck".

At the end of the day though, if people are fully informed of the risk they are taking, I agree they should have the choice. However, that requires that there is FULL DISCLOSURE on the true risk, i.e. not 3 cases out of 46,000 (as was stated in this article), but 3 cases in 1,100 (over three years).

Cherie

[jccgf]

On a different note related to psoriasis, I wonder how many doctors test for gluten sensitivity (antigliadin IgA, IgG) or celiac disease (anti-tTG , Total IgA) in their patients with psoriasis. There are several studies now which have shown patients with psoriasis who are gluten sensitive improve on a gluten free diet. Side effects: none.

Coeliac disease-associated antibodies correlate with psoriasis activity. PMID: 15491433 Oct 2004

High prevalence of celiac disease in psoriasis. PMID: 14638373 Nov 2003

In the entire group of patients, as well as in those on a gluten-free diet as the only treatment, Ki67 + cells in involved dermis were highly significantly decreased after the diet.
Gluten-free diet in psoriasis patients with antibodies to gliadin results in decreased expression of tissue transglutaminase and fewer Ki67+ cells in the dermis. PMID: 14690336 2003

The present case supports the association between CD and psoriasis and the concept that psoriasis in CD patients can be improved by GFD
Rapid Regression of Psoriasis in a Coeliac Patient after Gluten-Free Diet. A Case Report and Review of the Literature. PMID: 12949434 2003

Patients with PsoA have an increased prevalence of raised serum IgA AGA and of coeliac disease. Patients with raised IgA AGA seem to have more pronounced inflammation than those with a low IgA AGA concentration.
Psoriasis patients with antibodies to gliadin can be improved by a gluten-free diet. Full text PMID: 10651693 Jan 2002

Thirty of the 33 patients with AGA completed the GFD period, after which they showed a highly significant decrease in mean PASI. This included a significant decrease in the 16 AGA-positive patients with normal routine histology in duodenal biopsy specimens
Psoriasis patients with antibodies to gliadin can be improved by a gluten-free diet. PMID: 10651693 Jan 2000

It was recently observed that in six patients with psoriasis and one with palmoplantar pustulosis, with newly discovered gluten intolerance, a gluten-free diet had a remarkable effect on the skin lesions.
Patients with psoriasis often have increased serum levels of IgA antibodies to gliadin. PMID: 8286249 Dec 1993




Hi Cherie! Hope all is well. I don't post here often, but read occasionally and post even more occasionally... but, good to see you here!

[lady_express_44]

Originally Posted by jccglutenfree

Hi Cherie! Hope all is well. I don't post here often, but read occasionally and post even more occasionally... but, good to see you here!

Hiya jCj! I'm glad you are still popping in to keep an eye on us, and thanks for the posting. Looks like I have more reading to do. I'm still alive, so I guess it's all good. Hope you are doing well too!

Cherie