I was wondering if there are any relatively long-term studies on the
efficacy of Embrel (for RA and autoimmune disorders).  I'm not certain
how long that drug has been in the market, but it is a new type of
drug (biological) and just wanted to know what sort of results have
been experienced by users.

Howdy again, Purrsian.

I suffer from a form of juvenile rheumatoid arthritis (in case anyone
wonders, the name is misleading: this is not a disease which only
affects children). I also have a growing collection of other
autoimmune disorders. I've been following the progress of Enbrel
(etanercept) for some time, so this was a research project of some
interest to me. Were it not for the cost, I would probably be among
the users of this drug.

Enbrel is proving to be quite effective in many patients, particularly
when combined with methotrexate. Enbrel was approved by the FDA in
1998, and reports indicate that many of the earliest users sustain
improvement seven years after having begun treatment.

"Etanercept is an injectable drug that blocks tumor necrosis factor
alpha (TNF alpha) and is used for treating rheumatoid arthritis,
ankylosing spondylitis, and psoriatic arthritis. TNF alpha is a
protein that the body produces during the inflammatory response, the
body's reaction to injury. TNF alpha promotes the inflammation and its
associated fever and signs (pain, tenderness, and swelling) in several
inflammatory conditions including rheumatoid arthritis and ankylosing
spondylitis. Etanercept is a synthetic (man-made) protein that binds
to TNF alpha. It thereby acts like a sponge to remove most of the TNF
alpha molecules from the joints and blood. This prevents TNF alpha
from promoting inflammation and the fever, pain, tenderness and
swelling of joints in patients with rheumatoid or psoriatic arthritis
and ankylosing spondylitis. Etanercept reduces the signs and symptoms
of rheumatoid arthritis, the arthritis of psoriasis, and ankylosing
spondylitis.  It prevents the progressive destruction of the joints in
patients with rheumatoid arthritis and the arthritis of psoriasis."

MedicineNet: Etanercept (Enbrel)
http://www.medicinenet.com/etanercept/article.htm 

"The Scottish Medicines Consortium (SMC) has completed its assessment
on the above product and advises NHS Boards and Area Drug and
Therapeutic Committees (ADTCs) that etanercept is accepted for use
within NHS Scotland for the treatment of active and progressive
psoriatic arthritis in adults.  It is the first drug to be licensed
for this indication and not only improves symptoms of arthritis and
psoriasis, but may slow the progression of joint damage (at least over
a period of one year)...

Dr Neil McHugh... was quoted in the Glasgow Herald as saying
'Etanercept is a drug that was a breakthrough for rheumatoid arthritis
and recent studies have shown that it is as effective, if not more
effective for psoriatic arthritis, both in combating joint
inflammation and the psoriasis as well. Patients enjoy a double
benefit from it. It's not a treatment you would use straight away but,
with psoriatic arthritis, there are not really many effective forms of
treatment that can shut off inflammation."

MSeC Portal: The Scottish Medicines Consortium issues advice on
etanercept for psoriatic arthritis
https://www.msecportal.org/portal/editorial/PublicPages/bsr/536883279/smcetanercept.doc

"According to a report published in the Lancet, treating rheumatoid
arthritis with a combination of methotrexate and Enbrel is more than
twice as effective as either drug alone. Here are the data: After
using both drugs for 1 year, 35 percent of 682 rheumatoid arthritis
patients went into remission as compared with 13 percent of those on
methotrexate alone and 16 percent taking only Enbrel. The other point
to note is that all these patients had been suffering from the disease
for years. It may be that starting this combination therapy sooner
could slow down the rate of joint destruction and have an even greater
effect...

There is no cure for rheumatoid arthritis. However, there are several
different ways to reduce the joint pain, swelling, and deformity.
Combining methotrexate and Enbrel, both of which affect the disease
mechanism in addition to improving its symptoms, is more effective
than either one alone. And the earlier this is done, the better."

About Arthritis
http://arthritis.about.com/od/arthritistreatments/a/ratreatcombo.htm

"Treatment with ENBREL Had a Positive Effect on Activities of Daily
Living for Patients with Psoriasis...

Data Also Show Many ENBREL Patients Experienced Improvements in
Symptoms and the Impact of the Disease on Their Daily Life

... Statistically significant improvements were seen in many people
treated with ENBREL across a variety of measurements including mean
improvement from baseline in the Psoriasis Area and Severity Index
(PASI), a measure of disease severity and in the patient's assessment
of psoriasis and itching. These new psoriasis data on ENBREL are
consistent with previous studies showing that ENBREL treatment
provided significant relief of psoriasis symptoms."

Morningstar Business Wire: Treatment with ENBREL 
http://news.morningstar.com/news/BW/M02/D18/20050218005418.html

"As a rule, etanercept (Enbrel) is more effective and safer than
methotrexate for psoriatic arthritis. It treats not only the pain of
psoriatic arthritis, but also prevents joint destruction more
effectively than methotrexate. Unfortunately, it is much more
expensive... Etanercept (Enbrel) and methotrexate do suppress the
immune system and patients may be a little more prone to developing
infections."

WebMD: Psoriatic Arthritis Diagnosis and Treatment
http://my.webmd.com/content/chat_transcripts/1/102606.htm?printing=true

"Despite optimization of the use of the traditional disease modifying
antirheumatic drugs (DMARD) as mono- or combination therapy, between
25% and 50% of patients with rheumatoid arthritis (RA) still have
clinically active synovitis with progressive structural articular
damage. Several clinical trials with the anti-tumor necrosis factor
(TNF) agents etanercept, infliximab, and adalimumab, used alone or in
combination with methotrexate, in patients with early or established
RA have shown consistent improvement in signs and symptoms as well as
function, with a dramatic slowing of radiographic damage. The anti-TNF
agents combined with optimal doses of MTX currently constitute the
best therapeutic regimen for the management of patients with RA
failing to adequately respond to traditional DMARD."

PubMed: The anti-tumor necrosis factor agents... (abstract)
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=15660467

"Etanercept is a tumor necrosis factor antagonist with
anti-inflammatory effects. It is currently approved in the US for
psoriasis, psoriatic arthritis, ankylosing spondylitis, rheumatoid
arthritis and juvenile rheumatoid arthritis. Clinical trials have
shown this agent to have an excellent safety profile and to be well
tolerated by both adult and pediatric patients."

PubMed: Etanercept (Enbrel) -- an update.
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=15657632

"Clinical trials show etanercept is effective and safe to use in
rheumatoid arthritis (RA). It reduces disease activity and limits
progressive joint damage in both early and late disease. It can be
used as a monotherapy or in combination with methotrexate, and in
this, the latter approach appears most effective. It is also effective
in psoriatic arthritis and ankylosing spondylitis. Although the
biologic appears safe, caution is needed to ensure it does not
re-activate tuberculosis. It should not be used in patients with
disseminated sclerosis, and there are concerns about a potential
relationship to lymphoma. Its high cost means there will be continuing
debate about the ideal position of this new biologic within the
treatment pathway of RA. At present, it is recommended for use when
methotrexate and another disease-modifying drug have failed."

PubMed: Etanercept in arthritis (abstract)
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=15707475

"SAN ANTONIO, TX -- October 22, 2004 -- In patients on long-term
therapy for rheumatoid arthritis (RA), etanercept (Enbrel) continues
to be both effective and safe, according to research presented here on
October 20th at the 68th Annual Scientific Meeting of the American
College of Rheumatology.

In addition, long-term use of etanercept allows patients to reduce
their background corticosteroid doses, reported investigator Michael
Weinblatt, MD, associate director of the Center for Arthritis and
Joint Diseases, Brigham and Women's Hospital, Boston, Massachusetts...

They reported that patients achieved statistically significant
improvements in multiple measures of disease activity, and the
improvements were sustained for up to 7 years of treatment. Patients
with early RA received etanercept for a median of 5.5 years, and those
with long-standing RA received the drug for a median of 5.6 years. Of
the 558 early RA patients, 58% continue treatment with etanercept, as
do 44% of the 884 long-standing RA patients...

The investigators reported that rates of adverse events and serious
adverse events remained low over time and were consistent with rates
observed in the placebo groups from the controlled phase of the
studies."

Doctor's Guide: Etanercept (Enbrel) Shows Long-term Efficacy and
Safety for Rheumatoid Arthritis
http://www.docguide.com/news/content.nsf/news/8525697700573E1885256F35004A795C

The Enbrel website has put together a batch of testimonials from
users. Of course, since this site is promoting the drug, it is to be
expected that a rosy picture will be presented:

Ebrel: Voices of Experience
http://www.enbrel.com/voe/enbrel-voe.jsp

Here you'll find a large collection of links to online articles
related to etanercept:

QualityCounts: Enbrel (etanercept)
http://qualitycounts.com/drugs/arthritis/enbrel(etanercept).htm

My Google search strategy: 

Google Web Search: etanercept OR enbrel effective OR efficacy
://www.google.com/search?hl=en&q=etanercept+OR+enbrel+effective+OR+efficacy

I hope this helps! Please let me know if you need anything further.

Best wishes,
pinkfreud

---

Clarification of Answer by pinkfreud-ga on 06 Mar 2005 10:05 PST

Enbrel appears to offer very good news to psoriasis patients:

"The Phase 2 clinical study has demonstrated that 56 percent of
patients treated with EnbrelŪ (etanercept) had at least a 75 percent
improvement in their psoriasis over the six month period compared to 5
percent of patients receiving placebo."

http://www.docguide.com/news/content.nsf/news/8525697700573E1885256B680061EEDA

Fabulous, Pink.  Thank you.  My husband suffers from a pretty base
case of psoriasis and, although I might just be second-guessing how
deep the emotional scars are, is really unhappy and insecure about
that.  When his doctor prescribed Embrel, I could see a veil lift. 
So, I'm just crossing my fingers and toes.  My husband will not be on
methotrexate because the doctor feels that having had prior treatments
with it, he didn't want to expose my husband's liver to anymore.  So,
thanks, again.  You're quite a terrific researcher. :-))

Many thanks for the kind words, the five stars, and the generous tip!

Best of luck to your husband. One of my in-laws has a horrendous case
of psoriasis, and I'm hoping that Enbrel may be able to help.
Autoimmune diseases are receiving a lot of attention and research
money these days, which is good news for those of us whose defense
systems are our own worst enemies.

~pinkfreud

One more comment, because I know you are a busy bee.  I just finished
reading a book called, "Leaky Gut Syndrome" by Elizabeth Lipsky, Ph.D.
 It was a truly fascinating tour through the gut's immune system. 
It's her assertion that most, if not all autoimmune disorders can be
traced to a condition called "leaky gut" where microtears in the villi
of the stomach and intestines allow the passage of large food
molecules into the body.  Because those large molocules are detected
as invasive bodies, the immune system is mobilized.  It's quite a
fascinating theory.
Thanks for the good wishes.  I think that both my husband and I will
experience a new and different quality to our lives together if he
loses all those terrible scales and patches.  That condition has
really cast a dark cloud over him, which I think he's grown used to. 
I would love to see him not suffer anymore.

I'm aware of the "leaky gut syndrome" theory. It is not highly
regarded by most reputable medical authorities. In the view of a
gastroenterologist whose opinions I trust, this is one of those
pseudoscientific fads that makes a faint (but distinct) quacking
sound.

Well, Pink, I try to keep an open mind, in any case.  You know, no
duck left unturned.  Elizabeth Lipsky has a very charming personality
in any case, and if enthusiasm were a pharmaceutical, she would
certainly have a popular product.
Parenthetically, I once met a urologist who felt it was silly to drink
eight glasses of water everyday - "that's WHY your urine turns
yellow!".  I suppose even medical professionals disagree with each
other.  Thanks, ever so much for your insights and wit.  :-)

>> if enthusiasm were a pharmaceutical, she would
>> certainly have a popular product.

Yes, but if enthusiasm were a pharmaceutical, Charo would own Pfizer.

Hmm. I am starting to think about the Charo wonder drug.
Cuchicuchitol, perhaps. Makes viruses dance a conga line right out of
your body.

Cuchicuchi probably has great healing potential . . .;o)

Thanks for the additional posting.  The drug sounds very promising. 
Am wondering if Remicade is the same type of biological - tnf-blocker.

My husband's doctor has also prescribed a new type of light therapy,
which my husband is going to try first.  Seems odd to approach a
systemic disorder at the symptom level, but the doc thinks it might
work.

Yes, Remicade (infliximab) is a TNF blocker. Another one is Humira (adalimumab).