Hi all,
I was searching for info and came across the fourms. After looking at alot of the posts I registerd. Awsome job Fred, It is cool to hear other talking about psoriasis and World wide too. Seemed like the only people you can talk to about it is family and not the people who you would really like to talk or hear about. looks like a good group on here and couldnt wait to join in. My name is Mike and im 53, married and in Chicago, IL. My first outbreak was 2000 and it came to me on my genitals and my scalp. (I was single at that time and dating.) I went to the docs to hear what it may have been. It wasnt what I thought... It was Psoriasis, the doc new knew to quick. I went to another doc and for the second opp. he told me the same, still couldnt beleave it, told him to take a sample.. came back pos. so now just had my last flareup in 2011 and it took over 80% of me in three dayz. doing much better now with just light treatment and Clobex lotion. I was offered stelara but turning it down and tryin to stay on topical lotions and light for now. Buying a boat this year, anyone for some sun and tan treatment on Lake Michigan this summer...

Replying on this thread
Methotrexate
the following:

Of course I totally do not agree about what is written in this thread (sorry Fred, it's her again).

Methotrexate, well regarding what I read of it, it is quite heavy stuff. I mean that for instance the rule is that you may not get pregnant, that is not nothing. It at least means that the attack that methotrexate does to your cells and replication mechanism is threatening for new life.

What I than not understand is the sentence: "however you should not worry you to much as it has been prescribed by your dermatologist or arthritis consultant....."
It is as if the opinion, although specialist, of theirs is enough to make it sensible to use the stuff.
What do these people know about you? They see you a few times per year, during 15-20 minutes. They see some blood-tests of yours, but those are just momentarily impressions of the state of your health. And on the basis of that they decide if you can use it or not??

In my opinion, the only real expert, is you yourself. Your contact with your own body lasts from the moment that you wake up till the moment you go to sleep. In fact you are the only one that has a 24/7 impression of how you feel.

I have used methotrexate myself. For about 4 months. In that time I have carefully listened to my body. What I felt is hard to describe in Dutch, let alone hard to describe in English. It was as if my body was ehm.. grinding in all its corners, it was devastating. I really got scared of these feelings.
And after 4 months I, not any "specialist" in arthritic psoriasis, no "I" decided to stop with this. This could not be good for me.

I am glad I stopped... I restarted my search for something better and now I am quite happy and healthy again, it's not perfect, but it is way better.

Caroline

If you are thinking of using Methotrexate (MTX) for Psoriasis or Psoriatic Arthritis, you may find this information of use. When you look at all the information about Methotrexate it can be very worrying especially concerning the side affects. however you shouldn't let it worry you to much as long as it has been prescribed by your dermatologist or arthritis consultant, and you are getting and will continue to receive regular check ups.

Methotrexate was originally developed and continues to be used for chemotherapy either alone or in combination with other agents. It is effective for the treatment of a number of cancers. It is also used as a treatment for some autoimmune diseases including: rheumatoid arthritis, psoriasis, psoriatic arthritis, lupus and Crohn's disease. It is commonly taken orally, but can also be given via injection. Although Methotrexate was originally designed as a chemotherapy drug (in high doses), in low doses Methotrexate is a generally safe and well tolerated drug in the treatment of psoriasis and psoriatic arthritis.

Dosage: It is recommended that a test dose of 5-10 mg should be administered, one week prior to therapy to detect idiosyncratic adverse reactions.

In most cases of severe uncontrolled psoriasis, unresponsive to conventional therapy, 10-25 mg orally once a week and adjusted by the patient's response is recommended. The prescriber should specify the day of intake on the prescription.

When shouldn't I use Methotrexate?

• It has not been prescribed by a specialist.
  
• If you're not getting regular blood and liver check ups.
  
• If you're trying for a baby (male & female), pregnant, or breast feeding.
  
• If you have an impaired renal function or impaired hepatic function.
  
• If you have marrow hypoplasia, leukopenia, thrombocytopenia or anaemia.
  
• You should also try to limit you're alcohol intake or preferably give it up all together.
  
• If you have suicidal thoughts.
  
• This is not a complete list but they are the basics, if you are not sure you should consult a specialist!
  

My dermatologist just told me about HUMIRA today and said that's where I would start if I started biologics. What are some of the side effects that have been tested for? This is the first time I've considered something other than topicals, but I don't know much about it. Any knowledge would be appreciated.

He said it would weaken the immune system, any clarity would be great in the form of numbers or anything!

I just wanted to share (and have a positive 100th post)
Tomorrow (23rd) I am going to be reviewed by my dermatologist and hopefully my UVB treatment will come to an end.
I'm over the moon with the results, I have changed my psoriasis score from 22 to a 3.
I haven't even got that much 'staining' and my legs have never been so clear in the past 10 years :-) 

I am really hoping that with my change in diet and quitting smoking plus a bit of positive attitude that my remission will last longer than usual or that when it does come back it won't be as bad!!!

Hope everyone else finds some relief too

x 

The U.S. Supreme Court rejected Johnson & Johnson's request to reinstate the largest patent- infringement verdict in American history, a $1.67 billion award it won against Abbott Laboratories over arthritis treatments.

The high court today declined to review a lower court ruling that a patent on a method to make antibodies was invalid because it inadequately described what J&J’s Janssen Biotech said it invented. J&J and patent co-owner New York University want to collect on the verdict they received over the drug Humira, which accounts for about 20 percent of Abbott’s annual revenue.

A U.S. appeals court said inventors must describe clearly their work to show they conceived the invention, and that failure to do so may lead to the patent being tossed out. J&J contends that requirement is too onerous when it comes to patents on basic research or discoveries that have broad applications.

“The directive has become unhinged from statutory text, is judicially unadministrable, and is erratic and unpredictable in outcome,” J&J said in its petition.

The dispute centers on a method to create antibodies that block the action of tumor necrosis factor, or TNF. When the body produces too much TNF, it can cause the immune system to attack healthy tissue and leads to inflammation.

J&J’s original research focused on mouse antibodies, and moved to chimeric antibodies that combine mouse and human. The company, whose own Remicade arthritis drug is based on chimeric technology, said its patent also covered a method of making fully human antibodies.

Dispute Over Claims

In ruling the patent invalid, the U.S. Court of Appeals for the Federal Circuit said the claims made in the invention, as written, “constitute a wish list of properties” that a human antibody should have.

Abbott said its researchers discovered ways to create human antibodies and J&J tried to “expand its patent rights to cover a class of antibodies that it did not invent or describe.”

A March 2010 Federal Circuit decision laying out the written description requirement got U.S. support, Abbott said, and J&J “seeks to disrupt the settled expectations of innovators like Abbott by upending decades of precedent.”

Novo Nordisk, the world’s largest insulin maker, and vaccine maker Bavarian Nordic urged the high court to take the case, saying they need broadly written patents to protect their research.

Drug Sales

Sales of Humira were $7.93 billion last year, including $3.43 billion in the U.S., Abbott reported Jan. 25. The drug accounts for about 20 percent of the Abbott Park, Illinois-based company’s revenue.

Abbott has filed its own lawsuit, claiming J&J’s arthritis drug Simponi, made with human antibodies, is infringing an Abbott patent. It also claims a J&J psoriasis medicine, Stelara, violates two other patents. Those cases are pending in federal court in Worcester, Massachusetts.

Arthritis involves the breakdown of the cartilage protecting joints and affects one in seven Americans, or 37 million people, according to the National Institutes of Health. Three of the largest drugs used to treat arthritis are Humira, Remicade and Thousand Oaks, California-based Amgen’s Enbrel.

Source: nj.com

Multiple studies have found that psoriasis has a greater impact on women than men, and a new finding that women with psoriasis are less likely to become pregnant adds to the list of disease-related concerns.

Dr. Jennifer C. Cather and her colleagues recently completed a claims database study that found psoriasis to be significantly associated with lower rates of pregnancy and live births in women aged 35 or younger.

The Abbott-funded study matched 30,733 pairs (1:1) of women with and without psoriasis, said Dr. Cather at the annual Hawaii Dermatology Seminar, sponsored by Skin Disease Education Foundation (SDEF). Overall, women with psoriasis were found to have lower rates of pregnancy (3.1% vs. 3.6%) and live births (1.4% vs. 2.1%), compared with the women without psoriasis.

In the 7,374 matched pairs of women aged 35 or younger, the psoriasis patients had a 22% lower likelihood of pregnancy and a 39% lower likelihood of having a live birth, compared with the patients without psoriasis.

Three other recent studies on pregnancy outcomes in psoriasis offer conflicting findings; however, Dr. Cather noted that the study populations were very different for each.

The first study found that pregnant women with psoriasis are at an increased risk of having preterm delivery and low birth weight infants.

Dr. Cather reported the findings of the U.S. study of 162 pregnancies in 122 women with psoriasis, compared with 501 pregnancies in 290 women without psoriasis. The women with psoriasis were found to have a 1.89 increased risk in odds of having a poor outcome composite, compared with the patients without psoriasis (J. Invest. Dermatol. 2012;132:85-91). Psoriasis was not found to be associated with having a caesarian delivery, preeclampsia/eclampsia, or spontaneous abortion.

However, the opposite was found in a European study of 68 deliveries in 35 women with moderate-to-severe psoriasis, compared with 237 deliveries in 236 women without psoriasis. Psoriasis patients “had a higher mean of past spontaneous and induced abortions than controls,” noted Dr. Cather, who is in private practice in Dallas. The psoriasis patients also had an increased rate of pregnancy-induced hypertension, premature rupture of the membranes, large-for-gestational age babies, and macrosomia (J. Eur. Acad. Dermatol. Venereol. 2011;25:1041-7).

In the third study, 1,463 mothers with psoriasis were compared with 11,704 control patients. Pregnant Taiwanese women with psoriasis were found to have a 1.4 times increased risk of having low birth weight infants, compared with controls. Mild psoriasis did not increase the risk of low birth weight, preterm birth, small-for-gestational age infants, caesarian section, or preeclampsia/eclampsia (J. Am. Acad. Dermatol. 2011;64:71-7).

Dr. Cather noted that more studies are needed to assess the true impact of psoriasis on pregnancy.

Source: skinandallergynews.com

I just found this forum while browsing reddit and I'm excited to have a group of individuals who help and know what I am going through.

My name is Josh I'm 25 and I have been suffering from psoriasis since the age of 17. It is generally difficult to talk about because it mostly effects my genital region. As of late quarter sized flares have appeared on my lower leg and since the beginning I have had pitted and yellowed nails. Although treatment for those sensitive regions seems to be more difficult.

I have only tried topical solutions like Fluocinonide, Taclonex and over the counter Hydrocortisone 1%. They all seem to work for periods of time but if I slack at all it comes back stronger.

Hard to write this thread without sharing a lengthy health saga. Ill try to be brief...GL

I know intellectually the benfits of biologics. However, I am on call for a lymph node removal, thyroid cancer screening - ongoing...polycyctic ovaries and and bladder nerve conduction issues. Notwithstanding several back surgeries. And an overdo hip replacement.
I have flare up and my face is presenting now as lupus and MS. Wow one big mix.
I had 4 doctors tell me I will have cardio vascular disease.
Ironically, had shortness of breath and chest pain and landed up being screened for blood clot last Friday night in my emergency room.

Bottom line I had a panic attack for fear of using a biologic- I think. I was calm had no idea and I had anxiety.

Apparently you breathe in so much and you get dizzy, shaky and faint and your blood pressure goes up and you feel like you are dying.
I am still on hold for remicade....in the mean time....

I am trying a new version of skin cap Ps Val?, kalawalia?
and maybe as a last resort a Dr. no names mentioned- protocol....

I took 60 blood tests last week for his asessment. My friend who has breast and ovarian cancer genectics. and had near death issues with lymph leaking in her body
... found him, pleaded with me to try it out.
plus the BHIH hormones etc....I m kind burnt on the alternative thing,
but I figured why not she looks fabulous lost 25 pounds.. radiant... at 51 and sufferred....

I also got a virus after giving lots of blood last week....... and that was part of the whole dam nightmare.
It gets better.....I gave the virus to it to my husband, who is on bed rest with his automine disease. (two peas in a dam pod).
Trying to not feel sorry at all. I just got very anxious and it is embarassing; not good at having stiff upper lip - no kidding.
I am not taking xanax or tranquilzers.

I have work to do and this has been quite debilitating on many levels. Making the most of a scary situation that could be worse...trying to not catastrophize....
Ill be in touch
Battling myself

LL

UCB announced today that it intends to submit regulatory applications for Cimzia® (certolizumab pegol) in psoriatic arthritis, by end of 2012.

Top-line results from the RAPID-PsA™ phase 3 study evaluating the efficacy and safety of Cimzia® (certolizumab pegol) in patients with adult onset active psoriatic arthritis (PsA) demonstrated a clinically relevant and statistically significant improvement at week 12 in the signs and symptoms of psoriatic arthritis. Initial analyses suggest that no new safety signals were observed in this study and adverse events were consistent with those seen in other trials of certolizumab pegol.

"We are pleased that Cimzia® has the potential to also benefit patients living with psoriatic arthritis and we are currently preparing for submissions to the regulatory authorities later this year," said Professor Dr Iris Loew-Friedrich, Chief Medical Officer and Executive Vice President UCB. "We shall discuss the study results with the regulatory authorities and present them at upcoming major rheumatology congresses."

In this 48 week, multicenter, double-blind, parallel-group, phase 3 study, 409 patients were randomized to receive certolizumab pegol (200 mg every two weeks or 400 mg every four weeks) or placebo.

In the European Union, Cimzia® in combination with methotrexate is approved for the treatment of moderate to severe active RA in adult patients inadequately responsive to disease-modifying antirheumatic drugs (DMARDs) including methotrexate. In the U.S., Cimzia® is approved for reducing signs and symptoms of Crohn's disease and maintaining clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy and for the treatment of adults with moderately to severely active rheumatoid arthritis.

Source: ucb.com

Hello,

I'm a bit of a newbie, but have had psoriasis (scalp and body) for as long as i can remember, so maybe that makes me more of an oldie?...

Anyway, always been in and out of these forums reading other peoples 'miracle cures' and going off and trying them for myself and nothing happening. have come to the conclusion that different things work for different people. 



But recently (only been 2 weeks now so it is still early days) i started using a new one called Salcura DermaSpray Intensive and the moisturiser that goes with it. Only decided to give it a go cos they give away free samples on their website but i have already seen a massive difference. -still slight redness where a few of my bigger patches were, but its nowhere near as red, raised, itchy or angry-looking as it was. my scalp is starting to feel a lot smoother too -can't feel any big clumps like i could before and i'm noticing less and less flakes.



I don't want to count my chickens before they've hatched but its made such a phenomenal difference already that i cant help but feel really optimistic.



Obviously, i still believe different things work for different people but I thought i'd share this with all of you, in case this one works for you too. Hope it does xx

Anyone else using it or tried it before?

The FDA has approved the addition of a secondary supplier of Methoxsalen USP, an integral component of a treatment for the relief of moderate to severe psoriasis prescribed under the brand name Oxsoralen-Ultra® (methoxsalen) Capsules, USP, 10mg.

"We are pleased to obtain FDA approval of an additional manufacturer of Methoxsalen, the key active ingredient for this important drug," said David Mullarkey, senior vice president and general manager of Valeant Dermatology, a division of Valeant Pharmaceuticals North America LLC. "This approval enables us to ensure a steady supply of Oxsoralen-Ultra and is a key step in restoring the supply of our other Methoxsalen containing drug products."

Patients can obtain Oxsoralen-Ultra® with a prescription from their physician.  Oxsoralen-Ultra, in combination with a special type of phototherapy called PUVA (Psoralen plus UVA light) therapy, has been shown to improve severe, recalcitrant, disabling psoriasis.

Did you know as a member of Psoriasis Club you have a Personal Notepad?

To access your Personal Notepad click "Control Panel" in the green menu bar when logged-in, then scroll down and there it is. Put in your content and click "Update Notepad"

Your Personal Notepad can only be seen by you and is not seen by other members (but please remember it is stored on the forum database) the database is protected, but it wouldn't be wise to include personal information like bank details etc just in case!

You can make changes as and when you like. It's handy for keeping notes about your treatments and what is working, or maybe make a note of your next rendezvous. or just put a note in to remind yourself to buy me cake for my birthday.

What's in your Personal Notepad ?

Hi my daughter is 8 and had psoriaisis since june last year,she went to a dermatoligist in december and had been issued with light treatment 3 times per week since then has palmaplanter pustulor psoriasis on feet and hands,guttate,cronic plaque,scalp, she has it everywere including face etc,light treatment has been working on face i must admit and we were sent back early to the consultant as she was getting more psoriasis etc,he said give her another 4 weeks which 3 more to go and if not cleared putting her on systemics which sounds serious for an 8 year ol.also she has special bath,steroid for face,scalp substance,creams,etc about 7 different products to use to,can anyone give me advice on this i just dont know where to turn or speak with as its worrying me,dont know what else to do for her any help or has anyone been in this situation and do you think lights will clear her in time thankyou to all who will read this post

Hello to everyone - just found this site whilst googling( a dangerous pastime I know )

Have only had my last flare up for 5 months but is already causing me difficulties.

Have palm/sole psoriasis with 3 nails on their way out as I write.

Last had same form over 10 years ago- now wishing I hadn't taken all those years so forgranted!

You would never see this posted in the usa. Might be something for others around the world to look into.I know the esters work for some here.

Suzy



Effectively and without much effort: Ambulatory Phototherapy balneo

A brief assessment: Is Balneo phototherapy for the treatment of moderate to severe psoriasis

It is a century old experience: Certain climatic conditions
have a beneficial effect on chronic skin diseases. Stays at the Dead Sea, the North Sea or in the mountains are still very popular holiday destinations of human psoriasis. Hospitals in these areas use the therapeutic effect of the combination of swimming and natural ultraviolet radiation in sunlight. Other clinics, these conditions produced synthetically. More in PSO Magazine 6/11


----------------------------
Effectiveness and benefits of drugs

Systemic therapy with fumaric acid esters:
Historical development of a therapy for psoriasis

The therapy with fumaric acid esters in psoriasis has taken for medical science with a unique history. From a single observation was from an initially supported by only a few doctors wave of applications in psoriasis patients treated with preparations in pharmacies. The path to approval and the current state of Germany and a few other countries, licensed therapy describes Ulrich Mrowietz, Kiel, a member of the Scientific Advisory Board of the DPBS. More in PSO Magazine 6/11
----------------------
Full [/align]Webpage Translated from German to English below

==

The inclusion of balneotherapy phototherapy
in the service catalog of statutory
Health insurance is a major
Success for the dermatology dar. this very
particular form of treatment is a
exclusive power of Dermatologists in
Supply and the availability of psoriasis
to be welcomed.
During the period in which the Balneo phototherapy
was fought, the therapy
of moderate to severe psoriasis
however, experience a minor revolution.
The approval of biologics currently four
(Adalimumab, etanercept, and Infl iximab
Ustekinumab) as a "second-line" therapies *
has achieved considerable success of the therapy
conducted at the patients treated with
the conventional ways not
were adequately treated. The suitability
these new drugs for
continuous long-term therapy is
The new finding contrary to that psoriasis
Today, as a systemic disease
must be considered. Accordingly,
a long-term control of immunologically
mediated inflammation desirable
which not only the skin lesions **
effectively improved, but also some
Concomitant diseases (comorbidity) were positive
can they make will shape.
During this time, under
an intensive care research
also examined which factors in
Therapies related to stressful
are for patients. This could
are well represented, that for a
Therapy required time and effort
the number of doctor visits negative
Infl uence on the health-related quality of life
psoriatic patients have
can.
Thus, should the importance of balneotherapy
Phototherapy for the treatment medium
to severe psoriasis in the light of a
changed situation of the supply
ned redefined.
According to the Scientific Advisory Board
the German Federal psoriasis e.V.
suitable before the Balneo phototherapy
particularly for patients, the medical contraindications
for systemic therapy
and have the time and physically
are capable of the frequent gene treatments
perceive the doctor.
With a known, stable course of disease
Phototherapy may also balneotherapy
for the treatment of short bursts of
Psoriasis can be useful.
Fewer indicated (recommended) is the balneotherapy
Phototherapy for patients with a longer-term
Control of inflammation
Psoriasis, require as to the recommendations
the current S3 guideline
for the treatment of psoriasis long term
Treatment with UV light (maintenance therapy)
should not be performed.
In psoriasis patients, the successful under a
and acceptable treatment system
stand should be changed to
Balneotherapy, phototherapy does not occur.
Prof. Dr. Ulrich Mrowietz
For the Scientific Advisory Board of DPBS
* "Second line" therapy: A treatment may only
be used if other therapeutic
Options were used, not tolerated
are or are not used individually
can.
Skin lesions ** = diseased skin
A short positioning
Balneotherapy, phototherapy for the treatment of moderate to severe psoriasis
==

Background:  Severity assessment of patients with psoriasis is a critical issue. Classical clinical assessment has been recently combined with quality of life (QoL) scores, but a number of instruments are used. Moreover, studies have focus on patients with moderate to severe psoriasis.

Objectives:  To compare the characteristics of QoL instruments in patients with the full range of psoriasis severity attending dermatology clinics.

Methods:  Observational, prospective, multicentre study. Patients completed Skindex-29 (anchor) and a second instrument randomly selected from Dermatology Life Quality Index (DLQI), Psoriasis Disability Index (PDI), and Medical Outcome Study Short Form 36 (SF-36).

Results:  Demographic data, PASI and BSA were not different between the 3 groups. Skindex showed a weak but significant correlation with clinical severity; only PDI showed similar correlation. PDI, DLQI and SF-36 had substantial floor effect in patients with mild to severe psoriasis. Skindex showed strong correlations with the other 3 QoL instruments. SF-36 was more sensitive that the other instruments in detecting worse QoL in male patients.

Conclusion:  Skindex has better sensitivity to clinical severity with minimal floor effect, and cover the main domains explored by the other 3 QoL instruments in patients with mild to severe psoriasis.

Source: onlinelibrary.wiley.com

There are a lot of Psoriasis advice websites on the internet today. Some good, some bad, and some just want to rip you off for your money. But what do you think about the help and information websites that are run by the drug manufacturers? 

I’m not talking about their own sites which tell you about the company and the drugs they make, they are an important part of internet information and are needed.
I’m talking about websites that offer information and advice that give the impression of being independent, but when you look closely at them and dig a little deeper you find they are owned by drug manufacturers.

I’m not saying the information is wrong; In fact a lot of it is good. But would the manufacturer of say Humira recommend you use Dovonex on that information website?
Take for example the biological treatments. This is a huge market and Abbot, Amgen-Pfizer, Janssen , Johnson & Johnson, and Merck & Co are all in competition to promote their product as the best. 

I use Stelara which is manufactured by Janssen, and today I found out that psoriasis360 and livingwellwithpsoriasis are owned and run by Janssen!
I dug a little deeper and found the following

Quote:A Janssen Canada educational campaign around psoriasis goes a step further, offering a list of available treatments, and a dermatology locator that returns only those dermatologists who “agree that they will use biologics” – Janssen markets Stelara, an immunomodulating biologic – and who have voluntarily signed up to be listed on Janssen’s Living Well With Psoriasis website, according to Spilios Asimakopoulos, director of marketing technology, Janssen Pharmaceuticals Canada.

Anacor Pharmaceuticals (NASDAQ:ANAC) announced today positive preliminary results from two safety studies of AN2728 - a maximal use systemic exposure (MUSE) study in psoriatic patients and a local tolerability study. The results of these two studies demonstrate that AN2728 Ointment, 2% appears to be safe and well-tolerated when applied to very large body surface areas and that it is well-tolerated when applied to areas of sensitive skin. AN2728 has previously demonstrated safety and efficacy in multiple Phase 1 and 2 trials for mild-to-moderate psoriasis and most recently in a Phase 2a study in atopic dermatitis.

"These data confirm the safety of AN2728 and the potential for it to be used on areas of the body that are susceptible to side effects from steroids and tend to be sensitive to irritation from vitamin D analogs," said David Perry, CEO of Anacor Pharmaceuticals. "All of the clinical studies we have done to date on AN2728 in psoriasis and atopic dermatitis support that it could be a potentially safe and effective topical treatment for patients who suffer from mild-to-moderate psoriasis or atopic dermatitis."

AN2728 MUSE Study

The MUSE study was designed to obtain a full pharmacokinetic profile in psoriatic patients under Phase 3 maximal use conditions. The multi-center, open label study enrolled 33 patients with extensive psoriasis with a mean involvement of 38% of total body surface area. Patients applied AN2728 Ointment, 2% twice daily for eight days. No serious adverse events were reported and no subjects discontinued early from the study. Application of AN2728 Ointment, 2% on larger body surface areas resulted in higher plasma exposure levels but did not correlate with greater adverse events.

AN2728 Local Tolerability Study

The local tolerability study was designed to examine the potential irritancy of AN2728 Ointment, 2% when applied to sensitive skin areas such as the face, skin folds (groin, armpits), genitals, etc. This single-center, double-blind, vehicle-controlled study randomized 32 adult healthy volunteers (3:1) to receive AN2728 Ointment, 2% or Ointment vehicle. Subjects applied study drug as instructed twice daily for 21 days to sensitive skin areas. At each of seven visits, each tolerability parameter was graded on a scale of 0 (none) to 3 (severe) in intervals of 0.5. Overall, almost 99% of the nearly 8,700 tolerability measurements were scored as 0 (none). None of the treated anatomic areas appeared to be particularly sensitive to irritation by the study drug or vehicle. No serious adverse events were observed in the trial. Adverse events occurred at a low rate and were generally mild.

Updated Results from Phase 2a Study of AN2728 and AN2898 in Atopic Dermatitis

On December 12, 2011, Anacor announced preliminary results of a Phase 2a study of AN2728 and AN2898 in atopic dermatitis, a chronic rash characterized by inflammation and itching. The final audited data demonstrate a slight improvement in the AN2728 treatment group, while the results for AN2898 did not change. The primary endpoint for both compounds was successfully achieved after 28 days of twice-daily treatment. In the final analysis, 68% of AN2728-treated lesions showed greater improvement in Atopic Dermatitis Severity Index (ADSI) score versus 20% for vehicle (P = 0.02) and 71% of AN2898-treated lesions showed greater improvement in ADSI score versus 14% for vehicle (P = 0.01). There were no severe adverse events reported that were considered related to either study drug.

In addition, lesions treated with AN2728 showed a 66% mean improvement in ADSI score at day 28 compared to 39% mean improvement in ADSI score for lesions treated with vehicle (P < 0.01). Lesions treated with AN2898 showed a 68% mean improvement in ADSI score at day 28 compared to 45% mean improvement in ADSI score for lesions treated with vehicle (P = 0.02).

Finally, the proportion of lesions achieving total or partial clearance (ADSI score ≤ 2.0) at day 28 was 52% for lesions treated with AN2728 compared to 16% for lesions treated with vehicle and 48% for lesions treated with AN2898 compared to 33% for lesions treated with vehicle.

In this multicenter, randomized, double-blind, vehicle-controlled, bilateral comparison study, 46 patients with mild-to-moderate dermatitis were randomized (1:1) to receive either AN2728 Ointment, 2% vs. Ointment vehicle or AN2898 Ointment, 1% vs. Ointment vehicle, applied twice daily to two similar target lesions on the trunk or extremities for six weeks. Lesion severity was measured by the ADSI score which is the sum of the severity scores of five clinical features (erythema, pruritus, exudation, excoriation and lichenification) from 0 (none) to 3 (severe) for each feature, for a total score of 0 to 15.

AN2728 Regulatory Update

Anacor requested a Special Protocol Assessment (SPA) from the U.S. Food and Drug Administration (FDA) for the Phase 3 trial design of AN2728 in psoriasis and has reached concurrence on the major parameters of the Phase 3 trial design.

AN2728 Development Plan Update

Given the safety profile exhibited by AN2728 in 13 clinical studies, the positive outcome from the atopic dermatitis trial, and the large unmet medical need in atopic dermatitis relative to psoriasis, Anacor intends to focus its AN2728 development activities on atopic dermatitis in 2012 and will defer the start of the Phase 3 trial in psoriasis. Anacor will provide more specific information on these activities in a future communication.

Source: anacor.com

Results from a large study carried out in US women suggest that people with psoriasis have increased risk for venous thromboembolism (VTE).

"Recently there has been considerable interest in whether systemic inflammation is a risk factor for VTE, as inflammation is associated with a procoagulant state," explain Pamela Lutsey (University of Minnesota, Minneapolis) and colleagues in the Journal of Thrombosis and Haemostasis.

This interest extends to investigations into associations between VTE risk and medical conditions characterized by chronic systemic inflammation, such as rheumatoid arthritis, psoriasis, and inflammatory bowel disease.

In the present study, Lutsey and team used data from the Iowa Women's Health Study to investigate whether psoriasis in particular is associated with an elevated risk for incident VTE.

The analysis included data from 38,608 women, aged a mean of 68.1 years at baseline, who were followed-up for a median of 11.3 years.

During the follow-up period, 859 (2.2%) women developed psoriasis. Women who developed psoriasis were more likely to be young, highly educated, be smokers, have higher body mass index (BMI), be diabetic, and be using hormone therapy than women who did not develop the condition.

There were 1825 VTE events recorded during the course of the study, 37 of which were preceded by a diagnosis of psoriasis.

Age-adjusted multivariate analysis showed that women who developed psoriasis had a 40% increased risk for VTE compared with those who did not. Additional adjustment for education, smoking status, BMI, diabetes, and hormone use attenuated the risk by just 1%.

The researchers say that their findings are in line with those of other recent studies, which have suggested that psoriasis is associated with an increased risk for VTE.

However, the current results extend previous work because they controlled for lifestyle and anthropometrics, and included outpatient psoriasis cases, they add.

Lutsey et al say that while their findings contribute to ongoing discussions about whether chronic systemic inflammation causes VTE, they are probably of little clinical impact.

"Given the modest hazard ratio and relatively low incidence of VTE, a diagnosis of psoriasis would not justify special VTE prevention," they write.

Furthermore, since individuals with moderate and severe psoriasis have an increased risk for atherosclerotic cardiovascular disease, they may already be targeted for cardiopreventive therapies, such as weight loss and statins, which may also lower VTE risk, the team concludes.

Source: medwire-news.md