Abbott scientists and independent researchers will highlight the latest research findings on HUMIRA® (adalimumab) at this year's American College of Rheumatology (ACR) Annual Scientific Meeting, scheduled for November 5-9 in Chicago.  The presentations include data on rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA), ankylosing spondylitis (AS) and spondyloarthritis (SpA), as well as health economics research.

"At this year's ACR, taking place in our home town of Chicago, researchers will share a broad spectrum of compelling data for HUMIRA across approved and investigational indications," said John Leonard, M.D., senior vice president, Global Pharmaceutical Research and Development, Abbott.  "These studies underscore our commitment to advancing treatment for rheumatologic diseases and meeting the needs of patients, physicians and payors around the world."
Presentation Highlights

Abbott data being presented at ACR include the first presentation of results from ABILITY-1, the first Phase 3 study to evaluate an anti-tumor necrosis factor medication (anti-TNF) in patients with non-radiographic axial spondyloarthritis. These data were selected for an oral presentation on November 8.

The company also will present clinical and patient-reported outcomes from OPTIMA, the first global prospective trial using a treat-to-target philosophy in the treatment of moderate to severe rheumatoid arthritis. Treat to target is focused on achieving a clearly defined treatment goal within a set duration of time and adjusting the treatment if the target is not met. In OPTIMA, the treatment goal was a composite primary endpoint of low disease activity score (DAS28<3.2) and no radiographic progression (change from baseline in modified total Sharp score of less than or equal to 0.5).

Additionally, Abbott is presenting data from among the longest open-label extension studies in RA: 10-year data from the open-label extension of the DE019 trial of patients with moderate to severe long-standing RA and eight-year data from the open-label extension of the PREMIER trial of patients with early moderate to severe RA. Abbott also will present five-year results from the open-label extension of the ATLAS study. ATLAS is a Phase 3, multicenter, double-blind trial of patients with active AS randomized to HUMIRA 40 mg every other week or placebo for 24 weeks followed by an open-label extension up to five years.

Identified below are some HUMIRA abstracts of interest (all times are CST):
Rheumatoid Arthritis

Study Related to Clinical and Radiographic Implications of Time to Treatment Response in Early Rheumatoid Arthritis Patients with Baseline Levels of Disease Activity Reflective of a Clinical Practice Setting; E. Keystone, et al

    Abstract 417; Poster Session; November 6, 2011; 9 a.m. – 11 a.m.;
    Location: Poster Hall

Analysis of Genetic Influence of HLA-DRB1, IL4R and FcγRIIb on Radiographic Responses to Methotrexate Monotherapy or Adalimumab Plus Methotrexate Through 26 Weeks in Patients with Early Rheumatoid Arthritis; A. Skapenko, et al

    Abstract 154; Poster Session; November 6, 2011; 9 a.m. – 11 a.m.;
    Location: Poster Hall

Eight-Year Results of an Open-Label Extension of a Phase 3 Trial Related to Initial Combination Therapy with Adalimumab Plus Methotrexate in Patients with Early Rheumatoid Arthritis; F. Breedveld, et al

    Abstract 1231; Poster Session; November 7, 2011; 9 a.m. – 11 a.m.;
    Location: Poster Hall

Study Related to Baseline Levels of the Inflammatory Biomarker C-Reactive Protein Correlation with Magnetic Resonance Imaging Measures of Synovitis at Baseline and After 26 Weeks of Treatment in Patients with Early Rheumatoid Arthritis; C. Peterfy, et al

    Abstract 1612; Oral Abstract Session; November 7, 2011; 2:45 p.m.;
    Location: W 474 A

Study Related to Outcomes and Predictors in Early Rheumatoid Arthritis Patients Treated with Adalimumab Plus Methotrexate, Methotrexate Alone or Methotrexate Plus Subsequent Adalimumab; J. Smolen, et al

    Abstract 1698; Oral Abstract Session; November 7, 2011; 5:15 p.m.;
    Location: W 375 C

Results of a Phase 4, Double-Blind, Placebo-Controlled Trial Related to Withdrawal of Adalimumab in Early Rheumatoid Arthritis Patients Who Attained Stable Low Disease Activity with Adalimumab Plus Methotrexate; A. Kavanaugh, et al

    Abstract 1699; Oral Abstract Session; November 7, 2011; 5:30 p.m.;
    Location: W 375 C

Final 10-Year Results of an Open-Label Extension of a Phase 3 Trial Related to Initial Combination Therapy with Adalimumab Plus Methotrexate in Patients with Long-standing RA; E. Keystone, et al

    Abstract 2228; Poster Session; November 8, 2011; 9 a.m. – 11 a.m.;
    Location: Poster Hall

Phase 3b and Post-Marketing Observational Study Related to Safety and Effectiveness of Adalimumab in Patients with Rheumatoid Arthritis During More Than Five Years of Therapy; G. Burmester, et al

    Abstract 2216; Poster Session; November 8, 2011; 9 a.m. – 11 a.m.;
    Location: Poster Hall

Juvenile Idiopathic Arthritis

Study Related to Long-Term Efficacy and Safety of Adalimumab for up to Six Years in Patients with Juvenile Idiopathic Arthritis; D. Lovell, et al

    Abstract 265; Poster Session; November 6, 2011; 9 a.m. – 11 a.m.;
    Location: Poster Hall

Ankylosing Spondylitis/Spondyloarthritis

Five-Year Results Related to Improvement of Spinal Mobility, Physical Function and Quality of Life in Patients with Ankylosing Spondylitis; D. van der Heijde, et al

    Abstract 535; Poster Session; November 6, 2011; 9 a.m. – 11 a.m.;
    Location: Poster Hall

Results from a Phase 3 Study Related to Efficacy and Safety of Adalimumab in Patients with Non-Radiographic Axial Spondyloarthritis; J. Sieper, et al

    Abstract 2486A; Oral Abstract Session; November 8, 2011; 2:30 p.m.;
    Location: W 475 A

Health and Economic Outcomes

Study Related to The Impact of Disease Duration on Work Status in Patients with Rheumatoid Arthritis; L. Harrold, et al

    Abstract 108; Poster Session; November 6, 2011; 9 a.m. – 11 a.m.;
    Location: Poster Hall

Impact of Juvenile Idiopathic Arthritis on Parents' Work Absences; R. Rasu, et al

    Abstract 259; Poster Session; November 6, 2011; 9 a.m. – 11 a.m.;
    Location: Poster Hall

Work Absences and Costs Associated with Rheumatoid Arthritis: A Comparison between Employees with and without Rheumatoid Arthritis in a U.S. Population; R. Brook, et al

    Abstract 913; Poster Session; November 7, 2011; 9 a.m. – 11 a.m.;
    Location: Poster Hall

Study Related to Effect of Adalimumab on Function, Health-Related Quality of Life, Work Productivity and Daily Activities in Patients with Non-Radiographic Axial Spondyloarthritis; W. Maksymowych, et al

    Abstract 1312; Poster Session; November 7, 2011; 9 a.m. – 11 a.m.;
    Location: Poster Hall

Validation of the Patient Acceptable Work State: Establishing Thresholds for Patient-Reported Outcomes in a Longitudinal, Observational Study in Patients with Ankylosing Spondylitis; W. Maksymowych, et al

    Abstract 1326; Poster Session; November 7, 2011; 9 a.m. – 11 a.m.;
    Location: Poster Hall

Results from a 26-Week Analysis of Combination Therapy with Adalimumab+Methotrexate Related to Work Ability, Physical Function, Fatigue and Other Patient-Reported Outcomes in Early Rheumatoid Arthritis; R. van Vollenhoven, et al

    Abstract 2189; Poster Session: November 8, 2011; 9 a.m. – 11 a.m.;
    Location: Poster Hall

Souce: abbott.com

Hi Everyone!

My names Amy!
I'm 19.. And i have suffered with psoriasis since I was born! Since i can remeber ive been passed from pillar to post In hospitals! Ive never been on a support forum before, So thought i would give it go!

Im hoping i can get some advice on here and also give other people advice too!

Amy xx

A Dublin woman has revealed how psoriasis, a disease that most regard as superficial, caused her to come "close to suicidal".

Denise McGowan developed the condition when she was three years old and by the time she was in her teens, as it spread on most areas of her body, she started to feel like an outcast.

"Most people think that psoriasis is just a 'skin thing', but it's not, it affects your immune system, for some people it causes arthritis, but it also has a profound psychological effect on people," the 32-year-old Clonsilla native told the Herald.

"When I was very small it wasn't too much of an issue, I wasn't worried about my appearance, some treatments were painful but as a little one, I dealt with it very well.

"As I got older, it got more and more difficult, I had to cover up, I started getting it on my legs, my arms, my chest, my scalp -- and it's a vicious circle, the more you have it, the more you might scratch at it and it only gets worse.

"It came to a point where I was in hospital for three weeks, and I was close to suicidal in my teenage years.

"I felt so isolated, there was no one in my school who had it and I would get a lot of remarks.

"It was nothing physical but you'd be told: 'I hope you don't go near the same hairdresser as me' and so on. I had very few friends.

"My parents were brilliant but I didn't confide in them, I was really quiet, but they'd do anything for me so when they realised, I left school and got a fresh start elsewhere."

A clinical psychologist at Queen's University Belfast, Dr Kate Russo explained this disease can often lead to "depression and severe anxiety" as sufferers lose their self-esteem and try to avoid social situations.

In Ireland, over 100,000 suffer from the disease and in the long run, they may feel like "this can impact upon their ability to meet a partner; or they may avoid intimacy which can interfere with a long term relationship," Dr Russo said.

"This can result in not being able to live their lives in the way that they would wish, which can be very upsetting. Even choices of career can be influenced by psoriasis."

Vitamin D is essential in helping psoriasis. It is in the group of fat-soluble secosteroids and is unique both because it functions as a prohormone and because the body can synthesize it (as vitamin D3) when sun exposure is adequate (hence its nickname, the "sunshine vitamin").

Vitamin D is obtained from sun exposure, food, and supplements. it is biologically inert and must undergo two hydroxylations in the body for activation. The first occurs in the liver and converts vitamin D to 25-hydroxyvitamin D [25(OH)D], also known as calcidiol. The second occurs primarily in the kidney and forms the physiologically active 1,25-dihydroxyvitamin D [1,25(OH)2D], also known as calcitriol.

So where do we get it?
#1 Your first place to look for a source of Vitamin D is the Sun. It’s free and exposure of 15 minutes three times a week is sufficient.

#2 Next you should be looking at foods. Good sources of Vitamin D in food are, Oily Fish including Salmon, Mackerel, Sardines, Tuna. Eggs (Vit D is in the yolk). Beef Liver. Mushrooms. Some manufactured foods are also supplemented with Vitamin D including, Powdered Milk, Breakfast Cereal, and Margarine. (Look for it on the label)

#3 Light Therapies: Pure UVA sunbeds are supposedly ineffective for the treatment of psoriasis on their own so make sure you have UVB.

#4 Supplements: Most people should be able to get the vitamin D they need by eating a varied and balanced diet and by getting some sun. If you insist on taking vitamin D supplements, do not take too much and check with your GP for the maximum daily intake.

OK so how much do you need?
You do not need vitamin D in your diet every day. This is because any of the vitamin your body does not need immediately is stored for future use. The recommended upper dose for an average adult is 4,000 IU (100 mcg) daily.

Salmon, cooked, 100 g (3.5 oz) 360 IU (3.6 IU/g)
Mackerel, cooked, 100 g (3.5 oz), 345 IU (3.45 IU/g)
Sardines, canned in oil, drained, 50 g (1.75 oz), 250 IU (5 IU/g)
Tuna, canned in oil, 100 g (3.5 oz), 235 IU (2.35 IU/g)
A 60g egg provides 20 IU (0.33 IU/g)
Beef liver, cooked, 100 g (3.5 oz) 15 IU (0.15 IU/g)
Cod liver oil, 1 Tbs. (15 ml) 1360 IU (90.6 IU/ml)
Mushrooms, 100-g portion (grilled) from about 14 IU (0.14 IU/g non-exposed) to about 500 IU (5 IU/g exposed to UV light).

Anyone with any more information on Vitamin D please add.

You may not have time to visit the forum to see if there are any new threads or answers to your posts, but our members can get an email if someone starts a new thread in a section they are interested in or if another member posts an answer to your thread

Lets say you always want to know if there is a new thread in the "Psoriasis In The News" board.
Go to that board and just under the New Thread button (top right) you will see Subscribe to this forum click that and you will get an email if a new thread is started in "Psoriasis In The News"

Note: you can subscribe to as many forums as you wish, but you will only get notified if you have "Instant email notification" turned on in your UserCP options and accept emails from The Administrators

So now you can keep a check on your favourite boards via email.

You can also subscribe to a thread without posting in it: If you look at the bottom of the thread on the left hand side you will see "Subscribe To This Thread" Click it and a window will open, make sure Instant Email Notification is ticked and click Subscribe To Thread.

*If you just want to know if someone answers you? Click "Subscribe and receive email notification of new replies" when making your post.

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My experience at Vanier started in grade 10. It was a fresh start. I didn't have friends and I didn't start with expectations. That first year I made a few good friends, those who graduated previously. The two years we grew closer in school, they made me feel I had comfort and incentive to walk through the halls each day.

Due to having a condition like Psoriasis, I have always felt I don't fit in and feel like an outcast. When I get strange looks after someone glances at my face and body, I feel disintegrated and put below them. Not only do I feel their looks, but I hear talking about me as they walk away.

On my second last day spent at Vanier this year, sitting in my Math 12 class, I heard talking once again, but this time it was about what I was wearing. (I was simply wearing jeans, a tank and a crocheted top. Acceptable? I think so). Anyways, it didn't stop at that, these girls went on to say how "pathetic", "slutty" and "awkward" I am. Within the same conversation, I heard one girl specifically say, "I would invite her to a party to see how awkward she would be but she's native, my parents would never allow her at my house". That is racism. And I am no self-confident person to begin with, but I know that these facts are certainly not true about myself. I shouldn't have to leave a place, certainly not a classroom, feeling so uncomfortable and degraded.

I grew up in a community with two small schools, both of which I attended. These schools and teachers taught all students not only the required lessons (math, English, P.E., etc), but to truly respect everyone and everything around you, including nature. They taught me how to be an intuitive, considerate and openminded person.

In my experiences at Vanier, in certain teachers' classes, I was demonstrated the care and patience of the teacher. The students that recognize these traits in the teacher would in return show the respect that they are given. It takes different ways to inspire and be inspired, but I feel everyone can be successful at this.

Such is life, there is a giving and receiving of most things. But at some times, there is a one way street and for me this year, that was bullying. I think that at some point, we as humans all need to learn about acceptance of each and every person's distinctions.

Well I have just gone into my 8th week of treatment with Methotrexate, no apparent side effects, so far!!!
My blood test's are now every 2 weeks, instead of weekly.
I have seen the Consultant twice now, where he increased my dosage from 7.5mg to 10mg on my last visit.
I am starting to see early results, I have a marked improvement in the scaling of the skin, and so far, things are seamingly going in the right direction.
I have another blood test next week and a visit to the Consultant again the week after.
Everything good at the moment, will keep you posted, any questions.....just ask!!

hello everyone.

I am 33 and have had p since i was 18. On the face , scalp and speckled over body. Have had all the creams etc .. they work but all have their pitfalls. uvb was great for the body but the face went back to 'normal' after a week or two. Went to the derm last week and have now been put on the waiting list for Methotrexat. have read about it and am considering it, i need a break .

I am sure like many of you, p has totally affected your lives like mine. Relationships , employment , your happiness all aspects . Most people just dont get it and dont understand the grip p has. Would be really happy with some feed back, thanks.

ajc

Background:
Briakinumab is a monoclonal antibody against the p40 molecule shared by interleukin-12 and interleukin-23, which is overexpressed in psoriatic skin lesions. We assessed the efficacy and safety of briakinumab as compared with methotrexate in patients with psoriasis.

Methods:
In this 52-week trial, we randomly assigned 317 patients with moderate-to-severe psoriasis to briakinumab, at a dose of 200 mg at weeks 0 and 4 and 100 mg at week 8 and every 4 weeks thereafter (154 patients), or methotrexate, at a dose of 5 to 25 mg weekly (163 patients). The primary end points were the percentages of patients with at least 75% improvement in the score on the psoriasis area-and-severity index (PASI) at weeks 24 and 52 and a score on the physician's global assessment of 0 (clear; i.e., no apparent disease) or 1 (minimal disease) at weeks 24 and 52. A total of 248 patients were enrolled in an ongoing 160-week open-label continuation study.

Results:
At week 24, a total of 81.8% of the patients in the briakinumab group versus 39.9% in the methotrexate group had at least 75% improvement in the PASI score, and 80.5% versus 34.4% had a score of 0 or 1 on the physician's global assessment. The corresponding percentages at week 52 were 66.2% versus 23.9% with at least a 75% improvement in the PASI score and 63.0% versus 20.2% with a score of 0 or 1 on the physician's global assessment (P<0.001 for all comparisons). During the 52-week study, serious adverse events occurred in 9.1% of the patients in the briakinumab group (12.9 events per 100 patient-years) and in 6.1% in the methotrexate group (10.6 events per 100 patient-years). Serious infections occurred in 2.6% of the patients in the briakinumab group (4.1 events per 100 patient-years) and in 1.8% in the methotrexate group (2.7 events per 100 patient-years); cancers occurred in 1.9% (2.0 events per 100 patient-years) versus 0%.

Conclusions:
Briakinumab showed higher efficacy than methotrexate in patients with moderate-to-severe psoriasis. Serious infections and cancers occurred more frequently with briakinumab, but the differences were not significant.

Source: nejm.org

As much as I like the idea of having Psoriasis Awareness Campaigns, and I do appreciate the work that everyone does, I’m starting to get a little confused over when they are on, who is actually in charge of running them, and what is the aim!

Obviously the aim is to raise awareness about Psoriasis. But is it? Looking at some of the advertising that sometimes goes with “Awareness Campaigns” I have noticed the big 5 are often present. Abbott / Janssen / Leo / Novartis / Pfizer.

The International Federation of Psoriasis Associations (IFPA) looks like a good idea at first glance. But again there are the big 5! And why do members have to pay a minimum of $25 per year to be a member?

World Psoriasis Day: Is on October 29 of each year; however it looks like the website is only updated once a year. Oh look its run by IFPA and there are the big 5 again!

The National Psoriasis Foundation (NPF) has “Psoriasis Awareness Month” each August. Whilst checking this on their website I did spot Amgen / Abbott / Janssen / and Pfizer at the foot of the page.

The Psoriasis Association UK tells us that it’s Psoriasis Awareness Week 1st-7th November. I’m pleased to say that I didn’t find any advertising. stop press check out their links page!

Well I think I should stop there as this post will obviously upset some people. But you know what I don’t care. I’m just a person with psoriasis, sharing information with others in the hope that someone will get some useful information.

My Psoriasis Campaign: Share information, support you fellow sufferers all year round as and when you can. Let the people do the advertising for the drug manufacturers by sharing their own experience. Oh and I hereby announce 2012 as World Psoriasis Year.

*PC Note: This post is not intended to take anything away from the hard work that Abbot / Janssen / Leo / Novartis / Pfizer / Amgen / IFPA / World Psoriasis Day / NPF / Psoriasis Association do. it’s just my personal opinion, and let’s hope one day we can all work together to find a cure for Psoriasis. (Then again would the big 5 want that!)

ALL PSORIASIS sufferers should be provided with psychological support for their condition, a new campaign will claim.

The Under the Spotlight campaign, a joint initiative between the International Federation of Psoriasis Associations and the Psoriasis Association of Ireland, aims to highlight the psychological effects of the condition.

Studies have shown that the condition also has a debilitating psychological effect on sufferers. Psoriasis can be brought on by stress and is often exacerbated by it.

Dr Kate Russo, principal clinical psychologist at Queens University Belfast, said the international evidence showed that nearly all psoriasis patients experienced psychological trauma too.

Dr Russo said there were not enough co-ordinated services for people with psoriasis, and that GPs were left with the burden of care in the Republic.

“In the UK, there are more clinical pathways for psoriasis sufferers. It is easy to think of it on the surface as it is just a skin condition, but it has huge effect on how you see yourself as a person and how you relate to other people. It can cause people to be isolated from each other,” she said.

She explained that the impact on the disease necessitated psychosocial care as part of the management of the condition.

Source: irishtimes.com

Analyses of data from two large, prospective, phase 3 studies investigating ustekinumab (Stelara, Janssen Biotech) for the treatment of moderate-to-severe plaque psoriasis are consistent in demonstrating the safety and efficacy of restarting the biologic if treatment is temporarily interrupted.

The findings from post-hoc analyses investigating responses to retreatment with ustekinumab were presented in a poster at the 2011 summer meeting of the American Academy of Dermatology. They showed that among patients who initially responded to ustekinumab; withdrew from therapy; and then reinitiated treatment because of relapse, about 85 percent or more recaptured the treatment benefit.

The responses to retreatment in terms of rapidity of onset and magnitude of benefit approached the outcomes with initial therapy, and review of adverse event data showed no difference in the safety profile of ustekinumab comparing 12-week periods of initial treatment and retreatment.

Dr. Lebwohl says the positive efficacy and safety profile of reinitiated ustekinumab contrasts with outcomes of restarting treatment with other biologics. For example, responders to infliximab (Remicade, Janssen Biotech) who stop treatment are likely to develop antibodies to the biologic agent that mitigate future therapeutic response, and they also are at increased risk for developing an infusion reaction.

"Analyses of responses in patients restarting ustekinumab identified negative status for antibodies to the biologic as a potential predictor of response. However, antibody development occurs much less frequently in patients treated with ustekinumab compared with infliximab," Dr. Lebwohl says.

Source: modernmedicine.com

The Minister was speaking after his department was allocated £25million in-year funding by the Executive. This consisted of £5million to purchase crucial drugs and treatments, £15million to implement an invest to save scheme and £5million in capital funding.

Mr Poots said: “Recently I outlined in the Assembly my intention to address the problem of access to specialist drugs and other NICE recommended treatments. The shortfall is unacceptable. This funding will provide specialist drugs such as anti TNFs/ biologic treatment for rheumatoid arthritis and psoriasis, cochlear implants and also address the backlog in accessing drug therapies including treatment for cancer, hepatitis C, growth failure in children, rheumatoid arthritis and eye disease.

“This is good news for hundreds of people waiting for life-enhancing treatments. This allocation is of real importance in correcting a serious gap in the access to therapies which can relieve symptoms and, in some cases, extend life. This is a demonstration of my commitment to providing life-enhancing drugs. This funding will assist in this regard this year, but it is essential that we find a longer-term stream of funding to ensure their availability going forward.”

Source: northernireland.gov.uk

GBI Research, the leading business intelligence provider, has released its latest research, "Anti-Inflammatory Therapeutics Market to 2017 - Respiratory Diseases and Arthritis Continue to Dominate", which provides insights into anti-inflammatory therapeutics revenue forecasts until 2017. The report also examines the global anti-inflammatory treatment usage patterns. In addition, the geographical distribution of anti-inflammatory therapies across the US, the top five countries in Europe, and Japan is also provided in the report. The report also includes insights into the anti-inflammatory R&D pipeline. The report provides an in-depth analysis of the top seven inflammatory therapeutic indications, which are respiratory diseases, arthritis, multiple sclerosis, psoriasis, spondyloarthropathies, inflammatory bowel disease and gout. Furthermore, it also includes the market forecasts and treatment usage patterns of these seven therapeutic indications. The report also explores the competitive landscape, including top companies benchmarking. Finally, the key trend analysis on Mergers and Acquisitions (M&As) and licensing agreements involving anti-inflammatory treatments is also presented.

The in-depth analysis of the report is based on proprietary databases, primary and secondary research, and in-house analysis by the GBI Research team of experts.

GBI Research analysis showed that the global inflammatory therapeutics market was estimated at $57.8 billion in 2010, representing a cumulative annual growth rate of 7.6% between 2002 and 2010. GBI Research forecasts that the market will grow at a Compound Annual Growth Rate (CAGR) of 5.8% between 2010 and 2017, to record a sales value of $85.9 billion. The patent expiry of some major drugs by 2017 is expected to make way for the entry of generics, whereas this impact will be reversed by a number of strong pipeline molecules.

GBI Research has segmented each section of the anti-inflammatory therapeutics market into branded and generics, and estimates the global inflammatory therapeutics to gain 73.1% of revenue from the branded market, whereas 26.9% was achieved from the generics market in 2010. Due to the presence of a strong pipeline portfolio for anti-inflammatories, the branded share is forecast to increase to 78.6% in 2017, and the generics market will decrease to 21.4%.

GBI Research analysis shows that the R&D pipeline for anti-inflammatory therapeutics is strong. Many of the major pharmaceutical companies such as Abbott, Amgen Inc., Johnson & Johnson, GlaxoSmithKline, AstraZeneca, Merck, Pfizer, Eli Lilly, Boehringer Ingelheim and Sanofi are either entering or expanding into the market. They are collaborating with or acquiring small and medium-sized enterprise (SME) pharmaceuticals, which have promising anti-inflammatory drugs in their pipeline. Currently, more than 1,000 molecules are in R&D, with 12% of them in Phase III, 36% in Phase II, 15% in Phase I, 29% in preclinical stage, and 7% in discovery phase. This indicates that anti-inflammatory R&D will be very active for at least the next seven to eight years.

Source: prnewswire.com

Introduction:
Zostavax, a live attenuated vaccine, has been approved in the US for use in older individuals to reduce risk and severity of herpes zoster (HZ), also known as shingles. The vaccine is contraindicated in individuals taking anti-tumor necrosis factor alpha (anti-TNF) therapies or other biologics commonly used to treat autoimmune diseases due to the safety concern that zoster vaccine may be associated with a short-term HZ risk. The objective of the study was to examine the use, safety (short-term HZ risk after vaccination), and effectiveness of zoster vaccine in individuals with rheumatoid arthritis, psoriasis, psoriatic arthritis, ankylosing spondylitis, and/or inflammatory bowel diseases.

Methods:
We conducted a cohort study of patients aged 50 years and older with rheumatoid arthritis, psoriasis, psoriatic arthritis, ankylosing spondylitis, and/or inflammatory bowel diseases using administrative claims data from a nationwide health plan from January 1st 2005 to August 31st 2009. We examined the extent to which zoster vaccine was used; assessed factors associated with vaccine use (Cox proportional hazards regression); and compared the incidence rates of herpes zoster (HZ) between vaccinated and unvaccinated patients.

Results:
Among 44,115 patients with the autoimmune diseases, 551 (1.2%) received zoster vaccine and 761 developed HZ. Zoster vaccine use increased continuously after approval in 2006. Younger and healthier patients, those who had a HZ infection within the past 6 months, and those who were not using anti-TNF therapies were more likely to receive the vaccine. Approximately 6% of vaccinated patients were using anti-TNF therapies at the time of vaccination. The incidence rates of HZ were similar in vaccinated and unvaccinated patients (standardized incidence ratio, 0.99; 95% confidence interval, 0.29 to 3.43).

Conclusions:
Use of the zoster vaccine was uncommon among older patients with autoimmune diseases, including those not exposed to immunosuppressive medications. The short-term risk of HZ did not appear to be increased in vaccinated patients, even among those using immunosuppressive therapies (e.g. biologics) at the time of vaccination. However, our study was limited by the small number of vaccinated patients, and further evidence is needed to confirm the vaccine's safety and efficacy in this population.

Source: arthritis-research.com

Novartis has announced positive results from three Phase II trials showing that AIN457 (secukinumab) produced a quick and significant improvement of symptoms in patients with moderate-to-severe plaque psoriasis. The results were presented at the annual European Academy of Dermatology and Venereology (EADV) Congress, in Lisbon, Portugal.

In one study, 81% of patients receiving AIN457 150mg subcutaneously once a month experienced at least a 75% improvement of psoriasis signs and symptoms as measured by PASI (Psoriasis Area and Severity Index) vs 9% for placebo at week 12 (p<0.001). In another study, results also showed that 83% of patients who were given an intravenous starting dose of AIN457 experienced at least a 75% improvement of symptoms vs 10% for placebo[3]. A third study showed that receiving AIN457 in the first month was beneficial to 55% of patients vs 2% for placebo at week 12.

"These data suggest that AIN457 could potentially bring about a considerable improvement in the lives of patients with moderate-to-severe plaque psoriasis by producing a rapid response and substantial relief of symptoms," said Dr. Kim Papp, Dermatologist and Director of Research at Probity Medical Research, Waterloo, Ontario, Canada, and one of the investigators of the studies. "Plaque psoriasis is a disruptive and often painful chronic immune disease and there is a critical need for new treatment options that combine long-term efficacy with a favourable safety profile."

AIN457 is a fully human, targeted monoclonal antibody that specifically and rapidly binds to and neutralizes interleukin-17A (IL-17A), an inflammatory cytokine implicated in a number of immune-mediated diseases, including psoriasis.

"We are encouraged by these positive Phase II results and look forward to receiving the results of larger-scale and longer-term Phase III studies with AIN457 which began this year," said John Hohneker, Global Head of Development for Integrated Hospital Care at Novartis. "Novartis is committed to providing new treatment options for patients with moderate-to-severe plaque psoriasis, who face significant daily physical discomfort as well as the serious psychological impact of living with this disease."

Source: novartis.com

A mutation in the interleukin-36 receptor antagonist (IL-36Ra) has been identified as a cause of the unregulated secretion of inflammatory cytokines and generalized pustular psoriasis (GPP) by a multicenter consortium.

Their research was presented here at the 12th International Congress of Human Genetics and the 61st American Society of Human Genetics Annual Meeting.

Asma Smahi, PhD, from Hôpital Necker-Enfants Malades, Paris, France, and colleagues identified a highly significant linkage to an interval of 1.2 Mb on chromosome 2q13-q14.1, as well as a homozygous missense mutation in the IL-36Ra, an antiinflammatory cytokine gene.

"We performed homozygosity mapping and direct sequencing on 9 Tunisian multiplex families with autosomal recessive GPP," Dr. Smahi reported, "and results reveal a key role for IL-36Ra-regulated autoinflammation in the pathogenesis of GPP via unregulated IL-1 family inflammatory cytokine secretion in the skin."

Chromosome Region Pinpointed

As Dr. Smahi told Medscape Medical News, they first identified a chromosome region in which the mutation was implicated, and then sequenced the gene located in that region. "What we found specifically was a mutation in the gene that encodes for the IL-36Ra, and in vitro studies on keratinocytes from our patients showed that this mutation was responsible for loss of function of this receptor."

Because this receptor functions as an inhibitor, "inflammation is not regulated," she added, "and this leads to GPP and potentially other forms of psoriasis."

Importantly, a separate group of researchers from London have identified another mutation in the same gene in another group of families with GPP living in the United Kingdom — suggesting that there is a common pathway giving rise to GPP, and psoriatic diseases in general.

These observations could have direct therapeutic implications. As Dr. Smahi explained, they previously identified another autoinflammatory syndrome — deficiency of IL-1 Ra, which has been shown to respond to treatment with a targeted IL-1 Ra, restoring the phenotype in patients with this deficiency.

"This gives us good reason to believe that IL-36Ra treatment will restore the impaired function of this receptor [giving rise to GPP] and stop the upregulation of inflammatory cytokines," she said.

Hervé Bachelez, MD, PhD, from teh service de dermatologie, Hôpital Saint-Louis, Paris, France, told Medscape Medical News that from its initial description in 1910, the GPP form of psoriasis has been shown to be a rare, life-threatening variant displaying a filiation with plaque-type psoriasis — the most frequent form of psoriasis — with which it is combined in a single patient in roughly one quarter of cases.

"Likewise, studying genetic and molecular mechanisms underlying these rare variants may identify new key pathogenic mechanisms and therapeutic targets shared by GPP and plaque-type psoriasis (also called psoriasis vulgaris)," he said. Our results and those from the London team support the therapeutic targeting of the IL-36 receptor pathway as an appealing strategy in familial and sporadic cases of GPP, he explained.

Furthermore, Dr. Bachelez added, even though genetic abnormalities of IL-Ra have not been shown in patients with psoriasis vulgaris so far, "there have been convincing demonstrations that both IL-36 and its receptor are activated in psoriatic plaques from patients with psoriasis vulgaris. Altogether, these recent insights emphasize the key role of innate immunity in psoriatic inflammation."

Source: medscape.com

New findings from the TRANSIT study were presented today at the 20th European Academy of Dermatology and Venereology (EADV) congress, which showed treatment with STELARA® (ustekinumab) is well-tolerated and effective in patients with moderate to severe plaque psoriasis inadequately responsive to methotrexate therapy. Health-related quality of life was also significantly improved according to the study results reported.

The TRANSIT study, a 52 week, open-label, phase IV study of 489 patients, was designed to compare two methods of transitioning patients from methotrexate to ustekinumab. The first was discontinuation of methotrexate with immediate initiation of ustekinumab and the second was initiation of ustekinumab with overlap and gradual dose reduction of methotrexate over four weeks. Results up to week 16 were presented today at the EADV congress.

The primary endpoint of the TRANSIT study was the proportion of patients experiencing at least 1 treatment-emergent adverse event through week 12 in arm 1 versus arm 2.  The number and types of adverse events were similar in the two treatment arms. Serious adverse events were infrequent regardless of the transition strategy: 2.9% of patients in the methotrexate immediate cessation arm versus 2.0% of patients in the methotrexate gradual withdrawal arm. Substantial improvement in efficacy was also observed above and beyond the results patients had achieved on methotrexate, which all patients had been receiving for at least 8 consecutive weeks prior to baseline, and which was considered to be inadequately effective.  Through week 12, the majority of patients in both arms achieved a Psoriasis Global Assessment (PGA) rating of 'cleared' or 'minimal' (65.3% in the methotrexate immediate cessation arm and 69.5% in the methotrexate gradual withdrawal arm). The median Psoriasis Area and Severity Index (PASI) score decreased from approximately 15 in both arms at baseline to 2.9 in the methotrexate immediate cessation arm versus 2.8 in the methotrexate gradual withdrawal arm.

Improvements in health-related quality of life, as assessed by the Dermatology Life Quality Index (DLQI), were observed as early as week four in both arms of the study. Over the study period of 16 weeks, the mean improvement in DLQI was demonstrated by a reduction from 8.0 in the immediate cessation arm and 9.0 in the gradual withdrawal arm to a score of 1.0 in both arms, a clinically meaningful improvement in health-related quality of life.Substantial improvement in the EuroQOL-5D Visual Analogue Scale (EQ-5D VAS) was also observed in both arms.

"Until now there has been very limited data on how to safely and effectively transition patients with moderate to severe plaque psoriasis from conventional systemic agents to biologics," said Professor Carle Paul, University of Toulouse, France and one of the lead investigators for the TRANSIT study. "Results from the TRANSIT study are important because they further advance our understanding of biologics, not just in terms of efficacy, safety and tolerability, but also health-related quality of life. The health-related quality of life improvements are particularly notable given that patients were already being treated with methotrexate when they entered the study, and over a quarter of patients included in the study had been previously treated with other biologic therapies."

Also presented at EADV were findings from pooled analyses of the ongoing ustekinumab psoriasis clinical development programme (which includes the Phase 2 trial, and the Phase 3 PHOENIX 1, PHOENIX 2 and ACCEPT trials). Data showed that the safety profile of ustekinumab and rates of adverse events remained consistent and stable over time in adults with moderate to severe plaque psoriasis receiving up to four years of treatment. More than 1100 patients had been treated for at least three years with ustekinumab and more than 600 patients had been treated for at least four years, representing a total of nearly 6800 patient years (PY).

"Biological therapies are a valuable advancement in the treatment of moderate to severe psoriasis. To support dermatologists in their decision-making about the most suitable treatment option for patients, it is important to have long-term data on available therapies. This pooled 4-year safety data provides a growing and significant body of evidence about the role ustekinumab can play in the management of this chronic, life-long condition", said Professor Christopher Griffiths, University of Manchester, UK, and lead trial investigator for the ACCEPT study.

Methotrexate is not a disease-modifying antirheumatic drug in psoriatic arthritis, despite how well it works in psoriasis, according to Dr. Christopher T. Ritchlin.

Methotrexate is the most widely used drug in the world for psoriatic arthritis (PsA), based on almost no supporting evidence. There have been only two published double-blind, randomized, controlled trials of methotrexate in PsA done over the last 20 years, and both were underpowered and used a low dose of methotrexate (10 mg/week), said Dr. Ritchlin, professor of medicine and director of the clinical immunology research centre at the University of Rochester (N.Y.).

A still-unpublished study that was presented at the annual meeting of the American College of Rheumatology in 2010 showed that methotrexate was not more effective than placebo in PsA The study involved 221 patients who were given 15 mg/week of methotrexate or placebo for 6 months. About 65% of subjects in each group dropped out. The primary outcome measure was the psoriatic arthritis response criteria (PsARC), which most rheumatologists do not think is a good outcome measure, Dr. Ritchlin said at the Perspectives in Rheumatic Diseases 2011 meeting.

At the end of 3 and 6 months of the study, there were no differences between methotrexate and placebo on the PsARC, the ACR 20 (the American College of Rheumatology scale based on a 20% improvement in certain parameters), the DAS28 (Disease Activity Score based on a 28-joint count), a sensitive joint count, a tender joint count, and the C-reactive protein level/erythrocyte sedimentation rates. Only the patient and physician global scores and the skin score showed significant improvement in the methotrexate group.

Indirect data supporting the inefficacy of methotrexate come from NOR-DMARD. These data show that 6 months of treatment with a tumor necrosis factor inhibitor (146 patients) had significantly greater beneficial effects on patients with PsA than did methotrexate.

The propensity toward liver disease is another reason not to use methotrexate in patients with PsA, said Dr. Ritchlin at the meeting, which was sponsored by Skin Disease Education Foundation. Methotrexate is hepatotoxic. Data on the findings of 169 liver biopsies that were done on 71 patients with psoriasis showed that methotrexate significantly increased the risk for stage 3 or 4 fibrosis.