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Johnson & Johnson (JNJ) won U.S. approval for an expanded use of Remicade to treat children with a chronic inflammatory bowel disease who don’t respond to traditional therapy.

The Food and Drug Administration cleared the medicine chemically known as infliximab for pediatric ulcerative colitis, the company said today in a statement.

Remicade was approved in 1998 as the first anti-tumor necrosis factor (TNF)-alpha treatment in the U.S. It is used in Crohn’s disease in adults and children, and ulcerative colitis, rheumatoid arthritis and psoriasis in adults. Most children with ulcerative colitis are first treated with anti-inflammatory drugs and with steroids, according to the Pediatric IBD Foundation.

“Ulcerative colitis can be a devastating disease and previously, there had been no approved therapeutic options for pediatric patients who had an inadequate response to conventional therapy,” Jeffrey Hyams, head of digestive diseases and nutrition at Connecticut Children’s Medical Center, said in the statement from New Brunswick, New Jersey-based J&J.

Hyams, also a professor of pediatrics at the University of Connecticut School of Medicine, was the lead investigator in a company-sponsored study that showed 73 percent of children with ulcerative colitis responded to the drug within eight weeks.

About 150,000 children younger than age 17 are living with the symptoms of inflammatory bowel disease, J&J said. Ulcerative colitis can slow growth in children and delay sexual maturation, according to the Mayo Clinic based in Rochester, Minnesota.
Serious Risks

While the drug’s approval provides a new treatment option for children with moderate to severe ulcerative colitis, there are “serious risks” associated with its use because it suppresses the immune system, Donna Griebel, director of the FDA’s Division of Gastroenterology and Inborn Errors Products, said in a statement.

The drug carries a boxed warning, the FDA’s strongest caution, for increased risks of cancer and viral, fungal or bacterial infections.

A rare, often fatal type of cancer called Hepatosplenic T- cell Lymphoma is among malignancies that have been reported in adolescent and young adult patients using TNF blockers, the agency said in the statement.

An FDA advisory panel on July 21 backed Remicade for pediatric ulcerative colitis to induce and maintain clinical remission and induce mucosal healing. The panel didn’t recommend the therapy to maintain mucosal healing or eliminate corticosteroid use. The medicine generated $4.6 billion in revenue last year, according to data compiled by Bloomberg.

Source: bloomberg.com

Psoriasis is a stronger predictor of elevated cholesterol in children than is body weight, according to an analysis of electronic medical records from Kaiser Permanente Southern California (KPSC). The findings reinforce the need for physicians to address the condition as a systemic metabolic disorder rather than as a superficial skin disease.

The study examined the records of 710,949 children ages 2 through 19 who had at least one visit to KPSC that recorded height and body weight during the years 2007 and 2008. It identified those with a coding for psoriasis or a prescription associated with the treatment of psoriasis; a chart review confirmed the diagnosis in 1,350 patients.

The patient records were stratified into categories of underweight, normal weight, overweight, moderately obese and extremely obese using standard age-adjusted BMI criteria. Excessive body weight was associated with a higher odds for psoriasis. Analyses found the odds ratios for psoriasis were 0.68, 1.00, 1.31, 1.39 and 1.78, respectively.

The odds ratios for severe psoriasis, as assessed by use of systemic therapy or phototherapy by 53 patients, were 0.00, 1.00, 2.78, 2.93 and 4.19, respectively.

Comparing those characterized as overweight to extreme obese to normals, adolescents (ages 12 to 19) with psoriasis had significantly higher mean total cholesterol (P = .020), LDL cholesterol (P = .007), triglycerides (P = 0.14) and ALT (P = .016) than those who did not have psoriasis. The differences were moderate but significant. There was no significant difference between the two groups with regard to HDL.

"I think the most important point for clinicians is that teens with psoriasis have higher cholesterol levels, regardless of their body weight, and this may be a risk factor for cardiovascular disease," says Corinna Koebnick, Ph.D., research scientist at the KPSC's Department of Research & Evaluation and the lead author of the study.

"The second point is that children who are obese have a much higher prevalence of psoriasis. When physicians treat young people for psoriasis, they should monitor for risk factors of cardiovascular disease, especially if the patient is obese," she says.

Source: .modernmedicine.com

Psoriasis is an inflammatory disease that affects women in their reproductive years. Other similar diseases have been associated with adverse pregnancy outcomes. We sought to assess whether pregnant women with psoriasis are at higher risk of developing complications, such as preterm birth (PTB) and low birth weight (LBW).

A retrospective cohort, performed at two large tertiary centers, evaluated the outcomes of 162 pregnancies in 122 women with psoriasis and 501 pregnancies in 290 women without psoriasis.

Univariable and multivariable analyses, adjusting for important demographic factors, comorbidities, or a propensity score, were performed to evaluate the association of psoriasis and a poor outcome composite (POC), including PTB (<37 gestational weeks) and LBW (<2,500 g).

Repeated measures analysis was used to account for the multiple pregnancies per woman. Cesarean delivery, preeclampsia/eclampsia, and spontaneous abortion were also evaluated.

For women with psoriasis, there was a 1.89-fold increase in odds of POC (95% CI 1.06–3.39) in the univariable analysis. This effect remained statistically significant in the multivariable analyses. Psoriasis was not associated with cesarean delivery, preeclampsia/eclampsia, and spontaneous abortion.

This study has shown higher odds of POC in patients with psoriasis. Further larger population-based studies are required to confirm these findings.

Source: Journal of Investigative Dermatology

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Janssen Inc. announced today that Health Canada has expanded the approved indication for SIMPONI® (golimumab), in combination with methotrexate, to include the inhibition of progression of structural damage in adult patients with moderately to severely active rheumatoid arthritis who had not previously been treated with methotrexate. Health Canada also approved an expanded indication in the improvement of physical function in adult patients with moderately to severely active rheumatoid arthritis.1  Rheumatoid arthritis is an inflammatory condition that if left untreated, can lead to permanent damage such as joint deformity and disability.2

"This is an exciting and welcome development for Canadians with moderate to severe rheumatoid arthritis," said Dr. Edward Keystone, Professor, Faculty of Medicine, University of Toronto and one of the principal investigators of the studies on which the approval was based. "Inhibiting the progression of the disease and improving physical function, allowing patients to retain their ability to carry out daily tasks, are key considerations in managing this potentially debilitating autoimmune condition."

The new approval is based on data from the Phase 3 GOlimumab Before Employing methotrexate as the First-line Option in the treatment of Rheumatoid arthritis of Early onset (GO-BEFORE) trial that showed the efficacy of SIMPONI®, in a methotrexate-naïve patient population, in reducing the rate of joint damage as evaluated by X-ray; and on data from the Phase 3 GOlimumab FOR subjects With Active RA Despite Methotrexate (GO-FORWARD) trial that showed sustained improvement, in physical function as measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI).3,4,5

A chronic inflammatory condition and autoimmune disease, rheumatoid arthritis affects approximately 300,000 Canadians, with three times as many women as men having the disease.2 It most often develops in young adulthood (ages 25 to 50) and is characterized by symptoms of joint inflammation, stiffness and pain that over time involves more joints on both sides of the body.2 SIMPONI® was first approved in Canada in 2009 for the treatment of moderately to severely active rheumatoid arthritis, active psoriatic arthritis and active ankylosing spondylitis. SIMPONI® is a 50 mg once-monthly, subcutaneously-administered anti-tumor necrosis factor (TNF)-alpha treatment.1

Hi there,

I like the looks of the forum.

A new meta-analysis links tumor necrosis factor-alpha inhibitors, also called anti-TNFs or TNF blockers, to a higher incidence of skin cancer, but not to an increase in the risk of other cancers.

A type of biologic drug, all of which interfere with the immune system, TNF blockers are used to treat rheumatoid arthritis, or RA, as well as ankylosing spondylitis, psoriatic arthritis and polyarticular juvenile idiopathic arthritis. Drugs in this class include infliximab, or Remicade; etanercept, or Enbrel; adalimumab, or Humira; certolizumab pegol, or Cimzia; and golimumab; or Simponi.

“Doctors can be reassured that there doesn’t look like there’s an increase in [most] cancers,” says the lead author of the analysis, Xavier Mariette, MD, PhD. However, the medical community needs to be cautious about the increased risk of skin cancer – particularly for people who live in sunny climates, says Dr. Mariette, professor of rheumatology and head of the rheumatology department at Bicêtre Hospital and Paris South University, in France.

The findings, published online in September in the Annals of Rheumatic Diseases, add to the body of information about whether TNF blockers increase the risk of cancer, which has been an issue of much concern and debate among patients and doctors. Since biologics are relatively new – dating back to a little more than 10 years – there is no long-term data, and any cancer link could take many years to show up. Clouding the picture is the fact that people with inflammatory arthritis, especially RA, are at higher risk of developing certain cancers.

The meta-analysis pooled the results of almost 30 previously published studies and study summaries on TNF blockers and different types of cancer. Among the studies that looked at skin cancer, the researchers calculated that the risk of developing non-melanoma skin cancer was 45 percent higher among patients who received TNF blockers than those who didn’t. The risk of developing melanoma (the deadliest form of skin cancer) was 79 percent higher among patients on TNF blockers, but the results were based on only the two studies that looked at melanoma.

Among the other findings: There is no increase in cancer risk in patients who used anti-TNF drugs for longer periods or in people who had previously had cancer more than five years before..

Source: arthritistoday.org

A new psoriasis survey in Ireland commissioned by Leo Pharma shows that many are confused.

Despite it affecting some 100,000 people in Ireland, many members of the public remain confused about the skin condition, psoriasis, with almost one in 10 thinking it is a disease of the liver.

The survey of over 1,100 adults nationwide revealed that 7% of people think that the condition is contagious, while another 7% think that those with psoriasis should not be allowed to work in certain jobs, such as jobs involving food.

The survey also noted that among people with psoriasis, almost four in 10 men and almost one in five women do not attend a healthcare professional for it.

Commenting on these findings, Dr Anne Marie Tobin, a consultant dermatologist at Tallaght Hospital in Dublin, urged people with psoriasis to seek medical advice for it.

"People should not be embarrassed by their condition. They should talk to their doctor as psoriasis treatments have improved and new treatments are available that can effectively control the condition," she said.

Also commenting on the findings, Ronan Farrelly, of the Psoriasis Association of Ireland, emphasised that the public ‘needs to know that this is a common skin disorder'.

"It is not contagious and anyone can develop it. Those of us with the condition often feel frustrated with the treatment they receive from people who do not understand the condition. This can often lead to a sense of hopelessness," he explained.

Source:  irishhealth.com

Abstract:
Aim Genes that differentiate patients with psoriatic arthritis (PsA) from those with cutaneous psoriasis (PsC) may serve as markers for the development of PsA in patients with psoriasis. The authors aimed to identify human leucocyte antigen (HLA) alleles that are associated with the development of PsA in patients with psoriasis.

Methods: 712 adult patients with PsA, 335 adult patients with PsC and 713 healthy controls were genotyped for HLA-A, HLA-B, HLA-C, HLA-DR and HLA-DQ alleles. Differences in allelic distributions for each of the HLA loci were compared using a likelihood ratio test. Logistic regression analysis of multiple loci was performed to account for linkage disequilibrium. Haplotype information was inferred using the expectation–maximisation algorithm (given HLA-C and HLA-B genotypes) and analysed similarly.

Results: The following HLA alleles were found to be significantly associated with patients with PsA compared to patients with PsC in multivariate regression analysis: B*08 (OR 1.61, p=0.009), B*27 (OR 5.17, p<0.0001), B*38 (OR 1.65, p=0.026) and C*06 (OR 0.58, p=0.0002). HLA-B*27, HLA-B*38 and HLA-C*06 frequencies were also significantly higher in patients with PsA than in healthy controls (B*27: OR 3.05, p<0.0001; B*38: OR 5.9, p<0.0001; HLA-C*06: OR 1.71, p<0.0001). The following haplotypes were independently associated with PsA compared to PsC: HLA-B*18-C*07 (OR 10.1, p=0.004), HLA-B*27-C*01 (OR 41.1, p<0.0001), HLA-B*27-C*02 (OR 19.9, p<0.0001), HLA-B*38-C*12 (OR 2.9, p=0.01), HLA-B*08-C*07 (OR 2.6, p=0.004) and HLA-B*57-C*06 (OR 0.5, p=0.03).

Conclusions: Certain HLA-B and HLA-C alleles confer susceptibility to PsA among patients with psoriasis and may be used to identify patients with PsC who may develop PsA.

Source: ard.bmj.com

There is a thread on the old forum about Stelara. It was mainly me talking about my time using it, and it had received a lot of hits. so I thought it could be of interest to someone if I gave a run down of my past 16 months.

I started Stelara in May 2010 after Humira failed. I have also tried Remicade & Enbrel but I have to say that Stelara has been the best for me. I noticed a change within a week as my skin started to improve, and within 4 weeks the scales had gone and my skin started to feel smooth again. you could still see the patches but it wasn't flaky / red / & sore. this progress has continued to the stage of you could hardly notice any sign at all.

Stelara has not been so good at helping with the Psoriatic Arthritis as the other biologicals, and I do get a bit of pain when it's damp and cold. having said that it's not been bad enough to stop me getting about to much and I did manage to get through the winter without to many problems.

Side Affects: I have noticed a few mild side affects that come and go. After the injection I can feel tired, I sometimes get a Flu feeling, and some mild headaches. this usually lasts for a week or two and it is not severe enough to put me off, and I have got used to it now. Apart from that I have had no side affects, although my blood tests have been showing a high reading for the Eosinophils. they are keeping a good eye on me and say it's not to much of a problem but I must let them know if I get any infections.

The Stelara Tail Off: I have noticed that the Stelara is not working for the full 12 weeks, It seems to tail off after about week 8. I sometimes get a small flare up but it soon goes away again when I have my injection. I have also noticed that it's not working as well as it used to but I guess after 16 months I suppose your body gets used to it. it's still working but just not as good as it did when I first started. I often get chapped lips and sometimes have to resort to Dovobet between my toes.

All in all though I have been pleased with it and will just have to see if it gets me through another winter, or if they decide my blood tests have been to high for to long they may take me off it! got an appointment next month so will update after that.

I hope this has helped someone and if I can I will answer your questions.

Fred.

Rena Ramani is a young woman from north London who has battled with the disease since her early teens. Now, at what she describes as the lowest physical and emotional point of her life, Rena shares with us her journey to better understand this illness. She hears the moving stories of fellow sufferers from around the country, and gets the chance to talk to the healthcare community directly – even challenging one GP to spend some time in her shoes. In this groundbreaking film by acclaimed director James Routh, we are given access to the intimate thoughts and feelings of a young woman whose life has been turned upside down by psoriasis. And, as Rena Ramani’s journey draws to an end, we watch as this brave woman is left to face one of her greatest fears.

Pharmaceutical company Pfizer is to invest €145m at its site in Clondalkin in Dublin. The company said it would expand its production and product testing facilities at the plant.

It is thought up to 400 construction jobs will be created during peak construction periods.

The site currently employs approximately 1,100 full time staff. It is one of the largest biotech manufacturing sites in the world and produces two of Pfizer's main drugs, Enbrel and Prevenar 13.

The news has been welcomed by the Taoiseach and the IDA. Taoiseach Enda Kenny said the investment is a further demonstration of the company's continuous commitment to Ireland.

''This investment gives a substantial boost to Ireland's Life Sciences sector and is a vote of confidence in Ireland's attractiveness as a location for bio-pharmaceutical manufacturing,'' commented IDA Ireland's chief executive Barry O'Leary.

Pfizer has about 4,300 workers across eight locations in Cork, Dublin, Kildare and Limerick.

Source: rte.ie

New report on Archives Of Dermatology suggest that There is a discrepancy in treatment of children with psoriasis between specialties, children of different ages, and adults.

"There were an estimated 3.8 million visits for psoriasis over the study interval with a median of 123 420 visits per year. Dermatologists saw 63% of patients, pediatricians saw 17%, and internists, 14%. The numbers of visits were equal between sexes but ranged by age group: patients ages 13 to 18 years accounted for 47% of visits, those ages 8 to 12 years for 35%, and those ages 0 to 7 for 18%. Ninety-three percent of patients were white. Topical corticosteroids were the most commonly prescribed medications. Children 0 to 9 years old received equally potent corticosteroids as children 10 to 18 years old. Among all patients, the most prescribed medication was topical betamethasone; among those ages 0 to 9 years, tacrolimus; and among those ages 10 to 18 years, betamethasone. By physician specialty, the most prescribed medications were high-potency steroids for dermatologists and internists, and topical tacrolimus for pediatricians. Topical calcineurin inhibitors were not among the top 20 most prescribed medications by dermatologists, and systemic antipsoriatic agents were not among the top 20 most prescribed medications in any age group.


Treatment: The most common medications prescribed overall were topical corticosteroids, which accounted for 7 of the top 10 most prescribed medications. Betamethasone diproprionate, a high-potency topical corticosteroid, was the most listed medication for all children in the study, followed by fluocinonide (high potency) and fluocinolone acetonide (low to medium potency). The most common noncorticosteroid topical medications included a keratolytic (salicylic acid), vitamin D analog (calcipotriene), and coal tar. Topical calcineurin inhibitors occupied the fifth position of most listed medication by class in the nonsteroidal group, the second position by age in the 0- to 8-year-old group, and the first (tacrolimus), and third (pimecrolimus) position by specialty among pediatricians. Systemic antipsoriatic agents were not observed among the top 20 most listed medications by any physician group.


Conclusions: There is a discrepancy in treatment of children with psoriasis between specialties, children of different ages, and adults. Although these data may be biased toward milder or localized disease, the results suggest that pediatric patients with psoriasis, compared with adults, may be undertreated. The documented impairment of quality of life in children with psoriasis, together with recent data suggesting a potential increased risk of comorbid conditions, creates a compelling argument for adequately addressing all aspects of psoriasis management in children. Although treatment guidelines specific to pediatric psoriasis would be useful, formal evidence on which to base such guidelines is not yet available. The current state-of-the-art care for pediatric psoriasis is based primarily on experience and expert consensus. Some differences in approach to management between dermatologists and nondermatologists seem due in part to the "art" of dermatology (choice of vehicle, potency, combination, and rotational therapy) and thus may not be reasonably anticipated to change, even with standardized treatment guidelines. As such, education of our dermatology and nondermatology colleagues about unique clinical and treatment aspects of pediatric psoriasis, rather than guidelines alone, may decrease the treatment gap by creating more comfortable, safe, and effective use of topical and systemic regimens for children with psoriasis.

Source: archderm

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Trident Pharmaceuticals Inc., a biotechnology company developing therapies for autoimmune diseases and allergic conditions, today announced the initiation of a Phase 1a study for HF1020, a first in class recombinant protein with immunomodulatory activity. HF1020 is believed to offer a novel approach for treating the underlying inflammatory pathology of autoimmune disease and allergic asthma, without causing systemic immunosuppression.

HF1020 is an oral biopharmaceutical product which acts by inducing naturally occurring T-regulatory cells as a mechanism for selectively down regulating the inflammatory response associated with allergic asthma, as well as autoimmune disorders, including rheumatoid arthritis, inflammatory bowel disease and psoriasis.
HF1020 is a stable protein and is administered orally by capsule. In extensive pre-clinical animal safety and efficacy testing, HF1020 was safe and well tolerated, demonstrating positive effects on multiple disease parameters and efficacy endpoints in animal models of asthma, rheumatoid arthritis, inflammatory bowel disease and diabetes.

“Entering the clinic with HF1020 is an important milestone for Trident,” said Dr. Robin Brown, Chief Scientific Officer of Trident Pharmaceuticals Inc. “Based on extensive published research and data from preclinical studies, we believe this drug has true disease modifying potential offering long term control of underlying inflammation to allergic asthma patients as well as broad applicability across a range of patients
suffering from autoimmune disease."

The Phase 1a randomized, placebo-controlled, blinded, single-ascending dose escalation study is being conducted in the UK by Dr. David Singh, Medical Director at the Medicines Evaluation Unit in Manchester, UK and Professor of Respiratory Medicine and Clinical Pharmacology, University Hospital of South Manchester. The trial will involve 32 subjects, and is designed to investigate the safety and tolerability of HF1020 in healthy volunteers and to identify a dose that can be used in further Phase 1b and Phase IIa studies planned in mild-to-moderate allergic asthma patients.

Professor David Singh, Principal Investigator for the HF1020 study, said: “We are delighted that the clinical phase of this exciting new compound has begun. We anticipate that new compounds such as HF1020, when fully researched, will provide new therapeutic options to patients with asthma and autoimmune diseases.”

Source: tridentpharma.com

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Please choose an option on the Pole Above. Members can tell us more on this thread if they wish, Guests can also vote but why not come and join us you will find a friendly bunch of people here.

Thank You.

Objective:
To determine the demographics, usage patterns, attitudes, and experiences of online support site users.

Design:  
Online survey.

Patients:  
A total of 260 subjects recruited from 5 online psoriasis support groups.

Main Outcome Measures:  
An exploratory analysis was performed to determine demographic and disease characteristics of online support site users. Perceived benefits were also documented.

Results:  
The mean (SD) age of respondents was 40.1 (11.5) years (range, 18-75 years), most (75.7%) were white, female (60.4%), and college educated (84.3%). Key factors associated with use of online support sites included availability of resources (95.3%), convenience (94.0%), access to good advice (91.0%), and the lack of embarrassment when dealing with personal issues (90.8%). The most common activities were posting messages (65.0%) and searching for information (63.1%). Nearly half of all respondents perceived improvements in their quality of life (49.5%) and psoriasis severity (41.0%) since joining the site. Intensity of participation in online support activities was associated with improved quality of life (P = .002), but not with improvements in psoriasis severity.

Conclusions:  
Our data demonstrate that psoriasis virtual communities offer users both a valuable educational resource and a source of psychological and social support. Such benefits could be further enhanced by physician engagement within these communities.

Quote:

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Psoriasis currently affects approximately 0.6% to 4.8% of the world's population. In addition to the well-recognized skin and joint manifestations, psoriasis impairs many aspects of individual well-being, including emotional, physical, sexual, and financial status. An estimated 10% of individuals affected by psoriasis have had suicidal ideations, a prevalence surpassing many other medical conditions. As a result, it is a necessity to provide patients with access to psychological support.

Patient support groups are one source of such assistance. They are designed to develop and reinforce positive coping styles known to be associated with improvements in both medical and social outcomes. In the United States, approximately 3% to 4% of the population annually engages in support group activity, and around 25 million Americans are estimated to have participated at some point in their lifetime. There are, however, a number of challenges with traditional face-to-face groups, including geographic barriers, embarrassment, limited space, and time constraints.

The worldwide rise in Internet usage has offered new ways for patients to interact. Despite initial concerns that online activity might lead people to withdraw from social interaction, a number of recent reports have noted that use of the Internet can empower people, thus improving social support and self-esteem. There has been a dramatic rise in the number of user-generated health care–related Web sites and online support sites. People with chronic disease are believed to relate best to Web-based information produced by other patients. Internet support groups share common objectives with their face-to-face counterparts but have strengths and weaknesses unique to the online setting. Although online support may lack the immediacy and intensity of a group meeting, it allows members to access information at a time and place of their choice. In addition, it offers individuals the advantage of anonymity and perceived lack of judgment. The benefits of structured, moderated online support programs have been demonstrated for patients with back pain, heart disease, lung disease, and type 2 diabetes mellitus. However, no structured programs have been developed for patients living with chronic skin disease. Indeed, little is currently known about the online user population living with certain dermatologic conditions, their drive to participate in online support groups, and their experiences within these virtual communities.

We conducted a Web-based cross-sectional survey study of people with psoriasis involved in online support groups. To our knowledge, this is the first survey study to describe user characteristics and the perceived benefits of online support groups in the field of dermatology. This study offers a richer insight into the demographics, usage patterns, attitudes, and experiences of participants involved with these virtual communities.