Institute of Medicine report urges "comparative effectiveness" research on psoriasis, but beware risk of rationing
"Psoriasis Cure Now," a nonprofit patient advocacy group, today applauded the Institute of Medicine (IOM) for including psoriasis and psoriatic arthritis among its Top 100 health topics meriting priority "comparative effectiveness" research, but the organization expressed concern that treatment rationing could result from the research.
The IOM included the use of biologics for treating inflammatory diseases including psoriatic arthritis among its top ("First Quartile") priorities for the first round of comparative effectiveness research, and included comparing the effectiveness of various treatments for psoriasis among its Second Quartile priorities. According to the IOM, "A committee convened by the IOM developed the list of priority topics at the request of Congress as part of a $1.1 billion effort to improve the quality and efficiency of health care through comparative effectiveness research outlined in the American Recovery and Reinvestment Act of 2009."
"We applaud the IOM committee for including treatments for psoriasis and psoriatic arthritis among its priority research areas, as it can be very challenging for patients with these lifelong diseases to navigate their myriad treatment options, each of which has its own set of short and long-term risks," said Michael Paranzino, president of Psoriasis Cure Now. "But as with most things in life, the devil is in the details. Comparative effectiveness research requires assigning extremely controversial dollar amounts to various levels of patient improvement, and also assigns monetary values to various levels of risk of side-effects, even though a 25 year-old mother and a 70 year-old man might have very different levels of willingness to risk serious side-effects. Today's comparative effectiveness research can very easily become tomorrow's rationing mandate."
Paranzino continued, "Different psoriasis treatments vary widely in cost, effectiveness, and side-effects. Some patients will trade less effectiveness for fewer side-effects. Others will accept serious long-term risks to feel better now. In addition, some psoriasis treatments cause catastrophic birth defects if given to women who become pregnant while taking them, but help men without these risks. In short, for a researcher to conclude that Treatment A helps an 'average' patient improve for less money than Treatment B, that researcher must make assumptions that may fly in the face of reality for real patients in real-world circumstances.
"It is essential that patient voices be heard throughout the actual comparative effectiveness research, or else this could become just a fancy way to deny advanced, but costly, treatments to people with serious but incurable diseases like psoriasis."
Psoriasis Increases Risk of Cardiovascular Disease
A University of Miami study published in the June issue of the Archives of Dermatology concluded that psoriasis patients face an increased risk of heart attack, stroke, or death. According to Forbes.com, the 20 year study, which compared 3,235 psoriasis patients with 2,500 patients without the disease, found a "78 percent higher incidence of heart disease, a 70 percent higher incidence of stroke, and a 98 percent higher incidence of peripheral arterial disease (blockage of arteries in the legs) in the psoriasis group." The overall death rate for psoriasis patients was 86 percent higher than those without psoriasis. Significantly, the study's co-author, Dr. Robert S. Krisner, pointed out that "psoriasis imposes the same level of risk as high blood lipids and smoking." Researchers believe that the increased risk may be related to chronic inflammation, but further studies are needed to determine whether controlling psoriasis can reduce the risk of cardiovascular disease.
These results are further supported by a University of Pennsylvania study which also found a relationship between psoriasis and cardiovascular disease (55 percent increased cardiovascular risk and a 78 percent increased death rate in psoriasis patients). Both studies stressed the importance of psoriasis patients understanding their risk and emphasized that further studies are needed to fully understanding the link. Patients should talk with their doctor about the controllable risk factors of cardiovascular disease, such as obesity, smoking and diabetes.
At-Home UVB Treatment for Psoriasis is as Safe as Hospital Treatment, Study Finds
A Dutch study published in the British Medical Journal (BMJ) concluded that home-based ultraviolet B (UVB) treatment for psoriasis is as effective and safe as outpatient treatment typically conducted in a physician's office or dermatology clinic.
Traditional UVB treatment for psoriasis can be time-consuming, often requiring three trips per week, for several months, to a doctor's office. But doctors have been resistant to at-home treatments--the study found almost a third of skin specialists thought home treatment was riskier--and some insurers have balked at the up-front cost of purchasing a home unit for psoriasis patients.
The study found, however, no discernible difference in safety or effectiveness between treatments (about 70% of patients in both groups achieved a 50% improvement in psoriasis symptoms). But according to The Guardian, those who were selected to receive at-home treatment "were twice as likely to rate their experience as excellent."
UVB treatment, at home or in a doctor's office, is not without risks, and in a home setting the light machine must obviously be kept away from children, as dangerous burns can result from misuse. But UVB remains one of the safest treatment options, and this study might lead dermatologists and insurers to take a fresh look at the benefits of home UVB therapy. Learn more about UVB therapy for psoriasis.
The study found that the higher one's BMI at age 18, the more likely to develop psoriatic arthritis down the road. "Among patients with a BMI at [age] 18 of less than 25, 26.5% went on to develop psoriatic arthritis, compared to 35.4% of those with a BMI between 25 and 30, and 40% of those with a BMI over 40." Someone is considered overweight with a BMI of 25 or greater, and obese with a BMI of 30 or greater. (One shortcoming of the study is that weight at age 18 was based on participants' memories--an average of 30 years after the fact--rather than medical records.)
Of significant note is data in this study suggesting that psoriasis occurs before the onset of obesity. Other research has found the reverse. It is an important question that needs careful study to sort out. Does obesity make psoriasis and psoriatic arthritis more likely? Or do psoriasis and psoriatic arthritis lead to obesity by making exercise painful, and/or by depressing patients who then eat excessively, and/or by triggering internal body changes that make obesity more common? The interplay among psoriasis, obesity, heart disease and diabetes has major implications for people's health and for health care costs nationwide. We need federal research to sort it all out. (MedPage Today noted that this study's findings should be considered "preliminary until published in a peer-reviewed journal.")
The company Abbott (which markets the psoriasis and psoriatic arthritis treatment Humira) is hosting informational meetings about psoriasis and its treatments in five cities during June 2009, as follows:
June 13, Baton Rouge, LA June 16, Grand Rapids, MI June 18, Jacksonville, FL June 25, Syracuse, NY June 27, Richmond, VA
For more information or to register, call Abbott at 1-866-598-9536 or visit www.psoriasisdialogues.com . Meetings like this are good opportunities to meet other psoriasis patients, and to ask questions you might have about your treatment options.
Check out our June Psoriasis Calendar profile of Jason, a law student who recounts life with, then without, then again with his preferred treatment. Many psoriasis patients will relate completely with his story.
Because many cases of psoriasis are (thankfully) mild, people can sometimes not realize how severe psoriasis can get. Cindy, a young woman who was just released from the hospital for psoriasis treatment, has given us permission to post this slide show, which was made this past week by the love of her life, Fred. The pictures show starkly what psoriasis can do. But the slide show also shows how people can draw strength from one another.
We're glad Cindy's home but know that living with psoriasis this severe can be even harder when you don't have doctors and nurses there to help. You might consider visiting Cindy's page on our Online Psoriasis Community, Psoriasis.Name, and leaving her some words of encouragement.
Psoriasis and increased risk of diabetes and hypertension
A new study published in the Archives of Dermatology provided further evidence of a link between psoriasis, diabetes and hypertension. Researchers from Harvard Medical School and Brigham Women's Hospital in Boston concluded "psoriasis was independently associated with an increased risk of diabetes and hypertension."
78,061 female nurses aged 27 to 44 were studied (none had diabetes at the start of the study) for 14 years. Women diagnosed with psoriasis during the 14 years were 63 percent more likely to develop diabetes and 17 percent more likely to develop high blood pressure. The link remained strong even after taking into account other diabetes and high blood pressure risk factors such as age, weight and smoking.
According to the BBC, the study's authors stressed the necessity of "considering psoriasis a systemic disorder rather than simply a skin disease." Many researchers believe chronic inflammation--present in the skin of psoriasis patients and a known risk factor for high blood pressure and a condition that often leads to type 2 diabetes--could explain the link between psoriasis and the other conditions. Under this theory, treating psoriasis might reduce the increased risk of these other conditions. But another theory suggests that the side-effects of certain psoriasis treatments might account for the increased risk. The study's authors urged future studies to investigate the role of psoriasis treatment in impacting the risk of diabetes and hypertension.
Voclosporin vs. cyclosporine study in psoriasis shows mixed results
Cyclosporine is a powerful immune suppressant that is very effective in treating serious psoriasis, but its side-effects (most commonly, kidney damage, and the increased potential for cancers), limits its use in psoriasis to relatively short bursts of time (generally no more than 1-2 years). Cyclosporine is a type of immune suppressant called a calcineurin inhibitor.
Voclosporin did prove to be effective in treating psoriasis. The study found that more than 40% of patients at both 12 weeks and 60 weeks had achieved a 75% improvement in their psoriasis symptoms. And the study found voclosporin to have improved safety over cyclosporine at weeks 24 and 60. But the study also found cyclosporine significantly more effective than voclosporin in treating psoriasis.
Dr. Robert Foster, President & CEO of Isotechnika, was quoted in the news release saying "we are pleased with the risk-benefit of voclosporin and consider it a valuable treatment option." Isotechnika has forged a partnership with Canada-based Paladin Labs Inc. to seek, by the end of 2009, regulatory approval to market the drug in Canada (but not yet the United States or Europe). Voclosporin was formerly known as ISA247.
New biologic Simponi (golimumab) approved for psoriatic arthritis by FDA
On April 24, the U.S. Food and Drug Administration (FDA) approved Simponi (golimumab) for the treatment of three forms of arthritis, including active psoriatic arthritis. Described in media reports as a "potential blockbuster drug," Simponi is administered once monthly via injection under the skin. As WebMD put it: "Simponi is in a class of drugs that target and neutralize tumor necrosis factor-alpha (TNF-alpha), a protein that, when overproduced in the body due to chronic inflammatory diseases, can cause inflammation and damage to bones, cartilage, and tissue." There are three other TNF blockers approved for psoriatic arthritis (and all three are also approved for psoriasis): the biologics Enbrel, Humira and Remicade. (In the United States, Remicade and Simponi are both marketed by Centocor Ortho Biotech.)
Simponi was studied in a Phase 3 trial in 405 adults with moderately to severely active psoriatic arthritis. The study found that at week 24, roughly 40% of patients achieved a significant, 20% improvement in their arthritis symptoms. In addition, roughly 30% of patients improved by 50%, and roughly 20% of patients showed a 70% improvement. Most of the improvement seen in patients had been achieved by week 14, and was sustained through continued treatment.
Like other TNF blockers, Simponi carries warnings about potentially serious side effects that can infrequently occur, including risk of tuberculosis (TB) and other serious infections. In addition, with use of TNF blockers, the risk of developing lymphoma or other cancers may increase; and heart failure and liver problems may occur more frequently in patients using TNF blockers.
"Psoriatic arthritis is a little-known, but potentially devastating disease," said Michael Paranzino, president of Psoriasis Cure Now. "It is always exciting when patients get access to an additional, promising treatment option. Psoriasis patients who experience joint pain should mention that to their doctor and discuss their treatment options, as psoriatic arthritis can worsen over time, even causing permanent damage."
To access the Simponi website, which includes a detailed patient guide, click here.
Tim Gunn offers fashion tips for psoriasis - final days to enter contest!
Hurry! The Addressing Psoriasis (TM) Contest entry period ends on April 30, 2009. Winners will win a trip to New York City to walk the runway in the Addressing Psoriasis (TM) Fashion Show, hosted by Project Runway mentor Tim Gunn.
Genentech has decided to remove Raptiva (efalizumab) from the US market. Raptiva will become unavailable in June, 2009.
All psoriasis patients currently on Raptiva should see their physician at once and not stop taking Raptiva without consulting their physician, as significant worsening of psoriasis can occasionally occur with an abrupt withdrawal of the drug.
Raptiva was recently found to have led to at least 3 deaths in patients who had taken the treatment for at least three years.
We had hoped Raptiva would remain on the market as at least an emergency option for those unable to find relief from other treatments, but we understand Genentech's decision and respect how Genentech has handled this issue all along.
Our latest psoriasis patient profile is now live. In it, we hear from Greg, who battles painful hand psoriasis...while having a job that requires working with his hands. Greg is clearly a fighter who does not give up...appropriate since he is also a committed Chicago sports fan. You might even say that being a Cubs fan can teach you something about the endurance race that is living with psoriasis.
New online resource for psoriasis patients in final testing
Imagine a place where people with psoriasis and psoriatic arthritis, and their friends and families, could make new friends, share ideas, ask and answer questions, and even help accelerate the quest for a cure.
It would be like Facebook or MySpace, but where everyone cared about psoriasis.
We are in final testing of just such an online world. Why not check it out?!
Amgen and Wyeth today announced that they have partnered with Tim Gunn, television host and fashion consultant ("Project Runway," "Tim Gunn's Guide to Style") to launch Addressing Psoriasis (TM), an awareness campaign designed to help people with plaque psoriasis get more information about managing their disease and feel more confident in their everyday style. Dermatologist Susan C. Taylor, M.D., and Gunn are working together to encourage people with plaque psoriasis to visit a dermatologist and take the first step in managing their condition.
The cornerstone of the campaign is a contest to recognize people who have moderate to severe plaque psoriasis but who try not to allow the condition to inhibit their personal style. Individuals 18 or older with moderate to severe plaque psoriasis are eligible to enter for a chance to participate in the Addressing Psoriasis (TM) Fashion Show hosted by Gunn in New York City on Sept. 2, 2009. Eight winners will walk the runway and help raise public awareness of this condition. To learn how to enter the contest, view official rules, find useful resources about psoriasis and obtain style tips from Gunn, visit www.addresspsoriasis.com.
"This program is designed to help people with psoriasis feel more confident with their everyday style, because style is just as much about confidence as it is clothing. When someone doesn't feel confident, it is reflected in the clothing choices he or she makes," said Gunn. "Psoriasis is a chronic condition, but it doesn't have to define who you are or how you present yourself to the world. If you have psoriasis, it is important to educate yourself about how you can take an active role in your condition--and your style.
Entrants are asked to submit a video testimonial or personal essay explaining their story of how they have overcome the challenges of living with moderate to severe plaque psoriasis and how the condition has impacted their personal style and the clothing they wear. Entries will be judged based on the inspirational nature of their story, not on specific psoriasis treatment options.
The "Addressing Psoriasis(TM)" essay/video contest is open to legal residents of the 50 United States and the District of Columbia, 18 years of age and older on date of entry. Contest begins at 12:00:00 (Noon) PM Eastern Time ("ET") on Monday, March 2, 2009 and ends at 11:59:59 PM ET on Thursday, April 30, 2009.
Addressing Psoriasis(TM) is sponsored by Amgen and Wyeth with participation from the American Academy of Dermatology, the National Psoriasis Foundation and Psoriasis Cure Now. To learn more about Addressing Psoriasis(TM) or to enter the contest, visit www.addresspsoriasis.com.
Important information about Raptiva (efalizumab) and PML
Raptiva is being pulled from the US market as of June 2009 due to safety issues. **See your physician before stopping Raptiva treatment.** More info at Raptiva.com.
Final stimulus plan includes $10 billion for medical research over 2 years
According to the New York Times, the final stimulus bill that will be voted on and become law this week includes $10 billion over two years for medical research funding through the National Institutes of Health (NIH), thanks to Sen. Arlen Specter of Pennsylvania.
NIH funding has been stagnant for five years, and currently totals about $30 billion annually.
While Psoriasis Cure Now takes no position on whether the stimulus bill should become law--there are concerns that spending $800 billion now will starve NIH and other programs of funding for many years to come--the $10 billion for NIH does improve our chances of achieving our goal of seeing psoriasis and psoriatic arthritis funding rise to $20 million by 2012. Last year, psoriasis finding equaled just $8 million.
Thanks to all who wrote to Congress through this website and through our www.StimulateResearch.org sister site.
"Psoriasis Cure Now," a nonprofit patient advocacy organization, has launched a micro-Web site, www.StimulateResearch.com, to help everyday Americans interested in medical research be heard in the stimulus debate that has been dominated by powerful lobbyists and special interests. The Web site allows people to write their lawmakers urging them to make biomedical research a meaningful part of any stimulus bill that emerges in the coming days. The nearly $1 trillion bill sweeping through Congress could crowd out medical research funding at the National Institutes of Health (NIH) for years to come.
"This is the fastest I have seen Washington allocate $1 trillion in my quarter century following politics," said Michael Paranzino, president of Psoriasis Cure Now. "It seems to have caught the patient advocacy community flat-footed. But medical research is every bit as 'shovel ready' and 'stimulative' as Austin's proposed Frisbee golf course or the projects Chicago won't even disclose. Dollars wasted now will not cure cancer, arthritis or psoriasis tomorrow. Our Web site lets Americans concerned about curing disease make sure medical research is not neglected as the final stimulus package is hammered out in the coming week."
The House-passed stimulus bill includes a few billion for NIH (much of it to build new buildings), and the current Senate version includes $10 billion for NIH over two years. But a bipartisan group of Senators is looking to cut more than $100 billion from the current version, and the House-Senate Conference Committee is expected to make significant additional revisions, meaning the fate of medical research is highly uncertain. For the last five years, NIH funding has been stagnant, with thousands of well-designed and 'shovel ready' grant requests by scientists from all 50 states being held up by a lack of funding.
Psoriasis Cure Now takes no position on whether the stimulus bill should pass or fail; rather, it is pointing out that spending $1 trillion in lobbyist-driven spending now could mean that vital NIH research could be starved for years to come. Its www.StimulateResearch.com site is designed to give everyday Americans a chance to be part of this debate as well.
"Silence may be golden when it's time for my kids to go to bed, but silence by patient advocates is definitely not golden during this stimulus debate," Paranzino added. "The asphalt lobbyists, the honey bee lobbyists, the state politician lobbyists --- all are out in force, seeking parts of the one trillion dollars in play. It's essential that people who want cures for AIDS, MS, autism, heart disease and diabetes be heard as well. StimulateResearch.com lets us be heard."
Newly released figures indicate the federal government spent just $8 million on psoriasis research in the last fiscal year, down from $10 million the previous year. This still leaves us ahead of the $5-6 million range we were stuck in for more than a decade through 2005, but shows that psoriasis research is still woefully underfunded relative to its negative impact on so many lives.
One of the challenges facing advocates of psoriasis research is that the overall budget for biomedical research (on cancer, AIDS, diabetes, etc.) has been stagnant for the last five years, at roughly $30 billion annually. But within that, psoriasis must do better.
