Roche pulls support for experimental psoriasis treatment BCX-4208
Roche is "terminating an agreement to develop BCX-4208 to treat psoriasis," according to its partner in the program, BioCryst Pharmaceuticals. BioCryst will retain rights to the experimental treatment, and is committed to continuing to try to develop it.
Roche's decision came after its review of results from a Phase IIa clinical trial of BCX-4208 involving 66 patients with moderate to severe plaque psoriasis. While it showed that "BCX-4208 was safe and well-tolerated, clinical efficacy was not demonstrated," BioCryst said.
Roche spokeswoman Kim Cayz said the company is looking for a drug that stands out from current treatments and believed the work on BCX-4208 was not going in that direction.
Roche has apparently spent about $30 million on BCX-4208. (It is not clear how much BioCryst has spent on it so far.) Just another reminder that even though name-brand drug prices seem too high, there are many failures along the way that burn through a lot of money (although it is the Phase Three testing where the biggest dollars are consumed).
First, we are pleased to see multi-year studies of these new therapies. Major clinical trials are usually based on safety and efficacy performance after a number of weeks. But psoriasis lasts a lifetime, and treatment is typically needed for decades. A 36-month trial is valuable, particularly with respect to safety concerns.
Second, the good news is that the Raptiva study found no new safety concerns other than those previously identified. The study underscored that Raptiva (and other biologics) are serious treatments -- and some patients develop serious (though usually reversible) side-effects from these treatments -- but the vast majority of patients who see a benefit from Raptiva appear to manage it well for the 36 months studied.
Third, for those who benefit from Raptiva, the significant improvement they see can be maintained for 36 months (and certainly longer). An even longer study is in progress, so in the future we should see data for even longer periods of use.
Finally, we should note that we support trying to get new treatments to patients as quickly as possible, which typically means before these types of long studies can be completed. That underscores the importance of longer studies like this, conducted after a treatment is made available to the public. Of course, what physicians see from the actual use of treatments in tens of thousands of patients worldwide is also a critically important way to assess safety and effectiveness in the real world.
Cimzia approved for Crohn's disease, may also help psoriasis patients
Cimzia, a biologic anti-TNF therapy, has been approved by the U.S. FDA for Crohn's disease. This is good news for psoriasis patients as well, because Cimzia was shown two years ago to be effective in a Phase Two psoriasis trial. Our philosophy regarding treatment options is pretty straightforward: the more options for psoriasis patients, the better.
While the FDA approval for Crohn's means Cimzia can now be prescribed off-label as a psoriasis treatment, most insurers will want to see further clinical testing and FDA approval before reimbursing Cimzia as a psoriasis treatment, particularly since five biologics are already FDA-approved for psoriasis.
Cimzia is a product of European pharmaceutical giant UCB.
A new study that reviewed more than 50,000 U.S. melanoma cases found that patients with melanoma "lesions in the scalp and neck died almost twice as fast after diagnosis as those whose tumors started anywhere else on the body." As Time magazine reported:
Interestingly, cancers of the face and ear, other common locations for melanoma, were not linked to reduced survival. In fact, cancers starting in these areas actually had better prognosis than those beginning in the trunk or extremities, which usually have the best survival rates.
Possible reasons: the extensive lymph and blood vessels in the scalp and neck "can make it easier for cancer cells to both grow and spread;" these areas receive the most sun exposure; and "scalp lesions are harder to detect, and less likely to be screened, given that in most cases, the region is covered with hair."
The bottom line: get screened regularly, especially if you seek out sunlight or use artificial ultraviolet (UV) light to treat your psoriasis.
A Canadian Phase Three trial of Voclosporin (ISA247) in patients with moderate to severe plaque psoriasis showed promising results, the British medical journal The Lancet is reporting. The drug is made by Isotechnika, based in Canada.
Voclosporin is designed to be, the company hopes, a safer alternative to cyclosporine, which is highly effective in treating serious psoriasis but that usually causes kidney damage that limits the duration of its use to months, or one or two years.
In the study, nearly half of the patients receiving the biggest dose of Voclosporin/ISA247 achieved a 75% improvement in psoriasis symptoms at week 12 (the standard test demanded by the US Food and Drug Administration), and effectiveness was maintained through week 24. The safety profile was considered strong by the study's authors, again through week 24, although there was some "mild to moderate glomerular filtration rate reductions" in some patients, a reduction in kidney function that can prove serious. This will have to be watched closely in future studies, and in longer dosing regimens.
Voclosporin is currently in a head-to-head study against cyclosporine, comparing its safety and effectiveness. If the new drug proves safer on the kidneys than cyclosporine while able to improve psoriasis similarly for many patients, it will be a promising new treatment option for psoriasis patients. (So far, it appears cyclosporine may clear more patients more thoroughly than ISA247, but if the trade-off is more serious side-effects, patients and their physicians may choose to try ISA247.) Voclosporin is taken in pill form, and is, like cyclosporine, a calcineurin inhibitor (CNi). There are also suggestions that Voclosporin may be priced less expensively than some of the new biologic psoriasis treatments, but that won't be known unless and until it receives FDA approval.
"Tier 4" insurance co-pays could threaten psoriasis patients
The New York Times today reports on a troubling trend by some insurers that could threaten psoriasis patients who depend on biologic treatments for their psoriasis and psoriatic arthritis: "Co-Payments Go Way Up for Drugs With High Prices" (link may require free registration):
Health insurance companies are rapidly adopting a new pricing system for very expensive drugs, asking patients to pay hundreds and even thousands of dollars for prescriptions for medications that may save their lives or slow the progress of serious diseases.
With the new pricing system, insurers abandoned the traditional arrangement that has patients pay a fixed amount, like $10, $20 or $30 for a prescription, no matter what the drug's actual cost. Instead, they are charging patients a percentage of the cost of certain high-priced drugs, usually 20 to 33 percent, which can amount to thousands of dollars a month.
The system means that the burden of expensive health care can now affect insured people, too. ...
The system, often called Tier 4, began in earnest with Medicare drug plans and spread rapidly. ...
And private insurers ... can legally change their coverage to one in which some drugs are Tier 4 with no advance notice.
If you have been hit with "Tier 4" pricing, please let us know.
Researchers have identified seven new DNA variations linked to psoriasis. From the press release:
In a comprehensive study of the genetic basis of psoriasis, researchers at Washington University School of Medicine in St. Louis have discovered seven new sites of common DNA variation that increase the risk of this troublesome skin condition. They also found that variations in one genetic region link psoriasis and psoriatic arthritis to other autoimmune disorders. ...
"Common diseases like psoriasis are incredibly complex at the genetic level," says lead investigator Anne Bowcock, Ph.D., professor of genetics at the School of Medicine. "Our research shows that small but common DNA differences are important in the development of psoriasis. Although each variation makes only a small contribution to the disease, patients usually have a number of different genetic variations that increases their risk of psoriasis and psoriatic arthritis." ...
Bowcock and her team found seven novel DNA variations linked to psoriasis. Notably, DNA variations on chromosome 4 were strongly linked to psoriatic arthritis. These same variations were also associated with psoriasis and had been previously linked to type 1 diabetes, rheumatoid arthritis, Grave's disease (caused by an overproductive thyroid gland), and celiac disease (caused by the inability to digest gluten).
The press release is worth reading in its entirety.
Kudos to the National Institutes of Health (NIH) for supporting this research with funding. Would you like to see more of this type of research? Write to Congress and ask for it!
Imagine being on stage three to six nights a week with visible psoriasis. And doing this for 20 years. For many with psoriasis, that sounds like torture. But singer-songwriter Nik Everett sees it a bit differently. Read Nik Everett's profile, now live on our calendar website.
"Step therapy" insurance rules for biologics not always fair to psoriasis patients
The high cost of biologics and other specialty drugs, and insurers' efforts to rein in their costs, was the subject of a Wall St. Journal article the other day (paid registration may be required to view article), but the article only told part of the story.
Specialty drugs include biotech and other drugs for serious diseases such as cancer, multiple sclerosis and inflammatory maladies such as rheumatoid arthritis. The average prescription for these medicines runs more than $1,500 and some top $100,000 a year. By contrast, conventional brand-name pills for problems such as high blood pressure, high cholesterol, and depression run roughly $90 to $120 a month.
The article also included a chart indicating that the average monthly prescription cost for specialty drugs to treat "inflammatory conditions" (of which psoriasis is one) rose 4.6% last year to $1,547.97--and that increase was actually much smaller than the increase in prices for specialty cancer and MS treatments.
To combat this trend, Express Scripts and Medco say they are tightly managing their formularies with rules governing drug selection, usage and dose. Medco is enforcing what it calls step therapy rules, says Tim Wentworth, president of its Accredo unit. Patients are required to start treatment on the lowest-priced drug first, advancing to more expensive alternatives only if and when the cheaper drug fails to work.
We have several complaints, not with what the article says but with what it does not address. The article totally ignores another strategy used by some insurers--increasing co-pays on specialty drugs to make these treatments prohibitively expensive for patients. It ignores the great health benefits many patients have enjoyed with these therapies. And it ignores the "dark side" of so-called "step therapy." Here is part of what we wrote to the author and WSJ Editor about this:
With some insurers, step therapy in practice means requiring less effective and more dangerous drugs based solely on price, rather than on any balance of cost and benefit or safety to the patient. In psoriasis treatment, this can mean forcing patients to use the Korean War-era chemotherapy drug methotrexate, despite its known risks to the liver and, for women of child-bearing age, abortion-inducing properties. The biologics are finding a market precisely because past treatment options for many diseases were so inadequate.
The article closes with a very interesting concept:
Aetna Inc., the big Hartford, Conn., health insurer, is exploring a "pay-for-performance" strategy in which a drug's price would be tied to efficacy. "Some people have spectacular results" taking pricey biotech drugs while "others have no results," says Edmund Pezalla, national medical director of Aetna Pharmacy Management. The idea, already being tried in Europe, is to negotiate drug prices based on whether a patient responds to a treatment. While details are scarce, some companies provide rebates in cash for product if patients don't achieve the desired therapeutic benefit.
Over two decades, she tried virtually everything, like so many of us, and time and time again she had to look again for another option. Now on her second biologic, she is, at the moment, winning her psoriasis battle. Let's hope it continues for her.
A new study confirming an association between psoriasis and diabetes has been released. The study looked at a large group of psoriasis patients and a large group of patients without psoriasis, and found "diabetes was significantly higher in psoriasis patients as compared to the control group...."
But the summary of the study (we have not yet seen the full text) does not indicate if the psoriasis group and control group had similar average body weights or other diabetes risk factors. Other studies have shown that psoriasis patients tend to be heavier than non-psoriasis patients. What would be most useful would be studies that tell us if it is the extra pounds on many psoriasis patients that bring about more diabetes, or something inherent in psoriasis (inflammation, genetics, etc.) that leads to more diabetes.
Until that's cleared up, the fact remains that the medical community seems pretty confident that psoriasis patients could improve their overall health (and perhaps their psoriasis symptoms) by reducing obesity, smoking and excessive alcohol consumption.
An article in the New York Times (free registration may be required) makes several note-worthy points. The article talks about how extremely difficult it is for medical students to be selected to study dermatology--difficult because so many very smart people want the same few training spots available. It turns out relatively humane hours, and the riches from cosmetic procedures, are driving much of this demand. But it's still nice to know that many of the brightest people in the country may be treating psoriasis patients in between delivering Botox injections. Some excerpts follow. The article begins:
March Madness has a different meaning for Thomas Hocker and Meena Singh, a married couple in their final year at the Harvard Medical School, who are waiting to learn Thursday if they have been accepted into their residency programs of choice.
Already saddled with about $330,000 in education loans, they borrowed $20,000 more so they could fly around the country this winter for about two dozen residency interviews each. All told, each applied to 90 such training programs. ...
The search has been difficult not because they are mediocre students; indeed, each has a brand-name education, academic honors and published research on disease. No, it has been hard because they aspire to be dermatologists.
Then we get some statistics:
Only 61 percent of seniors at American medical schools whose first choice was dermatology received a residency in that field last year, compared with 98 percent for those whose first choice was internal medicine and 99 percent for those seeking family medicine, according to a report by the Association of American Medical Colleges and the National Resident Matching Program, which pairs candidates and programs. Although there are far fewer positions in dermatology (320 residencies in 2007) than in internal medicine (5,517) and family medicine (2,603), the field is attracting some of the best and brightest future doctors.
Seniors accepted in 2007 as residents in dermatology and two other appearance-related fields -- plastic surgery and otolaryngology (ear, nose and throat doctors, some of whom perform facial cosmetic surgery) -- had the highest median medical-board scores and the highest percentage of members in the medical honor society among 18 specialties, the report said. ...
For an idea of the competition facing dermatology aspirants, consider the application numbers. Last fall, 383 people applied for 6 places -- an average of about 64 applicants per spot -- in Harvard's dermatology program. By comparison, Harvard College received an average of 11 applications per offer of admission in the class of 2010.
The article also recognizes the profound impact psoriasis can have on patients.
"People greatly value the skin because it is what is on the outside that is the face you present to the world," Mr. Hocker said one evening last month after coming off a hospital shift in which he dealt with afflictions like heart failure and kidney failure. "Most dermatological diseases won't kill you, but they can greatly affect your quality of life."
[... Ms. Singh said:] "Having something on your skin is not life or death for people, but it can be equally important for them emotionally as a life-threatening disease."
Indeed, dermatology can be a psychological lifeline for people with severe skin problems. At pools or the beach, some people shun those with psoriasis who have scaly skin, fearing the condition is contagious, doctors said. ...
Dermatologists say they enjoy the variety of a specialty that encompasses serious illnesses like skin cancer and psoriasis as well as conditions like uncombable hair syndrome.
And we'll close with an excerpt that reminds us all that we should have paid more attention in science class:
But students interested in such work also often factor in personal benefits. Internists, for example, worked an average of 50 hours a week in 2006 while dermatologists worked about 40 hours, according to an annual survey by Medical Economics magazine. Dermatology also offers more independence from the bureaucracy of managed care, because patients pay up front for cosmetic procedures not covered by health insurance.
And while an internist earns an average of $191,525, a dermatologist earns an average of $390,274, according to an annual survey conducted by the Medical Group Management Association, whose membership includes more than 21,000 managers of medical practices. Dermatologists who specialize in cosmetic treatments or in skin-cancer operations can earn much more.
Golimumab, an anti-TNF-alpha monoclonal antibody, demonstrated strong efficacy in Phase Three clinical trials, improving both joint and skin symptoms for significant proportions of patients. For example, at week 14, roughly forty percent of patients achieved a 20% improvement in arthritic symptoms. And at week 24, one-fifth of patients had achieved a 70% improvement. In addition, thirty percent of patients achieved a 90% improvement in skin symptoms. The treatment was similarly effective for nail psoriasis.
In U.S. and Canadian clinical trials, the rate of tuberculosis infection has been roughly 0.007% of patients, or about 1 in 14,000 cases; but in actual practice, rare cases of tuberculosis have been seen in patients using tumor necrosis factor (TNF) inhibitors like Enbrel, Remicade and Humira.
It's a good reminder that patients should be screened for active and latent TB before beginning anti-TNF psoriasis treatments and periodically during treatment.
Save the Dates: Short Sleeve Days 2008 set for Sept. 12-14
Last year, hundreds of people from 32 states participated in Short Sleeve Day--educating the public about psoriasis while raising thousands of dollars for psoriasis research and education efforts. Public events were held in four cities; in other places, people simply wore the official Short Sleeve Day t-shirt or handed out our Psoriasis Info Cards to their friends and neighbors.
This year, the celebration will be bigger and better, and one day is not enough. So we will celebrate Short Sleeve Days on September 12-14, 2008, with goals of major events in 10 cities, participants from all 50 states, and $25,000 raised for psoriasis research and education.
New anti-TNF (ART621) being tested on psoriasis abroad
"Arana Therapeutics Limited (AAH) has commenced recruitment for a Phase II trial in psoriasis for its lead anti-TNF drug candidate ART621." Other anti-TNF's are already on the market, including Enbrel, Humira and Remicade. The psoriasis trial, to be conducted in Australia, is designed to help the company get the product approved one day for rheumatoid arthritis: "Arana chief executive John Chiplin said the strategy was to use information from the psoriasis trials to push along trials for the treatment of rheumatoid arthritis -- a significantly larger market."
XTRAC excimer laser effective for some moderate to severe psoriasis patients
A small pilot study has found the XTRAC excimer laser effective in treating certain cases of moderate to severe psoriasis, the company reported this week. The laser uses targeted ultraviolet (UV) light to treat psoriasis patches, while leaving unaffected skin alone.
This report should not come as a surprise. UV light--whether from the sun, special boxes designed for psoriasis treatment, or the lasers used in this pilot study--is very effective and safe for treating most psoriasis. What's odd is that some insurers' foolish reimbursement and co-pay policies are making UV treatments less attractive to their patients and physicians.
[The XTRAC study was done by a leading psoriasis researcher, but the sample was tiny (about 10 patients) and did not have a comparable placebo group, nor has it been peer-reviewed or published in an academic journal, so we would not make too much of the specific statistics cited.]
Turmeric/curcumin tasty, but no psoriasis cure, study finds
Indian food is delicious, but a highly touted spice in this food largely failed in a small trial designed to test its value in treating psoriasis.
Researchers at the University of Pennsylvania School of Medicine found that despite strong scientific evidence in the laboratory demonstrating the ability of curcumin (the active ingredient in the spice turmeric) to inhibit a critical pathway of psoriasis, the positive response in patients was so low that scientists suggest the placebo effect or the disease's natural remission might be the reason.
We would all love an easy and 'natural' cure for psoriasis, but one does not exist. That's why we need more research.
One problem the researchers note is that most curcumin consumed is not "bioavailable"--instead, it is eliminated by the body's digestive system before it can do any good.
So enjoy that Tandoori chicken, but don't expect it to cure your psoriasis. Then again, the researchers theorize that a topical formulation could potentially still prove helpful. So maybe instead of eating that bird, you should .... nevermind.
Psoriasis Calendar February profile...Tony's (and Jim's) story
If you have not yet seen it, be sure to check out the February expanded profile of Tony and Jim, who appear in our 2008 Psoriasis Patient Calendar. Biologic therapy, has, in his words, "saved his life." It's certainly helped him spend better time with his son.
In retrospect, we should have saved these two for June--Father's Day!
Psoriasis Cure Now applauds record government psoriasis research funding
Psoriasis Cure Now today applauded Congress and the National Institutes of Health (NIH) for delivering a record $10 million in psoriasis research funding during fiscal year 2007. Psoriasis research has traditionally been underfunded at NIH. Since 1995, NIH funding on other diseases has risen 159% (before inflation), but psoriasis and psoriatic arthritis research had been stuck between $5 and $6 million every year from FY 1995 until FY 2006, when it reached $8 million, and now $10 million in FY 2007. [Click on the chart to see a larger version of it.]
"Psoriasis Cure Now was founded in 2005 because it was disturbing to see psoriasis research funding not even keep pace with inflation as research on other diseases more than doubled," said Michael Paranzino, president of Psoriasis Cure Now. "We are thrilled to see Congress and NIH working to reverse this funding shortfall with the second significant funding increase in a row."
Even after two years of strong growth, psoriasis research at NIH remains $40 million short of what would have been invested in psoriasis research had its funding merely kept pace with NIH's growth since 1995. Psoriasis Cure Now has urged policymakers to increase annual psoriasis and psoriatic arthritis research to $20 million by 2010, reflecting the disease's severe impact on millions of Americans and the years that were lost as psoriasis funding languished.
"Many people helped get funding for psoriasis research moving in the right direction," Paranzino added, "from the citizens who wrote letters to and visited with their lawmakers, to leaders like Reps. Rosa DeLauro, Ralph Regula and Jim Gerlach, Chairmen Tom Harkin and David Obey, and Senator Arlen Specter. The NIH and NIAMS leadership also deserve our thanks for supporting valuable research that will lead to treatment breakthroughs in the years ahead. With new research linking psoriasis to increased risk of heart attack and even premature death, continued increases in psoriasis research could not be more timely."
Promising new data released on ustekinumab (CNTO 1275) for psoriasis
One-year data on ustekinumab (CNTO 1275), Centocor's experimental psoriasis treatment, were reported last week at a dermatology conference and showed that the treatment sustained its effectiveness and safety for 52 weeks. (Ustekinumab's 12-week data was reported here.)
In addition, a scientific poster at the conference reported 76 week data consistent with earlier reports. Specifically, of those who were strong responders at week 28 and week 40, the vast majority sustained their improvement through week 76 when maintained on a once-every-12-weeks injection regimen. (In other words, if this treatment works well for you for 40 weeks, it is likely to work at least another 9 months after that.) Nor were any new safety concerns identified.
Ustekinumab is designed to block two inflammatory proteins, Interleukin-12 and Interleukin-23 (IL-12 and IL-23), which makes this treatment different than existing biologics.
The FDA has begun its review of this potential new treatment. A decision is likely near the end of 2008. We'll keep you posted.
When treated with a 20 mg dose of the drug, taken orally twice a day, 24% of patients in the study achieved a 75% improvement in psoriasis symptoms, compared with 10% receiving a placebo. The treatment was also well-tolerated. While that improvement rate (14% better than placebo) is not impressive compared to numerous existing psoriasis treatments, it is statistically significant and has encouraged the company to try a 30 mg dose for up to six months. Also, some psoriasis patients may prefer taking pills to injections or UV treatments.
Apremilast, according to Celgene Corp., the company developing it, is a small molescule "with anti-inflammatory activities that impedes the production of multiple pro-inflammatory mediators by inhibiting PDE4 resulting in reductions in TNF-alpha as well as interleukin-2 (IL-2), IL-17 and IL23, interferon-gamma, leukotrienes, and nitric oxide synthase." (Several of the currently available biologics inhibit TNF-alpha and an IL23 inhibitor is coming before the FDA later this year.)
While apremilast is at least several years away from reaching the market (if at all), it's good news to have additional treatment strategies and methods in the pipeline.
Search or shop online and raise money for Psoriasis Cure Now
Would you like to raise money for Psoriasis Cure Now every time you conduct an internet search or buy a product online? Simply click on the link to get started. Thanks!
The 2008 Psoriasis Cure Now patient calendar is out, and the website, featuring our first expanded patient profile, is now live. The calendar tells the story of psoriasis and psoriatic arthritis through 12 profiles, and will be used to educate lawmakers and the media about psoriasis, as well as to inspire patients and the physicians who treat them.
But we need your help. Which VIP do YOU think most needs to be educated about psoriasis? Check out the calendar website and learn how to get the word out to VIP's, and how to get a copy of the calendar for yourself.
