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.
