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2009-04-08

WARNING

ALERT:
Psoriasis drug Raptiva is withdrawn due to risk of fatal brain infection

The maker of the psoriasis drug Raptiva (efalizumab) is pulling the drug from the U.S. market because of its association with a rare and usually fatal brain infection. Psoriasis patients taking Raptiva should immediately talk to their doctor about finding an alternative treatment, says the National Psoriasis Foundation. Stopping Raptiva abruptly could lead to a severe psoriasis flare, so patients should be sure to talk to their doctors before they stop treatment.  

Genentech, the drug’s maker, has announced a phased withdrawal of the drug, which is associated with a higher risk of developing progressive multifocal leukoencephalopathy (PML), which can attack people with weakened immune systems. 

Genentech researchers say that Raptiva’s effects typically wear off by 12 weeks after the patient’s last dose. “The risk of developing PML after 12 weeks should be greatly reduced,” said Bruce Bebo, Ph.D., Psoriasis Foundation research director. “Raptiva has a fairly short life in the immune system once the patient stops using the drug.”  The removal of Raptiva underscores the need for more and better treatment options for people with psoriasis and psoriatic arthritis.

We need your help to stop this backward trend and demand that people with psoriatic diseases have access to safe and effective treatments.  

Here are three ways you can help right now:

·         Write your senator and representatives in Congress, asking them to support the Psoriasis and Psoriatic Arthritis Research, Cure and Care Act.

·         Donate your DNA to the National Psoriasis Victor Henschel BioBank to be used for psoriasis research.

·         Support Alyssa’s Fund, a campaign dedicated to finding what role the immune system plays in causing psoriatic diseases.

Warning
 
 A key treatment for psoriasis is PUVA which stands for psoralen (P) + ultraviolet A (UVA). A person is first given psoralens (drugs containing chemicals that react with ultraviolet light) and then exposed to UVA light. This treatment is very effective but elevates the risk of skin cancer. Why has not been known.

New Finding: There is an increased prevalence of the human papillomavirus (HPV) in hairs plucked from patients with psoriasis treated with PUVA. HPV is tumorigenic (it causes the formation of tumors).

Comments: This is an important new finding because psoriasis is common and PUVA is a key treatment for it. The idea is that PUVA promotes skin cancer by increasing HPV in the skin. PUVA may do this by stimulating the replication of the virus or by immune suppression, or both.

 

FDA committee votes against oral retinoid recommendation

First posted July 13, 2004
Last updated July 16, 2004

On Monday, July 12, 2004, two Food and Drug Administration advisory committees--the Dermatologic and Ophthalmic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee--meeting in a joint session voted to recommend against approving the drug oral tazarotene for the treatment of moderate to very severe psoriasis.

Technically, the committees voted on whether they found "a favorable balance of risks and benefits which would support approval of this product." They said, "no" by a vote of 9 to 3, with 4 abstentions. The FDA is not legally bound to follow the advisory committees’ recommendations, but it usually does. The original deadline for a decision by the FDA was September 26, but that may change.

The decision came after Allergan, the company that manufactures the drug, presented evidence about oral tazarotene's efficacy and safety, and agreed to a proposed program to track patient, physician and pharmacy compliance.

The National Psoriasis Foundation testified on behalf of the drug with moving accounts from patients who have used oral tazarotene, and from Dale White, the vice president of the Board of Trustees, whose son has psoriasis. Said White to the committees as he encouraged them to recommend approving oral tazarotene, "By expanding the array of choices available to treat this serious chronic disease, [the committees] empower patients to choose the treatment that works best for them."

Janey Freeman, a psoriasis patient from Yantis, Texas, was diagnosed with psoriasis at age 34. After using steroids, tar, light, creams, occlusion, methotrexate and shampoos with varying degrees of success, she enrolled in the Tazoral clinical trial. She had 60 percent improvement, and experienced mild joint pain and dry skin.

After describing how psoriasis substantially altered her life choices, she said that "I believe Tazoral should be available to patients that it might help."

Tyrone Gorey, a patient from Newcastle, California, agreed with the need for "more tools" to treat his psoriasis. "I was really embarrassed because I had psoriasis on 45 percent of my body." After being in the oral tazarotene clinical trial, he became 95 percent clear. "The confidence of not having psoriasis is huge, and so rewarding to not worry about this problem."

However, the committee expressed concern over reports of bone mineral density loss, potential off-label use of the drug for acne and the chance of pregnancy. Oral tazarotene is a probable teratogen (an agent that can cause malformations of a developing embryo or fetus). In clinical trials the drug did not accumulate in the body and cleared rapidly when treatment stopped. This may make it an option for women of childbearing potential who are excluded from other retinoids due to the risk of these drugs causing severe birth defects.

In answer to a question about bone mineral density, Mark Lebwohl, M.D., professor and chairman of the Mt. Sinai School of Medicine of New York University, and a member of the Psoriasis Foundation's Medical Board, said that the data "compares favorably to other retinoids." To a question about off-label use, Patricia Walker, M.D., Ph.D., Allergan's Vice President of Skin Care Clinical Research and Development, said that Allergan wouldn't promote it for off-label use. Said Walker, "the program does protect vulnerable populations by tracking the known marketing databases."

The answers were not enough to assuage the concerns of the committees, however. The vote will next go to the FDA, which will consider the arguments and evidence put forth during the joint committee hearing.

Tazoral, an oral retinoid, selectively targets two receptors in the skin, and clears out of the bloodstream significantly faster than other retinoids. It is taken as a once daily oral medication in a 4.5 milligrams (mg) dose. It should not be confused with Tazorac, which is a topical retinoid available in gel and cream formulations that has been available since 1997 for the treatment of psoriasis.

Results from two phase III studies of Tazoral found that patients experienced peak clearing at four weeks after the treatment period, with no significant side effects. Adult patients with plaque psoriasis covering at least 10 percent of their body surface took 4.5 mg once daily for up to 52 weeks. More than half of the patients achieved moderate to complete clearing by week 12. The majority of patients maintained improvement throughout the treatment period and for at least 12 weeks post treatment.

The most common adverse events were mild, and included dry skin, joint pain, muscle ache, infection, back pain, headache and itch.

The National Psoriasis Foundation will continue to urge the FDA to support the approval of Tazoral. The FDA will likely make its decision by end of September.

Extensive background information presented during the hearing is available at http://www.fda.gov/ohrms/dockets/ac/cder04.html#Dermatologic

FDA approves Enbrel for psoriasis

First biologic approved to treat moderate to severe psoriasis and psoriatic arthritis

First posted May 3, 2004

The U.S. Food and Drug Administration (FDA) approved on April 30, 2004, a new use for the biologic drug Enbrel; it now can be used to treat moderate to severe plaque psoriasis in adults who are candidates for systemic treatment or phototherapy. National Psoriasis Foundation Press Release

In January 2002, Enbrel became the first biologic approved for psoriatic arthritis; it is now the first biologic to be approved to treat both psoriasis and psoriatic arthritis. In addition to psoriasis and psoriatic arthritis, Enbrel is approved for rheumatoid arthritis, juvenile rheumatoid arthritis and ankylosing spondylitis, a disease that causes inflammation in the spine.

"Managing psoriasis is a lifelong battle, and patients frequently tell us they need additional treatment options," said Gail Zimmerman, president and CEO of the National Psoriasis Foundation. "The past 18 months have brought several new choices for patients, and with Enbrel, we now have a drug approved for both psoriasis and psoriatic arthritis. This is an exciting time for psoriasis patients and their families."

How will patients use it?

Enbrel is given by injection under the skin; patients give themselves the shot once or twice per week at home. The medication is meant to be taken continuously to maintain the results.

The FDA approved dose administration for Enbrel is 50 milligrams (mg) twice per week for three months, followed by a maintenance dose of 50 mg once weekly thereafter. Each dose is taken in two 25 mg injections within a 24-hour period or three or four days apart.

How effective is Enbrel for psoriasis?

The new label use is significant because the dosing regimen has been shown in many patients to improve symptoms quickly and maintain the results.

The FDA's decision was based on two phase III studies evaluating more than 1200 patients with moderate to severe psoriasis, which demonstrated that psoriasis patients may be able to speed their clearing time at a higher dose and then maintain it at a lower dose. Patients received placebo, or Enbrel 25 mg twice weekly or 50 mg twice weekly for 12 weeks. Patients then continued treatment for an additional 12 weeks, but those who were given 50 mg initially were "stepped down" to 25 mg twice weekly.

Of those given the 50 mg loading dose and then stepped down, nearly half (47 percent) achieved 75 percent improvement in their psoriasis score.

In psoriasis studies, many patients experienced clinical improvement as early as four weeks or up to a few months after starting Enbrel.

How is Enbrel different?

The medicine works by blocking a chemical in the immune system that overstimulates inflammation. This chemical is called "tumor necrosis factor-alpha" (TNF-alpha), an immune-system chemical messenger.

More treatments to target psoriasis pathway
The psoriasis approval follows the approvals in January 2003 of Amevive and in October 2003 of Raptiva, two other biologic medications for psoriasis treatment.

Other biologics are on their way:

  • Remicade is already on the market for rheumatoid arthritis and Crohn's disease; additional late-stage clinical studies in psoriasis and psoriatic arthritis are ongoing.
  • Humira is already on the market for rheumatoid arthritis; additional late-stage clinical studies in psoriasis and psoriatic arthritis are ongoing.
More than 5 million Americans and their families are affected by psoriasis and/or psoriatic arthritis. Moderate psoriasis is defined as affecting between 2 percent and 10 percent of the body's surface, and psoriasis covering more than 10 percent of the body is considered severe. (The area of skin that can be covered by the palm of the hand is considered to be 1 percent of the body.)

What are the side effects?

Injection site reactions (redness, itching, pain, swelling) were the most common short-term side effect among patients taking Enbrel in the psoriasis studies.

Serious infections, including some fatalities, have been reported with the use of Enbrel. The infections often occurred in patients using other medications that suppress the immune system, like methotrexate. Serious infections are rare in patients taking Enbrel alone. Also, rare cases of tuberculosis have been observed in patients taking medications that target TNF-alpha.

The medication should not be started in someone with an active infection, and it may not be recommended for someone with a history of recurring infections. If a serious infection develops, a doctor will most likely stop Enbrel treatment.

Cases of multiple sclerosis and other central nervous system disorders have been observed in association with Enbrel and medications that target TNF-alpha, although the connection between the disorders and the medications remains unclear. Due to rare reports of blood disorders, people taking Enbrel are advised to contact their doctor if they experience persistent fever, bruising, bleeding or paleness.

In 2003, the FDA reviewed the association between TNF-alpha medications like Enbrel and an increased risk of developing lymphoma, a type of cancer. There is not enough data to know if the medication contributed to higher risk. Enbrel's safety and side effects continue to be monitored by Amgen and Wyeth and the FDA.

Who should not take Enbrel?

  • People with active infections should not start Enbrel
  • Caution is advised for the elderly, due to the already increased risk of infection for this age group
The impact of Enbrel on pregnant women or developing fetuses is not known, nor is it known if the medication passes into breast milk in nursing women. Enbrel should only be given to pregnant or nursing women if there is a clear medical need, and if this decision is reached by a patient and doctor together.

How will I get it?

Amgen does not expect any major change in insurance reimbursement or distribution for the new psoriasis approval. For more information, including prescribing information, please visit our Biologic Fact Sheets or our Biologic Medications for Psoriasis and Psoriatic Arthritis booklet.

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Oral Form of Tazorac Shows Efficacy and Safety

First posted March 18, 2004

Results from two phase III studies of oral tazarotene, an oral version of the retinoid Tazorac, found that patients experienced peak clearing at four weeks after the treatment period, with no significant side effects.

A total of 263 adult patients with plaque psoriasis covering at least 10 percent of their body surface took 4.5 milligrams (mg) once daily for up to 52 weeks.

More than half of the patients achieved moderate to complete clearing by week 12. The majority of patients maintained improvement throughout the treatment period and for at least 12 weeks post treatment.

The most common adverse events were mild, and included dry skin, joint pain, muscle ache, infection, back pain, headache and itch.

Oral tazarotene did not accumulate in the body and cleared rapidly when treatment stopped. This may make it an option for women of childbearing age who are excluded from other retinoids due to the risk of these drugs causing severe birth defects. In a conference presentation on psoriasis treatment, Jeffrey Weinberg, M.D., assistant professor at New York Medical College commented, "There is a negligible amount of oral tazarotene in the body after seven days, which offers hope that women will be able to conceive one month after discontinuation of therapy."

Allergan, oral Tazorac's manufacturer, filed for U.S. Food and Drug Administration approval in November 2003. Allergan hopes to have approval for the drug by the end of the year.

Psoriasis research at center of AAD conference

Biologics studies show improvement for moderate to severe psoriasis

First posted March 18, 2004

Research on psoriasis and its treatments continues to gather steam. The American Academy of Dermatology's (AAD) 62nd Annual Meeting in Washington, D.C., had several presentations, including a psoriasis symposium led by the National Psoriasis Foundation, that focused exclusively on breaking research in psoriasis treatments.

The following are highlights of the research presented at the February 2004 conference on biologics that are in the pre-approval stages for psoriasis.

Humira study shows promise for psoriasis

New phase II data showed that patients with moderate to severe plaque psoriasis who received Humira for 12 weeks achieved significant results. Humira, an anti-tumor necrosis factor biologic treatment, is given by subcutaneous injection (under the skin).

In clinical trials, patients were given either placebo or an initial 80 mg the first week, and then were split into two groups, one receiving 40 mg weekly and the other 40 mg every other week. By week 12, of those taking the drug weekly, 80 percent achieved 75 percent improvement in psoriasis severity score and 76 percent were "clear" or "almost clear." More than half the patients taking 40 mg every other week achieved 75 percent improvement in their psoriasis score and nearly half were "clear" or "almost clear."

The most common side effects were injection site reactions, upper respiratory infection, injection site pain, headache, rash and sinusitis.

Commented Dr. Jeffrey Weinberg, "people are very excited about the potential efficacy and safety of this drug for psoriasis," after preliminary results were announced at the AAD. Humira, manufactured by Abbott Laboratories, is approved for rheumatoid arthritis.

"Loading dose" of Enbrel found to be effective

Psoriasis patients may be able to speed their clearing time at a higher dose and then maintain it at a lower dose, according to research presented on Enbrel. The biologic medication is approved for treatment of psoriatic arthritis, and adult and juvenile rheumatoid arthritis.

In the phase III trial for psoriasis treatment, 583 patients with moderate to severe psoriasis received placebo, 25 mg twice weekly or 50 mg twice weekly for 12 weeks. Patients then continued treatment for an additional 12 weeks, but those who were given 50 mg initially were "stepped down" to 25 mg twice weekly.

During the first twelve weeks, 34 percent of those given 25 mg throughout the study achieved 75 percent improvement in their score. Of those given the 50 mg loading dose, 49 percent achieved 75 percent improvement in their psoriasis score, and 77 percent maintained this response with the lower dose through week 24. In a session on biologic drugs for psoriasis, Mark Ling, M.D., Ph.D., medical director of Medaphase, Inc., said "This study suggests that we may be able to achieve the higher response rate of the 50 mg dose, then drop to the lower 25 mg dose for maintenance, while maintaining the improved response of the higher dose."

Side effects were similar to those reported in other Enbrel clinical trials, with injection site reactions being the most common. Enbrel is manufactured by Amgen Wyeth.

Remicade study shows quality of life improvement

A phase II trial of 249 patients found that Remicade significantly improved their quality of life.

In this phase II trial of 249 patients, patients were divided into three groups: those who received 5 mg/kg, 3 mg/kg or placebo. Quality of life was evaluated for 30 weeks using the Dermatology Life Quality Index (DLQI). The index rates symptoms and feelings, daily activities, leisure, work and school, personal relationships, and annoyance with psoriasis treatment.

The median change in DLQI was 84 percent for patients on the 3 mg/kg and 91 percent for those given 5 mg/kg. At week 10, 40 percent of patients given 5 mg/kg scored 0. In a presentation about biologics used in psoriasis, Ken Gordon, M.D., from Loyola University Medical Center in Chicago, interpreted this finding to mean that patients report that disease had no effect after treatment. "People who use topicals or phototherapy rarely report these results compared to biologics," he said.

Remicade, manufactured by Centocor, is approved for Crohn's disease and rheumatoid arthritis, and is in ongoing clinical trials for the treatment of psoriasis and psoriatic arthritis.

Researchers Link Psoriasis to Increased Lymphoma Rate

First posted Nov. 21, 2003

According to a study published in the November Archives of Dermatology, psoriasis patients in a British database had a 3-fold increase in lymphoma compared to patients with no psoriasis.

The researchers, from the University of Pennsylvania, state that lymphoma is a rare form of cancer, however, with incidence rates similar to melanoma. The increased rate translates to an additional 12 cases per 10,000 people with psoriasis. They also commented that it is not clear whether the increased rate was due to psoriasis severity or treatment, or whether the results apply to younger patients.

The original data was collected from a registry of patients 65 years or older. More than 2700 patients in the database had psoriasis. After following the database of patients with and without psoriasis for a median time of 46 months, researchers found 276 lymphomas. The psoriasis patients had nearly 3 times the rate of lymphomas than the general population.

The researchers hypothesized that the increased rate may be due to the following:

  • Psoriasis leads to increased T-lymphocyte activity because it is an immune mediated disease.
  • Newer immunosuppressive treatments that target anti-TNF and T cells may "be an independent risk factor" for developing malignancies.
  • Or, the combination of immunosuppressive treatments and the disease itself may lead to the increased rate.

The researchers recommended that the above hypotheses be tested, and that clinicians "consider the risks and benefits of long-term exposure" to medications that may induce lymphomas in psoriasis.

The U.S. Food and Drug Administration is investigating the increased rates of malignancy among rheumatoid arthritis patients using anti-TNF treatments. No conclusive research has linked malignancy from anti-TNF treatments to psoriasis and psoriatic arthritis patients.

Lymphoma includes more than 35 subtypes, consisting of 5 types of Hodgkin's lymphoma and over 30 types of non-Hodgkin's lymphoma. Over 500,000 Americans have lymphoma.

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