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Soriatane (Acitretin) Label Update Clarifies Use In Severe Psoriasis

NUTLEY, NJ -- May 8, 2003 -- Soriatane® (acitretin), an oral medication that has been a staple of treatment for severe psoriasis for six years, has received approval for an enhanced, updated product label from the U.S. Food & Drug Administration (FDA), Roche (OTC: RHHBY.PK) announced today.

The major changes to the label include:

-- Amended indication for "severe psoriasis in adults," no longer saying "including erythrodermic and pustular."

-- Clarification of how to use Soriatane safely in combination with phototherapy

-- More rigorous pregnancy testing requirements and warnings about birth defects

-- Clarified dosing flexibility, with a starting range of 25mg to 50mg, rather than 25 or 50mg, as it had been before.

-- Inclusion of efficacy results from pivotal clinical trials in which Soriatane was shown to be effective in five major types of psoriasis -- plaque, guttate, palmoplantar, erythrodermic, and pustular. -- Inclusion of data to further support the use of Soriatane in maintenance therapy.

-- Addition of a Medication Guide, an FDA-approved consumer version of the Soriatane label, to ensure that patients clearly understand how the drug should be used.

The Role of Soriatane in Psoriasis
Soriatane is the only oral systemic drug for severe psoriasis that does not suppress the immune system or kill cells. Since Soriatane is neither immunosuppressive nor cytotoxic, it can be used without the potential for reducing a patient's resistance to common infections.

"According to our 2002 National Psoriasis Foundation Benchmark Survey, only 35 percent of people with moderate to severe psoriasis have ever tried phototherapy or systemic therapy and 27 percent of patients are very unsatisfied with their physicians' lack of aggressive treatment," said Gail Zimmerman, President and CEO of the Psoriasis Foundation. "We are glad to see more information in the Soriatane label to assist doctors in making treatment choices."

The new label also provides information for prescribers on using Soriatane with phototherapy.

"The guidance in the new label about significantly reducing the phototherapy dose in Soriatane patients is welcome," said Alan Menter, M.D., Chief, Division of Dermatology, Baylor University Medical Center. "Soriatane and medically supervised phototherapy are effective together when used properly."

Information on Efficacy Added
The updated label provides detailed information on clinical trial results that were the foundation for the original approval of Soriatane. They show that patients taking Soriatane had significant improvement over baseline at 8 weeks, 6 months, 12 months, and for a small sample of patients, 18 months. "These clinical efficacy results will help prescribers gain a more precise understanding of how well Soriatane works," said Ronald Gottschalk, M.D., Medical Director of Dermatology at Roche.

-- 8 weeks: 76% of patients taking Soriatane showed statistically significant improvement in as little as 8 weeks.

-- 6 months: 40% of patients experienced complete or almost complete clearing of their psoriasis.

-- 12 months: Patients continued to experience statistically significant improvement in symptoms.

-- 18 months: Four patients on Soriatane, followed for 18 months, showed continued improvement, including a decrease from baseline in severity of scaling, thickness and erythema; improvement in physicians' global evaluations, and reduction in percentage of body surface involved.

More Flexible Dosing Initially and Over Time

The revised labeling clarifies dosing flexibility. The recommended initial dose has been changed to 25mg to 50 mg per day, rather than 25mg or 50 mg. The availability of 10 mg and 25 mg capsules gives prescribers the ability to adjust the dose up or down in small increments.

Also changed is the prescribed use of Soriatane in maintenance therapy. The therapy may be continued at doses of 25 to 50 mg per day once the lesions have cleared.

Pregnancy Warnings Enhanced

Soriatane is a retinoid compound, and from the start was known to cause severe birth defects. An effective pregnancy prevention program has been in place since the product was launched in the U.S. in 1997. More than 75% of patients with severe psoriasis, however, are either men or are women who are not of childbearing potential.

The updated label strengthens warnings about birth defects and requires two negative pregnancy tests before the start of therapy. Female patients must use two effective forms of birth control simultaneously and sign an informed consent agreement acknowledging that they are aware that they must not be pregnant when they start taking Soriatane, or get pregnant during therapy or for three years after stopping treatment.

Women of childbearing potential who take Soriatane also are warned not to consume any alcohol during therapy or for two months after stopping treatment. Acitretin, the active chemical in Soriatane, can interact with alcohol to form etretinate, which can remain in the body for some time and cause severe birth defects. Soriatane also must not be used by females who may not use reliable contraception while undergoing treatment or for at least three years following discontinuation of treatment.

In males taking Soriatane, the drug "poses little, if any, risk to a fetus while the male patient is taking the drug or after it is discontinued." The limit of how much residue can be present with no effect on the fetus is not known.

Other Side Effects
Aside from birth defects, less frequent but potentially serious adverse events that have been reported include liver toxicity, pancreatitis and increased intracranial pressure, as well as bone spurs, alteration in lipid levels and possible cardiovascular effects, and eye problems.

In addition, the revised label includes precautions about depression, noting, "Depression and/or other psychiatric symptoms such as aggressive feelings or thoughts of self-harm have been reported." The section also states, however, "Since other factors may have contributed to these events, it is not known if they are related to Soriatane." Patients should be counseled to stop taking Soriatane and notify and notify their prescriber immediately if they experience psychiatric symptoms.

Consumers and health professionals can obtain additional information about psoriasis and Soriatane by visiting http://www.soriatane.com. Patients may join an educational program at http://www.Psoria-Sense.com for thoughtful advice and suggestions on symptom relief, as well as educational materials and special patient offers.

About Psoriasis
(From the National Psoriasis Foundation, http://www.psoriasis.org) Psoriasis, often misperceived as a mere skin rash, is a serious and often painful and debilitating disease of the immune system.

Psoriasis occurs when faulty signals in the immune system cause skin cells to regenerate too quickly -- every three to four days instead of the usual 30- day cycle. Extra skin cells build up on the skin's surface, forming red, flaky, scaly patches, called plaques, which are often itchy and uncomfortable. Psoriasis generally appears on the joints, limbs and scalp, but it can appear anywhere on the body, covering some people from head to toe.


SOURCE: Roche

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