Analysis of Acitretin to Treat Psoriasis

Miami Beach—An analysis of national survey data found that patients with psoriasis typically use acitretin in combination with other agents. However, women of childbearing potential are typically not prescribed the drug due to serious side effects, including severe birth defects.

Results were presented during a poster session at the ACC meeting. The poster was titled Acitretin for the Treatment of Psoriasis: An Assessment of National Trends.

The FDA has approved acitretin as an oral agent to treat severe psoriasis in adults. The 25-mg to 50-mg capsule is to be taken once daily with a meal and is most effective when complemented with other topical and systemic treatments, according to the authors. Women who can become pregnant are advised only to use acitretin if they are not currently pregnant and can avoid becoming pregnant while taking the drug and for 3 years after stopping use of acitretin.

In this analysis, the authors examined the use of acitretin in combination with other psoriasis treatments to determine if women of childbearing potential are using the drug. They examined data from the National Ambulatory Medical Care Survey, which is collected via visits to nonfederal-employed office-based physicians who are primarily engaged in direct patient care. The survey, conducted annually since 1989, excludes physicians working in anesthesiology, pathology, and radiology.

The authors found that acitretin was prescribed with other medications during 62% of office visits, including with topical corticosteroids in 51% of visits, calcipotrience in 31% of visits, biologics in 6% of visits, cyclosporine in 5% of visits, methotrexate in 5% of visits, and tazarotene in 2% of visits.

From 1996 to 2009, only 1 female patient <50 years of age was prescribed acitretin, according to the authors, who said that accounted for 2.3% of all female patients analyzed. The authors hypothesized that the drug was infrequently prescribed to women of childbearing potential due to acitretin’s long-lasting teratogenic effects.

However, because of acitretin’s immune-sparing method of action, the authors noted that acitretin in combination with systemic agents such as biologics, topical corticosteroids, and calcipotriene is an effective treatment option, particularly for patients where further immunosuppression is unwarranted.

Stiefel, the manufacturer of acitretin, has implemented the PART (Pregnancy Prevention Actively Required During and After Treatment) program to educate women and their physicians about the serious risks associated with the drug and to help women prevent pregnancies while taking acitretin. Patients participating in the program receive a brochure with detailed information about the side effects associated with acitretin and various types of birth control.

Women who can become pregnant also receive a patient agreement/informed consent form, which they must sign before beginning treatment, as well as a voluntary patient survey. They are also advised to avoid drinks, food, and all medicines (including over-the-counter products) containing alcohol during treatment and for 2 months after stopping use of acitretin.

People should also not take acitretin if they have severe liver or kidney disease, repeated high blood lipids, an allergic reaction to the drug or take methotrexate or tetracyclines.

This study was supported by a grant from Stiefel, a GlaxoSmithKline company.