The US Food and Drug Administration (FDA) has approved the indication of Stelara (ustekinumab) for adolescent patients with moderate to severe plaque psoriasis. Janssen Biotech, the manufacturer of the drug, described the approval as a "significant milestone" in the treatment of young people with the skin condition. More than 6.7 million Americans suffer from psoriasis, according to figures from National Health and Nutrition Examination Surveys.
Stelara has been available for adult patients since 2009. However, an estimated one-third of those who develop plaque psoriasis first experience symptoms before they reach 20 years of age, resulting in a significant demand for medication and treatment options for adolescent patients.
"It is essential that these younger patients and their caregivers have options that can effectively reduce the difficult-to-conceal and often misunderstood plaques," commented Michael Siegel, PhD, senior vice-president of research and clinical affairs for the National Psoriasis Foundation. "It is encouraging to have new treatment options where few exist for adolescents living with psoriasis during such formative times in their lives," he added.
Psoriasis is an autoimmune disease in which the body's own immune system becomes overactive and attacks healthy body tissue. Symptoms of the condition include red and inflamed patches of skin, silver-white scales or plaques developing, dry cracked skin, itching, burning, and soreness. It is easily confused with other skin conditions such as eczema, so in suspected cases of psoriasis, it is usually best to consult with a specialist dermatologist.
The condition is usually treated with the application of creams and ointments to the affected area. These medicated products include topical corticosteroids, such as Temovate (clobetasol), topical antipruritics, and specialist topical antipsoriasis products like Dovonex (calcipotriene). Other drugs may also be prescribed, for example, calcineurin inhibitors or antipsoriatic monoclonal antibodies.
Stelara is not the only drug recently approved for treatment of psoriasis by the FDA. Earlier this month, the regulatory body approved the intravenous drug Simponi Aria (golimumab) for treatment of adults with active psoriatic arthritis following Phase III clinical trials. The injectable biologic works by inhibiting the activity of the protein involved in systemic inflammation.
What is Stelara?
Stelara is a prescription medicine indicated for adults and children aged 12 and older with moderate to severe psoriasis who may benefit from systemic therapy using injections or pills, or phototherapy using ultraviolet light. It is also indicated for adults with active psoriatic arthritis, either alone or alongside methotrexate.
What are the side effects of Stelara?
Stelara lowers the body's ability to fight off infections, so there is a risk that patients will develop serious infections, such as tuberculosis, bacterial, viral or fungal infections. Doctors should check for tuberculosis before starting patients on a course of Stelara.
Before starting taking Stelara inform your doctor if you exhibit any symptoms of infection, are being treated for infection, or if you (or someone you have been in close contact with) have had tuberculosis.
For more information on Stelara, visit http://www.stelarainfo.com