Stelara (ustekinumab) approved by FDA to treat severe plaque psoriasis in US

Stelara (ustekinumab) marketed by Janssen-Ortho Inc has been approved for the treatment of moderate to severe plaque psoriasis in adults by USFDA.

Stelara (ustekinumab) contains monoclonal antibody ustekinumab which blocks the action of two proteins that contribute to the overproduction of skin cells and inflammation in psoriasis.

Stelara (ustekinumab) targets the activity of cytokines interleukin- 12 (IL-12) and interleukin-23 (IL-23), naturally occurring proteins that are important in regulating the immune system and that are thought to be associated with some immune related inflammatory diseases including plaque psoriasis.

Stelara (ustekinumab) treatment regulates IL-12 and IL-23 interactions, reducing inflammation in the skin cells and helping to control the signs and symptoms of psoriasis.

Stelera is self-injected every 12 weeks following two starter doses at weeks 0 and 4.The recommended dose of Stelara is 45 mg administered at weeks 0 and 4, then every 12 weeks thereafter.

Alternatively, 90 mg may be used in patients with a body weight greater than 100 kg. Stelara is indicated for adult patients who are candidates for phototherapy or systemic therapy

Stelera (ustekinumab) has demonstrated significant efficacy in clinical studies involving more than 3,000 participants from around the world.

Stelara was studied in two pivotal phase III clinical trials. The trials demonstrated that the majority of patients with moderate to severe plaque psoriasis who received Stelara sustained, clinically significant improvement in their disease severity.

At week 12, the primary endpoint of both studies, 66 percent to 76 percent of patients who
received just two doses of Stelara, 45 mg or 90 mg, respectively, at weeks 0 and 4, achieved PASI 75 (75 per cent improvement on the Psoriasis Activity and Severity Index) compared with 3 to 4 per cent of patients receiving placebo. Long-term results from these studies through 76 weeks were published in The Lancet in May 2008.

“This approval provides an alternative treatment for people with plaque psoriasis, which can cause significant physical discomfort from pain and itching and result in poor self-image for people who are self-conscious about their appearance,” Julie Beitz, MD, director of the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research, said in a news release.

Psoriasis is a chronic, recurring and often debilitating inflammatory disease. It is a common immune mediated skin disease in adults and one of the oldest skin conditions known to man. The symptoms of
psoriasis usually appear between the ages of 15 and 35 with 75 per cent of people developing it before the age of 40.Plaque psoriasis is the most common form and affects approximately 80 per cent of those suffering from the condition.8 It usually results in painful, itchy, sore patches of thick, red or inflamed skin covered with silvery scales known as plaques. Plaques can occur anywhere on the body – most commonly on the elbows, knees, lower back and the area around the bellybutton. Severity ranges from minor localized patches to complete body coverage.

Janssen-Ortho Inc. is  headquartered in Toronto. Janssen-Ortho has a drug portfolio covering psychiatry, neurology, dementia, attention deficit hyperactivity disorder, pain management, women’s health, gastroenterology,infectious disease and urology.

Centocor, Inc. developed Stelara and has exclusive marketing rights to the product in
the United States.