Centocor Ortho Biotech Inc announced that the US Food and Drug Administration (FDA) has approved Stelara (ustekinumab) for the treatment of adult patients 18 years or older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. The efficacy and safety of Stelara were evaluated in one of the largest clinical development programs for a biologic medication in the treatment of psoriasis.
Stelara is a first-in-class human monoclonal antibody that selectively targets the cytokines interleukin-12 (IL-12) and interleukin-23 (IL-23), naturally occurring proteins that are believed to play a role in the development of psoriasis.
"Findings from clinical studies showed that approximately seven out of 10 patients receiving Stelara achieved 75 percent skin clearance after just two doses, and maintained response for one year with continued treatment," said Mark Lebwohl, professor and chairman of the Department of Dermatology, The Mount Sinai School of Medicine, and study investigator. "Stelara is a meaningful new option for patients with psoriasis that offers maintenance dosing every 12 weeks following two starter doses."
Psoriasis is an inflammatory disorder characterized by raised, inflamed, red lesions, or plaques, which can cause physical pain. It is estimated that as many as 7.5 million Americans have psoriasis, which can present in various forms, ranging from mild to severe and disabling.
The clinical development program for Stelara included more than 2,200 patients, with two pivotal phase-3 trials serving as the primary basis for FDA approval. In each of these trials, a significantly higher proportion of patients receiving either Stelara 45 mg or 90 mg achieved at least a 75 percent reduction in psoriasis as measured by the Psoriasis Area and Severity Index (PASI), or PASI 75, at week 12 compared to patients receiving placebo. With every-12-week Stelara maintenance therapy, the majority of patients achieving a PASI 75 improvement maintained substantial skin clearance for one year.
Stelara is a subcutaneous injection given at weeks 0 and 4, followed by every-12-week dosing. The recommended starting dose of Stelara is 45 mg for patients weighing 220 lbs. (100 kg) or less, and 90 mg for patients weighing more than 220 lbs.
"We are pleased to be in the position to make Stelara available to patients living with this chronic, lifelong inflammatory disease and for dermatologists treating these individuals," said Kim Taylor, president, Centocor Ortho Biotech. "We have collaborated with the FDA to ensure that Stelara is supported by a Risk Evaluation and Mitigation Strategy, which will allow physicians to make treatment decisions based on the most comprehensive risk-benefit information. Importantly, we have already compiled three years of safety data from our ongoing five-year extension studies, which will aid in establishing the long-term safety profile of Stelara."
"Psoriasis is a serious disease that affects millions of Americans," said Randy Beranek, president and CEO of the National Psoriasis Foundation. "The approval of Stelara represents an important new treatment option for people who are living with this chronic condition."
Stelara, a human interleukin (IL)-12 and IL-23 antagonist, is approved for the treatment of adult patients (18 years or older) with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.
Centocor Ortho Biotech discovered Stelara and has exclusive marketing rights to the product in the United States.