The FDA has approved an expanded indication for ustekinumab (Stelara, Janssen Biotech, Inc.) for the treatment of adolescents (12 years of age or older) with moderate-to-severe plaque psoriasis who are candidates for phototherapy or systemic therapy.
About one-third of individuals with plaque psoriasis develop the disease before their 20th birthday, and treatment options for adolescents have been limited. Since receiving approval in September 2009 for the treatment of adults living with moderate-to-severe plaque psoriasis, ustekinumab has become a leading therapeutic option for dermatologists and their patients, with only four doses a year after two starter doses.
The approval ustekinumab for this indication is based on data from a phase 3 study designed to evaluate the efficacy and safety of subcutaneous administration of ustekinumab in patients 12 years of age or older. At least two-thirds of patients receiving ustekinumab were responders at the week 12 primary endpoint after two doses at weeks 0 and 4, defined by achieving a Physician’s Global Assessment (PGA) score of 0 or 1 (cleared or minimal psoriasis). Safety findings for adolescent patients treated with ustekinumab were consistent with those seen in studies in adults with plaque psoriasis.
“Psoriasis is a highly visible disease, and it is essential that these younger patients and their caregivers have options that can effectively reduce the difficult-to-conceal and often misunderstood plaques,” said 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.”
Psoriasis is a chronic, autoimmune inflammatory disorder that results in the overproduction of skin cells. It is estimated that more than 7.5 million Americans live with the disease. The most common form of psoriasis, affecting about 80% to 90% of psoriasis patients, is plaque psoriasis, characterized by raised, inflamed, red lesions, or plaques, which can cause physical pain. Approximately 80% of those affected with psoriasis have mild-to-moderate disease, while 20% have moderate to severe plaque psoriasis. The scalp and face are the most affected areas in adolescents, which can lead to emotional and social complications in this population.
Ustekinumab is a fully human interleukin (IL)-12 and IL-23 antagonist administered subcutaneously at weeks 0 and 4, and then every 12 weeks thereafter. It is also indicated for the treatment of adult patients 18 years and older with active psoriatic arthritis, alone or with the medicine methotrexate, and for the treatment of adult patients 18 years or older with moderately to severely active Crohn’s disease who have already taken other medicines that did not work well enough or they could not tolerate it.
Source: Janssen Biotech, Inc.; October 13, 2017.