Janssen Inc., one of the Janssen Pharmaceutical Companies, announced that Health Canada has approved Stelara (ustekinumab) for the treatment of chronic moderate-to-severe plaque psoriasis in adolescent patients (12 to 17 years) who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies.
Psoriasis is a chronic, inflammatory autoimmune disease, in which skin cells multiply faster than normal. This can result in raised, red, scaly patches that appear on the skin. While psoriasis can present at any age, approximately one-third of people living with the disease develop it before 20 years of age. Psoriasis affects 125 million people worldwide and nearly one million Canadians.
"The long-term efficacy and safety of Stelara is well-documented in adults," says Dr. Ian Landells, MD, FRCPC, clinical associate professor department of paediatrics and medicine, Memorial University of Newfoundland and clinical chief of dermatology, Eastern Health in St. John's, Newfoundland and Labrador. "It's encouraging that adolescents now have this effective treatment option to help manage their psoriasis, and one that has demonstrated good tolerability according to the CADMUS clinical study results."
The Health Canada approval of Stelara for adolescents with psoriasis is based on data from the phase 3 CADMUS study, designed to evaluate the efficacy and safety of Stelara in patients aged 12 to 17 years with moderate-to-severe plaque psoriasis. The primary endpoint of the study was the proportion of patients achieving a Physician's Global Assessment of cleared/minimal (PGA 0/1) at week 12. This psoriasis assessment tool demonstrated that 69.4 per cent of patients who received standard dosing of Stelara achieved PGA 0/1 at week 12.6
"The emotional and social impact of psoriasis can affect many aspects of day-to-day life," says Andrew Gosse, president, Canadian Psoriasis Network, who lives with psoriasis. "For adolescents living with the disease, this can be particularly devastating as they are in a pivotal time of life, when self-esteem and confidence can be fragile."
Stelara blocks the action of two naturally occurring proteins called interleukin 12 (IL-12) and interleukin 23 (IL-23) that are believed to play a role in inflammatory conditions such as psoriasis and psoriatic arthritis. Stelara received approval in Canada in 2008 for the treatment of adults living with psoriasis.
The most common side effects of Stelara include upper respiratory tract infections, such as the common cold and headache.