European Commission Approves Janssen’s STELARA® (ustekinumab) for Pediatric Patients Aged 6–11 with Moderate to Severe Plaque Psoriasis

Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson (JNJ), recently announced that the European Commission (EC) has approved an expanded indication for Stelara (Chinese brand name: Xidano; generic name: ustekinumab, ustekinumab injection) for the treatment of pediatric patients (aged 6–11 years) with moderate-to-severe plaque psoriasis. Previously, Stelara was approved for adolescent and adult patients aged 12 years and older with plaque psoriasis. Stelara is now the first selective IL-23/IL-12 biologic agent for the pediatric population aged 6–11 years, targeting the IL-23/IL-12 pathway, which is a key therapeutic target in this disease.

Among the 14 million cases in Europe, one-third of psoriasis cases begin in childhood. Psoriasis is an immune-mediated inflammatory disease that affects the skin, causing redness or inflammation, with silver scales covering the skin, known as plaques. This condition can have profound and long-term impacts on children's mental health and overall quality of life. Childhood psoriasis is also associated with a high incidence of low self-esteem and can have lasting effects into adulthood and beyond.

This approval is based on the results of the Phase III CADMUS Jr. study, which builds upon the prior Phase III CADMUS study. The study found that treatment with Stelara significantly improved the signs and symptoms of plaque psoriasis in pediatric patients aged 6 to 11 years, while also improving health-related quality of life (HrQOL).

Selara is the world’s first biologic agent capable of simultaneously and selectively targeting IL-12 and IL-23. IL-12 and IL-23 are two naturally occurring cytokines believed to play a pivotal role in immune-mediated inflammatory diseases, including ulcerative colitis (UC), plaque psoriasis, psoriatic arthritis, and Crohn’s disease. Stelara inhibits these two pro-inflammatory cytokines by binding to the shared p40 subunit of IL-12 and IL-23, thereby blocking their interaction with the cell-surface receptor IL-12β1.

Stelara was launched in September 2009. Its currently approved indications include the treatment of: (1) adolescents (≥6 years of age) and adults with moderate-to-severe plaque psoriasis; (2) adults with active psoriatic arthritis; (3) adults with moderate-to-severe Crohn’s disease (CD); and (4) adults with moderate-to-severe active ulcerative colitis (UC).

In China, Stelara® (Xidano®) was launched in June 2019. This biologic agent features an innovative dosing regimen—subcutaneous injection once every three months during the maintenance phase—and is indicated for the treatment of adult patients with moderate-to-severe plaque psoriasis who have failed to respond to, have contraindications to, or are intolerant of other systemic therapies, such as cyclosporine, methotrexate (MTX), or PUVA (psoralen and ultraviolet A).

Stelara is a core product in Johnson & Johnson’s expansion into the autoimmune disease field. The drug achieved sales of $6.361 billion in 2019, representing a 23.4% increase from 2018. Recently, an article published in the prestigious international journal Nature (“Top product forecasts for 2020”) pointed out that, with the continuous expansion of indications and growing market penetration, Stelara’s sales are projected to reach $7.241 billion in 2020, ranking seventh among the “Top 10 Best-Selling Drugs Worldwide in 2020.”

Original Source: The European Commission Approves Expanded Use of Janssen’s STELARA® (ustekinumab) for the Treatment of Paediatric Patients With Moderate to Severe Plaque Psoriasis

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