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

發(fā)布時間： 2020-01-27 閱讀：1036次

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January 23, 2020 / The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the European Commission (EC) has approved the expanded use of STELARA? (ustekinumab) for the treatment of paediatric patients (ages 6?11) with moderate to severe plaque psoriasis. Ustekinumab was previously approved for use in adolescent and adult patients with plaque psoriasis, aged 12 years and older, and is now the first available biologic treatment in this patient population to selectively address the IL?23/IL?12 pathway, an important therapeutic target for the condition.

In one third of the 14 million cases in Europe, psoriasis begins in childhood. Psoriasis is an immune-mediated inflammatory disease that affects the skin, resulting in areas of red or inflamed skin covered with silvery scales, which are known as plaques. The condition can have a profound, long-term impact on the psychological health and overall quality of life for children. The development of paediatric psoriasis is also associated with high incidence of low self-esteem, and it can have long-term ramifications into adulthood and beyond.

The EC approval is based on results from the Phase 3 CADMUS Jr study, building on the prior Phase 3 CADMUS study, which found ustekinumab improved the signs and symptoms of plaque psoriasis, as well as health?related quality of life (HrQOL), in paediatric patients aged six to 11 years old.