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2020-08-05| Trials & Approvals

Cosentyx Bags EU Approval for First-Line Treatment of Pediatric Psoriasis

by Tulip Chakraborty
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On August 3rd, Novartis announced that the European Commission (EC) has granted approval for Cosentyx to treat moderate-to-severe plaque psoriasis in children and adolescents in the age group of 6 – 18 years based on two successful Phase 3 studies.

By T. Chakraborty, Ph.D.

Psoriasis is a common chronic immune-mediated inflammatory disorder that affects the skin, nails, and joints in both children and adults. It flares up early in childhood in almost one-third of the cases and causes havoc both physically and mentally. In the period between 1970 – 2000, cases in children have increased, and to date, treatment options remain scant. At this juncture, Novartis’s Cosentyx (secukinumab) provides hope to millions as a first-line systemic treatment for psoriasis.

“Psoriasis is a life-long debilitating disease that significantly impacts children’s quality of life, both physically and emotionally. There are only a few approved treatment options available for the pediatric population, and so it is important to broaden the adult therapeutic options out to children when possible. This approval means Cosentyx is now available in Europe for children and adolescents and will provide an additional option to quickly gain relief from their symptom burden and to significantly improve their quality of life.” said Professor Christine Bodemer, Head of the Department of Dermatology, Necker–Enfants Malades Hospital, Paris.

Todd Fox, Global Head of Medical Affairs Immunology, Hepatology, and Dermatology at Novartis, added that “The impact of psoriasis on children is much deeper than skin and can potentially lead to life course impairment. This is the second European approval this year for Cosentyx, which also has approvals across four adult indications, reinforcing our commitment to reimagine medicine for both pediatric and adult patients.”

Research suggests that affected children lead a lackluster life compared to their peers due to multiple symptoms, including fatigue. Jan Koren, President of the European patient group EUROPSO commented that “Children with psoriasis are susceptible to bullying, name-calling, and shaming at school, leading to higher rates of depression and anxiety than their peers. We welcome this approval, as there is a need for additional treatment options that can help give children the freedom to enjoy full and active lives by improving psoriasis symptoms and, thus, overall quality of life.”

 

Cosentyx (secukinumab), an anti-IL-17A Monoclonal Antibody

Cosentyx is the first drug that inhibits interleukin-17A (IL-17A). IL-17 has been known to exert a defensive role in many infectious diseases and is responsible for promoting inflammatory pathology in immune-mediated diseases. The recommended dose for children up to 50 kg of weight is 75 mg (no lower weight restriction), and for children above 50 kg, the dose is 150 mg (can be increased to 300 mg based on individual cases). Cosentyx has proven to be an effective drug based on long term clinical studies ranging over 12 years, for psoriasis, psoriatic arthritis, and ankylosing spondylitis and has been used to treat over 340,000 patients since its inception.

 

Clinical Trials

Two-Phase 3 studies were conducted in children aged between 6-18 years. The trial was a multicenter open-label randomized study in children with plaque psoriasis where the dose of Cosentyx was dependent on the participant weight.

In patients with moderate-to-severe psoriasis, drug treatment resulted in skin clearance. 93% of the patients reached the Psoriasis Area Severity Index (PASI) 75 by 12 weeks, with almost 70% of patients reaching PASI by 12 weeks and 88% by 24 weeks. 60% of the patients achieved complete skin clearance by 12 weeks. PASI 90 was achieved by week 52 in patients with severe psoriasis. Around 50% of the children suffering from the disease reported improvement in the quality of life as measured by Children’s Dermatology Life Quality Index (CDLQI) responses. The safety and efficacy of Cosentyx were consistent with previous clinical trials in adults, and no new safety concerns were observed.

Editor: Rajaneesh K. Gopinath, Ph.D.

Related Article: Novartis’ Axial Spondyloarthritis Drug, Cosentyx Shines in Phase 3 Study

References
  1. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4744260/#:~:text=The%20incidence%20of%20pediatric%20psoriasis,36.6%E2%80%9345.1%5D%20per%20100%2C000.
  2. https://www.novartis.com/news/media-releases/novartis-cosentyx-receives-eu-approval-first-line-systemic-treatment-pediatric-psoriasis

 

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