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EADV 2020 | Secukinumab in Pediatric Psoriasis: Results from Two Phase 3 Trials

Pediatric, Research 2020

Presented by Nina Magnolo, MD, and Christine Bodemer, MD, PhD

 A report from the 29th Congress of the European Academy of Dermatology and Venereology


Introduction: Dr. Magnolo and Dr. Bodemer presented data from two Phase 3, Open-label, Multicenter Trials to assess the efficacy of subcutaneous secukinumab, a monoclonal antibody against interleukin (IL)-17A, in pediatric psoriasis. The 12 and 24 week data presented by Dr. Magnolo included historical placebo data used in Bayesian analysis, and the 12 and 52 week data presented by Dr. Bodemer included an etanercept arm and placebo arm.

 

Design: PASI and IGA(0,1) response in moderate-to-severe chronic plaque psoriasis, age 6-18 years, with monthly low dose (75/75/150mg) and high dose (75/150/300mg) arms based on weight (< 25kg / 25-50kg / ≥ 50kg), after induction dosing. Baseline demographics and disease severity were balanced and comparable across treatment arms.

 

Results: Both studies demonstrated significant superiority to placebo, and Dr. Bodemer’s study demonstrated significant superiority to etanercept in IGA(0,1) and PASI-90.

 

Study presented by Dr. Magnolo, 84 subjects

 

 IGA (0,1) 

 PASI-75 

 PASI-90 

 PASI-100 

 Week 12: SEC low dose 

 78.6%

 92.9%

 Week 12: SEC high dose 

 83.3%

 92.9%

 Week 24: SEC low dose 

 88.1%

 95.2%

 88.1%

 66.7%

 Week 24: SEC high dose 

 92.9%

 95.2%

 88.1%

 66.7%

 

Study presented by Dr. Bodemer, 162 subjects

 

 IGA (0,1) 

 PASI-75 

 PASI-90 

 PASI-100 

 Week 12: SEC low dose 

 70.0%

80.0% 72.5% 30.0%

 Week 12: SEC high dose 

60.0% 77.5% 67.5% 27.5%

 Etanercept arm

 34.1%  63.4%  29.3% 17.1%

 Placebo arm

 4.9%  14.6%  2.4% 0.0%

 Week 52: SEC low dose 

72.5%  87.5%  75.0% 40.0%

 Week 52: SEC high dose 

 75.0%  87.5%  80.0%  47.5%

 Etanercept arm

 56.1%  68.3%  51.2%  22.0%

Placebo arm - Placebo crossover
to secukinumab (week 12) response was comparable
to secukinumab treatment arms

 

Adverse events: Majority of AEs in both studies were mild to moderate, with few severe AEs and no deaths. Candida infections occurred in roughly 1-2% of patients in both studies.

 

Conclusion: Secukinumab appears highly effective and safe in pediatric patients, with rapid and durable response. The safety profile is consistent with the known safety profile from adult studies.


References


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