Secukinumab demonstrates favourable safety profile in paedia
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Secukinumab has demonstrated sustained long-term efficacy with a favourable safety profile in various psoriatic disease manifestations in adults. The efficacy and safety of two secukinumab dosing regimens (low dose [LD] and high dose [HD]) in paediatric patients with severe chronic plaque psoriasis over one year are reported.

In this double-blind study, patients aged 6 to less than 18 years with severe chronic plaque psoriasis were stratified and randomised by weight (less than 25 kg, 25 to less than 50 kg, more than 50 kg) and age (6 to less than 12 years, 12 to less than 18 years) to receive low-dose (LD: 75/75/150 mg) or high-dose (HD: 75/150/300 mg) subcutaneous secukinumab or placebo or etanercept 0.8 mg/kg (up to a max of 50 mg).

Overall, 162 patients were randomised to receive secukinumab LD (n=40) or HD (n=40), etanercept (n=41) or placebo (n=41). The co-primary objectives of the study were met with both secukinumab doses (LD and HD) showing superior efficacy compared to placebo with respect to PASI 75 response (80.0%, 77.5% vs. 14.6%) and IGA mod 2011, 0 or 1 response (70%, 60% vs. 4.9%) at Week 12. Both secukinumab doses were superior to placebo with respect to PASI 90 response at Week 12 (72.5%, 67.5% vs 2.4%). The efficacy of both doses was sustained to Week 52 with secukinumab achieving higher responses vs. etanercept (PASI 75/90/100: LD, 87.5%/75.0%/40.0% and HD, 87.5%/80.0%/47.5.% vs. etanercept, 68.3%/51.2%/22.0% and IGA 0 or 1: LD, 72.5% and HD, 75.0% vs. etanercept, 56.1%). The safety profile of secukinumab was consistent with the adult Phase 3 studies, with no new safety signals identified.

Both doses of secukinumab demonstrated high and sustained efficacy up to Week 52 with a favourable safety profile in paediatric patients with severe chronic plaque psoriasis.

Source: https://onlinelibrary.wiley.com/doi/epdf/10.1111/jdv.17002
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