Secukinumab Appears Effective and Safe for Children With Severe Chronic Plaque Psoriasis

TAKE-HOME MESSAGE

• Children aged 6 to 18 years with severe chronic plaque psoriasis were randomized to receive low-dose secukinumab (n = 40), high-dose secukinumab (n = 40), placebo (n = 41), or etanercept (n = 41). At week 12, the patients treated with secukinumab had a higher rate of PASI 75 than the patients treated with placebo (80% and 77.5% vs 14.6%). At 52 weeks, secukinumab achieved higher rates of PASI 75 (87.5% and 87.5% vs 68.3%), PASI 90 (75% and 80% vs 47.5%), and PASI 100 (40% and 47% vs 22%). No new safety signals were identified compared with adult studies, and no instances of inflammatory bowel disease occurred during the study.

• Systemic therapies for paediatric psoriasis are limited. However, based on this trial, secukinumab appears to be an effective and safe treatment in children as young as 6 years old.

– Margaret Hammond, MD

Written by

 

 

Douglas W. Kress MD

The mean onset of pediatric psoriasis is between 7 and 10 years of age. Until very recently in the United States, etanercept (ETN) was the only FDA-approved systemic treatment for patients in this age group with moderate to severe disease. In the last 18 months, both ustekinumab and ixekizumab were FDA-approved down to the age of 6 years. This multicenter, randomized, double-blind, placebo- and active-controlled trial compared both high-dose (HD) and low-dose (LD) secukinumab (SEC) with standard-dose ETN and placebo for 12 to 52 weeks. The primary endpoints were the percentage of patients achieving either a PASI 75 or an Investigator Global Assessment (IGA) of 0 or 1, with 99% of the patients having started the trial with a severe IGA of 4. Secondary endpoints included PASI 90 and 100, as well as patient-reported quality of life (QOL). Both HD and LD SEC were statistically significantly superior to both the ETN and placebo in getting patients to an IGA of 0 or 1 as well as to PASI 90.

There were no differences in treatment-emergent adverse events (AE) through 52 weeks for both doses of SEC or ETN. The most common AEs were nasopharyngitis and headache, and most were mild to moderate. Both HD and LD SEC showed greater improvement in health-related QOL as compared with ETN. In fact, the majority of patients treated with SEC for 52 weeks showed no impact on their QOL due to psoriasis symptoms by the end of the trial. Although we already have three systemic agents FDA-approved to treat pediatric psoriasis in the United States, based on trials such as this one, and our specialty's long experience with the safety and efficacy of SEC in adults, it would be nice to be able to add one more agent to our list of pediatric treatment options, should this agent be granted FDA approval down to the age of 6 years.

Abstract 

BACKGROUND

Secukinumab has demonstrated sustained long-term efficacy with a favourable safety profile in various psoriatic disease manifestations in adults.

OBJECTIVES

Here, 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.

METHODS

In this multicentre, double-blind study (NCT02471144), patients aged 6 to <18 years with severe chronic plaque psoriasis were stratified and randomized by weight (<25 kg, 25 to <50 kg, ≥50 kg) and age (6 to <12 years, 12 to <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).

RESULTS

Overall, 162 patients were randomized 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 (P < 0.0001) 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 (P < 0.0001) 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.

CONCLUSIONS

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.

Journal of the European Academy of Dermatology and Venereology: JEADV

Secukinumab Demonstrates High Efficacy and a Favourable Safety Profile in Paediatric Patients With Severe Chronic Plaque Psoriasis: 52-Week Results From a Phase 3 Double-Blind Randomized, Controlled Trial

J Eur Acad Dermatol Venereol 2020 Oct 17;[EPub Ahead of Print], C Bodemer, A Kaszuba, K Kingo, A Tsianakas, A Morita, E Rivas, P Papanastasiou, D Keefe, M Patekar, P Charef, L Zhang, S Cafoncelli, C Papavassilis 

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Benjamin Hidalgo-Matlock
Skin Care Physicians of Costa Rica

Clinica Victoria en San Pedro: 4000-1054
Momentum Escazu: 2101-9574

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