A phase 3 open-label, randomized multicenter study to evaluate efficacy and safety of secukinumab in pediatric patients with moderate to severe plaque psoriasis: 24-week results - 09/12/21
, Külli Kingo, MD, PhD b, Vivian Laquer, MD c, John Browning, MD d, Adam Reich, MD, PhD e, Jacek C. Szepietowski, MD, PhD, FRCP (Edin) f, Deborah Keefe, MD, MPH g, Rafal Mazur, MD h, Prayashi Ghelani, MSc i, Pascal Forrer, PhD h, LindaAnn Wraith, MBA g, Manmath Patekar, MD hAbstract |
Background |
Psoriasis affects 0.13%-2.1% of children and adolescents. Despite a high unmet need, the current treatment options approved for pediatric psoriasis are limited.
Objective |
To evaluate the efficacy and safety of 2 secukinumab dosage regimens (low dose: 75/75/150 mg; high dose: 75/150/300 mg) stratified and randomized by weight (<25 kg, 25 to <50 kg, ≥50 kg) and disease severity (moderate, severe) in pediatric patients aged 6-<18 years with moderate to severe plaque psoriasis.
Methods |
This is a phase 3, open-label, randomized, multicenter study (NCT03668613).
Results |
Both secukinumab doses were superior to historical placebo with respect to psoriasis area and severity index (PASI)-75/90 and investigator global assessment 0/1 responses at week 12. The estimated probability of a positive treatment effect (ie, log odds ratio > 0) for low- or high-dose secukinumab compared to historical placebo is 1 (ie, 100%). For the low and high doses at week 12, the investigator global assessment 0/1 response rates were 78.6% and 83.3%, respectively, and the PASI-90 response rates were 69% and 76.2%, respectively. The PASI-75 response rate was 92.9% for both the doses.
Limitations |
This is an open-label study design without a control arm.
Conclusion |
Secukinumab dosing regimens were efficacious and well tolerated in pediatric patients with moderate to severe plaque psoriasis.
Le texte complet de cet article est disponible en PDF.Key words : moderate to severe plaque psoriasis, pediatric psoriasis, secukinumab
Abbreviations used : AE, CDLQI, HD, IGA, LD, MedDRA, PASI, QoL
Plan
| Funding sources: This investigation was sponsored by Novartis Pharma AG, Basel, Switzerland. |
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| IRB approval status: Reviewed and approved by the independent ethics committee or institutional review board for each center. Clinicaltrials.gov (or equivalent) listing (if applicable): NCT03668613. |
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| Reprints available from Manmath Patekar, MD. |
Vol 86 - N° 1
P. 122-130 - janvier 2022 Retour au numéro
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