Ustekinumab in adolescent patients age 12 to 17 years with moderate-to-severe plaque psoriasis: Results of the randomized phase 3 CADMUS study - 14/09/15
Abstract |
Background |
Safe and effective therapies are needed for pediatric patients with psoriasis.
Objective |
The purpose of this study was to evaluate ustekinumab in patients age 12 to 17 years who had moderate-to-severe psoriasis.
Methods |
Patients (n = 110) were randomly assigned to ustekinumab standard dosing (SD; 0.75 mg/kg [≤60 kg], 45 mg [>60-≤100 kg], and 90 mg [>100 kg]) or half-standard dosing (HSD; 0.375 mg/kg [≤60 kg], 22.5 mg [>60-≤100 kg], and 45 mg [>100 kg]) at weeks 0 and 4 and every 12 weeks or placebo at weeks 0 and 4 with crossover to ustekinumab SD or HSD at week 12. Clinical assessments included the proportion of patients achieving a Physician's Global Assessment of cleared/minimal (PGA 0/1), at least 75% improvement in Psoriasis Area and Severity Index (PASI 75), and at least 90% in PASI (PASI 90). Adverse events (AEs) were monitored through week 60.
Results |
At week 12, 67.6% and 69.4% of patients receiving ustekinumab HSD and SD, respectively, achieved PGA 0/1 versus 5.4% for placebo (P < .001). Significantly greater proportions receiving ustekinumab achieved PASI 75 (HSD, 78.4%; SD, 80.6%; placebo, 10.8%) or PASI 90 (HSD, 54.1%; SD, 61.1%; placebo, 5.4%) at week 12 (P < .001). Through week 12, 56.8% of placebo patients, 51.4% of HSD patients, and 44.4% of SD patients reported at least one AE; through week 60, 81.8% reported AEs.
Limitations |
The study was small relative to adult trials.
Conclusions |
In this patient population (12–17 years), the standard ustekinumab dose provided response comparable to that in adults with no unexpected AEs through 1 year.
Le texte complet de cet article est disponible en PDF.Key words : adolescent, biologic, children, pediatric, psoriasis, systemic therapy, ustekinumab
Abbreviations used : AE, CDLQI, HRQoL, HSD, PASI, PASI 75, PASI 90, PGA, PGA 0/1, SAE, SD
Plan
Funding sources: This study (clnicaltrials.gov: NCT01090427) was sponsored by Janssen Research & Development, LLC. |
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Conflicts of interest: Dr Landells has served as a consultant to AbbVie, Allergan, Amgen, Astellas, Basilea, Celgene, Dermik, Galderma, GlaxoSmithKline, Graceway, Janssen, L'Oreal, Leo, Merck/Schering-Plough, Roche, Stiefel, Valeant, and Wyeth; has received research grants from AbbVie, Amgen, and Janssen; has served as a trial investigator for AbbVie, Allergan, Amgen, Astellas, Basilea, Galderma, GlaxoSmithKline, Janssen, Leo, Merck/Schering-Plough, Pfizer, Roche, Stiefel, and Wyeth; has received honoraria from AbbVie, Amgen, Astellas, Graceway, Janssen, Merck/Schering-Plough, Steifel, and Wyeth; and has served as a speaker for AbbVie, Allergan, Amgen, Merck/Schering-Plough, Janssen, Roche, Valeant, and Wyeth. Dr Eichenfield has served as a consultant for Janssen and Leo; has served as a trial investigator for Galderma and Leo; and has served on a safety monitoring board for Amgen. Dr Hoeger has served as a consultant for Janssen and as a speaker for Allmirall, Galderma, and Pierre Fabre. Dr Menter has served as a consultant for AbbVie, Allergan, Amgen, Convoy Therapeutics, Eli Lilly, Janssen, Leo, Maruho, Novartis, Pfizer, Syntrix, Wyeth, and XenoPort; has served as a trial investigator for AbbVie, Allergan, Amgen, ApoPharma, Boehringer Ingelheim, Celgene, Convoy Therapeutics, Eli Lilly, Genentech, Janssen, Leo, Maruho, Merck, Novartis, Pfizer, Syntrix, and Wyeth; and has served as a speaker for AbbVie, Amgen, Janssen, Leo, and Wyeth. Dr Paller has served as a consultant for AbbVie, Anacor, and Janssen and as an investigator for Abbvie, Amgen, and Anacor. Dr Taieb has served as a consultant for Janssen. Dr Philipp has served as a consultant Biogen Idec, Eli Lilly, and Pfizer; has received research support from Biogen Idec and Pfizer; has served as an investigator for AbbVie, Almirall, Amgen, Biogen Idec, Boehringer-Ingelheim, Celgene, Dermipsor Biomed LTD, Eli Lilly, GlaxoSmithKline, Janssen Cilag, Leo, Maruho, MSD, Novartis, Pfizer, UCB Pharma, and VBL Therapeutics; has served as a speaker for Almirall, Amgen, Biogen Idec, Leo, Novartis, and Pfizer; and has served on an advisory board for AbbVie and Novartis. Drs Marano, Hsu, Li, Zhu, Szapary, and Randazzo are employees of the study sponsor and own stock in Johnson & Johnson, of which Janssen Research & Development, LLC is a subsidiary. |
Vol 73 - N° 4
P. 594-603 - octobre 2015 Retour au numéroBienvenue sur EM-consulte, la référence des professionnels de santé.
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