Ustekinumab in adolescent patients age 12 to 17 years with moderate-to-severe plaque psoriasis: Results of the randomized phase 3 CADMUS study

doi:10.1016/j.jaad.2015.07.002

Journal of the American Academy of Dermatology

Volume 73, Issue 4, October 2015, Pages 594-603

https://doi.org/10.1016/j.jaad.2015.07.002 Get rights and content

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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.

Key words

adolescent

biologic

children

pediatric

psoriasis

systemic therapy

ustekinumab

Abbreviations used

adverse event

CDLQI

Children's Dermatology Life Quality Index

HRQoL

health-related quality of life

HSD

half-standard dose

PASI

Psoriasis Area and Severity Index

PASI 75

at least 75% improvement in PASI

PASI 90

at least 90% improvement in PASI

PGA

Physician's Global Assessment

PGA 0/1

PGA of cleared (0) or minimal (1)

SAE

serious adverse event

standard dose

Cited by (0)

: Funding sources: This study (clnicaltrials.gov: NCT01090427) was sponsored by Janssen Research & Development, LLC.

: 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.