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

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.

• Authors: Ian Landells, Colleen Marano, Ming-Chun Hsu, Shu Li, Yaowei Zhu, Lawrence F Eichenfield, Peter H Hoeger, Alan Menter, Amy S Paller, Alain Taieb, Sandra Philipp, Philippe Szapary, Bruce Randazzo
• Journal: Journal of the American Academy of Dermatology (J Am Acad Dermatol) Vol. 73 Issue 4 Pg. 594-603 (Oct 2015) ISSN: 1097-6787 [Electronic] United States
• PMID: 26259989 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2015 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.

Chemical References

• Antibodies, Monoclonal
• Ustekinumab

Topics

• Adolescent
• Age Factors
• Antibodies, Monoclonal (administration & dosage)
• Child
• Dose-Response Relationship, Drug
• Double-Blind Method
• Drug Administration Schedule
• Female
• Follow-Up Studies
• Humans
• Injections, Subcutaneous
• Male
• Psoriasis (diagnosis, drug therapy)
• Risk Assessment
• Severity of Illness Index
• Treatment Outcome
• Ustekinumab (administration & dosage)