Ian Landells1, Colleen Marano2, Ming-Chun Hsu2, Shu Li2, Yaowei Zhu2, Lawrence F Eichenfield3, Peter H Hoeger4, Alan Menter5, Amy S Paller6, Alain Taieb7, Sandra Philipp8, Philippe Szapary2, Bruce Randazzo9. 1. Memorial University of Newfoundland, St. Johns, Newfoundland, Canada. Electronic address: landells@nexusresearch.com. 2. Janssen Research & Development, LLC., Spring House, Pennsylvania. 3. University of California, San Diego, California. 4. University of Hamburg and Catholic Children's Hospital, Hamburg, Germany. 5. Baylor University Medical Center and Texas A&M Health Science Center School of Medicine, Dallas, Texas. 6. Northwestern University Feinberg School of Medicine, Chicago, Illinois. 7. Bordeaux University Hospitals, University of Bordeaux, Bordeaux, France. 8. Department of Dermatology and Allergy, Charité Universitätsmedizin Berlin, Germany. 9. Janssen Research & Development, LLC., Spring House, Pennsylvania; Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.
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 age12 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.
RCT Entities:
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 ustekinumabSD 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 ustekinumabHSD 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 HSDpatients, and 44.4% of SDpatients 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: Julie J Hong; Edward K Hadeler; Megan L Mosca; Nicholas D Brownstone; Tina Bhutani; Wilson J Liao Journal: J Psoriasis Psoriatic Arthritis Date: 2022-01-12
Authors: Inge M G J Bronckers; Marieke M B Seyger; Dennis P West; Irene Lara-Corrales; Megha Tollefson; Wynnis L Tom; Marcia Hogeling; Leah Belazarian; Claus Zachariae; Emmanuel Mahé; Elaine Siegfried; Sandra Philipp; Zsuzsanna Szalai; Ruth Ann Vleugels; Kristen Holland; Ruth Murphy; Eulalia Baselga; Kelly Cordoro; Jo Lambert; Alex Alexopoulos; Ulrich Mrowietz; Wietske Kievit; Amy S Paller Journal: JAMA Dermatol Date: 2017-11-01 Impact factor: 10.282