Journal
JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY
Volume 63, Issue 4, Pages 571-579Publisher
MOSBY-ELSEVIER
DOI: 10.1016/j.jaad.2009.11.012
Keywords
psoriasis; Psoriasis Area and Severity Index; serum concentration; ustekinumab; weight-based close
Categories
Funding
- Centocor Research & Development, Inc.
- Abbott Laboratories
- Abbott
- Amgen
- Biogen
- Centocor
- Novartis
- Wyeth
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Background: Patients with psoriasis tend to be overweight, and the efficacy of fixed-dose biologics may be compromised by high body weight. Objective: We sought to determine whether the optimal close of ustekinumab is affected by weight in patients with psoriasis. Methods: Patients were randomized in two phase III trials (PHOENIX 1 and 2) to receive 45 mg or 90 mg of ustekinumab every 12 weeks (n = 1331) or placebo with crossover to ustekinumab at week 12 (n = 665). Efficacy and serum ustekinumab concentrations were to be evaluated by 10-kg increments of body weight at week 28 (steady-state trough level). Results: Mean baseline weight was 93.9 and 91.0 kg in PHOENIX 1 and 2, respectively. Based on the analyses by 10-kg increments, a cutoff of 100 kg was determined to best differentiate the dose response. The proportion of patients with at least 75% improvement from baseline in Psoriasis Area and Severity Index score was 74.2% for 90 mg and 54.6% for 45 mg in heavier patients (>100 kg), but the proportion with a response of at least 75% improvement from baseline in Psoriasis Area and Severity Index score was similar between closes (80.8% vs 76.9%) in lighter patients (<= 100 kg). Serum ustekinumab concentrations were also affected by weight, with lower serum concentrations observed in heavier patients at each dose. Safety was not affected by weight. Limitations: Low numbers of patients at the extremes of body weight may limit the analyses of these subgroups. Conclusion: Results of weight-based analyses of clinical and pharmacokinetic data indicate that fixed dosing of ustekinumab based on weight is appropriate for the treatment of patients with psoriasis. Am Acad Dermatol 2010,63:571-9.)
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