Investigator-initiated, open-label trial of ustekinumab for the treatment of moderate-to-severe palmoplantar psoriasis
Autor: | Eva M. Volf, Melissa A Michelon, Noori Kim, Andrew C. Wang, Paul F. Lizzul, Israel D. Andrews, Ari M. Goldminz, Shimrat Yaniv, Todd Kerensky, Meghan T. Hession, Alice B. Gottlieb, Nicole Dumont, Shiu-chung Au |
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Rok vydání: | 2012 |
Předmět: |
Moderate to severe
Adult Male medicine.medical_specialty Palmoplantar pustulosis Dermatology Antibodies Monoclonal Humanized Interleukin-23 Drug Administration Schedule Quality of life Psoriasis Ustekinumab medicine Clinical endpoint Humans Dosing business.industry Middle Aged medicine.disease Interleukin-12 Treatment Outcome Quality of Life Palmoplantar psoriasis Female Dermatologic Agents business medicine.drug |
Zdroj: | The Journal of dermatological treatment. 24(3) |
ISSN: | 1471-1753 |
Popis: | Palmoplantar psoriasis is a variant of psoriasis resistant to many forms of treatment.Twenty subjects with moderate-to-severe psoriasis of the palms and soles, 50% with pustules at baseline, were treated with ustekinumab at weeks 0, 4, and 16. All subjects had previously failed topical corticosteroids. Dosing was 45 mg subcutaneously for subjects weighing100 kg and 90 mg for subjects weighing ≥100 kg. The primary endpoint was the percent of subjects achieving clinical clearance at week 16, defined as Palm-Sole Physician's Global Assessment ≤1. The study received Tufts Medical Center IRB approval.After 16 weeks of treatment, 35% (7/20) of subjects achieved clinical clearance. Sixty percent (12/20) improved two or more points on the Palm-Sole Physician's Global Assessment scale. Sixty-seven percent (6/9) of those receiving the 90 mg ustekinumab dose achieved clinical clearance compared with nine percent (1/11) receiving 45 mg (p = 0.02). At 24 weeks, mean values showed 56% improvement in Dermatology Life Quality Index, and 34% improvement in pain Visual Analogue Scale score (all p0.05).Assessment tools for palmoplantar psoriasis are not yet validated. Five subjects withdrew or were lost to follow-up.This study demonstrates that ustekinumab dosed at 90 mg is effective in controlling signs and symptoms of palmoplantar psoriasis. |
Databáze: | OpenAIRE |
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