Investigator-initiated, open-label trial of ustekinumab for the treatment of moderate-to-severe palmoplantar psoriasis

• Published in: The Journal of dermatological treatment Vol. 24; no. 3; pp. 179 - 187
• Main Authors: Au, Shiu-Chung, Goldminz, Ari M., Kim, Noori, Dumont, Nicole, Michelon, Melissa, Volf, Eva, Hession, Meghan, Lizzul, Paul F., Andrews, Israel D., Kerensky, Todd, Wang, Andrew, Yaniv, Shimrat, Gottlieb, Alice B.
• Format: Journal Article
• Language: English
• Published: Oslo Informa Healthcare USA on behalf of Informa UK Ltd 01-06-2013; Taylor & Francis
• Subjects: Adult; Antibodies, Monoclonal, Humanized - administration & dosage; Antibodies, Monoclonal, Humanized - therapeutic use; Biological and medical sciences; biologics; Bullous diseases of the skin; Dermatologic Agents - administration & dosage; Dermatologic Agents - therapeutic use; Dermatology; Drug Administration Schedule; Dyskeratosis; Female; Humans; IL-12/23 inhibitor; Interleukin-12 - antagonists & inhibitors; Interleukin-23 - antagonists & inhibitors; Male; Medical sciences; Middle Aged; palmoplantar hyperkeratotic psoriasis; palmoplantar pustulosis; plaque-type psoriasis; Psoriasis - drug therapy; Psoriasis - immunology; psoriasis of the palms and soles; Psoriasis. Parapsoriasis. Lichen; Quality of Life; Treatment Outcome; Ustekinumab; Palmoplantaris pustulosis; Dyskeratosis; Skin disease; palmoplantar hyperkeratotic psoriasis; Psoriasis; biologics; Pustulosis dermatosis; Palmoplantaris; Antipsoriatic agent; Hyperkeratosis; Ustekinumab; Interleukin 12; Monoclonal antibody; Investigator; Immunomodulator; palmoplantar pustulosis; Treatment; plaque-type psoriasis; psoriasis of the palms and soles; IL-12/23 inhibitor; Clinical trial; Inhibitor; Severe
• ISSN: 0954-6634; 1471-1753
• DOI: 10.3109/09546634.2012.672710

Abstract
Background: Palmoplantar psoriasis is a variant of psoriasis resistant to many forms of treatment. Methods: 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 weighing <100 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. Results: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 p < 0.05). Limitations: Assessment tools for palmoplantar psoriasis are not yet validated. Five subjects withdrew or were lost to follow-up. Conclusion: This study demonstrates that ustekinumab dosed at 90 mg is effective in controlling signs and symptoms of palmoplantar psoriasis.