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

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.

Key words::

• IL-12/23 inhibitor
• biologics
• palmoplantar hyperkeratotic psoriasis
• palmoplantar pustulosis
• psoriasis of the palms and soles
• plaque-type psoriasis

Declaration of interest: This investigator-initiated project was funded by a grant from Janssen Inc. The senior author currently has consulting/advisory board agreements with the following: Abbott Laboratories, Actelion, Amgen, Beiersdorf, Inc., Astellas Pharma US Inc, Novartis, Canfite, Celgene Corporation, Janssen Biotech Inc., DermiPsor, Incyte Corporation, Merck & Co. Inc., Novo Nordisk A/S, Pfizer Inc., and UCB. The senior author is the principal investigator for research/educational grants awarded to Tufts Medical Center from Abbott Laboratories, Amgen, Celgene, Janssen Biotech Inc., Immune Control, Novo Nordisk A/S, Pfizer, Novartis and UCB. One author is an investigator with the following: Abbott Laboratories, Janssen Biotech Inc., Celgene Corporation, Pfizer Inc., Novartis Inc.