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Baseline nail disease in patients with moderate to severe psoriasis and response to treatment with infliximab during 1 year.

Author(s): Rich P, Griffiths CE, Reich K, Nestle FO, Scher RK, Li S, Xu S, Hsu MC, Guzzo C

Affiliation(s): Oregon Health Sciences University, Dermatology and Clinical Research, Portland, Oregon 97210, USA. phoeberich@aol.com

Publication date & source: 2008-02, J Am Acad Dermatol., 58(2):224-31. Epub 2007 Dec 20.

Publication type: Clinical Trial, Phase III; Randomized Controlled Trial; Research Support, Non-U.S. Gov't

BACKGROUND: Although nail psoriasis occurs frequently in patients with psoriatic skin lesions, effective treatments are limited. OBJECTIVE: Occurrence of nail psoriasis by type and incidence of nail clearance using the Nail Psoriasis Severity Index were evaluated. METHODS: This was a 50-week, phase III study in which 378 patients with moderate to severe psoriasis were randomized 4:1 to infliximab (5 mg/kg) or placebo at weeks 0, 2, 6, and every 8 weeks through week 46, with placebo crossover to infliximab at week 24. RESULTS: Of the 373 evaluated patients, 305 (81.8%) had baseline nail psoriasis. The right thumbnail was most often the worst involved nail, and pitting and onycholysis were the most common lesions. Among patients with baseline nail psoriasis, 6.9%, 26.2%, and 44.7% in the infliximab group had nail disease clearance at weeks 10, 24, and 50, respectively, versus 5.1% in the placebo group at week 24 (P < .001). Mean percent improvements in Nail Psoriasis Severity Index score at weeks 10 and 24 were 26.8% and 57.2%, respectively, in the infliximab group versus -7.7% and -4.1%, respectively, in the placebo group (both P < .001). At week 24, mean percent improvements in nail matrix and nail bed features were 52.9% and 69.2%, respectively (vs -1.9% and 18.4% for placebo; P < .001). LIMITATIONS: The study did not evaluate nail response beyond 1 year. CONCLUSIONS: Patients with psoriasis receiving infliximab experienced marked and sustained nail improvement.

Page last updated: 2008-03-26

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