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

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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.

Section snippets

Procedures

Detailed methods and study design for EXPRESS have been reported elsewhere.10 Briefly, this phase III, randomized, double-blind, placebo-controlled study enrolled 378 patients with moderate to severe psoriasis. Eligible patients (ie, those with diagnosis for at least 6 months, PASI score ≥12, and psoriasis ≥ 10% of body surface area) were randomly assigned in a 4:1 ratio to receive either infliximab (Remicade, Centocor, Inc, Malvern, Pa) or placebo. Patients in the infliximab group were

Results

The mean percent improvement in NAPSI score from baseline for infliximab-treated patients was significantly greater than that for placebo-treated patients at week 10 (26.8% vs –7.7%; P < .001); this difference was more pronounced by week 24 (57.2% vs –4.1%; P < .001), indicating continued improvement. The mean percent improvement in NAPSI score from baseline to week 50 was 59.7% for the patients originally randomized to infliximab. These analyses of observed data were consistent with those

Discussion

We have documented in detail that, in addition to the significant efficacy in skin psoriasis shown in the EXPRESS trial,10 infliximab demonstrates efficacy with respect to improving nail psoriasis. Significant improvements were apparent in nail psoriasis features as early as week 10 in infliximab-treated patients compared with placebo. The percentage of treated patients with nail improvement continued to increase over time, and improvement was sustained in a high percentage of patients through

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    Supported by Centocor Inc, Malvern, Pa, and Schering-Plough, Kenilworth, NJ.

    Disclosure: Dr Rich has received advisory board honoraria from Abbott and investigator grants from Centocor, Wyeth, and Genentech. Dr Griffiths has received grants and/or honoraria as a speaker, investigator, and/or advisory member for Centocor, Wyeth, Schering-Plough, Serono, UCB, Abbott, Novartis, Galderma, Leo, and Novo Nordisk. Dr Reich has received honoraria as a consultant, investigator, speaker, and advisory board member for Centocor and Schering Plough. Dr Nestle has received honoraria as a consultant, speaker, and advisory board member for Centocor. Dr Scher has received honoraria as a consultant, advisory broad member, and/or speaker for Centocor, Stiefel Laboratories, Allergan, Galderma, Medicis, and Biovail. Dr Guzzo and Ms Li receive employee salaries and have received stock and stock options from Centocor. Dr Hsu and Mr Xu receive employee salaries from Centocor.

    Partially presented as an abstract and as a poster at the American Academy of Dermatology Annual Meeting, Washington, DC, February 2007 and at the American Academy of Dermatology Summer Meeting, San Diego, California, July 2006.

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