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A 24-week randomized clinical trial investigating the efficacy and safety of two doses of etanercept in nail psoriasis

Authors


  • Funding sources
    Wyeth Research, which was acquired by Pfizer in October 2009, sponsored this clinical trial and was responsible for the collection and analysis of data. Editorial/medical writing assistance was funded by Pfizer Inc.

  • Conflicts of interest J.P.O. has been an investigator or consultant for Schering-Plough, Abbott, Merck-Serono, Centocor, Pfizer, Janssen-Cilag, Meda-Pharma, Pierre-Fabre, Galderma and Leo-Pharma. C.P. has been an investigator or consultant for Abbott, Amgen, Celgene, Janssen Cilag, Leo Pharma, Novartis and Pfizer Inc. E.B. has no conflicts of interest. V.M., G.G., Y.B. and J.M.G. are employees of Pfizer Inc.

  • The study was registered at clinicaltrials.gov using the identifier: NCT00581100.

Jean-Paul Ortonne.
E-mail: ortonne@unice.fr

Summary

Background  Nail psoriasis is common in patients with psoriasis and can seriously affect their quality of life. Current treatments are limited and there is no standard course of therapy.

Objectives  To assess the efficacy and safety of etanercept (ETN) on nail psoriasis in patients with moderate-to-severe psoriasis.

Methods  Patients with moderate-to-severe plaque psoriasis, who had previously failed at least one form of systemic therapy for nail psoriasis, were randomized to receive open-label ETN 50 mg twice weekly (BIW) for 12 weeks followed by once weekly (QW) for 12 weeks (BIW/QW group) or ETN 50 mg QW for 24 weeks (QW/QW group). The primary endpoint was the mean improvement in the Nail Psoriasis Severity Index (NAPSI; score range 0–8) over 24 weeks in the target fingernail with the most severe abnormalities.

Results  Seventy-two patients received one or more doses of ETN (38 BIW/QW; 34 QW/QW) and 69 patients were included in the modified intent-to-treat population. At baseline, mean (standard error) target fingernail NAPSI score was 6·0 (0·3) in the BIW/QW group and 5·8 (0·3) in the QW/QW group. At week 24, mean target fingernail NAPSI score had decreased significantly by −4·3 [95% confidence interval (CI) −4·9 to −3·7; P < 0·0001] in the BIW/QW group and by −4·4 (95% CI −5·0 to −3·7; P < 0·0001) in the QW/QW group. Improvement in NAPSI showed significant correlation with Psoriasis Area and Severity Index improvement. ETN was well tolerated with no unexpected safety findings.

Conclusions  Both ETN regimens were effective at treating nail psoriasis in this patient population.

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