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

J. P. Ortonne, C. Paul, E. Berardesca, V. Marino, G. Gallo, Y. Brault, J. M. Germain

Research output: Contribution to journalArticle

Abstract

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.

Original languageEnglish
Pages (from-to)1080-1087
Number of pages8
JournalBritish Journal of Dermatology
Volume168
Issue number5
DOIs
Publication statusPublished - May 2013

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Nails
Psoriasis
Randomized Controlled Trials
Safety
Confidence Intervals
Etanercept
Population
Therapeutics
Quality of Life

ASJC Scopus subject areas

  • Dermatology

Cite this

Ortonne, J. P., Paul, C., Berardesca, E., Marino, V., Gallo, G., Brault, Y., & Germain, J. M. (2013). A 24-week randomized clinical trial investigating the efficacy and safety of two doses of etanercept in nail psoriasis. British Journal of Dermatology, 168(5), 1080-1087. https://doi.org/10.1111/bjd.12060

A 24-week randomized clinical trial investigating the efficacy and safety of two doses of etanercept in nail psoriasis. / Ortonne, J. P.; Paul, C.; Berardesca, E.; Marino, V.; Gallo, G.; Brault, Y.; Germain, J. M.

In: British Journal of Dermatology, Vol. 168, No. 5, 05.2013, p. 1080-1087.

Research output: Contribution to journalArticle

Ortonne, JP, Paul, C, Berardesca, E, Marino, V, Gallo, G, Brault, Y & Germain, JM 2013, 'A 24-week randomized clinical trial investigating the efficacy and safety of two doses of etanercept in nail psoriasis', British Journal of Dermatology, vol. 168, no. 5, pp. 1080-1087. https://doi.org/10.1111/bjd.12060
Ortonne, J. P. ; Paul, C. ; Berardesca, E. ; Marino, V. ; Gallo, G. ; Brault, Y. ; Germain, J. M. / A 24-week randomized clinical trial investigating the efficacy and safety of two doses of etanercept in nail psoriasis. In: British Journal of Dermatology. 2013 ; Vol. 168, No. 5. pp. 1080-1087.
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AU - Paul, C.

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AU - Gallo, G.

AU - Brault, Y.

AU - Germain, J. M.

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N2 - 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.

AB - 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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