Adalimumab for nail psoriasis

Efficacy and safety from the first 26 weeks of a phase 3, randomized, placebo-controlled trial

Boni E. Elewski, Martin M. Okun, Kim Papp, Christopher S. Baker, Jeffrey J. Crowley, Gérard Guillet, Murali Sundaram, Yves Poulin, Yihua Gu, Ziqian Geng, David A. Williams, Phoebe Rich

Research output: Contribution to journalArticle

11 Citations (Scopus)

Abstract

Background Previous clinical trials have not evaluated improvement in nail psoriasis as a primary end point. Objective This phase 3 trial evaluated the safety and efficacy of adalimumab in patients with moderate-to-severe fingernail psoriasis and moderate-to-severe plaque psoriasis. Methods Patients were randomized 1:1 to 40 mg adalimumab every other week or placebo. The primary efficacy end point was at least 75% improvement in total-fingernail modified Nail Psoriasis Severity Index (NAPSI75) response rate at week 26. Ranked secondary end point scores evaluated at week 26 were total-fingernail NAPSI and modified NAPSI, nail pain, Nail Psoriasis Physical Functioning Severity, Brigham Scalp Nail Inverse Palmo-Plantar Psoriasis Index, and Physician's Global Assessment (fingernail psoriasis). Results Of the 217 randomized patients (108 received placebo and 109 received adalimumab), 188 (86.6%) completed 26 weeks of treatment (period A) or escaped early to the open-label period. The study met the primary end point (response rate of 3.4% with placebo vs 46.6% with adalimumab [P <.001]) and all ranked secondary end points. The serious adverse event rates (placebo vs adalimumab) in period A were 4.6% versus 7.3%; the serious infections rates were 1.9% versus 3.7%. Limitations Patients with less than 5% BSA involvement were not eligible for enrollment. Conclusions After 26 weeks of adalimumab treatment, significant improvements were seen in the primary and all ranked secondary end points and in signs and symptoms of moderate-to-severe nail psoriasis versus with placebo and no new safety risks were identified.

Original languageEnglish (US)
Pages (from-to)90-99.e1
JournalJournal of the American Academy of Dermatology
Volume78
Issue number1
DOIs
StatePublished - Jan 1 2018

Fingerprint

Nails
Psoriasis
Randomized Controlled Trials
Placebos
Safety
Adalimumab
Scalp
Signs and Symptoms
Clinical Trials
Physicians
Pain
Therapeutics

Keywords

  • adalimumab
  • mNAPSI
  • nail pain
  • nail psoriasis
  • NAPSI
  • NPPFS
  • phase 3 placebo-control
  • skin psoriasis

ASJC Scopus subject areas

  • Dermatology

Cite this

Adalimumab for nail psoriasis : Efficacy and safety from the first 26 weeks of a phase 3, randomized, placebo-controlled trial. / Elewski, Boni E.; Okun, Martin M.; Papp, Kim; Baker, Christopher S.; Crowley, Jeffrey J.; Guillet, Gérard; Sundaram, Murali; Poulin, Yves; Gu, Yihua; Geng, Ziqian; Williams, David A.; Rich, Phoebe.

In: Journal of the American Academy of Dermatology, Vol. 78, No. 1, 01.01.2018, p. 90-99.e1.

Research output: Contribution to journalArticle

Elewski, BE, Okun, MM, Papp, K, Baker, CS, Crowley, JJ, Guillet, G, Sundaram, M, Poulin, Y, Gu, Y, Geng, Z, Williams, DA & Rich, P 2018, 'Adalimumab for nail psoriasis: Efficacy and safety from the first 26 weeks of a phase 3, randomized, placebo-controlled trial', Journal of the American Academy of Dermatology, vol. 78, no. 1, pp. 90-99.e1. https://doi.org/10.1016/j.jaad.2017.08.029
Elewski, Boni E. ; Okun, Martin M. ; Papp, Kim ; Baker, Christopher S. ; Crowley, Jeffrey J. ; Guillet, Gérard ; Sundaram, Murali ; Poulin, Yves ; Gu, Yihua ; Geng, Ziqian ; Williams, David A. ; Rich, Phoebe. / Adalimumab for nail psoriasis : Efficacy and safety from the first 26 weeks of a phase 3, randomized, placebo-controlled trial. In: Journal of the American Academy of Dermatology. 2018 ; Vol. 78, No. 1. pp. 90-99.e1.
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abstract = "Background Previous clinical trials have not evaluated improvement in nail psoriasis as a primary end point. Objective This phase 3 trial evaluated the safety and efficacy of adalimumab in patients with moderate-to-severe fingernail psoriasis and moderate-to-severe plaque psoriasis. Methods Patients were randomized 1:1 to 40 mg adalimumab every other week or placebo. The primary efficacy end point was at least 75{\%} improvement in total-fingernail modified Nail Psoriasis Severity Index (NAPSI75) response rate at week 26. Ranked secondary end point scores evaluated at week 26 were total-fingernail NAPSI and modified NAPSI, nail pain, Nail Psoriasis Physical Functioning Severity, Brigham Scalp Nail Inverse Palmo-Plantar Psoriasis Index, and Physician's Global Assessment (fingernail psoriasis). Results Of the 217 randomized patients (108 received placebo and 109 received adalimumab), 188 (86.6{\%}) completed 26 weeks of treatment (period A) or escaped early to the open-label period. The study met the primary end point (response rate of 3.4{\%} with placebo vs 46.6{\%} with adalimumab [P <.001]) and all ranked secondary end points. The serious adverse event rates (placebo vs adalimumab) in period A were 4.6{\%} versus 7.3{\%}; the serious infections rates were 1.9{\%} versus 3.7{\%}. Limitations Patients with less than 5{\%} BSA involvement were not eligible for enrollment. Conclusions After 26 weeks of adalimumab treatment, significant improvements were seen in the primary and all ranked secondary end points and in signs and symptoms of moderate-to-severe nail psoriasis versus with placebo and no new safety risks were identified.",
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AU - Okun, Martin M.

AU - Papp, Kim

AU - Baker, Christopher S.

AU - Crowley, Jeffrey J.

AU - Guillet, Gérard

AU - Sundaram, Murali

AU - Poulin, Yves

AU - Gu, Yihua

AU - Geng, Ziqian

AU - Williams, David A.

AU - Rich, Phoebe

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N2 - Background Previous clinical trials have not evaluated improvement in nail psoriasis as a primary end point. Objective This phase 3 trial evaluated the safety and efficacy of adalimumab in patients with moderate-to-severe fingernail psoriasis and moderate-to-severe plaque psoriasis. Methods Patients were randomized 1:1 to 40 mg adalimumab every other week or placebo. The primary efficacy end point was at least 75% improvement in total-fingernail modified Nail Psoriasis Severity Index (NAPSI75) response rate at week 26. Ranked secondary end point scores evaluated at week 26 were total-fingernail NAPSI and modified NAPSI, nail pain, Nail Psoriasis Physical Functioning Severity, Brigham Scalp Nail Inverse Palmo-Plantar Psoriasis Index, and Physician's Global Assessment (fingernail psoriasis). Results Of the 217 randomized patients (108 received placebo and 109 received adalimumab), 188 (86.6%) completed 26 weeks of treatment (period A) or escaped early to the open-label period. The study met the primary end point (response rate of 3.4% with placebo vs 46.6% with adalimumab [P <.001]) and all ranked secondary end points. The serious adverse event rates (placebo vs adalimumab) in period A were 4.6% versus 7.3%; the serious infections rates were 1.9% versus 3.7%. Limitations Patients with less than 5% BSA involvement were not eligible for enrollment. Conclusions After 26 weeks of adalimumab treatment, significant improvements were seen in the primary and all ranked secondary end points and in signs and symptoms of moderate-to-severe nail psoriasis versus with placebo and no new safety risks were identified.

AB - Background Previous clinical trials have not evaluated improvement in nail psoriasis as a primary end point. Objective This phase 3 trial evaluated the safety and efficacy of adalimumab in patients with moderate-to-severe fingernail psoriasis and moderate-to-severe plaque psoriasis. Methods Patients were randomized 1:1 to 40 mg adalimumab every other week or placebo. The primary efficacy end point was at least 75% improvement in total-fingernail modified Nail Psoriasis Severity Index (NAPSI75) response rate at week 26. Ranked secondary end point scores evaluated at week 26 were total-fingernail NAPSI and modified NAPSI, nail pain, Nail Psoriasis Physical Functioning Severity, Brigham Scalp Nail Inverse Palmo-Plantar Psoriasis Index, and Physician's Global Assessment (fingernail psoriasis). Results Of the 217 randomized patients (108 received placebo and 109 received adalimumab), 188 (86.6%) completed 26 weeks of treatment (period A) or escaped early to the open-label period. The study met the primary end point (response rate of 3.4% with placebo vs 46.6% with adalimumab [P <.001]) and all ranked secondary end points. The serious adverse event rates (placebo vs adalimumab) in period A were 4.6% versus 7.3%; the serious infections rates were 1.9% versus 3.7%. Limitations Patients with less than 5% BSA involvement were not eligible for enrollment. Conclusions After 26 weeks of adalimumab treatment, significant improvements were seen in the primary and all ranked secondary end points and in signs and symptoms of moderate-to-severe nail psoriasis versus with placebo and no new safety risks were identified.

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KW - skin psoriasis

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