Impact of Ixekizumab Treatment on Itch and Psoriasis Area and Severity Index in Patients with Moderate-to-Severe Plaque Psoriasis: An Integrated Analysis of Two Phase III Randomized Studies

Gil Yosipovitch, Adam Reich, Martin Steinhoff, Anke Beselin, Toby Kent, Martin Dossenbach, Lovisa Berggren, Carsten Henneges, Thomas Luger

Research output: Contribution to journalArticle

Abstract

Introduction: We evaluated baseline itch and its impact on the efficacy of ixekizumab (IXE) in clearing psoriasis and improving quality-of-life measures, and we explored the relationship between itch and psoriatic skin improvement. Methods: Data were analyzed from two double-blind, randomized, controlled phase III studies (UNCOVER-2/3) comparing etanercept (ETN), IXE, and placebo (PBO) in patients with moderate-to-severe plaque psoriasis. Long-term analysis included UNCOVER-3 data from week 0 to week 156. Results: At week 12, a clinically meaningful improvement in itch [Itch Numeric Rating Scale (NRS) reduction ≥ 4] was seen in 70.0%, 88.6%, and 90.8% of the IXE-treated patients in the baseline Itch NRS 4–6, 7–8, and 9–10 groups, respectively (all itch severity groups p < 0.001 versus ETN and PBO). Also, 68.9%, 67.1%, and 73.6% of the IXE-treated patients in the baseline Itch NRS 4–6, 7–8, and 9–10 groups, respectively, showed an improvement of ≥ 90.0% in the Psoriatic Area and Severity Index (PASI) at week 12 as compared to the baseline (PASI 90) (all itch severity groups p < 0.001 versus ETN and PBO). For most patients, itch reduction preceded psoriatic plaque improvement. Sustained effects of IXE on itch and PASI were observed during 3 years of treatment. Conclusions: Regardless of baseline itch severity, IXE treatment provided a rapid improvement in itch followed by clinically meaningful improvements in psoriasis. Funding: Eli Lilly and Company. Trial registration: ClinicalTrials.gov identifiers, NCT01597245 and NCT01646177.

Original languageEnglish (US)
Pages (from-to)621-637
Number of pages17
JournalDermatology and Therapy
Volume8
Issue number4
DOIs
StatePublished - Dec 1 2018

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Psoriasis
Placebos
Therapeutics
Quality of Life

Keywords

  • IL-17A
  • Itch
  • Ixekizumab
  • Psoriasis

ASJC Scopus subject areas

  • Dermatology

Cite this

Impact of Ixekizumab Treatment on Itch and Psoriasis Area and Severity Index in Patients with Moderate-to-Severe Plaque Psoriasis : An Integrated Analysis of Two Phase III Randomized Studies. / Yosipovitch, Gil; Reich, Adam; Steinhoff, Martin; Beselin, Anke; Kent, Toby; Dossenbach, Martin; Berggren, Lovisa; Henneges, Carsten; Luger, Thomas.

In: Dermatology and Therapy, Vol. 8, No. 4, 01.12.2018, p. 621-637.

Research output: Contribution to journalArticle

Yosipovitch, Gil ; Reich, Adam ; Steinhoff, Martin ; Beselin, Anke ; Kent, Toby ; Dossenbach, Martin ; Berggren, Lovisa ; Henneges, Carsten ; Luger, Thomas. / Impact of Ixekizumab Treatment on Itch and Psoriasis Area and Severity Index in Patients with Moderate-to-Severe Plaque Psoriasis : An Integrated Analysis of Two Phase III Randomized Studies. In: Dermatology and Therapy. 2018 ; Vol. 8, No. 4. pp. 621-637.
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abstract = "Introduction: We evaluated baseline itch and its impact on the efficacy of ixekizumab (IXE) in clearing psoriasis and improving quality-of-life measures, and we explored the relationship between itch and psoriatic skin improvement. Methods: Data were analyzed from two double-blind, randomized, controlled phase III studies (UNCOVER-2/3) comparing etanercept (ETN), IXE, and placebo (PBO) in patients with moderate-to-severe plaque psoriasis. Long-term analysis included UNCOVER-3 data from week 0 to week 156. Results: At week 12, a clinically meaningful improvement in itch [Itch Numeric Rating Scale (NRS) reduction ≥ 4] was seen in 70.0{\%}, 88.6{\%}, and 90.8{\%} of the IXE-treated patients in the baseline Itch NRS 4–6, 7–8, and 9–10 groups, respectively (all itch severity groups p < 0.001 versus ETN and PBO). Also, 68.9{\%}, 67.1{\%}, and 73.6{\%} of the IXE-treated patients in the baseline Itch NRS 4–6, 7–8, and 9–10 groups, respectively, showed an improvement of ≥ 90.0{\%} in the Psoriatic Area and Severity Index (PASI) at week 12 as compared to the baseline (PASI 90) (all itch severity groups p < 0.001 versus ETN and PBO). For most patients, itch reduction preceded psoriatic plaque improvement. Sustained effects of IXE on itch and PASI were observed during 3 years of treatment. Conclusions: Regardless of baseline itch severity, IXE treatment provided a rapid improvement in itch followed by clinically meaningful improvements in psoriasis. Funding: Eli Lilly and Company. Trial registration: ClinicalTrials.gov identifiers, NCT01597245 and NCT01646177.",
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T1 - Impact of Ixekizumab Treatment on Itch and Psoriasis Area and Severity Index in Patients with Moderate-to-Severe Plaque Psoriasis

T2 - An Integrated Analysis of Two Phase III Randomized Studies

AU - Yosipovitch, Gil

AU - Reich, Adam

AU - Steinhoff, Martin

AU - Beselin, Anke

AU - Kent, Toby

AU - Dossenbach, Martin

AU - Berggren, Lovisa

AU - Henneges, Carsten

AU - Luger, Thomas

PY - 2018/12/1

Y1 - 2018/12/1

N2 - Introduction: We evaluated baseline itch and its impact on the efficacy of ixekizumab (IXE) in clearing psoriasis and improving quality-of-life measures, and we explored the relationship between itch and psoriatic skin improvement. Methods: Data were analyzed from two double-blind, randomized, controlled phase III studies (UNCOVER-2/3) comparing etanercept (ETN), IXE, and placebo (PBO) in patients with moderate-to-severe plaque psoriasis. Long-term analysis included UNCOVER-3 data from week 0 to week 156. Results: At week 12, a clinically meaningful improvement in itch [Itch Numeric Rating Scale (NRS) reduction ≥ 4] was seen in 70.0%, 88.6%, and 90.8% of the IXE-treated patients in the baseline Itch NRS 4–6, 7–8, and 9–10 groups, respectively (all itch severity groups p < 0.001 versus ETN and PBO). Also, 68.9%, 67.1%, and 73.6% of the IXE-treated patients in the baseline Itch NRS 4–6, 7–8, and 9–10 groups, respectively, showed an improvement of ≥ 90.0% in the Psoriatic Area and Severity Index (PASI) at week 12 as compared to the baseline (PASI 90) (all itch severity groups p < 0.001 versus ETN and PBO). For most patients, itch reduction preceded psoriatic plaque improvement. Sustained effects of IXE on itch and PASI were observed during 3 years of treatment. Conclusions: Regardless of baseline itch severity, IXE treatment provided a rapid improvement in itch followed by clinically meaningful improvements in psoriasis. Funding: Eli Lilly and Company. Trial registration: ClinicalTrials.gov identifiers, NCT01597245 and NCT01646177.

AB - Introduction: We evaluated baseline itch and its impact on the efficacy of ixekizumab (IXE) in clearing psoriasis and improving quality-of-life measures, and we explored the relationship between itch and psoriatic skin improvement. Methods: Data were analyzed from two double-blind, randomized, controlled phase III studies (UNCOVER-2/3) comparing etanercept (ETN), IXE, and placebo (PBO) in patients with moderate-to-severe plaque psoriasis. Long-term analysis included UNCOVER-3 data from week 0 to week 156. Results: At week 12, a clinically meaningful improvement in itch [Itch Numeric Rating Scale (NRS) reduction ≥ 4] was seen in 70.0%, 88.6%, and 90.8% of the IXE-treated patients in the baseline Itch NRS 4–6, 7–8, and 9–10 groups, respectively (all itch severity groups p < 0.001 versus ETN and PBO). Also, 68.9%, 67.1%, and 73.6% of the IXE-treated patients in the baseline Itch NRS 4–6, 7–8, and 9–10 groups, respectively, showed an improvement of ≥ 90.0% in the Psoriatic Area and Severity Index (PASI) at week 12 as compared to the baseline (PASI 90) (all itch severity groups p < 0.001 versus ETN and PBO). For most patients, itch reduction preceded psoriatic plaque improvement. Sustained effects of IXE on itch and PASI were observed during 3 years of treatment. Conclusions: Regardless of baseline itch severity, IXE treatment provided a rapid improvement in itch followed by clinically meaningful improvements in psoriasis. Funding: Eli Lilly and Company. Trial registration: ClinicalTrials.gov identifiers, NCT01597245 and NCT01646177.

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