Long-term efficacy and safety results from an open-label phase III study (UNCOVER-J) in Japanese plaque psoriasis patients

impact of treatment withdrawal and retreatment of ixekizumab

the Japanese Ixekizumab Study Group

Research output: Contribution to journalArticle

2 Citations (Scopus)

Abstract

Background: Long-term management of moderate-to-severe psoriasis is usually discussed in terms of continuous administration; however, there are many situations in clinical practice where treatment may be withdrawn with subsequent retreatment. Objective: To assess the clinical course after ixekizumab treatment withdrawal and retreatment, as well as the effectiveness of ixekizumab retreatment, in Japanese patients with plaque psoriasis. Methods: This single-arm, open-label study (UNCOVER-J; NCT01624233) comprised 78 patients with plaque psoriasis. After ixekizumab treatment (160-mg loading dose, 80 mg every 2 weeks for the first 12 weeks, and then 80 mg every 4 weeks (IXE Q4W) until Week 52), 70 patients achieved a Psoriasis Area Severity Index (PASI)75 response at Week 52. These 70 patients withdrew from ixekizumab treatment from Weeks 52 to 100. Patients who relapsed (PASI ≤50) during the Treatment Withdrawal Period were retreated with IXE Q4W for 192 weeks. Results: At Weeks 52, 76 and 100, PASI75 response rates were 100%, 26% and 7%; PASI90 response rates were 87%, 11% and 3%; and PASI100 response rates were 53%, 0% and 0%. After treatment withdrawal, 87% of patients relapsed; median time to relapse was 143 days. After 12 weeks of retreatment with IXE Q4W, 83% of relapsed patients achieved PASI75, 68% achieved PASI90 and 25% achieved PASI100; improvements were maintained up to 120 weeks of retreatment. Treatment-emergent adverse events and serious adverse events were reported in 56% and 4% of patients during the Treatment Withdrawal Period, and in 88% and 14% of patients during the Retreatment Period. Conclusion: In patients withdrawn from ixekizumab after achieving PASI75, approximately half relapsed within 5 months of withdrawal; however, most patients recaptured response within 12 weeks, and response was maintained for up to 120 weeks of retreatment.

Original languageEnglish
Pages (from-to)568-576
Number of pages9
JournalJournal of the European Academy of Dermatology and Venereology
Volume33
Issue number3
DOIs
Publication statusPublished - 2019 Mar 1

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LY2439821
Retreatment
Psoriasis
Safety
Therapeutics

ASJC Scopus subject areas

  • Dermatology
  • Infectious Diseases

Cite this

@article{1daf9520af584195afcdf370e74b1f7d,
title = "Long-term efficacy and safety results from an open-label phase III study (UNCOVER-J) in Japanese plaque psoriasis patients: impact of treatment withdrawal and retreatment of ixekizumab",
abstract = "Background: Long-term management of moderate-to-severe psoriasis is usually discussed in terms of continuous administration; however, there are many situations in clinical practice where treatment may be withdrawn with subsequent retreatment. Objective: To assess the clinical course after ixekizumab treatment withdrawal and retreatment, as well as the effectiveness of ixekizumab retreatment, in Japanese patients with plaque psoriasis. Methods: This single-arm, open-label study (UNCOVER-J; NCT01624233) comprised 78 patients with plaque psoriasis. After ixekizumab treatment (160-mg loading dose, 80 mg every 2 weeks for the first 12 weeks, and then 80 mg every 4 weeks (IXE Q4W) until Week 52), 70 patients achieved a Psoriasis Area Severity Index (PASI)75 response at Week 52. These 70 patients withdrew from ixekizumab treatment from Weeks 52 to 100. Patients who relapsed (PASI ≤50) during the Treatment Withdrawal Period were retreated with IXE Q4W for 192 weeks. Results: At Weeks 52, 76 and 100, PASI75 response rates were 100{\%}, 26{\%} and 7{\%}; PASI90 response rates were 87{\%}, 11{\%} and 3{\%}; and PASI100 response rates were 53{\%}, 0{\%} and 0{\%}. After treatment withdrawal, 87{\%} of patients relapsed; median time to relapse was 143 days. After 12 weeks of retreatment with IXE Q4W, 83{\%} of relapsed patients achieved PASI75, 68{\%} achieved PASI90 and 25{\%} achieved PASI100; improvements were maintained up to 120 weeks of retreatment. Treatment-emergent adverse events and serious adverse events were reported in 56{\%} and 4{\%} of patients during the Treatment Withdrawal Period, and in 88{\%} and 14{\%} of patients during the Retreatment Period. Conclusion: In patients withdrawn from ixekizumab after achieving PASI75, approximately half relapsed within 5 months of withdrawal; however, most patients recaptured response within 12 weeks, and response was maintained for up to 120 weeks of retreatment.",
author = "{the Japanese Ixekizumab Study Group} and Y. Umezawa and H. Torisu-Itakura and Y. Morisaki and H. ElMaraghy and K. Nakajo and N. Akashi and H. Saeki and Toshihide Akasaka and Yoshihide Asano and Takafumi Etoh and Yasuyuki Fujita and Takashi Hashimoto and Mari Higashiyama and Atsuyuki Igarashi and Hironobu Ihn and Keiji Iwatsuki and Kenji Kabashima and Akira Kawada and Makoto Kawashima and Koichiro Nakamura and Yukari Okubo and Ryuhei Okuyama and Akira Ozawa and Koji Sayama and Mariko Seishima and Tetsuo Shiohara and Masakazu Takahara and Hidetoshi Takahashi and Kazuhiko Takehara and Keiji Tanese and Mamori Tani and Hideaki Watanabe and Keiichi Yamanaka",
year = "2019",
month = "3",
day = "1",
doi = "10.1111/jdv.15292",
language = "English",
volume = "33",
pages = "568--576",
journal = "Journal of the European Academy of Dermatology and Venereology",
issn = "0926-9959",
publisher = "Wiley-Blackwell",
number = "3",

}

TY - JOUR

T1 - Long-term efficacy and safety results from an open-label phase III study (UNCOVER-J) in Japanese plaque psoriasis patients

T2 - impact of treatment withdrawal and retreatment of ixekizumab

AU - the Japanese Ixekizumab Study Group

AU - Umezawa, Y.

AU - Torisu-Itakura, H.

AU - Morisaki, Y.

AU - ElMaraghy, H.

AU - Nakajo, K.

AU - Akashi, N.

AU - Saeki, H.

AU - Akasaka, Toshihide

AU - Asano, Yoshihide

AU - Etoh, Takafumi

AU - Fujita, Yasuyuki

AU - Hashimoto, Takashi

AU - Higashiyama, Mari

AU - Igarashi, Atsuyuki

AU - Ihn, Hironobu

AU - Iwatsuki, Keiji

AU - Kabashima, Kenji

AU - Kawada, Akira

AU - Kawashima, Makoto

AU - Nakamura, Koichiro

AU - Okubo, Yukari

AU - Okuyama, Ryuhei

AU - Ozawa, Akira

AU - Sayama, Koji

AU - Seishima, Mariko

AU - Shiohara, Tetsuo

AU - Takahara, Masakazu

AU - Takahashi, Hidetoshi

AU - Takehara, Kazuhiko

AU - Tanese, Keiji

AU - Tani, Mamori

AU - Watanabe, Hideaki

AU - Yamanaka, Keiichi

PY - 2019/3/1

Y1 - 2019/3/1

N2 - Background: Long-term management of moderate-to-severe psoriasis is usually discussed in terms of continuous administration; however, there are many situations in clinical practice where treatment may be withdrawn with subsequent retreatment. Objective: To assess the clinical course after ixekizumab treatment withdrawal and retreatment, as well as the effectiveness of ixekizumab retreatment, in Japanese patients with plaque psoriasis. Methods: This single-arm, open-label study (UNCOVER-J; NCT01624233) comprised 78 patients with plaque psoriasis. After ixekizumab treatment (160-mg loading dose, 80 mg every 2 weeks for the first 12 weeks, and then 80 mg every 4 weeks (IXE Q4W) until Week 52), 70 patients achieved a Psoriasis Area Severity Index (PASI)75 response at Week 52. These 70 patients withdrew from ixekizumab treatment from Weeks 52 to 100. Patients who relapsed (PASI ≤50) during the Treatment Withdrawal Period were retreated with IXE Q4W for 192 weeks. Results: At Weeks 52, 76 and 100, PASI75 response rates were 100%, 26% and 7%; PASI90 response rates were 87%, 11% and 3%; and PASI100 response rates were 53%, 0% and 0%. After treatment withdrawal, 87% of patients relapsed; median time to relapse was 143 days. After 12 weeks of retreatment with IXE Q4W, 83% of relapsed patients achieved PASI75, 68% achieved PASI90 and 25% achieved PASI100; improvements were maintained up to 120 weeks of retreatment. Treatment-emergent adverse events and serious adverse events were reported in 56% and 4% of patients during the Treatment Withdrawal Period, and in 88% and 14% of patients during the Retreatment Period. Conclusion: In patients withdrawn from ixekizumab after achieving PASI75, approximately half relapsed within 5 months of withdrawal; however, most patients recaptured response within 12 weeks, and response was maintained for up to 120 weeks of retreatment.

AB - Background: Long-term management of moderate-to-severe psoriasis is usually discussed in terms of continuous administration; however, there are many situations in clinical practice where treatment may be withdrawn with subsequent retreatment. Objective: To assess the clinical course after ixekizumab treatment withdrawal and retreatment, as well as the effectiveness of ixekizumab retreatment, in Japanese patients with plaque psoriasis. Methods: This single-arm, open-label study (UNCOVER-J; NCT01624233) comprised 78 patients with plaque psoriasis. After ixekizumab treatment (160-mg loading dose, 80 mg every 2 weeks for the first 12 weeks, and then 80 mg every 4 weeks (IXE Q4W) until Week 52), 70 patients achieved a Psoriasis Area Severity Index (PASI)75 response at Week 52. These 70 patients withdrew from ixekizumab treatment from Weeks 52 to 100. Patients who relapsed (PASI ≤50) during the Treatment Withdrawal Period were retreated with IXE Q4W for 192 weeks. Results: At Weeks 52, 76 and 100, PASI75 response rates were 100%, 26% and 7%; PASI90 response rates were 87%, 11% and 3%; and PASI100 response rates were 53%, 0% and 0%. After treatment withdrawal, 87% of patients relapsed; median time to relapse was 143 days. After 12 weeks of retreatment with IXE Q4W, 83% of relapsed patients achieved PASI75, 68% achieved PASI90 and 25% achieved PASI100; improvements were maintained up to 120 weeks of retreatment. Treatment-emergent adverse events and serious adverse events were reported in 56% and 4% of patients during the Treatment Withdrawal Period, and in 88% and 14% of patients during the Retreatment Period. Conclusion: In patients withdrawn from ixekizumab after achieving PASI75, approximately half relapsed within 5 months of withdrawal; however, most patients recaptured response within 12 weeks, and response was maintained for up to 120 weeks of retreatment.

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U2 - 10.1111/jdv.15292

DO - 10.1111/jdv.15292

M3 - Article

VL - 33

SP - 568

EP - 576

JO - Journal of the European Academy of Dermatology and Venereology

JF - Journal of the European Academy of Dermatology and Venereology

SN - 0926-9959

IS - 3

ER -