Efficacy and safety of ixekizumab treatment for Japanese patients with moderate to severe plaque psoriasis, erythrodermic psoriasis and generalized pustular psoriasis: Results from a 52-week, open-label, phase 3 study (UNCOVER-J)

Hidehisa Saeki, Hidemi Nakagawa, Ko Nakajo, Taeko Ishii, Yoji Morisaki, Takehiro Aoki, Gregory S. Cameron, Olawale O. Osuntokun, Toshihide Akasaka, Yoshihide Asano, Takafumi Etoh, Yasuyuki Fujita, Takashi Hashimoto, Mari Higashiyama, Atsuyuki Igarashi, Hironobu Ihn, Keiji Iwatsuki, Kenji Kabashima, Akira Kawada, Makoto KawashimaKoichiro Nakamura, Yukari Okubo, Ryuhei Okuyama, Akira Ozawa, Koji Sayama, Mariko Seishima, Tetsuo Shiohara, Masakazu Takahara, Hidetoshi Takahashi, Kazuhiko Takehara, Keiji Tanese, Mamori Tani, Yoshinori Umezawa, Hideaki Watanabe, Keiichi Yamanaka, the Japanese Ixekizumab Study Group

Research output: Contribution to journalArticle

41 Citations (Scopus)

Abstract

Psoriasis, a chronic, immune-mediated skin disease characterized by red, scaly plaques, affects approximately 0.3% of the population in Japan. The aim of this open-label study was to evaluate the long-term efficacy and safety of ixekizumab, a humanized, anti-interleukin-17A monoclonal antibody, in Japanese patients with plaque psoriasis (n = 78, including 11 psoriatic arthritis), erythrodermic psoriasis (n = 8) and generalized pustular psoriasis (n = 5). Ixekizumab was administrated s.c. at baseline (week 0, 160 mg), from weeks 2 to 12 (80 mg every 2 weeks), and from weeks 16 to 52 (80 mg every 4 weeks). At week 52, 92.3% of patients with plaque psoriasis achieved Psoriasis Area and Severity Index (PASI) 75, 80.8% achieved PASI 90, 48.7% achieved PASI 100, and 52.6% had remission of plaques (by static Physician Global Assessment, sPGA [0]). Difficult to treat areas of psoriasis (nail or scalp) also responded to ixekizumab. All patients with psoriatic arthritis who were assessed (5/5) achieved an American College of Rheumatology 20 response. Most patients with erythrodermic psoriasis or generalized pustular psoriasis responded to ixekizumab and the clinical outcome was maintained over 52 weeks (75% and 60% of patients achieved sPGA [0, 1] at week 52, respectively). Mostly mild or moderate treatment-emergent adverse events were reported by 79 of 91 patients; the most common were nasopharyngitis, eczema, seborrheic dermatitis, urticaria and injection site reactions. In conclusion, 52-week ixekizumab treatment was efficacious and well tolerated in Japanese patients with plaque psoriasis. Efficacy was also observed in patients with erythrodermic psoriasis, generalized pustular psoriasis and psoriatic arthritis.

Original languageEnglish
Pages (from-to)355-362
Number of pages8
JournalJournal of Dermatology
Volume44
Issue number4
DOIs
Publication statusPublished - Apr 1 2017

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LY2439821
Psoriasis
Safety
Therapeutics
Psoriatic Arthritis
Nasopharyngitis

Keywords

  • erythrodermic psoriasis
  • generalized pustular psoriasis
  • ixekizumab
  • Japan
  • plaque psoriasis

ASJC Scopus subject areas

  • Dermatology

Cite this

Efficacy and safety of ixekizumab treatment for Japanese patients with moderate to severe plaque psoriasis, erythrodermic psoriasis and generalized pustular psoriasis : Results from a 52-week, open-label, phase 3 study (UNCOVER-J). / Saeki, Hidehisa; Nakagawa, Hidemi; Nakajo, Ko; Ishii, Taeko; Morisaki, Yoji; Aoki, Takehiro; Cameron, Gregory S.; Osuntokun, Olawale O.; Akasaka, Toshihide; Asano, Yoshihide; Etoh, Takafumi; Fujita, Yasuyuki; Hashimoto, Takashi; Higashiyama, Mari; Igarashi, Atsuyuki; Ihn, Hironobu; Iwatsuki, Keiji; Kabashima, Kenji; Kawada, Akira; Kawashima, Makoto; Nakamura, Koichiro; Okubo, Yukari; Okuyama, Ryuhei; Ozawa, Akira; Sayama, Koji; Seishima, Mariko; Shiohara, Tetsuo; Takahara, Masakazu; Takahashi, Hidetoshi; Takehara, Kazuhiko; Tanese, Keiji; Tani, Mamori; Umezawa, Yoshinori; Watanabe, Hideaki; Yamanaka, Keiichi; the Japanese Ixekizumab Study Group.

In: Journal of Dermatology, Vol. 44, No. 4, 01.04.2017, p. 355-362.

Research output: Contribution to journalArticle

Saeki, H, Nakagawa, H, Nakajo, K, Ishii, T, Morisaki, Y, Aoki, T, Cameron, GS, Osuntokun, OO, Akasaka, T, Asano, Y, Etoh, T, Fujita, Y, Hashimoto, T, Higashiyama, M, Igarashi, A, Ihn, H, Iwatsuki, K, Kabashima, K, Kawada, A, Kawashima, M, Nakamura, K, Okubo, Y, Okuyama, R, Ozawa, A, Sayama, K, Seishima, M, Shiohara, T, Takahara, M, Takahashi, H, Takehara, K, Tanese, K, Tani, M, Umezawa, Y, Watanabe, H, Yamanaka, K & the Japanese Ixekizumab Study Group 2017, 'Efficacy and safety of ixekizumab treatment for Japanese patients with moderate to severe plaque psoriasis, erythrodermic psoriasis and generalized pustular psoriasis: Results from a 52-week, open-label, phase 3 study (UNCOVER-J)', Journal of Dermatology, vol. 44, no. 4, pp. 355-362. https://doi.org/10.1111/1346-8138.13622
Saeki, Hidehisa ; Nakagawa, Hidemi ; Nakajo, Ko ; Ishii, Taeko ; Morisaki, Yoji ; Aoki, Takehiro ; Cameron, Gregory S. ; Osuntokun, Olawale O. ; Akasaka, Toshihide ; Asano, Yoshihide ; Etoh, Takafumi ; Fujita, Yasuyuki ; Hashimoto, Takashi ; Higashiyama, Mari ; Igarashi, Atsuyuki ; Ihn, Hironobu ; Iwatsuki, Keiji ; Kabashima, Kenji ; Kawada, Akira ; Kawashima, Makoto ; Nakamura, Koichiro ; Okubo, Yukari ; Okuyama, Ryuhei ; Ozawa, Akira ; Sayama, Koji ; Seishima, Mariko ; Shiohara, Tetsuo ; Takahara, Masakazu ; Takahashi, Hidetoshi ; Takehara, Kazuhiko ; Tanese, Keiji ; Tani, Mamori ; Umezawa, Yoshinori ; Watanabe, Hideaki ; Yamanaka, Keiichi ; the Japanese Ixekizumab Study Group. / Efficacy and safety of ixekizumab treatment for Japanese patients with moderate to severe plaque psoriasis, erythrodermic psoriasis and generalized pustular psoriasis : Results from a 52-week, open-label, phase 3 study (UNCOVER-J). In: Journal of Dermatology. 2017 ; Vol. 44, No. 4. pp. 355-362.
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abstract = "Psoriasis, a chronic, immune-mediated skin disease characterized by red, scaly plaques, affects approximately 0.3{\%} of the population in Japan. The aim of this open-label study was to evaluate the long-term efficacy and safety of ixekizumab, a humanized, anti-interleukin-17A monoclonal antibody, in Japanese patients with plaque psoriasis (n = 78, including 11 psoriatic arthritis), erythrodermic psoriasis (n = 8) and generalized pustular psoriasis (n = 5). Ixekizumab was administrated s.c. at baseline (week 0, 160 mg), from weeks 2 to 12 (80 mg every 2 weeks), and from weeks 16 to 52 (80 mg every 4 weeks). At week 52, 92.3{\%} of patients with plaque psoriasis achieved Psoriasis Area and Severity Index (PASI) 75, 80.8{\%} achieved PASI 90, 48.7{\%} achieved PASI 100, and 52.6{\%} had remission of plaques (by static Physician Global Assessment, sPGA [0]). Difficult to treat areas of psoriasis (nail or scalp) also responded to ixekizumab. All patients with psoriatic arthritis who were assessed (5/5) achieved an American College of Rheumatology 20 response. Most patients with erythrodermic psoriasis or generalized pustular psoriasis responded to ixekizumab and the clinical outcome was maintained over 52 weeks (75{\%} and 60{\%} of patients achieved sPGA [0, 1] at week 52, respectively). Mostly mild or moderate treatment-emergent adverse events were reported by 79 of 91 patients; the most common were nasopharyngitis, eczema, seborrheic dermatitis, urticaria and injection site reactions. In conclusion, 52-week ixekizumab treatment was efficacious and well tolerated in Japanese patients with plaque psoriasis. Efficacy was also observed in patients with erythrodermic psoriasis, generalized pustular psoriasis and psoriatic arthritis.",
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T2 - Results from a 52-week, open-label, phase 3 study (UNCOVER-J)

AU - Saeki, Hidehisa

AU - Nakagawa, Hidemi

AU - Nakajo, Ko

AU - Ishii, Taeko

AU - Morisaki, Yoji

AU - Aoki, Takehiro

AU - Cameron, Gregory S.

AU - Osuntokun, Olawale O.

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 - Umezawa, Yoshinori

AU - Watanabe, Hideaki

AU - Yamanaka, Keiichi

AU - the Japanese Ixekizumab Study Group

PY - 2017/4/1

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N2 - Psoriasis, a chronic, immune-mediated skin disease characterized by red, scaly plaques, affects approximately 0.3% of the population in Japan. The aim of this open-label study was to evaluate the long-term efficacy and safety of ixekizumab, a humanized, anti-interleukin-17A monoclonal antibody, in Japanese patients with plaque psoriasis (n = 78, including 11 psoriatic arthritis), erythrodermic psoriasis (n = 8) and generalized pustular psoriasis (n = 5). Ixekizumab was administrated s.c. at baseline (week 0, 160 mg), from weeks 2 to 12 (80 mg every 2 weeks), and from weeks 16 to 52 (80 mg every 4 weeks). At week 52, 92.3% of patients with plaque psoriasis achieved Psoriasis Area and Severity Index (PASI) 75, 80.8% achieved PASI 90, 48.7% achieved PASI 100, and 52.6% had remission of plaques (by static Physician Global Assessment, sPGA [0]). Difficult to treat areas of psoriasis (nail or scalp) also responded to ixekizumab. All patients with psoriatic arthritis who were assessed (5/5) achieved an American College of Rheumatology 20 response. Most patients with erythrodermic psoriasis or generalized pustular psoriasis responded to ixekizumab and the clinical outcome was maintained over 52 weeks (75% and 60% of patients achieved sPGA [0, 1] at week 52, respectively). Mostly mild or moderate treatment-emergent adverse events were reported by 79 of 91 patients; the most common were nasopharyngitis, eczema, seborrheic dermatitis, urticaria and injection site reactions. In conclusion, 52-week ixekizumab treatment was efficacious and well tolerated in Japanese patients with plaque psoriasis. Efficacy was also observed in patients with erythrodermic psoriasis, generalized pustular psoriasis and psoriatic arthritis.

AB - Psoriasis, a chronic, immune-mediated skin disease characterized by red, scaly plaques, affects approximately 0.3% of the population in Japan. The aim of this open-label study was to evaluate the long-term efficacy and safety of ixekizumab, a humanized, anti-interleukin-17A monoclonal antibody, in Japanese patients with plaque psoriasis (n = 78, including 11 psoriatic arthritis), erythrodermic psoriasis (n = 8) and generalized pustular psoriasis (n = 5). Ixekizumab was administrated s.c. at baseline (week 0, 160 mg), from weeks 2 to 12 (80 mg every 2 weeks), and from weeks 16 to 52 (80 mg every 4 weeks). At week 52, 92.3% of patients with plaque psoriasis achieved Psoriasis Area and Severity Index (PASI) 75, 80.8% achieved PASI 90, 48.7% achieved PASI 100, and 52.6% had remission of plaques (by static Physician Global Assessment, sPGA [0]). Difficult to treat areas of psoriasis (nail or scalp) also responded to ixekizumab. All patients with psoriatic arthritis who were assessed (5/5) achieved an American College of Rheumatology 20 response. Most patients with erythrodermic psoriasis or generalized pustular psoriasis responded to ixekizumab and the clinical outcome was maintained over 52 weeks (75% and 60% of patients achieved sPGA [0, 1] at week 52, respectively). Mostly mild or moderate treatment-emergent adverse events were reported by 79 of 91 patients; the most common were nasopharyngitis, eczema, seborrheic dermatitis, urticaria and injection site reactions. In conclusion, 52-week ixekizumab treatment was efficacious and well tolerated in Japanese patients with plaque psoriasis. Efficacy was also observed in patients with erythrodermic psoriasis, generalized pustular psoriasis and psoriatic arthritis.

KW - erythrodermic psoriasis

KW - generalized pustular psoriasis

KW - ixekizumab

KW - Japan

KW - plaque psoriasis

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