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). Issue 4 (11th October 2016)

• Record Type: Journal Article
• Authors: Saeki, Hidehisa; Nakagawa, Hidemi; Nakajo, Ko; Ishii, Taeko; Morisaki, Yoji; Aoki, Takehiro; Cameron, Gregory S.; Osuntokun, Olawale O.
• Other Names: Akasaka Toshihide investigator.; Asano Yoshihide investigator.; Etoh Takafumi investigator.; Fujita Yasuyuki investigator.; Hashimoto Takashi investigator.; Higashiyama Mari investigator.; Igarashi Atsuyuki investigator.; Ihn Hironobu investigator.; Iwatsuki Keiji investigator.; Kabashima Kenji investigator.; Kawada Akira investigator.; Kawashima Makoto investigator.; Nakamura Koichiro investigator.; Okubo Yukari investigator.; Okuyama Ryuhei investigator.; Ozawa Akira investigator.; Sayama Koji investigator.; Seishima Mariko investigator.; Shiohara Tetsuo investigator.; Takahara Masakazu investigator.; Takahashi Hidetoshi investigator.; Takehara Kazuhiko investigator.; Tanese Keiji investigator.; Tani Mamori investigator.; Umezawa Yoshinori investigator.; Watanabe Hideaki investigator.; Yamanaka Keiichi investigator.
• Is Part Of: Journal of dermatology. Volume 44:Issue 4(2017)
• Page Start: 355
• Page End: 362
• Publication Date: 2016-10-11
• Subjects: erythrodermic psoriasis -- generalized pustular psoriasis -- ixekizumab -- Japan -- plaque psoriasis; Dermatology -- Periodicals; Dermatology -- Japan -- Periodicals; Skin -- Diseases -- Periodicals; 616.5005
• DOI: 10.1111/1346-8138.13622
• Languages: English
• ISSNs: 0385-2407

Abstract

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.