title: 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).
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.
authors.affiliation: Department of Dermatology, Nippon Medical School, Tokyo, Japan.
authors.forename: Hidehisa
authors.initials: H
authors.lastname: Saeki
authors.affiliation: Department of Dermatology, The Jikei University School of Medicine, Tokyo, Japan.
authors.forename: Hidemi
authors.initials: H
authors.lastname: Nakagawa
authors.affiliation: Lilly Research Laboratories, Eli Lilly Japan K.K., Kobe, Japan.
authors.forename: Ko
authors.initials: K
authors.lastname: Nakajo
authors.affiliation: Lilly Research Laboratories, Eli Lilly Japan K.K., Kobe, Japan.
authors.forename: Taeko
authors.initials: T
authors.lastname: Ishii
authors.affiliation: Lilly Research Laboratories, Eli Lilly Japan K.K., Kobe, Japan.
authors.forename: Yoji
authors.initials: Y
authors.lastname: Morisaki
authors.affiliation: Lilly Research Laboratories, Eli Lilly Japan K.K., Kobe, Japan.
authors.forename: Takehiro
authors.initials: T
authors.lastname: Aoki
authors.affiliation: Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, Indiana, USA.
authors.forename: Gregory S
authors.initials: GS
authors.lastname: Cameron
authors.affiliation: Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, Indiana, USA.
authors.forename: Olawale O
authors.initials: OO
authors.lastname: Osuntokun
mesh_terms: D000328:Adult; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D015535:Arthritis, Psoriatic / Q000188:drug therapy; D003879:Dermatologic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D007279:Injections, Subcutaneous; D020381:Interleukin-17 / Q000037:antagonists & inhibitors*; D007564:Japan; D000069451:Long Term Adverse Effects / Q000139:chemically induced / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D009262:Nails; D011565:Psoriasis / Q000188:drug therapy*; D012535:Scalp; D012720:Severity of Illness Index; D016896:Treatment Outcome
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D003879:Dermatologic Agents; C508717:IL17A protein, human; D020381:Interleukin-17; C549079:ixekizumab
keywords: Japan; erythrodermic psoriasis; generalized pustular psoriasis; ixekizumab; plaque psoriasis