title: Long-term clinical safety and efficacy of brodalumab in the treatment of Japanese patients with moderate-to-severe plaque psoriasis.
abstract: BACKGROUND
  Brodalumab (KHK4827) is a human anti-interleukin-17-receptor A monoclonal antibody. In Japanese patients with moderate-to-severe plaque psoriasis, brodalumab showed rapid and robust efficacy and a favourable safety profile in a 12-week, phase 2, double-blind, randomized controlled trial.
  
  
  OBJECTIVE
  To evaluate the long-term safety and efficacy of brodalumab, an extension of a phase 2 trial of Japanese patients with moderate-to-severe psoriasis was performed.
  
  
  METHODS
  Patients received open-label brodalumab 210 or 140 mg subcutaneously every 2 weeks for 52 weeks. Efficacy was measured using the Psoriasis Area and Severity Index (PASI) score and the static physician global assessment (sPGA) instrument. The endpoint of psoriatic arthritis was 20% improvement in American College of Rheumatology response criteria (ACR 20). The patients were also monitored for treatment-emergent adverse events (AEs), including serious AEs (SAEs).
  
  
  RESULTS
  Of 145 patients, 133 completed the study. The percentage of patients with ≥75% reduction of PASI scores (PASI 75), ≥90% (PASI 90) and 100% (PASI 100) at Week 52 (the last observation carried forward) were 94.4%, 87.5% and 55.6%, respectively, in the 210-mg group, and the corresponding values in the 140-mg group were 78.1%, 71.2% and 43.8%. At Week 52, 75.0% patients in 210-mg group achieved ACR 20, compared with 37.5% patients in 140-mg group. The most commonly reported AEs were nasopharyngitis (35.2%), upper respiratory tract inflammation (10.3%) and contact dermatitis (9.7%).
  
  
  CONCLUSIONS
  Brodalumab showed a sustained clinical response and an acceptable safety profile through 52 weeks in Japanese patients with moderate-to-severe plaque psoriasis in this open-label extension study.
authors.affiliation: Department of Dermatology, The Jikei University School of Medicine, Tokyo, Japan. yoshinori.umezawa@jikei.ac.jp.
authors.forename: Y
authors.initials: Y
authors.lastname: Umezawa
authors.affiliation: Department of Dermatology, The Jikei University School of Medicine, Tokyo, Japan.
authors.forename: H
authors.initials: H
authors.lastname: Nakagawa
authors.affiliation: Clinical Education Center, Kyushu University Hospital, Fukuoka, Japan.
authors.forename: H
authors.initials: H
authors.lastname: Niiro
authors.affiliation: Kyowa Hakko Kirin Co., Ltd., Tokyo, Japan.
authors.forename: K
authors.initials: K
authors.lastname: Ootaki
mesh_terms: D000328:Adult; D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D017322:Clinical Trials, Phase II as Topic; D005260:Female; D006801:Humans; D007564:Japan; D008297:Male; D008875:Middle Aged; D011565:Psoriasis / Q000188:drug therapy*; D012720:Severity of Illness Index
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; C571216:brodalumab