title: Efficacy and safety of ustekinumab in Chinese patients with moderate to severe plaque-type psoriasis: results from a phase 3 clinical trial (LOTUS).
abstract: BACKGROUND
  Available biologic agents for the treatment of psoriasis in China are limited.
  
  
  OBJECTIVE
  The LOTUS study is a phase 3, double-blind, placebo-controlled study that evaluated the efficacy and safety of ustekinumab in Chinese patients with moderate to severe plaque-type psoriasis.
  
  
  METHODS
  Patients (n=322) were randomized to receive ustekinumab 45 mg or placebo at weeks 0 and 4, with placebo crossover to ustekinumab at week 12; all patients were followed up to week 36. The primary end point was the proportion of patients achieving at least a 75% improvement in the Psoriasis Area and Severity Index (PASI 75) at week 12. Other end points at week 12 included the proportion of patients with a Physician's Global Assessment (PGA) score of 0 or 1 and the change in Dermatology Life Quality Index (DLQI) score from baseline.
  
  
  RESULTS
  At week 12, 82.5% of ustekinumab-treated patients achieved PASI 75 responses compared with 11.1% of placebo-treated patients (P<.001). Clinical responses were maintained through week 28, with maximum responses observed at week 24. Significant improvements in PGA and DLQI were observed at week 12 and were generally maintained through week 28. At week 12, adverse events rates were similar between groups (45 mg: 42.5% vs placebo: 38.5%), and serious adverse events were reported in 0.6% of patients in each group. Through week 36, no cases of active tuberculosis, serious infections, malignancies, or major adverse cardiovascular events were reported.
  
  
  CONCLUSIONS
  Consistent with results previously reported in global phase 3 studies, ustekinumab was highly effective and generally well tolerated in Chinese patients with moderate to severe psoriasis through 36 weeks.
authors: Department of Dermatology and Venereology, Peking University First Hospital, Beijing, China.
authors: Xuejun
authors: X
authors: Zhu
authors: Min
authors: M
authors: Zheng
authors: Michael
authors: M
authors: Song
authors: Yaung-Kaung
authors: YK
authors: Shen
authors: Daphne
authors: D
authors: Chan
authors: Philippe O
authors: PO
authors: Szapary
authors: Baoxi
authors: B
authors: Wang
mesh_terms: D000328:Adult; D061067:Antibodies, Monoclonal, Humanized / Q000009:adverse effects / Q000627:therapeutic use*; D015535:Arthritis, Psoriatic / Q000150:complications; D044466:Asian People; D002681:China; D004311:Double-Blind Method; D023381:Endpoint Determination; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D061214:Patient Safety; D011565:Psoriasis / Q000188:drug therapy* / Q000473:pathology; D011788:Quality of Life; D012720:Severity of Illness Index; D012867:Skin / Q000473:pathology; D000069549:Ustekinumab
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D000069549:Ustekinumab