title: Ustekinumab improves health-related quality of life in Korean and Taiwanese patients with moderate to severe psoriasis: results from the PEARL trial.
abstract: BACKGROUND
  The PEARL study showed that the proportion of psoriasis patients achieving the primary endpoint (at least 75% improvement from baseline to week 12 in the Psoriasis Area and Severity Index) was significantly higher in ustekinumab-treated patients compared with placebo. There is a paucity of data regarding the impact of psoriasis and its treatment on health-related quality of life (HRQoL) in Asian patients.
  
  
  OBJECTIVE
  To evaluate the effect of ustekinumab on HRQoL in Korean/Taiwanese patients with moderate to severe psoriasis enrolled in the phase III, randomized, double-blind, placebo-controlled PEARL study.
  
  
  METHODS
  In the PEARL study, 121 patients were randomized to receive ustekinumab 45 mg at weeks 0, 4, and 16 (n=61) or placebo at weeks 0 and 4 with crossover to ustekinumab at weeks 12 and 16 (n=60). A major secondary endpoint was the change in Dermatology Life Quality Index (DLQI) from baseline at week 12. Other endpoints included the change in individual DLQI domains, proportion of patients achieving DLQI ≤ 1 (no negative effect), and proportion of patients achieving ≥ 5-point reduction in DLQI (clinically meaningful improvement) at week 12.
  
  
  RESULTS
  At baseline, psoriasis had a very large effect on HRQoL (average DLQI, 15.7). At week 12, patients treated with ustekinumab 45 mg had significantly greater improvement from baseline in DLQI scores compared with placebo (mean decrease, 11.2 vs 0.5 (P<0.001). Likewise, 32.2% and 1.7% of patients receiving ustekinumab 45 mg and placebo, respectively, achieved a DLQI ≤ 1, and 81.4% and 18.3% achieved ≥ 5-point reduction (both P<0.001 vs placebo). Individual DLQI domains in the ustekinumab group were significantly improved compared with placebo (P<0.001). For ustekinumab-randomized patients, HRQoL improvements were sustained through week 28. Placebo patients who crossed over to ustekinumab experienced similar improvements compared with those randomized to ustekinumab.
  
  
  CONCLUSIONS
  Ustekinumab significantly improves HRQoL in Korean/Taiwanese patients with moderate to severe psoriasis.
authors.affiliation: Department of Dermatology, National Taiwan University Hospital, Taipei, Taiwan. tftsai@yahoo.com
authors.forename: Tsen-Fang
authors.initials: TF
authors.lastname: Tsai
authors.forename: Michael
authors.initials: M
authors.lastname: Song
authors.forename: Yaung-Kaung
authors.initials: YK
authors.lastname: Shen
authors.forename: Brad
authors.initials: B
authors.lastname: Schenkel
authors.forename: Yong-Beom
authors.initials: YB
authors.lastname: Choe
authors.forename: Nack-In
authors.initials: NI
authors.lastname: Kim
authors.forename: Joo-Heung
authors.initials: JH
authors.lastname: Lee
authors.forename: Ju-Hee
authors.initials: JH
authors.lastname: Lee
authors.forename: Hae-Jun
authors.initials: HJ
authors.lastname: Song
authors.forename: Jai-Il
authors.initials: JI
authors.lastname: Youn
mesh_terms: D000328:Adult; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D003879:Dermatologic Agents / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011565:Psoriasis / Q000188:drug therapy* / Q000523:psychology; D011788:Quality of Life / Q000523:psychology; D056910:Republic of Korea; D057566:Self Report; D012720:Severity of Illness Index; D018709:Statistics, Nonparametric; D013624:Taiwan; D000069549:Ustekinumab
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D003879:Dermatologic Agents; D000069549:Ustekinumab