Ustekinumab improves health-related quality of life in Korean and Taiwanese patients with moderate to severe psoriasis

Results from the PEARL trial

Tsen Fang Tsai, Michael Song, Yaung Kaung Shen, Brad Schenkel, Yong Beom Choe, Nack In Kim, Joo Heung Lee, Ju Hee Lee, Hae Jun Song, Jai Il Youn

Research output: Contribution to journalArticle

13 Citations (Scopus)

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. Objectives: 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.

Original languageEnglish
Pages (from-to)943-949
Number of pages7
JournalJournal of Drugs in Dermatology
Volume11
Issue number8
Publication statusPublished - 2012 Aug 1

Fingerprint

Psoriasis
Quality of Life
Dermatology
Placebos
Ustekinumab
Quality Improvement

ASJC Scopus subject areas

  • Dermatology

Cite this

Ustekinumab improves health-related quality of life in Korean and Taiwanese patients with moderate to severe psoriasis : Results from the PEARL trial. / Tsai, Tsen Fang; Song, Michael; Shen, Yaung Kaung; Schenkel, Brad; Choe, Yong Beom; Kim, Nack In; Lee, Joo Heung; Lee, Ju Hee; Song, Hae Jun; Youn, Jai Il.

In: Journal of Drugs in Dermatology, Vol. 11, No. 8, 01.08.2012, p. 943-949.

Research output: Contribution to journalArticle

Tsai, TF, Song, M, Shen, YK, Schenkel, B, Choe, YB, Kim, NI, Lee, JH, Lee, JH, Song, HJ & Youn, JI 2012, 'Ustekinumab improves health-related quality of life in Korean and Taiwanese patients with moderate to severe psoriasis: Results from the PEARL trial', Journal of Drugs in Dermatology, vol. 11, no. 8, pp. 943-949.
Tsai, Tsen Fang ; Song, Michael ; Shen, Yaung Kaung ; Schenkel, Brad ; Choe, Yong Beom ; Kim, Nack In ; Lee, Joo Heung ; Lee, Ju Hee ; Song, Hae Jun ; Youn, Jai Il. / Ustekinumab improves health-related quality of life in Korean and Taiwanese patients with moderate to severe psoriasis : Results from the PEARL trial. In: Journal of Drugs in Dermatology. 2012 ; Vol. 11, No. 8. pp. 943-949.
@article{dc9e21c4e9bf48878d0ebbeb1b08e5db,
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. Objectives: 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.",
author = "Tsai, {Tsen Fang} and Michael Song and Shen, {Yaung Kaung} and Brad Schenkel and Choe, {Yong Beom} and Kim, {Nack In} and Lee, {Joo Heung} and Lee, {Ju Hee} and Song, {Hae Jun} and Youn, {Jai Il}",
year = "2012",
month = "8",
day = "1",
language = "English",
volume = "11",
pages = "943--949",
journal = "Journal of Drugs in Dermatology",
issn = "1545-9616",
publisher = "Journal of Drugs in Dermatology",
number = "8",

}

TY - JOUR

T1 - Ustekinumab improves health-related quality of life in Korean and Taiwanese patients with moderate to severe psoriasis

T2 - Results from the PEARL trial

AU - Tsai, Tsen Fang

AU - Song, Michael

AU - Shen, Yaung Kaung

AU - Schenkel, Brad

AU - Choe, Yong Beom

AU - Kim, Nack In

AU - Lee, Joo Heung

AU - Lee, Ju Hee

AU - Song, Hae Jun

AU - Youn, Jai Il

PY - 2012/8/1

Y1 - 2012/8/1

N2 - 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. Objectives: 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.

AB - 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. Objectives: 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.

UR - http://www.scopus.com/inward/record.url?scp=84864768280&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84864768280&partnerID=8YFLogxK

M3 - Article

VL - 11

SP - 943

EP - 949

JO - Journal of Drugs in Dermatology

JF - Journal of Drugs in Dermatology

SN - 1545-9616

IS - 8

ER -