Efficacy and safety of ustekinumab for the treatment of moderate-to-severe
psoriasis: a phase III, randomized, placebo-controlled trial in Taiwanese and
Korean patients (PEARL).
Author(s): Tsai TF, Ho JC, Song M, Szapary P, Guzzo C, Shen YK, Li S, Kim KJ, Kim TY, Choi
JH, Youn JI; PEARL Investigators.
Collaborators: Chen CW, Choe YB, Kim NI, Lee JH, Lee JH, Song H, Wang WJ.
Affiliation(s): Department of Dermatology, National Taiwan University Hospital, National Taiwan
University College of Medicine, Taipei, Taiwan. tftsai@yahoo.com
Publication date & source: 2011, J Dermatol Sci. , 63(3):154-63
BACKGROUND: Ustekinumab has been evaluated in Caucasian patients with psoriasis,
but no studies have been conducted in Asian patients.
OBJECTIVE: To assess the efficacy and safety of ustekinumab in Taiwanese and
Korean patients with moderate-to-severe psoriasis.
METHODS: In this 36-week, multicenter, double-blind, placebo-controlled study,
121 patients with moderate-to-severe psoriasis were randomized (1:1) to receive
subcutaneous injections of ustekinumab 45mg at weeks 0, 4, 16 or placebo at weeks
0, 4 and ustekinumab 45mg at weeks 12, 16. Efficacy endpoints at week 12 included
the proportion of patients achieving at least 75% improvement from baseline in
Psoriasis Area and Severity Index (PASI 75; primary endpoint), proportion of
patients with Physician's Global Assessment (PGA) of cleared or minimal, and
change from baseline in Dermatology Life Quality Index (DLQI).
RESULTS: At week 12, the proportion of patients achieving PASI 75 was 67.2% and
5.0% in the ustekinumab 45mg and placebo groups, respectively (p<0.001). PGA of
cleared or minimal was achieved by 70.5% (ustekinumab) and 8.3% (placebo;
p<0.001), and median DLQI changes were -11.0 and 0.0, respectively (p<0.001).
Efficacy was maintained through week 28 in ustekinumab-treated patients. Adverse
event (AE) profiles at week 12 were similar between the ustekinumab and placebo
groups: 65.6% and 70.0%, respectively, had at least one reported AE. Through week
36, no disproportionate increase in AEs was observed, with the exception of
abnormal hepatic function, which was related to concomitant isoniazid treatment
for latent tuberculosis. Injection-site reactions were rare and mild. No deaths,
malignancies, or cardiovascular events were reported.
CONCLUSIONS: Treatment with subcutaneous ustekinumab 45mg offers a favorable
benefit/risk profile for Taiwanese and Korean patients with moderate-to-severe
psoriasis. The efficacy and safety profile is consistent with the global phase
III studies of ustekinumab in psoriasis.
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