Efficacy and Safety of Ustekinumab in Chinese Patients With Moderate to Severe Plaque-type Psoriasis: Results From a Phase 3 Clinical Trial (LOTUS)
February 2013 | Volume 12 | Issue 2 | Original Article | 166 | Copyright © 2013
Xuejun Zhu MD,a Min Zheng MD PhD,b Michael Song MD,c Yaung-Kaung Shen PhD,dDaphne Chan PhD MHEcon,c Philippe O. Szapary MD MSCE,c and Baoxi Wang MDe on behalf of LOTUS investigators*
*Investigators are listed in the Acknowledgments.
aDepartment of Dermatology and Venereology, Peking University First Hospital, Beijing, China bDepartment of Dermatology and Venereology, Second Affiliated Hospital, Zhejian University, School of Medicine, Hangzhou, Zhejiang, China cDepartment of Immunology, Janssen Research & Development LLC, Spring House, PA dDepartment of Biostatistics, Janssen Research & Development LLC, Spring House, PA eInstitute of Dermatology, Chinese Academy of Medical Sciences, Nanjing, Jiangsu, China
Background: Available biologic agents for the treatment of psoriasis in China are limited.
Objectives: The LOTUS study is a phase 3, double-blind, placebo-controlled study that evaluated the efficacy and safety of ustekinu-mab in Chinese patients with moderate to severe plaque-type psoriasis.
Patients and 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.
J Drugs Dermatol. 2013;12(2):166-174.
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Psoriasis is a chronic, immune-mediated skin disease affecting approximately 1% to 3% of the world’s population1; however, in China, the estimated prevalence is lower, at approximately 0.12% to 0.47%.2-4 Topical agents5 and traditional Chinese medicines6-8 are commonly used in China. Phototherapy9 and systemic agents, including methotrexate,10 etretinate,11 cyclosporine,10 and corticosteroids,12 are also prescribed in China, but their usage varies. Despite the different therapeutic options available for the treatment of plaque-type psoriasis in China, questions remain regarding the effectiveness of traditional Chinese medicine13 and end-organ toxicities associated with long-term use of conventional systemic agents10,14,15; hence, an unmet need exists for new treatment options in China. Several biologic agents have been shown to be efficacious and generally well tolerated in patients with moderate to severe psoriasis in studies conducted in North America and Europe,16-21 but there is currently only one biologic agent available in China to treat psoriasis.22
The cytokines interleukin (IL)-12 and IL-23 are known to play an important role in the pathogenesis of psoriasis.23 A genetic basis for susceptibility to psoriasis has been reported in the Chinese population.24-26 Patients with a specific allele of IL-12B, which encodes the p40 subunit of IL-12 and IL-23, had an increased risk of developing psoriasis.26
Ustekinumab (Stelara®; Janssen Biotech, Inc, Horsham, PA) is a human, monoclonal antibody that binds to the shared