Short-term effectiveness and potential factors of ustekinumab based on real-world data in Chinese psoriasis patients

Abstract

Background

As one of the most effective biologic treatments for psoriasis, the short-term effectiveness of ustekinumab has yet to be studied extensively.

Objective

The purpose of this study was to evaluate the short-term effectiveness and potential factors within four weeks after the first-dose ustekinumab treatment based on real-world data.

Methods

The study enrolled 98 patients with moderate-to-severe psoriasis, given ustekinumab 45 mg at week 0, week 4, and then every 12 weeks. Based on clinical data collected at baseline and week 4, we investigated the short-term effectiveness of ustekinumab after the first dose and potential factors associated with the treatment. For evaluation, we collected demographic information, body data, medical history, laboratory examination results, Psoriasis Area and Severity Index (PASI), body surface area (BSA), and dermatology life quality index (DLQI). Response rates were calculated based on the number of patients that achieved a 75/90/100% reduction in PASI (PASI 75/90/100), and the primary treatment goal was to achieve PASI 75.

Results

The response rates for PASI 75/90/100 at week 4 were 30.5%, 18.9%, and 16.8%, respectively. For PASI 75, the response rate was higher in patients without metabolic syndrome (MS) (without MS vs. with MS: 36.9% vs. 5.9%, p = 0.013); the serum triglyceride (TG) level was significantly lower in patients achieving PASI 75 (expressed as mean ± standard deviation, achieved vs. unachieved: 1.82 ± 1.79 vs. 3.59 ± 8.89, p = 0.010). For PASI 100, the response rates were higher in female patients (female vs. male: 26.3% vs. 10.5%, p = 0.044) and patients with a family history of psoriasis (with family history vs. without family history: 44.4% vs. 13.9%, p = 0.042). In addition, the possibility of achieving PASI 75/90/100 went up along with the serum high-density lipoprotein cholesterol (HDL-C) level (expressed as adjusted odds ratio < 95% confidence interval>: PASI 75: 28.484 < 2.035-248.419>, p = 0.011; PASI 90: 28.226 < 2.828-281.729>, p = 0.004; PASI 100: 12.175 < 1.876-79.028>, p = 0.009).

Conclusion

In this study, nearly one-third of patients achieved PASI 75 after only the first-dose ustekinumab treatment. Sex, family history of psoriasis, MS, serum TG level might affect the short-term effectiveness, and serum HDL-C level may be a potential factor. The possibility of achieving treatment goals (PASI 75/90/100) at week 4 increased along with serum HDL-C levels.

Keywords:

• Psoriasis
• biologics
• ustekinumab
• short-term effectiveness
• real-world data

Acknowledgment

The authors would like to extend their sincerest appreciation to all coordinators, dermatologists, and investigators who participated in this study.

Authors’ contribution

Xingyu Li and Xiaowen Xie performed the study design, data analysis, and manuscript writing. Jiashuai Li, Jingjin Hu, Minjia Tan, Jing Yang, Sichun Deng, and Yijie Liu contributed to the data collection and validation. Mi Zhang, Junchen Chen, Liqiu Liao, Yehong Kuang, and Wu Zhu performed the diagnosis, sample collections, and/or manuscript revising. Yehong Kuang and Wu Zhu were clinic experts and gave suggestions for manuscript revision. All authors read and approved the final version of the manuscript.

Disclosure statement

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Statement of ethics

The principles outlined in the Declaration of Helsinki were followed in our research. This study was reviewed and approved by the institutional research ethics boards of Xiangya Hospital (approval number: 2018121106). Written informed consent was obtained from all of the adult participants and from parents/legal guardians of all participants under 18 years old.

Data availability Statement

All data generated or analyzed during this research are included in this article. Further requires can be directed to the corresponding authors.

Additional information

Funding

This research was supported by National Natural Science Foundation of China (82073447, 81974479, 81974420, 81773329, 82073447, 82003362, 82003354), National key R & D program (2018YFC0117004), the Project of Intelligent Management Software for Multimodal Medical Big Data for New Generation Information Technology, Ministry of Industry and Information Technology of People’s Republic of China (TC210804V), and Natural Science Foundation of Hunan Province (2021JJ30041).