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使用替拉珠单抗改善银屑病相关工作生产力:一项针对中度至重度斑块状银屑病患者的4期真实世界研究结果

Improvements in Psoriasis-Related Work Productivity with Tildrakizumab: Results from a Phase 4 Real-World Study in Patients with Moderate-to-Severe Plaque Psoriasis.

作者信息

Bhutani Tina, Koo John, Heim Jayme, Bhatia Neal, Mathew Jacob, Ferro Thomas, Vasquez J Gabriel

机构信息

University of California San Francisco Health, 515 Spruce Street #101, San Francisco, CA, 94118, USA.

West Michigan Dermatology, Grandville, MI, USA.

出版信息

Dermatol Ther (Heidelb). 2024 Apr;14(4):1019-1025. doi: 10.1007/s13555-024-01131-1. Epub 2024 Apr 4.

Abstract

INTRODUCTION

Plaque psoriasis is a chronic condition that may impact patients' work productivity. Tildrakizumab, an interleukin-23 p19 inhibitor, is approved for treatment of moderate-to-severe plaque psoriasis in adults. However, the effect of tildrakizumab treatment on work productivity in patients with psoriasis is not well characterized.

METHODS

In this multicenter, open-label, uncontrolled phase 4 study (NCT03718299), patients with moderate-to-severe plaque psoriasis received tildrakizumab 100 mg at week 0, week 4, and every 12 weeks thereafter through week 52. Patients completed the Work Productivity and Activity Impairment Questionnaire: Psoriasis (WPAI:PSO) at baseline and every 12 weeks from week 16 through week 64. The following four domains of the WPAI:PSO were examined: absenteeism (percentage of time missed from work due to psoriasis), presenteeism (percentage reduction of productivity while at work due to psoriasis), total activity impairment (percentage impairment in activities other than work due to psoriasis), and total work productivity impairment (total percentage of work impairment from both absenteeism and presenteeism due to psoriasis). Missing data were not imputed.

RESULTS

Of the 55 patients enrolled, 31 patients completed all domains of the WPAI:PSO at week 64. From baseline to week 64, respectively, mean ± standard deviation (SD) scores improved for presenteeism (20.5 ± 21.7 to 2.6 ± 5.8; P < 0.001), total activity impairment (29.5 ± 26.6 to 4.4 ± 9.4; P < 0.001), and total work productivity impairment (20.9 ± 22.2 to 2.6 ± 5.8; P < 0.001). The mean ± SD score for absenteeism decreased from 1.1 ± 5.7 at baseline to 0.0 ± 0.0 at week 64, but this change was not statistically significant.

CONCLUSION

Tildrakizumab treatment mitigated work productivity loss due to psoriasis as measured by the presenteeism, total activity impairment, and total work productivity impairment domains of the WPAI:PSO.

TRIAL REGISTRATION

ClinicalTrials.gov identifier, NCT03718299.

摘要

引言

斑块状银屑病是一种慢性疾病,可能会影响患者的工作效率。替拉珠单抗是一种白细胞介素-23 p19抑制剂,已被批准用于治疗成人中度至重度斑块状银屑病。然而,替拉珠单抗治疗对银屑病患者工作效率的影响尚未得到充分描述。

方法

在这项多中心、开放标签、非对照的4期研究(NCT03718299)中,中度至重度斑块状银屑病患者在第0周、第4周接受100 mg替拉珠单抗治疗,此后每12周一次,直至第52周。患者在基线时以及从第16周至第64周每12周完成一次工作效率和活动障碍问卷:银屑病(WPAI:PSO)。对WPAI:PSO的以下四个领域进行了检查:旷工(因银屑病而缺勤的时间百分比)、出勤但生产力下降(因银屑病而在工作时生产力下降的百分比)、总活动障碍(因银屑病而在工作以外的活动中的障碍百分比)以及总工作效率障碍(因银屑病导致的旷工和出勤但生产力下降造成的工作障碍的总百分比)。缺失数据未进行插补。

结果

在纳入的55例患者中,31例患者在第64周完成了WPAI:PSO的所有领域。从基线到第64周,出勤但生产力下降(20.5±21.7至2.6±5.8;P<0.001)、总活动障碍(29.5±26.6至4.4±9.4;P<0.001)和总工作效率障碍(20.9±22.2至2.6±5.8;P<0.001)的平均±标准差(SD)得分均有所改善。旷工的平均±SD得分从基线时的1.1±5.7降至第64周时的0.0±0.0,但这一变化无统计学意义。

结论

根据WPAI:PSO的出勤但生产力下降、总活动障碍和总工作效率障碍领域衡量,替拉珠单抗治疗减轻了因银屑病导致的工作效率损失。

试验注册

ClinicalTrials.gov标识符,NCT03718299。

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