Quality of life and patient-reported symptoms in a Phase 4, real-world study of tildrakizumab in patients with moderate-to-severe psoriasis: Week 28 interim analysis

被引:8
作者
Bhatia, Neal [1 ,4 ]
Heim, Jayme [2 ]
Schenkel, Brad [3 ]
Vasquez, J. Gabriel [2 ]
机构
[1] Therapeut Clin Res, San Diego, CA USA
[2] West Michigan Dermatol, Grandville, MI USA
[3] Sun Pharmaceut Ind Inc, Princeton, NJ USA
[4] Therapeut Clin Res, 9025 Balboa Ave Suite 105, San Diego, CA 92123 USA
关键词
Health-related quality of life (HRQoL); psoriasis; Psychological General Well-Being Index (PGWBI); patient-reported outcomes; tildrakizumab; PLAQUE PSORIASIS; EFFICACY; ANTIBODY; PLACEBO; SAFETY;
D O I
10.1080/09546634.2023.2200872
中图分类号
R75 [皮肤病学与性病学];
学科分类号
100206 ;
摘要
Background: Tildrakizumab is an anti-interleukin-23 p19 monoclonal antibody approved for the treatment of adults with moderate-to-severe plaque psoriasis. Little real-world evidence is available regarding the effects of tildrakizumab on patients' health-related quality of life (HRQoL) and patient-reported symptoms.Objective: This real-world study of tildrakizumab evaluated changes in HRQoL and clinical symptoms in patients with psoriasis.Materials and methods: In this Week (W)28 interim analysis of a 64-week Phase 4 study (NCT03718299), patients received tildrakizumab 100 mg at W0, W4, and every 12 weeks thereafter. Endpoints were improvement from baseline in Psychological General Well-Being Index (PGWBI), Dermatology Life Quality Index (DLQI), and Itch-, Pain-, and Scaling-Numerical Rating Scale scores through W28.Results: Of 55 patients enrolled, 53 were assessed at W28. Mean (standard deviation [SD]) total PGWBI score improved from baseline to W28 (change, 3.7 [12.4]; p = .033), as did the positive well-being (1.0 [2.9]; p = .018) and general health (1.5 [2.2]; p < .001) domain scores. Mean (SD) DLQI score improved by-3.9 (4.3) at W4 and by-7.6 (5.1) at W28 (p < .001). Patient-reported symptoms improved starting at W4 (p < .001).Conclusion: Tildrakizumab treatment improved HRQoL and patient-reported symptoms in patients with psoriasis in a real-world setting. Clinical trial registration: https://clinicaltrials.gov/ct2/show/ NCT03718299
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页数:7
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