Impact of tildrakizumab on HRQoL in patients with psoriasis: real-world Week 28 analysis

Tildrakizumab, a monoclonal antibody that targets interleukin-23 p19, is used to treat adult patients with moderate-to-severe plaque psoriasis who qualify for systemic therapy or phototherapy.¹ Symptoms of psoriasis have negative effects on patients’ sleep and rest and place limitations on their daily activities, including mobility, which can affect mental health and wellbeing.¹ Here, we summarize a Week 28 interim analysis of health-related quality of life (HRQoL) and patient-reported outcomes from a phase IV, real-world study (NCT03718299) of tildrakizumab in patients with moderate-to-severe psoriasis.¹

Study design¹

This 64-week uncontrolled, open-label multicenter study included 53 patients aged ≥18 years who were immunocompetent and had moderate-to-severe plaque psoriasis affecting ≥3% of total body surface area. Patients received 100 mg of tildrakizumab at Weeks 0, 4, and every 12 weeks thereafter up to Week 52.

The Psychological General Well-Being Index (PGWBI) and Dermatology Life Quality Index (DLQI) were used to measure patients HRQoL at baseline and Weeks 4, 8, 12, 16, and 28. The PGWBI includes 22 questions that represent six domains, including anxiety, depressed mood, positive well-being, self-control, general health, and vitality. The DLQI was used to assess patients’ perception of symptoms, feelings, daily activities, leisure activities, work or school, personal relationships, and treatment. The study’s primary efficacy endpoint was a change in HRQoL as measured by the change from baseline in PGWBI at Week 28. Key secondary outcomes included change from baseline in DLQI, safety, and patient-reported severity of itch, pain, and scaling.

Key findings¹

Of the 55 patients enrolled in this study, 53 were assessed for PGWBI, DLQI, and itch, pain, and scaling severity. The primary endpoint of the study was met, with a mean absolute change from baseline of 3.7 (p = 0.033) in PGWBI at Week 28 (Figure 1).

Figure 1. Change from baseline in total PGWBI score at Week 28 in patients treated with tildrakizumab* 

PGWBI, Psychological General Well-Being Index.
*Adapted from Bhatia, et al.¹

Changes for each PGWBI domain from baseline to Week 28 are shown in Table 1. Notably, the changes in anxiety and vitality domain scores were not statistically significant.

Table 1. Change from baseline in PGWBI domain score to Week 28*

The mean DLQI score decreased from 9.4 (standard deviation [SD], 5.2) at baseline to 1.7 (SD, 1.9) at Week 28 with mean absolute change being −7.6 (SD, 5.1) and mean percentage change being −76.5% (p < 0.001). Mean patient-reported scores for itch, pain, and scaling from baseline to Week 28 are shown in Figure 2.

Figure 2.  NRS scores for A itch, B pain, and C scaling in patients treated with tildrakizumab from baseline to Week 28* 

NRS, numerical rating scale; PRO; patient-reported outcome.
*Adapted from Bhatia, et al.¹ 

Individual numerical rating scale instruments for itch, pain, and scaling are self-administered 11-point scales; scores ranged from 0 to 10, with higher scores indicating worse symptoms.

Table 2 shows treatment-emergent adverse events measured at Weeks 4, 8, 12, 16, and 28.

Table 2. TEAEs in patients treated with tildrakizumab*

Conclusion

In this Week 28 interim analysis of real-world data, tildrakizumab treatment resulted in statistically significant improvements from baseline in measures of patient-reported outcomes and HRQoL in adult patients with moderate-to-severe plaque psoriasis.¹ Clinical studies of biologics have highlighted the importance of improving psoriasis symptoms to achieve successful outcomes. Longer-term studies and additional real-world data are needed to guide healthcare professionals in making optimal treatment decisions to improve HRQoL in patients with psoriasis.