Tildrakizumab Linked With HRQOL Improvement in Psoriasis in a Real-World Setting

Treatment with tildrakizumab improved health-related quality of life (HRQoL) and patient-reported symptoms in those with psoriasis in a real-world setting, according to a new study published in The Journal of Dermatological Treatment.

The anti–interleukin-23 p19 monoclonal antibody is approved for treatment of adults with moderate to severe plaque psoriasis.

Psoriasis and its symptoms, which can include itch, pain and scaling, have substantial negative effects on patients’ QOL. Previous research shows patients report negative effects on sleep and rest, limitations on daily activities, and disruption to social interactions. Many also experience depression, anxiety or addiction.

The chronic multisystem disease manifests most noticeably as skin inflammation, the study authors said. Plaque psoriasis, the most common form of the condition, often appears on the skin of the knees, elbows, scalp, buttocks and trunk.

Of all the symptoms of psoriasis, itch has been reported to contribute the most to reductions in patients’ emotional well-being, sleep, and daily activity.

However, “in general, the relationship between clinical treatment of psoriasis and patients’ HRQoL is poorly understood and may be underestimated by clinicians,” the researchers wrote. “There is therefore an unmet need for greater understanding of this relationship to inform the choice of therapeutic intervention.”

To address the knowledge gap, the investigators carried out a phase 4 study under real-world conditions. The current research outlines results after 28 weeks of treatment with tildrakizumab.

All participants received tildrakizumab 100 mg at weeks 0 and 4, and every 12 weeks thereafter. The researchers measured progress via the Psychological General Well-Being Index (PGWBI), Dermatology Life Quality Index (DLQI), and Itch-, Pain-, and Scaling-Numerical Rating Scale scores. Of the 55 enrolled patients, 53 were evaluated at week 28.

Data showed:

• Mean (SD) total PGWBI score improved from baseline to week 28 (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 week 4 and by 7.6 (5.1) at week 28 (P < .001)
• Patient-reported symptoms improved starting at week 4 (P < .001)

Just over half of patients included were male and the majority were White. The mean patient age was 48.6 years.

Despites PGWBI score improvements seen for general health and positive well-being, no statistically significant improvements were seen from baseline to week 28 for anxiety, vitality, depressed mood, and self-control.

However, the treatment did result in improvements in reported itching, pain, and scaling beginning at week 4 and these were maintained throughout the study window.

“Clinical trials have often focused on the effects of skin clearance on the HRQOL of patients with psoriasis. Complete skin clearance has been associated with higher scores on measures of HRQOL compared with almost complete clearance,” the authors explained.

Previous research on the impact of the efficacy of tildrakizumab treatment has shown absolute Psoriasis Area Severity Index scores correlated with DLQI total scores.

In controlled clinical trials, strict inclusion and exclusion criteria may preclude findings from fully representing or characterizing the patient population in real-world clinical practice, the researchers said.

“To date, there has been little published real-world evidence regarding HRQOL in patients with moderate to severe plaque psoriasis treated with tildrakizumab,” they added.

The relatively small sample size marks a limitation to the current study, and it remains unclear whether tildrakizumab treatment may affect patients’ HRQOL over a longer period of time.

“Additional research is recommended to further guide clinicians in choosing optimal treatment strategies to improve HRQOL in patients with moderate to severe psoriasis,” the authors concluded.

Reference

Bhatia N, Heim J, Schenkel B, Vasquez JG. 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. J Dermatolog Treat. Published online May 11, 2023. doi:10.1080/09546634.2023.2200872