According to a new study published in The journal of dermatological treatment.
The anti-interleukin-23 monoclonal antibody p19 is approved for the treatment of adults with moderate to severe plaque psoriasis.
Psoriasis and its symptoms, which can include itching, pain and scaling, have substantial adverse effects on patients’ quality of life. Previous research shows that patients report negative effects on sleep and rest, limitations in daily activities and disruption of social interactions. Many also suffer from depression, anxiety or addiction.
Chronic multisystem disease manifests most prominently as inflammation of the skin, 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, itching has been reported to contribute the most to patients’ reduced 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 a greater understanding of this relationship to inform the choice of therapeutic intervention.
To fill the knowledge gap, the researchers conducted a phase 4 study under real-life 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 through the Psychological General Well-Being Index (PGWBI), Dermatology Life Quality Index (DLQI), and Itch, Pain, and Scaling Numerical Rating Scale scores. Of the 55 patients enrolled, 53 were evaluated at week 28.
The data showed:
- Mean (SD) total PGWBI score improved from baseline at week 28 (change, 3.7 [12.4];P=.033), as well as positive well-being (1.0 [2.9];P=.018) and general health (1.5 [2.2];P<.001) domain scores
- The 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 by week 4 (P< .001)
Just over half of the included patients were male and the majority were white. The mean age of the patients was 48.6 years.
Despite the observed PGWBI score improvements for general health and positive well-being, no statistically significant improvements from baseline to week 28 were observed for anxiety, vitality, depressed mood, and self-control.
However, the treatment led to improvements in reported itching, pain and scaling starting at week 4 and these were maintained throughout the study window.
Clinical studies have often focused on the effects of skin clearance on the HRQOL of patients with psoriasis. Complete skin clearance was associated with higher scores on HRQOL measures than near-complete clearance, explained the authors.
Previous research on the impact of treatment efficacy with tildrakizumab showed that absolute Psoriasis Area Severity Index scores correlated with total DLQI scores.
In controlled clinical trials, strict inclusion and exclusion criteria may prevent the results from fully representing or characterizing the patient population in real-world clinical practice, the researchers said.
To date, little real-world evidence has been published 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 is unclear whether tildrakizumab treatment would affect patients’ HRQOL over a longer period of time.
Further research is recommended to further guide clinicians in choosing the 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 real-world Phase 4 study of tildrakizumab in patients with moderate-to-severe psoriasis: interim analysis at week 28. J Dermatological treatment. Published online 11 May 2023. doi:10.1080/09546634.2023.2200872
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