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2024-04-10T11:10:26.000Z

Safety and efficacy of tildrakizumab in elderly patients with psoriasis: results from the ESTER study

Apr 10, 2024
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Learning objective: After reading this article, learners will be able to cite a new clinical development in psoriasis.

Psoriasis is increasingly prevalent in elderly populations due to improved life expectancy.1 However, psoriasis can be difficult-to-treat in this population due to immune system impairment and increased susceptibility to infections and malignancies. Additionally, there are few clinical trials which enroll patients aged ≥ 65 years.1 

Here, we summarize a paper by Orsini et al.1 published in the Journal of Dermatological Treatment on the real-world ESTER study evaluating the safety and efficacy of tildrakizumab for elderly patients with psoriasis. 


Study design and patient population1 

  • ESTER was a 28-week, multicenter retrospective study, conducted at five Italian centers. 

  • The study enrolled elderly patients aged ≥65 years with a diagnosis of moderate-to-severe plaque psoriasis. Patients received subcutaneous tildrakizumab 100mg at Weeks 0 and 4, then every 12 weeks after. 

  • Psoriasis Area and Severity Index (PASI) and Physician Global Assessment (PGA) scores were assessed at Weeks 4, 16, and 28. PGA was assessed in difficult-to-treat areas: 

    • Genitalia (sPGA-G) 

    • Fingernail (f-PGA) 

    • Palmoplantar (pp-PGA) 

    • Scalp (sc-PGA) 

  • A total of 49 patients were enrolled. The majority were male (57%), with a mean age of 73.1 years. Six patients had concomitant psoriatic arthritis. 

  • At baseline, the mean PASI was 13.6 and 53.1% of patients had difficult-to-treat area involvement. 

Key findings1 

  • A total of 40 patients completed 28 weeks of treatment. 

  • Over the 28 weeks of treatment, there was a notable increase in the percentage of patients achieving 75% improvement in PASI, 90% improvement in PASI, and 100% improvement in PASI. The percentage of patients achieving 75% improvement in PASI increased from 34% at Week 4 to 77.5% at Week 28. 

  • 29.8%, 64.4%, and 82.5% had a PASI score ≤2 after 4 weeks, 16 weeks, and 28 weeks of treatment, respectively. 

  • The percentage of patients achieving a PGA of clear or almost clear in all the difficult-to-treat areas increased from baseline to Week 24. Over 70% of patients in all difficult-to-treat areas achieved a clear PGA at Week 24 (Figure 1). 

  • There were no severe adverse events reported to Week 28. 

Figure 1. PGA scores at Week 24 for difficult-to-treat areas* 

PGA, Physician Global Assessment. 
*Data from Orsini, et al.1 Created with Biorender.com. 

 

Key learnings

  • In this study, tildrakizumab treatment led to improvements in PGA score for difficult-to-treat areas in elderly patients with plaque psoriasis. 

  • The findings of this study are consistent with other real-world experiences, with higher efficacy outcomes compared with phase III trials of tildrakizumab. 

  • Additional longer-term studies, with greater patient numbers are needed to evaluate the most effective long-term treatment for elderly patients with psoriasis. 

  1. Orsini D, Caldarola G, Dattola A, et al. Efficacy and safety of tildrakizumab in elderly patients: real-world multicenter study (ESTER – study). J Dermatolog Treat. 2024;35(1):2319304. DOI: 10.1080/09546634.2024.2319304 

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