Studies Presented at AAD Examine Safety and Satisfaction of Tildrakizumab for Psoriasis

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A postmarketing study presented at the American Academy of Dermatology 2023 Annual Meeting looked at how the biologic tildrakizumab (Ilumya) performed in real-world clinical settings in patients with moderate-to-severe plaque psoriasis.

Psoriasis is a chronic systemic inflammatory disorder that can significantly affect a person’s emotional and psychological well-being. Tildrakizumab, an anti-interlukin-23 p19 monoclonal antibody, demonstrated safety in patients with moderate-to-severe plaque psoriasis in the Phase 3 reSURFACE 1 (NCT01722331) study and reSURFACE 2 (NCT01729754) trials. However, limited real-world evidence demonstrated the safety of tildrakizumab.

In this phase 4 study, tildrakizumab showed favorable safety in this patient population.¹ The study screened 60 patients, with key criteria being aged 18 years or older, with moderate-to-severe plaque psoriasis, who were candidates for phototherapy or systemic therapy, and who had no active or untreated latent tuberculosis. Of the total, 55 patients were enrolled in the study, with other patients excluded for erythrodermic psoriasis, only pustular, guttate, or inverse psoriasis, and other skin conditions that could interfere with evaluation.

Patients enrolled were treated with tildrakizumab 100mg, administered by qualified staff at weeks 0 (baseline), 4, 16, 28, 40, and 52.

The researchers evaluated patient health-related quality of life (HRQoL), which examined change from baseline in Psychological General Well-Being Index (PGWBI) total score at week 28 and week 52, and the incidence, severity, and causality of adverse events.

Overall, 45 patients (81.8%) completed the study and 36 (65.5%) received all doses of tildrakizumab through week 52. Additionally, 34 (61.8%) patients experienced a total of 85 treatment-emergent adverse events (TEAEs). The most common TEAEs included skin and subcutaneous tissue disorders (20%), infections and infestations (16.4%), nervous system disorders (12.75), musculoskeletal and connective tissue disorders (10.9%), and gastrointestinal disorders (10.9%).

Of the total adverse events, 63 were mild in severity, 18 were moderate, and 4 were severe. Of the serious TEAEs identified, 2 were resulted in treatment discontinuation. No TEAEs were found to be related to tildrakizumab treatment.

Overall, tildrakizumab showed effective safety in patients with severe-to-moderate plaque psoriasis for up to 64 weeks in a real-world setting.

Patients Report Satisfaction with Tildrakizumab

Additionally, in the phase 4 study, patients reported significant improved satisfaction when treated with tildrakizumab.²

Treatment dissatisfaction among patients with moderate-to-severe plaque psoriasis is a known issue within clinical settings. In this study, researchers aimed to report overall patient satisfaction and specific treatment aspects after 64 weeks of treatment with tildrakizumab.

The researchers evaluated patient satisfaction using the Treatment Satisfaction Questionnaire for Medication (TSQM), which included effectiveness, side effects, convenance, and global satisfaction. Overall treatment satisfaction was measured by improvement in symptoms, speed of improvement, frequency of dosing, and side effects. Lastly, the researchers evaluated happiness with patient control of their psoriasis.

Demographically, the study included 27 females and 28 males. Most patients were White (52), with 2 Black or African American patients, and 1 Asian patient. Additionally, 50 patients (90.9%) were not Hispanic or Latino, and 5 (9.1%) were Hispanic or Latino. Patients had a mean age standard deviation (SD) of 48.6 (15.3), and mean SD happiness with psoriasis control of 2.7 (2.3).

As a result, the mean TSQM scores increased from week 4 to week 64, convenience score remained stable, and 6 or fewer patients reported a Side Effects domain score. Overall tildrakizumab satisfaction scores increased across all domains from week 4 to week 64. Lastly, happiness with psoriasis control increases significantly from baseline to week 64 (P <.01).

Overall, this study suggests that patients reported significant improvements in satisfaction when treated with tildrakizumab in a real-world setting.

References

1. Gabriel Vasquez J, Bhatia N, Schenkel B, et al. Safety of tildrakizumab in a Phase 4 real-world study in patients with moderate-to-severe plaque psoriasis. Abstract presented at: American Academy of Dermatology; March 17-21, 2023. New Orleans, Louisiana. Poster 422295

2. Bhatia N, Gabriel Vasquez J, Schenkel B, et al. Patient satisfaction with tildrakizumab treatment in a Phase 4 real-world study of tildrakizumab in patients with moderate-to-severe psoriasis. Abstract presented at: American Academy of Dermatology; March 17-21, 2023. New Orleans, Louisiana. Poster 42281