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Long-term, real-world data show the IL-23 inhibitor benefits patient-reported measures of psychological wellbeing.
Tildrakizumab, a monoclonal antibody interleukin 23 (IL-23) inhibitor approved by the US Food and Drug Administration (FDA) to treat moderate to severe plaque psoriasis, has been previously associated in clinical trials with improved quality of life metrics among study participants.
But now, investigators have available data showing quick, significant and sustained quality-of-life improvement among real-world patients receiving the drug for their plaque psoriasis—with benefit evidenced as far out as 64 weeks.
In new data presented at the Society of Dermatology Physician Assistants (SDPA) 2022 Annual Meeting in Miami, FL this week, a team of investigators supported by Sun Pharmaceuticals reported that measures including Psychological General Well-Being Index (PGWBI) total score and Dermatology Life Quality Index (DLQI) significantly improved among real-world psoriasis patients receiving long-term tildrakizumab.
Led by Jayme Heim, MSN, FNP-BC, a family nurse practitioner with West Michigan Dermatology, investigators sought to interpret improvements in health-related quality of life and treatment satisfaction among patients taking tildrakizumab to treat moderate to severe plaque psoriasis for up to 64 weeks. Due to its chronic, symptom-laden burden on patients’ skin, psoriasis is well established to negatively impact individuals’ emotional and psychological wellbeing, Heim and colleagues noted.
“Tildrakizumab’s efficacy was associated with better skin-related quality of life in the phase 3 reSURFACE 1 and reSURFACE 2 trials, but there is limited available real-world evidence regarding overall health-related quality of life and treatment satisfaction with tildrakizumab in patients with moderate-to-severe plaque psoriasis,” they wrote.
They conducted a phase 4, 64-week, uncontrolled, open-label, real-world assessment of immunocompetent patients ≥18 years old with moderate to severe disease receiving 100 mg tildrakizumab at weeks 0, 4, 16, 28, 40, and 52. The trial’s primary endpoint was improvement in PGWBI total score from baseline, with patient questionnaires completed at baseline and during each treatment appointment. Improvement in psychological wellbeing is reflected as an increased score in PGWBI.
The team additionally sought secondary endpoints including improvement in DLQI score from baseline, and patient satisfaction per Treatment Satisfaction Questionnaire for Medication (TSQM). For each questionnaire, improved patient status is reflected as increased scores.
Investigators recruited 55 patients; 45 were assessed at the study’s end at 64 weeks. Approximately half the patient were male (50.9%); nearly all were White (94.5%). Mean patient age was 48.6 years old; baseline total PGWBI among patients was 78.1, and baseline mean DLQI was 9.4.
Heim and colleagues observed a 5.1-point improvement in mean total PGWBI score from baseline to week 64, reaching 83.2 at trial’s end (P = .01).The domains of PGWBI to improve most significantly among patients were senses of Positive Wellbeing and General Health.
Additionally, mean DLQI scores improved significantly among tildrakizumab-treated patients—observed by week 4 and maintained through week 64 (P <.01). Mean TSQM scores improved gradually in patients as well, reaching 81.9 at week 64.
Investigators concluded the long-term findings further support real-world quality-of-life and wellbeing benefit among patients treating their psoriasis with tildrakizumab.
“Treatment with tildrakizumab in patients with psoriasis in a real-world setting significantly improved quality of life as measured by the PGWBI and DLQI,” they wrote. “Patient satisfaction as measured by the TSQM-Global Satisfaction domain improved throughout the study and peaked at Week 64.”
The study, “Patients’ quality of life and satisfaction with treatment in a phase 4 real-world study of tildrakizumab in moderate-to-severe plaque psoriasis,” was presented at SDPA 2022.