Impact of Actinic Keratosis (AK), as measured by patient-reported AK symptoms, and impact on emotions and functioning (using Skindex-16) among patients with AK administered tirbanibulin in real-world community practices across the U.S. (PROAK Study)

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Leon Kircik
Todd Schlesinger
April Armstrong
Brian Berman
Neal Bhatia
James Del Rosso
Mark Lebwohl
Vishal A. Patel
Darrell Rigel
Siva Narayanan
Volker Koscielny
Ismail Kasujee


Actinic Keratosis, AK, PROAK, Patient Reported Outcomes, PROs, Real World Evidence, RWE, Skindex-16, tirbanibulin, Symptoms, Emotions, Functioning


Introduction: Actinic Keratosis (AK) has been shown to negatively affect emotional functioning and skin-related quality of life of patients. Impact of tirbanibulin treatment on patients with AKs is not adequately understood. The primary objective of the study was to evaluate patient-reported outcomes in terms of AK symptoms, and impact of AKs on emotions and functioning, among AK patients treated with tirbanibulin in community practices across the U.S. Methods: A single-arm, prospective cohort study (PROAK) was conducted among adult patients with AK of the face or scalp who were newly initiated with tirbanibulin treatment in real-world community practices in the U.S, as part of usual care. Patients and clinicians completed surveys and clinical assessments at baseline, Week-8 (timeframe for main endpoints) and Week-24. Skindex-16, completed at baseline and Week-8, is a 16-item survey with 3 domains: symptoms (4 items), emotions (7 items) and functioning (5 items), with each domain score computed on a scale of 0 to 100 with higher score indicating severe impairment due to AKs. Changes from baseline in Skindex-16 scores were analyzed. Results: A total of 290 AK patients completed the study assessments at Week-8 (female: 31.38%; history of skin cancer: 61.72%; Fitzpatrick skin type: I: 7.59%, II: 71.38%, III: 18.62%, IV: 1.38%, V: 1.03%). Patient self-reported skin-texture was – dry: 39.66%, smooth: 47.59%, rough: 19.66%, bumpy: 18.62%, scaly: 35.17%, blistering/peeling: 6.55%. Baseline Skindex-16 domain scores were: symptoms: 22.30, emotions: 38.17, functioning: 14.41. At Week-8, a statistically significant (p<0.0001) decrease in scores from baseline was observed for all Skindex-16 domains, with Week-8 domain scores being: symptoms: 8.15, emotions: 13.49, functioning: 4.63. Conclusion: Patients with AKs who used once-daily tirbanibulin treatment for 5-days reported a significant reduction in AK burden, as indicated by the improvement in AK symptoms and emotional/functional impact, at Week-8.



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