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)

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.