Investigator Global assessment (IGA) of Actinic Keratosis (AK) among patients administered tirbanibulin in real-world community practices across the U.S., and clinician likelihood to consider tirbanibulin again for future AK treatments (PROAK Study)

Introduction: Actinic Keratosis (AK) are epidermal lesions with potential to progress to squamous cell carcinomas if left untreated. AKs have also been shown to negatively affect emotional functioning and skin-related quality of life of patients. The primary objective of the analysis was to evaluate IGA success at Week-8, and clinician-reported likelihood to consider tirbanibulin again for future treatments, among patients with AKs administered tirbanibulin in community practices across the U.S. Methods: A single-arm, prospective cohort study (PROAK) was conducted among adult patients with AKs on 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. Clinicians assessed AK responses using an IGA on a five-point adjectival response scale of 0 (completely cleared), 1 (partially cleared), 2 (moderately cleared), 3 (minimally cleared) and 4 (not cleared). IGA success was defined as achieving an IGA score of 0 or 1 at Week-8. Clinicians also reported their likelihood to reuse tirbanibulin treatment for their patients, as a surrogate measure of satisfaction with the treatment. 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%). At Week-8, proportion of patients with completely/partially cleared AK (Approximately 75-100% clearance of AK lesions in the treated area, IGA 1/0) was 73.79%; moderately cleared (IGA 2) was 17.24%, and minimally cleared/not cleared (IGA 3/4) was 8.97%. Correspondingly, IGA success in this cohort of patients treated with tirbanibulin was 73.79%. Proportion of patients for whom clinicians noted that they would ‘somewhat or very likely’ consider tirbanibulin treatment again, if need arises, was 85.17%, with 7.59% reporting a neutral response, and 7.24% reporting ‘somewhat or very unlikely’ to consider treatment with tirbanibulin again. Conclusion: Overwhelming majority of patients with AK using tirbanibulin experienced IGA success at Week-8, and an overwhelming majority of clinicians reported their desire to consider tirbanibulin again to treat AK lesions for their patients.