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)

Main Article Content

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


AK, Actinic Keratosis, tirbanibulin, IGA, Real World Evidence, RWE, PROAK, Clinician Reported Outcomes


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.



Most read articles by the same author(s)

1 2 3 4 5 6 7 8 9 10 > >>