Patient- and Clinician-Reported Outcomes of Tirbanibulin 1% in the Treatment of Actinic Keratosis on the Face and Scalp (PROAK Study)

Abstract

Introduction: Actinic Keratosis (AK) has been shown to negatively affect emotional and social functioning and skin-related quality of life [1]. The objective was to evaluate clinician- and patient-reported outcomes (ClinRO; PRO) for tirbanibulin treatment satisfaction and effectiveness among patients administered tirbanibulin in routine clinical practice across the U.S.
 Methods: A single-arm, prospective cohort study (PROAK: NCT05260073) was conducted in adults with AKs on the face or scalp as part of usual care. Patients and clinicians completed surveys and clinical assessments at baseline, Week-8, and Week-24. ClinRO and PRO comprised Treatment Satisfaction Questionnaire for Medication (TSQM-9) (with 3 domains: treatment effectiveness, convenience of use, and global satisfaction with treatment) and Expert Panel Questionnaire (EPQ) (assessing overall skin appearance, satisfaction with improvement in “skin texture” and “how skin looks”, and likelihood to consider tirbanibulin again). Clinicians assessed AK responses using Investigator's Global Assessment (IGA) and patient’s skin photodamage severity scale. IGA success was defined as achieving IGA score of 0-1 (≥75% AK lesions clearance). Data at Week-8 was already published [1]. Here we present the results obtained at Week-24.
 Results: A total of 278 patients completed study assessments at Week-24 (mean age: 66.3 years; 68.6% males; Fitzpatrick skin type II: 71.4%). Mean (standard deviations [SD]) TSQM-9 score in effectiveness, convenience and global satisfaction was 74.3 (21.2), 84.5 (15.6) and 74.9 (23.9) for clinicians and 73.4 (21.4), 85.0 (14.7) and 71.9 (24.7) for patients. 77.3% of clinicians and 78.4% of patients reported a high likelihood for considering tirbanibulin treatment in the future. At Week-24, 83.6% of clinicians and 78.5% of patients rated overall skin appearance after tirbanibulin treatment to be mostly somewhat/much improved. At Week-24, the proportion of patients with completely/partially cleared AK (IGA 0/1) was 71.9%, similar to that obtained at Week-8 (73.8%) [1].
 Conclusions: Effectiveness ≥75% clearance was achieved by 71.9% of patients, consistent with the results of the Phase III trials [2]. ClinRO and PRO demonstrated high satisfaction with once-daily tirbanibulin treatment for 5 consecutive days at Week-24, and both clinicians and patients reported a desire to consider tirbanibulin treatment in the future.
 [1] Schlesinger T et al. Skin. 2023;7(3):771-787.
 [2] Blauvelt A et al. N Engl J Med. 2021;384(6):512–20.