Patient- and Clinician-Reported Outcomes for Tirbanibulin in Actinic Keratosis in Clinical Practice Across the United States (PROAK)
May 2024 | Volume 23 | Issue 5 | 338 | Copyright © May 2024
Published online April 29, 2024
Todd Schlesinger MDa, Leon Kircik MDb,c, Mark Lebwohl MDb, Vishal A. Patel MDd, Brian Berman MD PhDe, Neal Bhatia MDf, Darrell Rigel MD MSg, April Armstrong MDh, James Del Rosso DOi,j,k, Siva Narayanan PhDl, Volker Koscielny MDm, Ismail Kasujee PhDm
aClinical Research Center of the Carolinas, Charleston, SC
bIcahn School of Medicine at Mount Sinai, New York, NY
cSkin Sciences, PLLC, Louisville, KY
dGeorge Washington School of Medicine and Health Sciences, Washington, DC
eUniversity of Miami Miller School of Medicine, Miami, FL
fTherapeutics Clinical Research, San Diego, CA
gNYU Grossman School of Medicine, New York, NY
hUniversity of California, Los Angeles, CA
iJDR Dermatology Research/Thomas Dermatology, Las Vegas, NV
jTouro University Nevada, Henderson, NV
kAdvanced Dermatology and Cosmetic Surgery, Maitland, FL
lAvant Health LLC, Bethesda, MD
mAlmirall SA, Barcelona, Spain
Abstract
Background: The Patient-Reported Outcomes in Actinic Keratosis (PROAK) study evaluated patient- and clinician-reported outcomes (PRO; ClinRO) during 24 weeks of follow-up among adult patients with actinic keratosis (AK) on the face or scalp who were administered tirbanibulin 1% ointment in real-world community practices in the United States.
Methods: Quality of life (QoL) was assessed by Skindex-16 at week (W) 8. Additionally, effectiveness (Investigator Global Assessment [IGA]), PRO and ClinRO (Treatment Satisfaction Questionnaire for Medication and Expert Panel Questionnaire), safety, and tolerability were assessed at W8 and W24.
Results: The safety population included 300 patients; the full analysis set included 290 patients (278 patients at W24). At W8, a statistically significant difference (P<0.03) was observed for Skindex-16 domains in all assessed subgroups. Clinicians and patients reported high global satisfaction (mean [SD] scores of 74.9 [23.9] and 72.0 [24.6], respectively) at W24. Overall skin appearance improved from baseline to W24 (83.6% clinicians; 78.5% patients). IGA success (IGA score of 0-1) was achieved by 71.9% of patients at W24 with a similar % at W8 (73.8%) suggesting a stable effectiveness over time. About 5% of patients reported at least one adverse event, 4% reported at least one serious adverse event and no patients reported serious adverse drug reactions. At W8, the most frequently reported local skin reactions were mild/moderate erythema (47.6%) and flaking/scaling (49.6%).
Conclusions: Treatment with tirbanibulin demonstrated effectiveness in the management of AK lesions and a favorable safety and tolerability profile. Furthermore, QoL was improved as early as W8, and both patients and clinicians reported high levels of treatment satisfaction, independently of patients' characteristics.
J Drugs Dermatol. 2024;23(5):338-346. doi:10.36849/JDD.8264
INTRODUCTION
Actinic keratoses (AKs) are epithelial lesions caused by ultraviolet radiation and cumulative sun exposure that have the potential to progress to invasive as squamous cell carcinoma (SCC) if left untreated.
1-5 AKs appear mainly in visible areas, impairing patients' quality of life (QoL).
3,6 Moreover, QoL can also be compromised by treatment characteristics, treatment-induced local skin reactions (LSR), and recurrence rates, impacting treatment adherence and leading to poor outcomes.
2,4,7 Patient-reported outcomes (PRO) and clinician-reported outcomes (ClinRO) inform about patients' health status and experience with treatment.
5 Comparing patient and clinician perspectives contributes to better patient management, enhancing clinician-patient communication.
7,8
Tirbanibulin is a reversible tubulin polymerization inhibitor with potent anti-proliferative and anti-tumoral effects. It was approved by the United States (US) Food and Drug Administration for the topical treatment of AK on the face or scalp in 2020 and by the European Medicines Agency in 2021.2,9
