Patient- and Clinician-reported Outcomes, Safety and Efficacy Profile of Tirbanibulin 1% for Actinic Keratosis Under Conditions Close to Routine Clinical Practice in Spain and Italy (TIRBASKIN Study).

OBJECTIVE

To assess patient- and clinician-reported outcomes, efficacy, and safety of tirbanibulin 1% administered to patients with actinic keratoses (AKs) in Spain and Italy.

METHODS

TIRBASKIN is a multicenter, single-cohort, phase IV, low-interventional clinical study conducted among adults with 4-8 AK lesions on the face or scalp in an area ≤25cm2. Patients applied tirbanibulin for 5 consecutive days. The primary endpoint was treatment satisfaction on day 57 (D57), assessed with the Treatment Satisfaction Questionnaire for Medication 9 (TSQM-9). Efficacy was assessed by the percentage of patients with complete clearance (CC) and partial clearance (PC) at D57. Tolerability was assessed by local tolerability signs (LTSs), also known as local skin reactions.

RESULTS

A total of 328 patients (mean age, 74.8 years; male, 83.5%; Fitzpatrick skin type II, 53.7%; AKs on the scalp, 52.7%) completed study assessments at D57. Patients reported high levels of satisfaction with tirbanibulin as assessed by TSQM-9 (effectiveness mean score, 73.6; convenience mean score, 82.8; global satisfaction mean score, 76.9). Moreover, 87.7% of clinicians and 81.8% of patients reported overall satisfaction with tirbanibulin as much/somewhat better compared with previous topical treatment. In addition, 87.1% of clinicians and 86.3% of patients reported a likelihood of reconsidering tirbanibulin in the future, if needed. CC was achieved by 54.3% of patients and PC by 76.2%. At D8, the most frequent LTSs were erythema/redness (mild/moderate, 72.2%; severe, 2.2%) and flaking/scaling (mild/moderate, 34.6%; severe, 0.6%), which had mostly resolved by D57.

CONCLUSIONS

Patients' and clinicians' satisfaction was high, and both groups reported a high likelihood of using tirbanibulin again, if needed.