Safety and tolerability of tirbanibulin ointment 1% treatment on 100 cm

Background

Tirbanibulin is approved for actinic keratosis (AK) field treatment up to 25 cm

Objective

Evaluate the safety and tolerability of tirbanibulin when applied to a field of approximately 100 cm

Methods

Phase 3, multicenter, open-label, single-arm study among adult patients having a treatment field on the face or balding scalp of approximately 100 cm

Results

A total of 105 patients were included. The most common LTS were erythema (96.1%) and flaking/scaling (84.4%), being mostly mild-to-moderate severity, and resolved/returned to or close to baseline by Day 29. The only severe LTS were erythema (5.8%) and flaking/scaling (8.7%). Most frequent treatment emergent adverse events were application site pruritus (10.5%) and application site pain (8.6%). Mean total number of AKs decreased from 7.7 AKs at baseline to 1.8 AKs at Day 57. Mean percent of change (reduction) from baseline in lesion count was 77.8% at Day 57.

Limitations

No control group. No long-term follow-up.

Conclusion

Safety and tolerability profiles in patients treated with tirbanibulin up to 100 cm

Informations de copyright

© 2024 by the American Academy of Dermatology, Inc. Published by Elsevier Inc.

Déclaration de conflit d'intérêts

Dr Bhatia is a consulting honoraria from and investigator for Almirall, Biofrontera, Leo, Ortho, and Sun Pharma. Dr Blauvelt is a speaker (received honoraria) for AbbVie, Eli Lilly and Company, Pfizer, and UCB; scientific adviser (received honoraria) for AbbVie, Abcentra, Aclaris, Affibody, Aligos, Almirall, Alumis, Amgen, Anaptysbio, Apogee, Arcutis, Arena, Aslan, Athenex, Bluefin Biomedicine, Boehringer Ingelheim, Bristol Myers Squibb, Cara Therapeutics, CTI BioPharma, Dermavant, EcoR1, Eli Lilly and Company, Escient, Evelo, Evommune, Forte, Galderma, HighlightII Pharma, Incyte, InnoventBio, Janssen, Landos, Leo, Lipidio, Microbion, Merck, Monte Rosa Therapeutics, Nektar, Novartis, Overtone Therapeutics, Paragon, Pfizer, Q32 Bio, Rani, Rapt, Regeneron, Sanofi Genzyme, Spherix Global Insights, Sun Pharma, Takeda, TLL Pharmaceutical, TrialSpark, UCB Pharma, Union, Ventyx, Vibliome, and Xencor; and clinical study investigator (institution has received clinical study funds) for AbbVie, Acelyrin, Allakos, Almirall, Alumis, Amgen, Arcutis, Athenex, Boehringer Ingelheim, Bristol-Myers Squibb, Concert, Dermavant, Eli Lilly and Company, Evelo, Evommune, Galderma, Incyte, Janssen, Leo, Merck, Novartis, Pfizer, Regeneron, Sanofi, Sun Pharma, UCB Pharma, and Ventyx. Dr Lain is a clinical investigator, consultant, advisor, and/or paid speaker for Almirall, Athenex, Gage Pharmaceuticals, UCB, Abbvie, Sanofi, Regeneron, Vyne Pharmaceuticals, Pfizer, Amgen, Novartis, Eli Lilly, Kadmon, Chemocentryx, Bausch Health, Galderma, Dermavant, Arcutis, Bristol Myers Squibb, Kiniksa, Mindera, Sebacia, Pulse BioSciences, Leo Pharmaceuticals, Aclaris, Biorasi, Brickell, Cassiopea, Dr Reddy, Endo Pharmaceuticals, and G&E Herbal Biotechnology. Dr Jarell is an investigator of or received grants/research funding from AbbVie, Almirall, Arcutis Biotherapeutics, Arcutis, Inc, Asana Biosciences, LLC, BMS, Castle Biosciences, Concert Pharmaceuticals, Dermira, Foamix Pharmaceuticals Ltd, Incyte Corporation, Leo Pharma Inc, Lilly ICOS LLC, Novartis, Sanofi/Regeneron, UCB, Vivex Biomedical, Inc. Dr DuBois is an investigator of or received grants/research funding from AbbVie, AiViva BioPharma, Allergan, Inc, Almirall, AnaptysBio, Arcutis Biotherapeutics, Bausch Health, Biofrontera, Bristol-Myers Squibb, Caliway Biopharmaceuticals Co, Ltd, Cara Therapeutics, Croma-Pharma GmbH Austria, Dermata Therapeutics, DermBiont, Dr Reddy, Endo Pharmaceuticals, Evommune, Inc., Galderma USA, Incyte Corporation, LEO Laboratories Ltd (LEO Pharma), Merck, Moberg Pharma, Palvella Therapeutics, RAPT Therapeutics, Scarless Laboratories, Therapeutics Inc, Veradermics Inc. Drs Tamarit, Falques, Kiyasova, Padulles, and Otero are employees of Almirall Spain.