Real-World Effectiveness and Safety of Field- and Lesion-Directed Treatments for Actinic Keratosis

August 2020 | Volume 19 | Issue 8 | Original Article | 756 | Copyright © August 2020

Published online July 31, 2020

Jes B. Hansen PhDa, Thomas Larsson PhDa, Nikeshia Dunkelly-Allen PharmDb, Karen A. Veverka PhDb, Steven R. Feldman MD PhDc

aLEO Pharma A/S, Ballerup, Denmark bLEO Pharma Inc, Madison, NJ cDepartment of Dermatology, Wake Forest University School of Medicine, Winston-Salem, NC

Background: Real-world data for actinic keratosis treatment in the United States is lacking.
Objectives: To understand real-world treatment patterns for actinic keratosis by type and modality, and compare effectiveness and safety of therapies, either alone or in combination.
Methods: Medical charts of 429 patients were identified; clinical and outcome data were analyzed.
Results: The first treatment after the index diagnosis was most frequently a procedure, followed by a topical agent. Treatment with 5-fluorouracil, ingenol mebutate, imiquimod, cryotherapy, or cryotherapy plus one topical (CRYO+One Topical) reduced actinic keratoses by 66.0%, 69.3%, 72.5%, 72.9%, and 73.0%, respectively; ≥75% clearance (AKCLEAR 75) was achieved in 57.1%, 72.7%, 57.1%, 62.4%, and 62.0% of those patients. Treatment effectiveness was positively correlated with the number of baseline actinic keratoses for topical and for procedural plus topical combination treatments, but not for procedural treatments alone. Adverse reactions (ARs) were more common with cryotherapy (9.7%); local skin responses (LSRs) were more common with field-directed (18.5%-43.1%) and CRYO+One Topical therapy (21.3%).
Limitations: This was a retrospective study of limited duration and population size.
Conclusions: The most commonly used treatments for patients with 6 or more actinic keratoses were topicals and a procedure plus topical combination, which also achieved higher rates of complete clearance than a procedure alone. ARs and LSRs were few in frequency and type. J Drugs Dermatol. 2020;19(8):756-762. doi:10.36849/JDD.2020.5123


Actinic keratosis is a chronic skin condition characterized by the formation of poorly delimited keratotic lesions of variable thickness that occur on areas of the skin subject to long-term exposure to the sun or ultraviolet radiation.1,2 It is the second most common condition diagnosed by dermatologists in the United States.3 Patients with actinic keratosis typically have fair skin and are of advanced age, representing a lifetime history of sun exposure.4-6 On average, most patients have 6 to 8 actinic keratoses that are surrounded by a field of photodamaged skin.1,4 The occurrence of actinic keratosis is a major cause of concern, as it can progress to squamous cell carcinoma (SCC), with the annual rate of transformation estimated at 0.025% to 16%.4 Actinic keratosis is the biggest risk factor for the development of SCC,7 and the risk of progression to SCC increases with the number of actinic keratoses.3 Therefore, preventative treatment is recommended toward the goal of reducing recurrence and the percentage of patients who progress to invasive SCC.6

The treatment approach for actinic keratosis is influenced bymany factors, including the number of keratotic lesions, the presence of actinic sun damage, and whether the patient is immunocompromised.6 Treatment options may be broadly classified into lesion-directed, field-directed, and combination therapies.6 Field-directed therapies target both visible and nonvisible, subclinical actinic keratoses; subclinical actinic keratoses are estimated to occur up to 10 times more frequently than visible ones.6,8 Field-directed therapies are strongly recommended for patients who have multiple (6 or more) actinic keratoses.6

Little comparative real-world data are available for actinic keratosis treatment options, either as monotherapies or in combination.7,9,10 To shed light on real-world outcomes and practice patterns for this condition, we conducted a retrospective medical chart review of patients with different actinic keratosis severities. Reported here are real-world outcomes indicating treatment effectiveness and safety in patients who received a range of therapies: procedural, lesion-directed, field-directed, or a combination of lesion- and field-directed therapy.