Can Klisyri (tirbanibulin) be used for field treatment of actinic keratosis?

Klisyri (Tirbanibulin) for Field Treatment of Actinic Keratosis

Klisyri (tirbanibulin) is specifically FDA-approved and recommended for field treatment of actinic keratosis on the face or scalp, with strong evidence supporting its efficacy and safety for this indication. 1, 2

Indication and Approval Status

Tirbanibulin 1% ointment (Klisyri) received FDA approval in December 2020 specifically for field-directed treatment of actinic keratosis (AK) on the face or scalp. The American Academy of Dermatology has issued a strong recommendation with high certainty evidence for its use in field treatment of AK. 2

Treatment Protocol and Application

• Application area: FDA-approved for treatment fields up to 100 cm² on face or balding scalp 1
• Dosing regimen: Once daily application for 5 consecutive days 1
• Administration: Apply evenly using one unit-dose packet per application 1
• Post-application care:
  • Wash hands immediately after application
  • Avoid washing or touching treated area for approximately 8 hours
  • Avoid application near eyes, mouth, and lips 1

Efficacy for Field Treatment

Tirbanibulin has demonstrated significant efficacy as a field treatment:

• Complete clearance rate: 49.3% of patients achieved complete clearance by day 57 in phase III trials 2
• Lesion reduction: 77.8% mean reduction in AK lesion count when used on larger treatment fields (100 cm²) 3
• Real-world effectiveness: Significant reduction in AKASI (actinic keratosis area and severity index) scores, with 47% of patients achieving complete clearance at first follow-up 4

Advantages for Field Treatment

1. Short treatment duration: 5-day application period versus weeks to months for other topical agents 5
2. Favorable tolerability profile: Primarily mild-to-moderate local skin reactions that resolve spontaneously 3, 6
3. Mechanism of action: Addresses pathways upregulated in AK by inhibiting tubulin polymerization and disrupting Src kinase signaling 2
4. Expanded treatment area: Recent evidence supports safety when used on larger fields (up to 100 cm²) 3

Side Effects and Safety Considerations

Most common local skin reactions include:

• Erythema (96.1% of patients)
• Flaking/scaling (84.4% of patients)
• Application site pruritus (10.5%)
• Application site pain (8.6%) 3

These reactions are typically mild-to-moderate and resolve spontaneously by day 29 without sequelae. 4, 3

Comparison to Other Field Treatments

While 5-fluorouracil remains a first-line therapy for field treatment of AK according to guidelines 2, 7, tirbanibulin offers advantages:

• Treatment duration: 5 days for tirbanibulin vs. 2-4 weeks for 5-FU 5% or 16 weeks for imiquimod 5% 2, 7
• Tolerability: Milder local skin reactions compared to more severe reactions often seen with 5-FU 6, 5
• Adherence: Shorter treatment duration may improve patient adherence 6

Clinical Pearls and Pitfalls

• Avoid occlusion after application as this increases risk of irritation 1
• Do not use on skin that hasn't healed from previous treatments or procedures 1
• Avoid transfer to periocular area to prevent eye irritation 1
• Cost considerations: May be prohibitive without adequate insurance coverage 2
• Treatment area limitations: Initially approved for 25 cm² areas, though recent evidence supports safety on larger areas up to 100 cm² 1, 3

Tirbanibulin represents an important addition to the treatment arsenal for field therapy of actinic keratosis, offering a shorter treatment duration with favorable efficacy and tolerability profile compared to traditional options.