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SAFETY & TOLERABILITY

KLISYRI® (tirbanibulin) WAS GENERALLY WELL-TOLERATED, WITH NO PATIENTS DISCONTINUING USE DUE TO TOLERABILITY ISSUES1

Almost all participants had local skin reactions (LSRs), mostly transient and mild/moderate.2

Other most common AEs were application-site pruritus and application-site pain, which resolved without intervention.1

None of the LSRs required treatment.2

Overall, LSRs peaked 8 days after starting the treatment and typically resolved within 2 to 3 weeks after completion of treatment with tirbanibulin ointment.2

LOCAL SKIN REACTIONS
All different types of severe LSRs had an incidence of <10%1

MOST LSRs WERE MILD TO MODERATE AND RESOLVED WITHOUT TREATMENT1

6 LSRs (erythema, flaking or scaling, crusting, swelling, vesiculation or pustulation, erosions or ulceration) were recorded independently using a grading scale: 0=absent, 1=mild (slightly, barely perceptible), 2=moderate (distinct presence), and 3=severe (marked, intense).

*Composite score was the sum of the 6 items at each visit (0 to 18).

References
1. Blauvelt A, Kempers S, Lain E et al. Phase 3 Tirbanibulin for Actinic Keratosis Group. Phase 3 Trials of Tirbanibulin Ointment for Actinic Keratosis. N Engl J Med. 2021 Feb 11;384(6):512. 2. KX01-AK-01-US CSR. A Phase I, single-centre, safety, tolerability and pharmacokinetic study of KX2-391 ointment 1% in subjects with actinic keratosis.

UK-ILU-2100106 September 2021

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