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STRENGTH FOR ACTINIC KERATOSIS, TOLERABILITY FOR PATIENTS1,2

KLISYRI®(tirbanibulin) is indicated for the field treatment of non-hyperkeratotic, non-hypertrophic actinic keratosis (Olsen grade 1) of the face or scalp in adults.2
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NOVEL MoA

FOR THE TREATMENT OF AK

Inhibition of tubulin polymerisation causing apoptosis2-6

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COMPLETE AK

CLEARANCE

At day 57, nearly half of patients treated with KLISYRI® (49%, n=174/353) achieved complete clearance vs 9% of patients treated with vehicle (n=30/349, p<0.0001)1

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GENERALLY WELL-TOLERATED

FIELD THERAPY

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

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CONVENIENT

SHORT TREATMENT COURSE

Once daily dose for only 5 consecutive days1,2,7

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NOVEL MoA

KLISYRI®, a topical therapy with a novel mechanism of action3-6

KLISYRI® is a novel inhibitor of tubulin polymerisation that induces cell cycle arrest and, ultimately, apoptotic cell death3-5

These events promote a potent antiproliferative effect resulting in clearance of the lesions through mainly mild or moderate LSRs which are resolving spontaneously3-6

Press play to see for yourself how KLISYRI® delivers strength with tolerability.

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AK CLEARANCE

KLISYRI® applied once-daily for just five days offers significant complete AK clearance at day 571,2 in 49% of patients.

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FACE*

50% – 61%
60/119 73/119

complete clearance1

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SCALP**
30% – 41%
60/119 73/119

complete clearance1

*vs vehicle: 6%-14% (p<0.001) | **vs vehicle: 2%-11% (p<0.001) (% range across both trials presented)

For the subgroup analyses (face and scalp) confidence intervals were not adjusted for multiple comparisons and no clinical conclusions can be drawn from this data.

KLISYRI® applied once-daily for just five days offers significant partial AK clearance at day 571,2

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7 out of 10 patients achieved 75% clearance
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SAFETY PROFILE

KLISYRI® was generally well-tolerated, with no patients discontinuing use due to tolerability issues1

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Almost all participants had LSRs, mostly transient and mild/moderate.1

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Other most common AEs were application-site pruritus and application-site pain, which resolved without intervention 1
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None of the LSRs required treatment. 1
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Overall, LSRs peaked 8 days after starting the treatment and typically resolved within two to three weeks after completion of treatment with tirbanibulin ointment 1
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LSRs were graded as absent, mild (slightly or barely perceptible), moderate (distinct presence), and severe (marked or intense). Please consult the SPC for full information on LSRs

Adapted from Blauvelt A, et al. N Engl J Med. 2021;384(6):512-520.
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KLISYRI®, SHORT TREATMENT COURSE WITH JUST 5 DAYS OF TREATMENT2

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Once a day for only 5 consecutive days2

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Compliance was over 99% in the trial setting1

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KLISYRI® IN PRACTICE

PCDS Guidelines

KLISYRI® (tirbanibulin) has received a strong recommendation from PCDS for Grade I lesions and small field change.7

AAD Guidelines

KLISYRI® (tirbanibulin) received a strong recommendation with a high certainty of evidence in the American Academy of Dermatology (AAD) Guidelines8

Guidelines of care for the management of actinic keratosis. J Am Acad Dermatol. 2022 Apr 18:S0190-9622(22)006 12-0

Recommendations for the Management of Actinic Keratosis with topical agents8

Topical Field TreatmentStrength of RecommendationCertainty of Evidence
TirbanibulinStrongHigh
5-FluorouracilStrongModerate
ImiquimodStrongModerate
Diclofenac*ConditionalLow

Adapted from Eisen DB, et al. Focused update: Guidelines of care for the management of actinic keratosis. J Am Acad Dermatol. 2022 Apr 18:S0190-9622(22)00612-0. doi: 10.1016/j.jaad.2022.04.013. Online supplement.

*For patients with AKs, nonsteriodal anti-inflammatory drugs (NSAIDs) carry a black box warning for cardiovascular and gastrointestinal side effects.

Meet Lisa

Lisa, 46 years old, financial adviser. Lisa is not an actual patient.

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THE CHALLENGE
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A facial skin condition is starting to affect Lisa’s self-confidence, as she feels it’s a distraction when presenting to clients

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You diagnose actinic keratosis (AK) and consider prescribing a first-line topical AK treatment, but recognise that adherence could be a problem, given Lisa’s busy life

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Lisa also mentioned that she loves playing tennis, and wants to get back to this as quickly as she can

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Lisa needs an effective topical treatment with as short a dosing duration as possible, to help reduce disruption to her busy life without compromising on lesion clearance

What Lisa could expect from five days’ treatment with KLISYRI®

Baseline

47b5a145

Day 8

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Day 15

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Day 29

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Day 57

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Adapted from Eisen DB, et al. Focused update: Guidelines of care for the management of actinic keratosis. J Am Acad Dermatol. 2022 Apr 18:S0190-9622(22)00612-0. doi: 10.1016/j.jaad.2022.04.013. Online supplement.

*For patients with AKs, nonsteriodal anti-inflammatory drugs (NSAIDs) carry a black box warning for cardiovascular and gastrointestinal side effects.

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Contact an Almirall Key Account Manager to speak about KLISYRI®

References

  1. Blauvelt A, et al. Phase 3 Tirbanibulin for Actinic Keratosis Group. Phase 3 Trials of Tirbanibulin Ointment for Actinic Keratosis. N Engl J Med. 2021;384(6):512-520.
  2. KLISYRI® SmPC. Almirall.
  3. Smolinski MP, et al. Discovery of Novel Dual Mechanism of Action Src Signaling and Tubulin Polymerization Inhibitors (KX2-391 and KX2-361). J Med Chem 2018;61:4707-4719.
  4. Niu L, et al. Reversible binding of the anticancer drug KXO1 (tirbanibulin) to the colchicine-binding site of ß-tubulin explains KXO1’s low clinical toxicity. J Biol Chem. 2019;294(48):18099-18108.
  5. Blauvelt A, et al. Tirbanibulin Ointment 1%, a Novel Inhibitor of Tubulin Polymerization and Src Kinase Signaling, for the Treatment of Actinic Keratosis (AK): Results from Two Pivotal Phase III Studies. SKIN The Journal of Cutaneous Medicine. 2020; 4(5), s63.
  6. Kempers S, et al. Tirbanibulin Ointment 1% as a Novel Treatment for Actinic Keratosis: Phase 1 and 2 Results. J Drugs Dermatol. 2020;19(11):1093-1100.
  7. Actinic (Solar) Keratosis – Primary Care Treatment Pathway. PCDS. 2022. https://www.pcds.org.uk/files/general/AK-Pathway-2022-Update-web-1.pdf [last accessed April 2023]
  8. Eisen DB, et al. J Am Acad Dermatol. 2022 Apr 18:S0190-9622(22)00612-0. doi: 10.1016/j.jaad.2022.04.013.

Klisyri® (tirbanibulin) Prescribing Information

Please consult the Summary of Product Characteristics (SmPC) before prescribing. Klisyri 10 mg/g ointment Active Ingredient: x Each gram of ointment contains 10 mg of tirbanibulin. Each sachet contains 2.5 mg of tirbanibulin in 250 mg ointment. Excipients with known effects: Propylene glycol 890 mg/g ointment Indication: Klisyri is indicated for the field treatment of non-hyperkeratotic, non hypertrophic actinic keratosis (Olsen grade 1) of the face or scalp in adults. Dosage and Administration: Tirbanibulin ointment should be applied to the affected field on the face or scalp once daily for one treatment cycle of 5 consecutive days. A thin layer of ointment should be applied to cover the treatment field of up to 25cm2. Consult SmPC and package leaflet for full method of administration.Contraindications, Precautions and Warnings:Contraindications: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 of SmPC. Precautions: Contact with the eyes should be avoided. Tirbanibulin ointment may cause eye irritation. In the event of accidental contact with the eyes, the eyes should be rinsed immediately with large amounts of water, and the patient should seek medical care as soon as possible. Tirbanibulin ointment must not be ingested. If accidental ingestion occurs, the patient should drink plenty of water and seek medical care. Tirbanibulin ointment should not be used on the inside of the nostrils, on the inside of the ears, or on the lips. Application of tirbanibulin ointment is not recommended until the skin is healed from treatment with any previous medicinal product, procedure or surgical treatment and should not be applied to open wounds or broken skin where the skin barrier is compromised. Local skin reactions in the treated area, may occur after topical application. Treatment effect may not be adequately assessed until resolution of local skin reactions. Due to the nature of the disease, excessive exposure to sunlight (including sunlamps and tanning beds) should be avoided or minimised. Tirbanibulin ointment should be used with caution in immunocompromised patients. Changes in the appearance of actinic keratosis could suggest progression to invasive squamous cell carcinoma. Propylene glycol may cause skin irritation. Consult SmPC and package leaflet for more information. Fertility, pregnancy and lactation: No human data on the effect of tirbanibulin ointment on fertility are available. Tirbanibulin ointment is not recommended during pregnancy and in women of childbearing potential not using contraception. It is unknown whether tirbanibulin/metabolites are excreted in human milk. A risk to the newborns/infants cannot be excluded. Consult SmPC and package leaflet for more information. Adverse Reactions:Very common (≥1/10): Application site – erythema; exfoliation; scab; swelling; erosion. Common (≥1/100 to <1/10): Application site – pain, pruritus and vesicles. Consult SmPC and package leaflet for further information. Legal Category:Ireland: POM Subject to prescription which may not be renewed (A). United Kingdom & Northern Ireland:POM Price: Ireland: Price to wholesaler United Kingdom & Northern Ireland: UK NHS Cost: £59.00 (excluding VAT). Marketing Authorisation Numbers: Ireland and Northern Ireland: EU/1/21/1558/001 Great Britain: PLGB 16973/0043 Marketing Authorisation Holder: Almirall, S.A., Ronda General Mitre, 151 08022 Barcelona, Spain Further information available from: Almirall Limited, Harman House, 1 George Street, Uxbridge, Middlesex, UB8 1QQ, UK. Date of First Issue: August 2021 Item code: IE-TIRBA-2100011

UK and UK(NI)-Adverse events should be reported. Reporting forms and information can be found at MHRA https://yellowcard.mhra.gov.uk Adverse events should be also reported to Almirall Ltd. Tel. 0800 0087 399

E-Adverse events should be reported. Reporting forms and information can be found at HPRA Website: www.hpra.ie Adverse events should also be reported to Almirall Ltd. Tel. +353 (0) 1431 9836

UK-KLI-2400001 April 2024

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