For UK healthcare professionals only.
This formulary decision guide was developed from content provided by Almirall Ltd in a format developed by Guidelines in Practice. It was commissioned by Almirall Ltd, who carried out full medical approval to ensure compliance with regulations.
- Klisyri is the only once daily five-day treatment course for actinic keratosis (AK)1
- Klisyri is indicated for the field treatment of non‑hyperkeratotic, non-hypertrophic actinic keratosis (Olsen grade 1) of the face or scalp in adults2
- Klisyri should be applied as a thin layer to cover the affected field (up to 25 cm2) once daily for one treatment cycle of 5 consecutive days2
- Cost of one treatment course: £59.00.
Klisyri® 10 mg/g ointment
- Klisyri is indicated for the field treatment of non-hyperkeratotic, non-hypertrophic actinic keratosis (Olsen grade 1) of the face or scalp in adults.2
Dosage and administration
- Klisyri ointment should be applied to the affected field on the face or scalp once daily for 5 consecutive days, at approximately the same time of day2
- Therapeutic effect can be assessed approximately 8 weeks after start of treatment2
- Klisyri ointment is for external use only; contact with eyes, lips, and the inside of nostrils or ears should be avoided2
- Before application, the treatment field should be washed with mild soap and water and dried; hands should be washed before and immediately after application of the ointment2
- A thin layer of ointment should be applied to cover the treatment field (of up to 25 cm2)2
- The treated area should not be bandaged or otherwise occluded; washing and touching of the treated area should be avoided for approximately 8 hours after application2
- For further information on dosage and administration, please refer to the summary of product characteristics.2
- An actinic keratosis is a common sun-induced scaly or hyperkeratotic lesion, which has the potential to become malignant3
- NICE estimates that over 23% of the UK population aged 60 and above has AK3
- Although the risk of an AK transforming into a squamous cell carcinoma (SCC) is very low, this risk increases over time and with larger numbers of lesions3
- The presence of 10 AKs is associated with a 14% risk of developing an SCC within five years3
- It is likely that the incidence of AKs is underestimated; it is difficult to measure the burden of AKs reliably in individuals and in populations.4
Mode of action
- Klisyri is a synthetic and highly selective novel inhibitor of tubulin polymerisation and Src tyrosine kinase signalling2,5
- It disrupts microtubules by direct binding to tubulin, which induces cell cycle arrest and apoptotic death of proliferating cells, and is associated with disruption of Src tyrosine kinase signalling.2
- Safety and efficacy of Klisyri applied on the face or scalp for 5 consecutive days were assessed in two large phase III, randomised, double blind, vehicle-controlled, parallel group, multicentre studies with a total of 702 patients6
- Complete (100%) and partial (≥75%) actinic keratosis lesion clearance rates at day 57 (the primary and secondary endpoints of these studies) were significantly higher in the Klisyri group than in the vehicle control group (p<0.0001).6
|Day 57||Overall (face and scalp)6|
|Klisyri 10 mg/g ointment (n=353)||Vehicle (n=349)|
|Complete (100%) clearance rate||49%||9%|
|Partial (≥75%) clearance rate||72%||18%|
Place in therapy
- Klisyri’s proven efficacy combined with its short treatment duration (5 days) and side effect profile may be considered an advantage over other current treatment options.
- Almost all participants had local skin reactions (LSRs), mostly transient and mild/moderate6
- LSRs: reddening, flaking/scaling, crusting, swelling, blistering, and ulceration6
- None of the LSRs required treatment and no patients discontinued use due to tolerability issues6
- Overall, LSRs peaked 8 days after starting the treatment and typically resolved within 2 to 3 weeks after completion of treatment with tirbanibulin ointment6
- Other most common adverse events were application-site pruritus and application-site pain, which resolved without intervention.6
- Klisyri (tirbanibulin) once daily 5-day treatment course £59.00
- PIP Code: 419-0716.
- Primary Care Dermatology Society. Actinic (solar) keratosis—primary care treatment pathway. PCDS, 2020. Available at: www.pcds.org.uk/files/gallery/AK_guidelines_Macrh_2020.pdf (accessed 15 July 2021)
- Almirall Ltd. Klisyri 10 mg/g ointment—summary of product characteristics. Available at: www.medicines.org.uk/emc/product/12932/smpc
- Primary Care Dermatology Society. Actinic (solar) keratosis clinical guideline.www.pcds.org.uk/clinical-guidance/actinickeratosis-syn.-solar-keratosis (accessed 15 July 2021)
- De Berker D, McGregor J, Mohd Mustapa M et al. British Association of Dermatologists’ guidelines for the care of patients with actinic keratosis 2017. Br J Dermatol 2017; 176: 20–43.
- Smolinski MP et al. J Med Chem 2018; 61: 4704–4719.
- Blauvelt A et al. NEJM 2021; 384: 512–520.
Date of preparation: October 2021