Klisyri (tirbanibulin) FDG - digital

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.

Key points

  • 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.

Download a PDF of this formulary decision guide

View prescribing and adverse event reporting information

Drug name

Klisyri® 10 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.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

National guidance

  • 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

Efficacy

  • 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.

Safety profile

  • 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

Order information

  • Klisyri (tirbanibulin) once daily 5-day treatment course £59.00
  • PIP Code: 419-0716.

References

  1. 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)
  2. Almirall Ltd. Klisyri 10 mg/g ointment—summary of product characteristics. Available at: www.medicines.org.uk/emc/product/12932/smpc
  3. Primary Care Dermatology Society. Actinic (solar) keratosis clinical guideline.www.pcds.org.uk/clinical-guidance/actinickeratosis-syn.-solar-keratosis (accessed 15 July 2021)
  4. 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.
  5. Smolinski MP et al. J Med Chem 2018; 61: 4704–4719.
  6. Blauvelt A et al. NEJM 2021; 384: 512–520.

Klisyri packshot_11Aug21

UK-KLI-2100016

Date of preparation: October 2021