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This formulary decision guide was developed from content provided by Almirall Ltd in a format developed by Guidelines in Practice. See below for full disclaimer.

Information intended for UK healthcare professionals only. 

View Wynzora® (calcipotriol and betamethasone dipropionate) prescribing and adverse event reporting information.

Wynzora FDG index image_V8

Key points

  • Wynzora is the only topical fixed dose combination formulation (calcipotriol + betamethasone dipropionate) currently available in a cream (other formulations include gel, foam, and ointment)1
  • Wynzora cream is indicated for the topical treatment of mild-to-moderate psoriasis vulgaris, including scalp psoriasis, in adults2
  • Wynzora is available for use within NHS Scotland and NHS Wales.3,4 Wynzora was excluded from HTA appraisal in Scotland under criterion 14. (SMC criterion 14: An alternative formulation of an established medicine (accepted for use by SMC/HIS or which pre-dates SMC) which costs the same per patient or less). In NHS Wales Wynzora was excluded from appraisal as it met AWMSG exclusion criteria 5.

View a PDF of the formulary decision guide here

Drug name

  • Wynzora® (calcipotriol and betamethasone dipropionate) 50 mcg/g + 0.5 mg/g cream

Indication

  • Wynzora cream is indicated for the topical treatment of mild-to-moderate psoriasis vulgaris, including scalp psoriasis, in adults.2

Dosage and administration

  • Wynzora cream should be applied to the affected areas once daily2
  • The cream should be rubbed in thoroughly in a thin layer2
  • Hands must be washed after use2
  • When using calcipotriol containing medicinal products, the maximum daily dose should not exceed 15 g, and the body surface area treated should not exceed 30%2
  • The recommended treatment period is up to 8 weeks1
  • Treatment should be discontinued when control is achieved2
  • If it is necessary to continue or restart treatment after this period, do so only after medical review and under regular medical supervision2
  • If used on the scalp, all the affected scalp area should be treated2
  • Wynzora cream should not be applied directly to the face or eyes2
  • To achieve optimal effect, it is not recommended to take a shower or bath immediately after application—allow 8 hours between application and showering to avoid washing it off.2

Mode of action

  • Wynzora Cream combines the pharmacological effects of calcipotriol hydrate as a synthetic vitamin D3 analogue and betamethasone dipropionate as a synthetic corticosteroid2
  • In combination, calcipotriol and betamethasone dipropionate promote greater anti-inflammatory and anti-proliferative effects than either component alone.2

Efficacy

  • The efficacy of once daily use of Wynzora Cream was investigated in two randomised, investigator-blind, 8-week clinical trials including 738 subjects treated with Wynzora Cream or corresponding vehicle with psoriasis on the body and trunk (also scalp in trial 1) of mild-to-moderate severity according to the Physician’s Global Assessment of disease severity (PGA)2
  • Results from both primary and secondary efficacy endpoints in both Trial 1 and Trial 2 demonstrated that Wynzora Cream had superior efficacy compared to vehicle (p < 0.0001) for all confirmatory efficacy endpoints in treating psoriasis on the body and trunk2
  • PGA treatment success was defined as ‘clear’ or ‘almost clear’ for patients with moderate disease at baseline and ‘clear’ for patients with mild disease at baseline.2

Guidance positioning

  • Wynzora is available for use within NHS Scotland and NHS Wales3,4 
  • PCDS guidelines recommend calcipotriol and betamethasone combination products first line for trunk and limb psoriasis to encourage a rapid improvement and hence adherence in chronic plaque psoriasis5
  • NICE psoriasis guideline recommends topical treatment for psoriasis as a first line treatment option, taking into account patient preference, cosmetic acceptability, practical aspects of application and the site(s) and extent of psoriasis to be treated. NICE recommends using the individual components separately first, however should a once daily preparation improve adherence a combination product can be offered6
  • SIGN Guidelines state that a short term intermittent use of a potent topical corticosteroid or a combined potent corticosteroid plus calcipotriol ointment is recommended to gain rapid improvement in plaque psoriasis (Grade of Recommendation A)7
  • The BAD have not produced psoriasis guidelines for topical treatment options.

Safety profile

  • In a pooled analysis of two phase III trials with over 1286 patients all reported adverse reactions were seen at a frequency below 1%8
  • The most common adverse reactions was in the ‘general administration site condition’ category8
    • the most frequent local site reactions were application site irritation, pain, pruritus, eczema, exfoliation, telangiectasia and folliculitis8
  • 2% of subjects reported a serious adverse event (AE) across the three treatment groups and none were assessed to be related to trial medication.8

Cost

  • The NHS tariff price of Wynzora® is 4% cheaper per gram than Dovobet gel®, and 10% cheaper per gram Enstilar Foam.9

References

  1. British National Formulary. Calcipotriol with Betamethasone. Available at: https://bnf.nice.org.uk/medicinal-forms/calcipotriol-with-betamethasone.html (accessed August 2022) 
  2. Almirall Ltd. Wynzora 50 mcg/g + 0.5 mg/g cream—Summary of product characteristics.
  3. Scottish Medicine Consortium. Calcipotriol and betamethasone. Available at: www.scottishmedicines.org.uk/search/?keywords=calcipotriol (accessed August 2022)
  4. All Wales Medicines Strategy Group. Calcipotriol/betamethasone (Wynzora®). Available at: https://awmsg.nhs.wales/medicines-appraisals-and-guidance/medicines-appraisals/calcipotriol-betamethasone-wynzora/ (accessed August 2022)
  5. Primary Care Dermatology Society. Plaque Psoriasis Management. Available at: www.pcds.org.uk/clinical-guidance/psoriasis-an-overview#management (accessed August 2022)
  6. NICE. Psoriasis: assessment and management. NICE Guideline 153. NICE, 2012 (last updated 2017). www.nice.org.uk/guidance/cg153 (accessed August 2022)
  7. SIGN. Diagnosis and management of psoriasis and psoriatic arthritis in adults. SIGN 121. October 2010. www.sign.ac.uk/assets/sign121.pdf (accessed August 2022)
  8. Pinter A et al. J Eur Acad Dermatol Venereol 2021; doi.org/10.1111/jdv.17734
  9. NHS. Amendments to the drug tariff February 2022. Available at: www.nhsbsa.nhs.uk/sites/default/files/2022-01/Drug%20Tariff%20February%202022.pdf (accessed August 2022)

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.

UK-WYN-2200002

Date of preparation: August 2022