Young male medical student with severe plaque psoriasis

Case presented by: Dr Anton Alexandroff FRCP, CCST (Dermat), Consultant Dermatologist at BMI, Nuffield Health and Spire Hospital


Initiated, funded and reviewed by LEO Pharma.

Case presentation

A young man, in his early 20s and his second year at medical school, sought medical advice for severe psoriasis after being told by his university that he was not allowed to attend clinical sessions with patients because of his condition. Although the reasons why the medical school stated this were unclear (as psoriasis is not contagious1), the patient could not continue studying without effective treatment.

The patient had a 2–3 year history of psoriasis, and while previously finding the condition to be inconvenient he had coped with it. However, the effect it was now having on his studies was making him increasingly anxious and depressed, as he felt his career was at stake.

Diagnosis and management

The patient had stable, severe, large plaque psoriasis. The plaques were not inflamed but were thick, red and quite sore, and were fairly widespread across his body. He had tried several previous topical treatments, which had been ineffective. Alongside minimal improvement, he found that they had an unpleasant odour, were greasy, and stained his clothes. Other topical treatments had also needed twice daily application and he had therefore not persisted with any treatment.

The patient was commuting 30 miles to the clinic, making it difficult to arrange treatment around lectures. Therefore, he was initially prescribed a course of once daily Enstilar® cutaneous foam (50 micrograms/g calcipotriol + 0.5 mg/g betamethasone dipropionate)2 to see if it reduced the severity of his psoriasis and the need for further therapy.

Patient’s experience and outcome

Three weeks after initiating treatment with Enstilar®, the patient’s skin was almost clear and continuing to improve. His response to Enstilar® was such that he did not require any further therapy, and could go back to his medical training.

The patient was incredibly pleased with the outcome, saying he was extremely grateful to now be able to return to his studies. Given his experience with other treatments, he had not expected Enstilar® to make much difference. He was therefore happy to see such a change in a short time, with a treatment that he found easy to use and non-greasy.

I was also pleasantly surprised at his response to Enstilar®. I had felt the severity of the case might require systemic treatment. In this case, Enstilar® offered an effective and convenient treatment that fitted around the patient’s life.

References

  1. NHS Choices. Psoriasis: Introduction. 2015; 27 May. http://www.nhs.uk/conditions/Psoriasis/Pages/Introduction.aspx (accessed 3 May 2017).
  2. Enstilar® Cutaneous Foam. Summary of product characteristics. 2016. Available from: www.medicines.org.uk/emc/medicine/31833 (accessed 3 May 2017).

Enstilar ® results following four-week treatment (response observed in a participant of the PSO-FAST vehicle-controlled efficacy and safety trial) 1

The below pictures are for illustrative purposes only and do not depict the patient discussed in the above case study

BASELINE

WEEK 1

WEEK 4

References

  1. Data on file: LEO90100–003 March 2016. PSO-FAST Clinical Images.

Initiated, funded and reviewed by LEO Pharma

Published by Haymarket Media Group Ltd, Bridge House, 69 London Road, Twickenham, TW1 3SP. This publication was compiled using a medical writer and is based on the views expressed by the author. These views are not necessarily those of Haymarket Media Group Ltd or LEO Pharma. Readers are advised to make their own further enquiries of manufacturers or specialists in relation to particular drugs, treatments or advice. The publishers and printers cannot accept liability for errors or omissions. No part of this publication may be reproduced. ©2017 Haymarket Media Group Ltd.

Date of preparation: May 2017; UK/MAT-08155.


Abbreviated Prescribing Information for

Enstilar ® 50 micrograms/g + 0.5 mg/g cutaneous foam

Please refer to the full Summary of Product Characteristics (SmPC) (www.medicines.org.uk/emc) before prescribing.

Indication: Topical treatment of psoriasis vulgaris in adults.

Active ingredients: 50 µg/g calcipotriol (as monohydrate) and 0.5 mg/g betamethasone (as dipropionate).

Dosage and administration: Apply by spraying onto affected area once daily. Recommended treatment period is 4 weeks. The daily maximum dose of Enstilar should not exceed 15 g, i.e. one 60 g can should last for at least 4 days. 15 g corresponds to the amount administered from the can if the actuator is fully depressed for approximately one minute. A two-second application delivers approximately 0.5 g. As a guide, 0.5 g of foam should cover an area of skin roughly corresponding to the surface area of an adult hand. If using other calcipotriol-containing medical products in addition to Enstilar, the total dose of all calcipotriol-containing products should not exceed 15 g per day. Total body surface area treated should not exceed 30%. Safety and efficacy in patients with severe renal insufficiency or severe hepatic disorders have not been evaluated. Safety and efficacy in children below 18 years have not been established. Shake the can for a few seconds before use. Apply by spraying, holding the can at least 3 cm from the skin, in any orientation except horizontally. Spray directly onto each affected skin area and rub in gently. Wash hands after use (unless Enstilar is used to treat the hands) to avoid accidentally spreading to other parts of the body. Avoid application under occlusive dressings since systemic absorption of corticosteroids increases. It is recommended not to take a shower or bath immediately after application.

Contraindications: Hypersensitivity to the active substances or any of the excipients. Erythrodermic and pustular psoriasis. Patients with known disorders of calcium metabolism. Viral (e.g. herpes or varicella) skin lesions, fungal or bacterial skin infections, parasitic infections, skin manifestations in relation to tuberculosis, perioral dermatitis, atrophic skin, striae atrophicae, fragility of skin veins, ichthyosis, acne vulgaris, acne rosacea, rosacea, ulcers and wounds.

Precautions and warnings: Adverse reactions found in connection with systemic corticosteroid treatment, e.g. adrenocortical suppression or impaired glycaemic control of diabetes mellitus, may occur also during topical corticosteroid treatment due to systemic absorption. Application under occlusive dressings should be avoided since it increases the systemic absorption of corticosteroids. Application on large areas of damaged skin, or on mucous membranes or in skin folds should be avoided since it increases the systemic absorption of corticosteroids. Due to the content of calcipotriol, hypercalcaemia may occur. Serum calcium is normalised when treatment is discontinued. The risk of hypercalcaemia is minimal when the maximum daily dose of Enstilar (15 g) is not exceeded. Enstilar contains a potent group III-steroid and concurrent treatment with other steroids on the same treatment area must be avoided. Skin on the face and genitals are very sensitive to corticosteroids. Enstilar should not be used in these areas. Instruct the patient in the correct use of the product to avoid application and accidental transfer to the face, mouth and eyes. Wash hands after each application to avoid accidental transfer to these areas. When lesions become secondarily infected, they should be treated with antimicrobiological therapy. However, if infection worsens, treatment with corticosteroids should be discontinued. When treating psoriasis with topical corticosteroids, there may be a risk of rebound effects when discontinuing treatment.

Medical supervision should therefore continue in the post-treatment period. Long-term use of corticosteroids may increase the risk of local and systemic adverse reactions. Treatment should be discontinued in case of adverse reactions related to long-term use of corticosteroid. There is no experience with the use of Enstilar in guttate psoriasis. During Enstilar treatment, physicians are recommended to advise patients to limit or avoid excessive exposure to either natural or artificial sunlight. Topical calcipotriol should be used with UVR only if the physician and patient consider that the potential benefits outweigh the potential risks. Enstilar contains butylhydroxytoluene (E321), which may cause local skin reactions (e.g. contact dermatitis), or irritation to the eyes and mucous membranes.

Pregnancy and lactation: There are no adequate data from the use of Enstilar in pregnant women. Enstilar should only be used during pregnancy when the potential benefit justifies the potential risk. Caution should be exercised when prescribing Enstilar to women who breast-feed. The patient should be instructed not to use Enstilar on the breast when breast-feeding.

Side effects: There are no common adverse reactions based on the clinical studies. The most frequently reported adverse reactions are application site reactions. Calcipotriol: Adverse reactions include application site reactions, pruritus, skin irritation, burning and stinging sensation, dry skin, erythema, rash, dermatitis, psoriasis aggravated, photosensitivity and hypersensitivity reactions, including very rare cases of angioedema and facial oedema. Systemic effects after topical use may appear very rarely causing hypercalcaemia or hypercalciuria. Betamethasone (as dipropionate): Local reactions can occur after topical use, especially during prolonged application, including skin atrophy, telangiectasia, striae, folliculitis, hypertrichosis, perioral dermatitis, allergic contact dermatitis, depigmentation and colloid milia. When treating psoriasis with topical corticosteroids, there may be a risk of generalised pustular psoriasis. Systemic reactions due to topical use of corticosteroids are rare in adults; however, they can be severe. Adrenocortical suppression, cataract, infections, impaired glycaemic control of diabetes mellitus, and increase of intra-ocular pressure can occur, especially after long-term treatment. Systemic reactions occur more frequently when applied under occlusion (plastic, skin folds), when applied on large areas, and during long-term treatment.

See SmPC for a full list of side effects.

Precautions for storage: Do not store above 30°C. Extremely flammable aerosol. Pressurised container. May burst if heated. Protect from sunlight. Do not expose to temperatures exceeding 50°C. Do not pierce or burn, even after use. Do not spray on an open flame or other ignition source. Keep away from sparks/open flames. No smoking.

Legal category: POM.

Marketing authorisation number and holder: PL 05293/0008. LEO Pharma A/S, Ballerup, Denmark.

Basic NHS price: £39.68/60 g

Last revised: May 2016

Further information can be found in the Summary of Product Characteristics or from: LEO Pharma, Horizon, Honey Lane, Hurley, Berkshire SL6 6RJ, UK. e-mail: medical-info.uk@leo-pharma.com

Reporting of Suspected Adverse Reactions

Adverse events should be reported. Reporting forms and information can be found at: www.mhra.gov.uk/yellowcard
Adverse events should also be reported to Drug Safety at LEO Pharma by calling +44 (0)1844 347333 or e-mail medical-info.uk@leo-pharma.com