Topical Calcipotriol Algorithm

Transcription

1 Topical Calcipotriol Algorithm Is this patient an adult previously diagnosed with psoriasis by a doctor? Do the skin patches look the same as those diagnosed as psoriasis? Is this psoriasis covering an extensive area, on the face or in the flexures? Are there pustules or systemic symptoms? Is the patient taking calcium, Vitamin D supplements or medicines that enhance availability of calcium e.g. lithium OTC calcipotriol is not recommended. Refer to Doctor or treat with an alternative as appropriate. Does the patient have a medical condition that could cause hypercalcaemia e.g. malignancy, hyperparathyroidism, Paget s disease? Is the patient able to avoid excessive sunlight or use good sunblock? Is the patient pregnant or planning pregnancy? Consider OTC topical calcipotriol (30g/30mL). Use twice a day initially (start with a small area first). Can reduce to once daily on improvement (takes around 3 weeks); discontinue when skin clear. Advise: Wash hands after applying, avoid application to the face, and minimise UV exposure. Skin irritation may occur, if problematic see a pharmacist or doctor. See your doctor if there is no improvement in 4-6 weeks, if the condition worsens or if using more than 30g/week. Tell your doctor you are using this treatment - blood tests for calcium might be needed if using for more than 3 months. Alternatively: notify patient s doctor of supply with patient s permission. Supply a consumer medicines information sheet (available from

2 Pharmacist Training tes - OTC Calcipotriol Topical calcipotriol 50μg/g is a Prescription Medicine except when a maximum of 30g or 30mL is sold by a pharmacist to an adult with mild to moderate psoriasis previously diagnosed by a doctor. Contraindications: Hypersensitivity to any ingredient, hypercalcaemia or known disorder of calcium metabolism, calcium or vitamin D supplementation. Safety in pregnancy has not been established; avoid OTC usage. Safety in renal or hepatic impairment has not been established. Adverse effects: Skin irritation, high doses occasionally cause hypercalcaemia (refer to doctor if needing more than 30g/week). See datasheets and training notes for further information. NZ is likely to have up to 2% of the population with psoriasis. That s around 100 people per pharmacy on average. A minority of these people will have severe or extensive psoriasis and require systemic therapy, but many are likely to be self-managing with occasional visits to the doctor. Types of psoriasis Topical calcipotriol is for psoriasis vulgaris (also known as plaque psoriasis) which affects around 90% of psoriasis sufferers. Classic symptoms are red, scaly, silvery raised plaques. While these may appear anywhere, they are most common on the extensor part of the knee and elbows, the scalp (especially behind ears), the hands and/or the lower back. These plaques are often circular or oval shaped and can be pruritic. Psoriasis can involve only a couple of small plaques through to involving most of the skin. Nails are often involved with small pits, separation of the nail plate from the nail bed, thickened nail plate and brown patches under the nail plate. Where just the scalp, the hands or the nails are affected without other skin areas, psoriasis can be more difficult to diagnose. Other psoriatic conditions (OTC calcipotriol not recommended) include: Guttate psoriasis (raindrop psoriasis) many small psoriatic lesions mainly on the trunk usually occurring after a streptococcal throat infection; may never recur and is more common in children Seborrhoeic psoriasis (psoriasis inversus) affects the body folds and has clearly demarcated redness but not scale. It is more difficult to diagnose and treat Pustular psoriasis pustules are seen at the edge of the lesions. It can be associated with high fever, leukocytosis and hepatotoxicity and usually requires inpatient treatment Erythrodermic psoriasis this is the head to toe version, risks infection, dehydration and electrolyte loss and requires inpatient treatment A doctor diagnosis of psoriasis is important as other conditions may be similar, for example: Dermatitis/eczema usually itchier and more inflamed. Often in the flexures (while plaque psoriasis is not usually) Ichthyoses usually very little pruritus, a lot of scaling and little inflammation Seborrhoeic dermatitis Ptyriasis rosea Bowen s disease one plaque on the trunk of an elderly person Skin cancer it is important that a one-off patch of dry scaly skin (particularly with no history of psoriasis) is considered carefully. If a single patch occurs and it is in a different place to previous psoriasis lesions refer to the doctor to ensure it is psoriasis. Patients need to know psoriasis is not contagious and there are no scars or marks after the lesions clear.

3 Treatment of Psoriasis vulgaris As there is no known permanent cure, the goal is to keep the condition under control and if possible induce a remission, while minimising adverse effects of therapy[1]. OTC calcipotriol should only be used in mild to moderate psoriasis vulgaris (plaque psoriasis) where the area to be treated is not extensive. This ensures high usage remains under medical supervision and that appropriate other treatment can be used for severe or extensive cases. If a patient does not improve with topical calcipotriol doctor referral is appropriate for other treatment options. Psoriasis goes into remission either spontaneously or from treatment in less than 40% of sufferers (based on a survey of 2000 patients). Thus while remission is desirable, the goal of treatment for many is control and minimising effect on quality of life. Stable psoriasis, when old plaques persist but no new plaques develop, is most likely to go into remission with treatment. More extensive disease, even if stable, has a worse prognosis. Calcipotriol is considered first line of the topical treatments for psoriasis[2]. A systematic review of studies found calcipotriol ointment to be more effective than coal tar, short contact dithranol, and hydrocortisone 0.5%, and at 6 weeks of treatment was more effective than potent topical steroids (but not at 8 weeks of treatment)[3]. Other topical treatments include: Mild emollients, e.g. emulsifying ointment, maintain skin hydration, minimise itching and scaling. Coal tar preparations both in creams/ointments for on the skin and coal tar solution added to the bath. Purified tar preparations are less smelly and messy than the crude coal tar preparations but may be less effective. Salicylic acid a keratolytic for reducing scale, more useful for scalps and palms of hands and soles of feet. Dithranol is a restricted medicine. This is effective but it is a skin irritant, and if used in too great a strength causes pain, redness and blistering. It is considered to be difficult for out-patient use. In the home setting it is usually only applied for minutes then washed off. This helps avoid staining clothing and bedding purple. Moderate potency and potent steroids are effective but avoid long-term due to local side effects (e.g. skin atrophy), tachyphylaxis and rebound of psoriasis[1]. Providing advice on soap substitutes, emollients and sunscreens alongside providing calcipotriol would be useful. Treatments for moderate to severe psoriasis include phototherapy, phototherapy plus psoralens (PUVA), methotrexate, cyclosporin, acitretin and biologics which are immunomodulators e.g. etanercept, adalimumab and efalizumab. How to Use Calcipotriol Apply calcipotriol to the lesions twice a day initially then reduce to once a day if desired after a response. Apply to a small area first to check tolerability and gradually work up to larger areas as needed. Wash hands after applying to avoid accidental application to the face which can be very sensitive to this medicine. The cream may be more acceptable to patients and less irritant[1]. Some prefer to use cream in the morning and ointment in the evening[1].

4 Time to effect can be around 3 weeks and trials have often evaluated at 6 week and 8 week time points[1]. Calcipotriol should be stopped if remission occurs. A recent review noted that the longer-term open-label studies indicated that calcipotriol is safe to use and effective for long-term treatment of plaque type psoriasis [2]. If there is no improvement by around 6 weeks or psoriasis worsens, stop use and refer to the doctor. Adverse Events Lesional or perilesional irritation are the most common adverse events, but are less common with the cream than the ointment. Around 15% will get skin irritation, usually within the first few weeks and about 2% stop treatment for this reason[2]. The face and skin folds are more sensitive. Calcipotriol is a vitamin D analog, however it is considerably less active on calcium metabolism than naturally available vitamin D (1,25(OH)2D3 )[4]. About 2-10% is absorbed systemically, and at maximum doses (100g/ week) hypercalcaemia is reported rarely. If 10% were absorbed, that is 5 μg available to the body for every gram applied. Using an OTC pack of 30g in a week could result in approximately μg calcipotriol absorbed in a week, less than the amount of Vitamin D that could be taken in an unscheduled vitamin supplement, noting however that Vitamin D supplements are more active on calcium metabolism than calcipotriol. The following extracts are from the Daivonex cream datasheet[4]: Occasional hypercalcaemia has been reported, usually related to excessive (greater than 100 g/week) use. Treatment with calcipotriol ointment in the recommended amounts up to 100 g per week for 1 year does not generally result in changes in laboratory values. Hypercalcaemia has been reported rarely at the recommended dose (i.e. up to 100g/week) of calcipotriol ointment when used for the approved indication. Serum calcium and renal function should be monitored at 3 monthly intervals during periods of usage of topical calcipotriol. If the serum calcium level is observed to be elevated, calcipotriol treatment should be discontinued and the condition should be treated appropriately. The levels of serum calcium should be measured once weekly until the serum calcium levels return to normal values. See the datasheet for further information on adverse reactions. Contraindications and Precautions Calcipotriol should not be used OTC in patients who are taking calcium or vitamin D supplementation or who have hypercalcaemia. Additionally, keeping OTC usage less than 30g/30mL per week and avoiding occlusion will minimise risk of effects on calcium. Causes of hypercalcaemia include:[5] Primary hyperparathyroidism Malignancy Milk alkali syndrome - usually from excess dietary calcium (>4g/day) sometimes with alkali Vitamin A or D toxicity Paget s disease Granulomatous diseases e.g. sarcoidosis Weeks of immobilisation Parenteral nutrition Drug causes include lithium and thiazide diuretics Other less common causes include some endocrine disorders e.g. acromegaly

5 Other contraindications/precautions include:[4] Avoid in known hypersensitivity to any ingredient (see datasheet and consumer medicines information for ingredients). Do not use in the eye wash hands after applying to avoid inadvertent ocular application. As safety information in pregnancy is not available, OTC use of calcipotriol should be avoided in known pregnancy or if planning a pregnancy. It is not known if calcipotriol is excreted in breast milk. If breastfeeding do not apply to the chest. Information is not available on use in hepatic or renal impairment. Do not use on the face as it can cause itching and redness on the face. Advise people using calcipotriol to wash hands after applying to avoid inadvertent application to the face or eyes. Treated areas should be protected from sunlight and UV light as there is no information about possible effects of calcipotriol when used for long periods of exposure to sunlight or UV light. te however, that sometimes dermatologists will combine calcipotriol and UV treatment. Calcipotriol is not licensed for use in children. See the datasheets for calcipotriol cream, ointment and scalp application (go to and click on datasheets). The consumer medicines information (CMI) is also available at It is recommended that these are printed for patients purchasing calcipotriol. References 1. Segaert, S. and L.B. Duvold, Calcipotriol cream: a review of its use in the management of psoriasis. Journal of Dermatological Treatment, (6): p Fogh, K. and K. Kragballe, New Vitamin D Analogs in Psoriasis. Current Drug Targets - Inflammation and Allergy, : p Ashcroft, D.M., et al., Systematic review of comparative efficacy and tolerability of calcipotriol in treating chronic plaque psoriasis. British Medical Journal, : p CSL Biotherapies (NZ) Ltd. Daivonex Cream Datasheet. January 2008 [cited January 2010]; Available from: 5. Shepard, M.M. and J.W. Smith, Hypercalcaemia. American Journal of Medical Science, (5): p General references used: Fogh, K. and K. Kragballe, New Vitamin D Analogs in Psoriasis. Current Drug Targets - Inflammation and Allergy, : p Fry, L., An Atlas of Dermatology. 1996, New York: The Parthenon Publishing Group. Kragballe, K., K. Fogh, and H. Sogaard, Long-term efficacy and tolerability of topical calcipotriol in psoriasis. Results of an open study. Acta Dermato-Venereologica, (6): p Levine, D. and A. Gottlieb, Evaluation and Management of Psoriasis: An Internist's Guide Medical Clinics of rth America, (6): p MacKie, R.M., Clinical Dermatology. 5th ed. 2003, Oxford: Oxford University Press. Russell, S. and M.J. Young, Hypercalcaemia during treatment of psoriasis with calcipotriol. British Journal of Dermatology, (6): p Acknowledgements: Thanks to Dr John Wishart, Dermatologist for reviewing the algorithm and providing advice to include in the training material.