Psoriasis - LEO Pharma Sarath

1. What is psoriasis?
Psoriasis is a chronic (long-lasting) skin disorder, characterized by scaling and inflammation.

2. What are the types of psoriasis?
Plaque psoriasis - Guttate psoriasis - Pustular psoriasis - Inverse psoriasis - Erythrodermic psoriasis

3. What are the causes of psoriasis?
The exact cause of psoriasis is unknown, but it is believed that a "triger" is needed to develop psoriasis.

4. Who gets psoriasis?
Research indicates that psoriasis is a disorder of the immune system which causes excessive skin cell reproduction in healthy skin (up to 7 times the normal rate).

5. How does the psoriatic skin look like?
Psoriasis results in patches of thick red skin covered with silvery scales - often called plaques - which itch and may burn.

6. Is psoriasis contagious?
Although it can be unaesthetic and can affect your quality of life. It is important to know that psoriasis is NOT contagious and can NOT be spread by touch of unaffacted areas of your skin, or that of other people.

7. How can we optimize the topical treatment of psoriasis?
Topical therapy is normally the first option for the management of mild to moderate psoriasis.

8. Can psoriasis be cured?
Unfortunately not. Psoriasis is a chronic condition that relapses through life, although not necessarily in the same form.

9. What are the available treatments of psoriasis?
Mild to moderate psoriasis used to be treated with topical applications containing either coal tar or dithranol: both are messy, smelly and stain both skin and clothes.

10. Is psoriasis more than skin deep?
The incidence of psoriasis can cause a great deal of distress.

11. What is scalp psoriasis?
Scalp psoriasis affects the majority of people who develop the condition.

12. What is the maximum size of skin areas that can be treated with Daivonex®?
Clinical studies have demonstrated that calcipotriol does not cause hypercalcaemia when used as recommended with a weekly dose not exceeding 100 g.

13. Can Daivonex® be mixed or diluted with other products?
We do not recommend any kind of mixing or dilution of Daivonex®, primarily because the stability of the product is challenged every time. Daivonex® can be very instable under certain circumstances and the conversion velocity can be very high, especially if the adjusted pH value of Daivonex® is challenged with more acid products.

14. Can Daivonex® be mixed with salicylic acid?
We would not recommend direct mixing of Daivonex® with salicylic acid or any other acidic products, because calcipotriol will be inactivated due to its low pH value.

15. Can Daivonex® be used in the genital area?
In general we do not recommend the use of Daivonex® in the genital area.

16. Can Daivonex® be used in flexural psoriasis?
Daivonex® ointment is not approved for flexural psorasis but is often used in this type of psoriasis (2, 4).

17. Can Daivonex® be applied in the auditory canal? If yes, what therapy/application can be recommended?
We have no experience regarding use of Daivonex® in the eardrums and we can, therefore, not recommend it.

18. How should a child be treated if it has eaten Daivonex® ointment?
Contact a doctor or hospital. The doctor should be advised that Daivonex® can be absorbed systemically but calcipotriol has a rapid rate of metabolism.

19. Can Daivonex® be used in pregnant women?
Although studies in experimental animals have not shown any teratogenic effect, the safety of Daivonex® (calcipotriol) for use during human pregnancy has not yet been established and therefore Daivonex® is not recommended in pregnant patients unless their is no safer alternative.

20. What is the shelf life of Daivonex® cream after opening the tube?
The shelf life of Daivonex® cream is 2 years after the date of manufacturing, when stored at controlled room temperature (250C or below).

21. Is psoriasis a blood disorder?
Psoriasis is not a blood disorder. Psoriasis is a disorder of the immune system.

22. What is the deference between Daivonex® Cream and Ointment? Can I use Daivonex® Ointment in stead of Daivonex® Cream for my 6-years-old child?
The Daivonex® Ointment formulation is more greasy and more occlusive than the Daivonex® Cream.

23. How many patients have been treated with Daivobet® in clinical phase III studies?
To date (Jan 2006), more than 7,000 patients have been enrolled in seven large studies.

24. Is Daivonex® a complete control of psoriasis?
If by complete control of psoriasis you mean a cure for the disease then the answer is NO.

QUESTION
1. What is psoriasis?

ANSWER
Psoriasis is a chronic (long-lasting) skin disorder, characterized by scaling and inflammation.

It can appear in many different forms and can affect any part of the body including nails and scalp.

Psoriasis is classified as mild, moderate or severe depending on the percentage of the body surface involved and its impact on the patient's quality of life.

QUESTION
2. What are the types of psoriasis?

ANSWER

Plaque psoriasis: raised, red-based lesions covered by silvery scales; it is the most common type of the disease.
Guttate psoriasis: small, drop-like lesions on the trunk, limbs and scalp; often triggered by bacterial infections.
Pustular psoriasis: pus-like blisters triggered by medications, infections, emotional stress or exposure to certain chemicals.
Inverse psoriasis: large, dry, smooth, vividly red plaques in the folds of the skin near the genitals, under the breasts or in the armpits.
Erythrodermic psoriasis: intense redness and swelling of a large part of the skin surface, often accompanied by itching or pain; may be precipitated by severe sunburn or be drug-related (use of cortisone).

QUESTION
3. What are the causes of psoriasis?

ANSWER
The exact cause of psoriasis is unknown, but it is believed that a "triger" is needed to develop psoriasis.

Possible triggers include emotional stress, certain medications, skin injury, sunburn, hormonal change, systemic infections, and change in climate.

Hereditary predisposition is an important factor.

QUESTION
4. Who gets psoriasis?

ANSWER
Research indicates that psoriasis is a disorder of the immune system which causes excessive skin cell reproduction in healthy skin (up to 7 times the normal rate).

Psoriasis occurs in both children and adults at any age, although it is most common between 15 and 35 years jof age.

Both men and women of any race may be affected.

QUESTION
5. How does the psoriatic skin look like?

ANSWER
Psoriasis results in patches of thick red skin covered with silvery scales - often called plaques - which itch and may burn. The skin at the joints may crack.

Psoriasis most often occurs on the elbows, knees, scalp, lower back, face, palms and soles, but it can affect any skin site, including nails and soft tissue, inside the mouth and genitalia.

The skin condition might worsen at times (flare-up) and then improve (remission) alternatively.

QUESTION
6. Is psoriasis contagious?

ANSWER
Although it can be unaesthetic and can affect your quality of life. It is important to know that psoriasis is NOT contagious and can NOT be spread by touch of unaffacted areas of your skin, or that of other people.

Remember that it is an excess of production of new skin.

QUESTION
7. How can we optimize the topical treatment of psoriasis?

ANSWER
Topical therapy is normally the first option for the management of mild to moderate psoriasis.

An optimal therapy should give quick improvement, long remission period, and minimum side effects.

An effective treatment plan for a chronic disease like psoriasis involves a sequence of strategies using in the initial phase an agent for fast relief of disease symptoms, followed in the maintenance phase by an agent that provides long term control with safety.

QUESTION
8. Can psoriasis be cured?

ANSWER
Unfortunately not. Psoriasis is a chronic condition that relapses through life, although not necessarily in the same form.

However, today most sufferers can be helped by a multitude of available treatments. Months or even years may pass before the condition recurs.

QUESTION
9. What are the available treatments of psoriasis?

ANSWER
Mild to moderate psoriasis used to be treated with topical applications containing either coal tar or dithranol: both are messy, smelly and stain both skin and clothes.

Other treatments include:

Emollients, can not control the condition
Skin softeners, help remove the thick surface layers
Salicylic acid, softens and lifts off scales
Topical steroids, useful but causing skin thinning
Vitamin D ointments and creams, odourless, stain-free, quick and easy to use; the newest effective treatment of psoriasis

QUESTION
10. Is psoriasis more than skin deep?

ANSWER
The incidence of psoriasis can cause a great deal of distress.

Everyday life can become a source of embarrassement: swimming, sunbathing, visiting the hairdresser, trying new clothes, finding a new job and anything related to general appearance in society can become a hard task.

Added to that, the debilitating features of living with psoriasis can lower self-esteem. This psychological consequence is one of the most profound aspects of psoriasis.

QUESTION
11. What is scalp psoriasis?

ANSWER
Scalp psoriasis affects the majority of people who develop the condition.

Scaling occurs especially around the hairline. Scales are thick and patchy. Although some hair may fall out when scales are removed, it normally grows back just as thick as before.

QUESTION
12. What is the maximum size of skin areas that can be treated with Daivonex®?

ANSWER
Clinical studies have demonstrated that calcipotriol does not cause hypercalcaemia when used as recommended with a weekly dose not exceeding 100 g.

Usually this will be enough to treat 15-20% of the body surface twice daily, but the usage differs a lot from person to person. It is therefore possible to treat patients with much larger lesions.

In some of our clinical trials 40-50% of the body surface has been covered with lesions. In very severe cases it is of course possible to start treatment on smaller lesions, e.g. on the legs, and when they have cleared proceed to the body.

QUESTION
13. Can Daivonex® be mixed or diluted with other products?

ANSWER
We do not recommend any kind of mixing or dilution of Daivonex®, primarily because the stability of the product is challenged every time. Daivonex® can be very instable under certain circumstances and the conversion velocity can be very high, especially if the adjusted pH value of Daivonex® is challenged with more acid products.

We have not investigated all the interactions that may be possible when Daivonex® is mixed with other products.

QUESTION
14. Can Daivonex® be mixed with salicylic acid?

ANSWER
We would not recommend direct mixing of Daivonex® with salicylic acid or any other acidic products, because calcipotriol will be inactivated due to its low pH value.

Normally patients will not directly mix the formulations on the skin which would of course be comparable to mixing the formulations in the laboratory.

Patients may use Daivonex® in the morning and salicylic acid in the evening for the first 3-4 days or salicylic acid for 3-4 days followed by Daivonex® twice a day with no expected special risk of accelerated calcipotriol breakdown.

Application of salicylic acid to the skin does not influence skin surface pH to any extent that could influence the stability of calcipotriol in its in vivo situation.

BACKGROUND
We do not recommend that Daivonex® is directly mixed with other acidic presentations particularly salicylic acid which is one of the ingredients most often used in home-made mixtures. Corticosteroid products are also acidic with a buffer system.

Salicylic acid does not directly react chemically with calcipotriol. Calcipotriol is preserved at alkaline pH to keeep it stable for months or years.

QUESTION
15. Can Daivonex® be used in the genital area?

ANSWER
In general we do not recommend the use of Daivonex® in the genital area.

BACKGROUND
The German authorities in particular are greatly concerned about application of creams and ointments to the genital/anal area, as the base cream/ointment may compromise the use of condoms. This potential problem is not specifically related to Daivonex®.

As compromised condoms may contribute to unwanted pregnancy, spread of HIV infection etc. we are not in a position to recommend this particular use of our product.

QUESTION
16. Can Daivonex® be used in flexural psoriasis?

ANSWER
Daivonex® ointment is not approved for flexural psorasis but is often used in this type of psoriasis (2, 4).
6 weeks of treatment with Daivonex® ointment twice a day was found to be effective and safe for the treatment of flexural psoriasis (2). Minimal burning was reported in 2 out of 12 patients. In the remaining no side effects occurred.

BACKGROUND
Flexural psoriasis (inverse psoriasis, intertriginous psoriasis) is found in the body folds such as the groins, vulva, axillae, submammary folds and other body folds.
The border of the surrounding skin is distinct, and lesions have a characteristic red colour. Silvery scaling will not be seen on the moist skin of the flexure, but may be seen on the edge of the plaque. Often psoriasis is present elsewhere to confirm diagnosis (2).
Flexural psoriasis may occur as a primary disorder or as a Koebner phenomenon on top of infective or seborrheic or antibacterial dermatoses and assured diagnosis may therefore be difficult. Failure to respond to antibacterial or antifungal preparations should arouse suspicion (1).
Topically applied agents penetrate better in a skin fold than on exposed skin.
This has to be considered when choosing topical agents for the treatment of flexural psoriasis. The reduced barrier function of the horny layer is caused by a combination of sweat, heat, friction and occlusion. Tar and dithranol will often cause irritation and topical steroids will have an increased effect with risk of atrophy and stria already after shorter periods of use (5). Daivonex is a useful alternative.

REFERENCES
1. Rook/Wilkinson/Ebling
Textbook of Dermatology
Six Edition, 1998/edited by R H Champion, J L Burton, D A Burns and S M Breathnach

2. Differential Diagnosis in Dermatology
Radcliff Medical Press 1993
Richard Ashton & Barbara Leppard

3. Kienbaum S, Lehmann P, Rutzicka T
Topical calcipotriol in the treatment of intertreginous psoriasis
Br. J Dermatol 1996; 135 (4): 647-650

4. Kienbaum S, Lehmann P, Rutzicka Th
Intertrginøse

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