Taclonex- A once-daily psoriasis ointment

May 02, 2006

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Company:

Warner Chilcott

Pharmacologic class:

Antipsoriatic (vitamin D3 derivative + potent topical steroid)

Active ingredients:

Calcipotriene (as hydrate) 0.005% + betamethasone dipropionate 0.064%; ointment.

Indication:

Psoriasis vulgaris.

Pharmacology:

Taclonex ointment is a topical combination product that contains calcipotriene hydrate and betamethasone dipropionate. The exact mechanism of action of these two drugs in treating psoriasis is uncertain.

Calcipotriene is a synthetic vitamin D3 analog that is metabolized in the liver to less potent metabolites. It has been shown to reduce disease severity in adult patients with psoriasis vulgaris.

Betamethasone is a fluorinated corticosteroid that has anti-inflammatory, antipruritic, and vasoconstrictive actions. Topical steroids can be absorbed systemically and may have systemic effects, particularly when potent corticosteroids are applied to inflamed skin for prolonged periods of time.

Clinical trials:

A double-blind, vehicle- and active-controlled parallel group study was conducted in 1,603 adults with mild to very severe psoriasis vulgaris on the trunk and limbs. They were treated with either Taclonex ointment, calcipotriene 0.005%, betamethasone dipropionate 0.064% (both in the same vehicle), or vehicle only once daily for four weeks. The proportion of patients with “absent” or “very mild” disease according to the Investigator’s Global Assessment of Disease Severity was determined for each group. “Absent disease” was defined as no evidence of redness, thickness, or scaling; “very mild disease” was defined as controlled disease but not entirely cleared (e.g., lesions with some discoloration with absolutely minimal thickness).

Patients with mild disease at baseline were required to have “absent” disease to be considered a success. The proportion of patients with “absent” or “very mild disease” after four weeks’ treatment was 48% in the Taclonex group, compared to 16.5% for calcipotriene, 26.3% for betamethasone, and 7.6% for vehicle.

Four other double-blind, vehicle- or active-controlled parallel-group studies were conducted that provided supportive evidence of efficacy. In these studies, a total of 1,058 patients were treated with Taclonex once daily for up to four weeks.

Adults:

18 years: Apply to affected area once daily for up to four weeks; maximum 100 g/week. Limit treatment area to 30% body surface area. Do not occlude.

Children:

<18 years: Not recommended.

Contraindication:

Disorders of calcium metabolism. Do not use for erythrodermic, exfoliative, or pustular psoriasis. Do not use on face, axillae, groin, or atrophic skin.

Precautions:

Avoid sun, UV light (e.g., phototherapy). Discontinue if hypercalcemia, hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing’s syndrome, hyperglycemia, glucosuria, or irritation occurs. Treat infection if present. Severe renal or hepatic dysfunction. Pregnancy (Cat. C). Nursing mothers.

Interactions:

Systemic absorption potentiated by other corticosteroids.

Adverse reactions:

Hypercalcemia, headache, HPA axis suppression (especially in children), local effects (e.g., pruritus, rash, burning, atrophy, skin hypopigmentation, erythema, telangiectasia, contact dermatitis, folliculitis, pustular psoriasis).