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Elidel and Dovonex for Psoriasis: Fewer Side Effects

A new study shows that Elidel (pimecrolimus) or Dovonex (calcipotriol) may be as effective as topical corticosteroids in ongoing treatment of intertriginous psoriasis – with fewer adverse effects.

Importantly, despite the study’s results, lead investigator Alexander Kreuter, MD, of Ruhr University in Bochum, Germany, says betamethasone and other topical corticosteroids should remain frontline treatment for acute intertriginous psoriasis.

The study was published in the September 2006 issue of the Archives of Dermatology and reported by MedPage Today on September 18.

What are Elidel and Dovonex?

Elidel and Dovonex are topical drugs that are used to treat intertriginous psoriasis – that is, psoriasis that occurs where folds in the skin create skin-to-skin contact (e.g., the armpit). Note: Elidel is FDA-approved as second-line treatment for eczema (atopic dermatitis), and has been used investigationally for psoriasis. Dovonex is approved to treat psoriasis.

Dovonex is a vitamin D3 analogue (i.e., a molecule similar to Vitamin D3). Elidel is a calcineurin inhibitor, which inhibits cytokine production in mast cells and T-lymphocytes. Previous studies have suggested both drugs are effective for treating intertriginous psoriasis, but none has directly compared them with corticosteroids in this setting, the investigators said.

Recent FDA Warning

In January 2006, the US Food & Drugs Administration (FDA) issued a warning regarding Elidel, as studies in animals and drug monitoring suggest that Elidel may be associated with increased risk of cancer – particularly lymphoma and particularly among young children.

The FDA has clearly cautioned that Elidel should not be used in children under two years of age. Furthermore, Elidel should be used only as a second-line agent, when other initial treatments have failed, and "only for short periods of time, not continuously," according to the FDA.

Clinical Trial

In the study by Dr Kreuter and colleagues, short-term treatment (four weeks) with betamethasone (a steroid sold under brand-name Celestone) was “clearly more effective” in reducing symptoms of intertriginous psoriasis than Elidel or Dovonex (85% vs 40% vs 62%, respectively).

However, after 70 days’ treatment, symptom-scores were similar among study-groups receiving Elidel, Dovonex or betamethasone.

This longer-term similarity in effectiveness is significant, because long-term use of topical corticosteroids, such as betamethasone, is associated with a range of adverse effects that includes skin atrophy (shrinkage), irreversible stretch-marks and adrenocortical suppression. Dr Kreuter and colleagues therefore reasoned that using "less potent" agents – such as Elidel and Dovonex – as maintenance therapy for this type of psoriasis might be safer.

Study participants included 80 adults with intertriginous psoriasis. Each participant was randomized to receive either Elidel (1%), Dovonex (0.005%), betamethasone (0.1%) or placebo (an emollient cream with no active drug).

Interestingly, at four weeks, the placebo group experienced a 21% symptom reduction, which the authors said "may not be explained by a placebo effect alone but underline[s] the known beneficial effects of emollients in the treatment of psoriasis through increased hydration of the stratum corneum and keratolytic effects."

Among all study groups, from week four through day 70 symptoms increased but remained significantly lower than at baseline. By day 70, no significant difference in symptoms existed between the treatment groups.

Dr Kreuter and colleagues said that the study results confirmed corticosteroids are still the most effective topical treatment for psoriasis, but added, "However, their use in long-term management, particularly for the treatment of intertriginous areas, which are more prone to steroid adverse effects, is limited.”

They concluded, "To combine the rapid anti-inflammatory effects of a topical corticosteroid with the favorable long-term effects and safety profile of pimecrolimus or calcipotriol, short-term application of topical corticosteroids for acute disease followed by maintenance treatment with one of these agents seems to be a reasonable approach in the treatment of intertriginous psoriasis."

Although no participants reported serious adverse events, five patients (25%) in the Elidel group reported increased itching and burning shortly after drug-application and for two weeks thereafter. In the Dovonex group, two participants reported increased erythema (skin-reddening), warmth and irritation for two weeks.

Sources:
Nonsteroidal Maintenance Therapies for Psoriasis Evaluated, MedPage Today, September 18, 2006.
1% pimecrolimus, 0.005% calcipotriol and 0.1% betamethasone in the treatment of intertriginous psoriasis. Kreuter A et al, Archives of Dermatology, volume 142, pages 1139-1143, 2006.

Posted: September 2006


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