Alitretinoin Decreases Activity of Chronic Hand Eczema

Deborah Brauser

March 12, 2010

Dr. Charles Lynde

March 12, 2010 (Miami Beach, Florida) — Alitretinoin (9-cis retinoic acid; Panretin, Basilea), an endogenously occurring physiological retinoid, significantly reduces the symptoms of severe chronic hand eczema (CHE), according to results from 3 phase 3 studies presented during a poster session here at the American Academy of Dermatology 68th Annual Meeting.

"Daily oral dosing with alitretinoin is highly effective in treating severe CHE in patients unresponsive to potent topical corticosteroids, providing "almost clear" or "clear" hands in nearly half," said lead author of the studies, Charles Lynde, MD, assistant professor of dermatology at Toronto Western Hospital in Ontario.

He reported that hand eczema occurs in about 10% of the population, including doctors, nurses, dentists, janitors, firefighters, hair dressers, and others who use chemicals, detergents, and other products in their jobs.

"Topical steroids have been kind of the mainstay of treatment but, basically, [they] just don't work very well, and we haven't had anything else to really offer these patients," explained Dr. Lynde. "This retinoid provides successful long-term management of CHE through effective, intermittent treatment."

Increased Response in All 3 Studies

In the first study presented, 1032 patients were enrolled in 111 centers in Europe and Canada and randomized to receive alitretinoin, either 10 mg (n = 418) or 30 mg (n = 409) once a day, or placebo (n = 205).

"This was the biggest study ever done with hand dermatitis," reported Dr. Lynde.

At the end of 24 weeks, 48% of the alitretinoin-treated patients experienced a response (defined as clear or almost clear) in their hands, as assessed by the Physician's Global Assessment, compared with just 17% of those treated with placebo (P < .001), and a 75% reduction in disease signs and symptoms.

"In other words, the itching, fissuring, dryness, and redness went away for those patients," Dr. Lynde added.

Response time was significantly shorter in patients who received the 30 mg active treatment dose than in patients who received placebo (median time, 85 vs 141 days; P < .001).

The second study assessed 249 patients who received alitretinoin 30 mg daily for up to 24 weeks. Results at the end of that trial showed a response in 47% of the patients, a median time to response of 87 days, and an 82% median reduction in disease signs and symptoms

In the third trial, 117 of the patients who responded to alitretinoin treatment in the first study but who relapsed within 24 weeks were randomized to either the same treatment dose they received previously or placebo.

A total of 80% of the patients retreated with alitretinoin experienced a response, compared with only 8% to 10% of those who received placebo.

"This study is important because it showed that patients who relapse after initial treatment can be effectively retreated with alitretinoin," said Dr. Lynde.

"The overall bottom line is that, although not everyone responded, the results were very promising, with the 30 mg dose working better than the 10 mg dose. So I would say that is the go-to dose. However, the 10 mg dose also made people respond."

He explained that this product is now approved and on the market in Europe, has been approved in Canada, and is involved in several trials in the United States.

"The number 1 takeaway message for clinicians is that there is hope in hand dermatitis," summarized Dr. Lynde. "This is a disease that was thought to be incurable, but alitretinoin is a treatment that can be very effective in these patients."

Impressive Results

"This is a large study with impressive results," said Susan Nedorost, MD, associate professor of dermatology at University Hospitals Case Medical Center in Cleveland, Ohio.

"Hand eczema is often multifactorial, with irritation from wet–dry cycles or chemical irritants in susceptible patients, frictional hyperkeratosis, secondary infection in fissures, and allergic contact dermatitis all playing a role," explained Dr. Nedorost, who was not involved in the study.

She noted that a subgroup analysis of effectiveness by type of hand eczema would have been helpful. "It would be very difficult to characterize all of these factors in this large group of study subjects, but classification of hand eczema in responders vs nonresponders would potentially enlighten us regarding mechanism, and also allow more cost-effective selection of patients to receive this drug."

This study was sponsored by Basilea Pharmaceutica International. Dr. Lynde reports being on the advisory board for and receiving honoraria from Basilea. Dr. Nedorost has disclosed no relative financial relationships.

American Academy of Dermatology (AAD) 68th Annual Meeting: Abstract P1405. Presented March 7, 2010.

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