Apremilast Shows Promise for Inflammatory Rosacea

By Will Boggs MD

July 30, 2014

NEW YORK (Reuters Health) - The oral phosphodiesterase inhibitor apremilast relieves signs of inflammatory rosacea, according to a pilot study in patients with moderate to severe disease.

Some patients with rosacea, a chronic skin disorder characterized by facial flushing, persistent erythema, telangiectasia, and inflammatory papules and pustules, do not respond to conventional treatments (such as brimonidine tartrate) or cannot tolerate their adverse effects.

Based on the experience with oral phosphodiesterase inhibitors in other inflammatory dermatologic diseases, Dr. Julian Mackay-Wiggan and colleagues from Columbia University in New York investigated the safety and efficacy of apremilast (20 mg twice daily for 12 weeks) in an open-label pilot study of three men and seven women with moderate to severe inflammatory rosacea.

At the end of treatment, there were statistically significant improvements in ratings on the Physician Global 7-Point Assessment, Physician Overall Erythema Severity, erythemato-telangiectatic rating, and nontransient erythema, according to the July 23 JAMA Dermatology online report.

None of the other outcomes, including the primary end point of papule and pustule count, changed significantly with treatment.

One month after discontinuation of treatment, Physician Overall Erythema Severity and nontransient erythema ratings remained improved over baseline.

Few patients experienced adverse effects, and no patient altered or discontinued treatment because of adverse effects.

"Apremilast may represent a novel alternative treatment for rosacea and rosacea-associated erythema," the researchers conclude. "Larger randomized clinical studies are needed to more adequately evaluate the drug's efficacy and safety."

Dr. Steven R. Feldman from Wake Forest University School of Medicine in Winston-Salem, North Carolina has published research on inflammatory rosacea. He told Reuters Health by email, "We have many good treatments for rosacea already. While more would be welcome, the great majority of patients can control their rosacea with the current (relative to apremilast) low cost, safe options. The recent approval of topical brimonidine has given us a good treatment for the redness associated with rosacea."

"The lack of statistically significant improvement in papules and pustules is disappointing, as we might have expected those to be most sensitive to improvement with anti-inflammatory treatment," Dr. Feldman said.

"At over $20,000 per year," Dr. Feldman said, apremilast treatment should be reserved as the "last line for refractory disease."

Dr. Juergen Schauber from Ludwigs Maximilans Universitaet Muenchen in Germany, who has studied treatments for rosacea, was less impressed with the findings. He told Reuters Health by email, "There were no effects on inflammatory lesions in this report. The number of papules and pustules remained unchanged. Hence, there is no role for (apremilast in) the management of inflammatory rosacea."

"We still need more drugs to treat patients with rosacea, especially erythemato-telangiectatic rosacea," Dr. Schauber said. "Brimonidine tartrate is the only approved drug for this indication but not tolerated by all. Apremilast needs to prove if it is an alternative for brimonidine. This current data is not sufficient."

Dr. Mackay-Wiggan did not respond to a request for comments.

The study was funded by an investigator-initiated research grant from Celgene Corporation.

SOURCE: http://bit.ly/Xa4BTh

JAMA Dermatol 2014.

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