Off-label lenalidomide might be alternative to thalidomide for erythema multiforme


By Scott Baltic

NEW YORK (Reuters Health) - Lenalidomide might be considered as off-label treatment for chronic erythema multiforme (EM) if the adverse effects of thalidomide are not acceptable, according to French researchers.

Lenalidomide is a thalidomide analogue and has direct cytotoxic effects and immunomodulatory and antiangiogenic effects, as well as a more acceptable toxicity profile than thalidomide.

In a paper online February 14 in JAMA Dermatology, Dr. Saskia Ingen-Housz-Oro of Henri Mondor Hospital in Creteil and colleagues describe three women successfully treated for EM with lenalidomide. The patients had been suffering from chronic EM for seven to 18 years without evidence of herpes infection. The diagnosis of EM was based on typical cutaneous targets with mucous membrane involvement and on histological findings.

In all three cases, valacyclovir was unsuccessful, while thalidomide was ineffective at low doses and poorly tolerated at higher doses. Lenalidomide was initiated at 10 mg/d for the first 21 days of a 28-day cycle and was combined with contraception and with 75 mg/d aspirin to prevent thrombosis.

One patient experienced a relapse during the last week of the first lenalidomide cycle, so lenalidomide was subsequently administered continuously. Following two more relapses over five months, the dose was increased to 15 mg/d and then to 20 mg/d, which led to partial remission, then complete remission.

Another patient showed complete response after one month of lenalidomide treatment. Because of mild neutropenia, the dose was reduced to 5 mg/d, then to 5 mg twice weekly after eight months. The patient maintained complete response at a one-year follow-up.

The third patient also showed complete response after one month of treatment. As a result of fatigue, the dose was tapered to 5 mg/d, yet there was no relapse at a four-month follow-up.

Lenalidomide has been used successfully off-label for several inflammatory skin conditions such as chronic lupus with fewer adverse effects than thalidomide, which has been used effectively for such difficult-to-treat skin conditions, the report stated.

One disadvantage to lenalidomide vis-a-vis thalidomide, the researchers note, is that it is about 10 times as expensive.

Dr. Whitney A. High, a dermatologist at the University of Colorado Denver who was not involved in the work, also stressed the high price of lenalidomide, noting that a one-month supply costs about $14,000.

He told Reuters Health by email that he has a patient with chronic EM, “but I really, sincerely doubt that his health plan will allow me to do this therapy due to the cost of the medicine, the off-label use” and the limited evidence from this report.

Dr. Joseph F. Merola, a dermatologist at Brigham and Women's Hospital and Harvard Medical School, in Boston, who also was not linked to the report, echoed Dr. High’s concerns. Off-label use of both lenalidomide and thalidomide are challenging in the U.S., he told Reuters Health by email, and “our access to lenalidomide is even more difficult than thalidomide.”

The authors reported no conflicts of interest.

Dr. Ingen-Housz-Oro did not respond to a request for comments.


JAMA Dermatol 2018.

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