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Thalidomide Derivative Studied in Cutaneous Lupus Erythematosus

Patients show clinical improvement within 2 weeks (Dec. 7)

Although cutaneus lupus erythematosus (CLE) is a relatively rare disorder, several treatment options are available. Nevertheless, other therapies are needed for patients who fail to respond to drug treatment or who experience relapse. According to a new report, published online in the December 7 issue of Arthritis Research & Therapy, the thalidomide derivative lenalidomide (Revlimid, Celgene Corporation) may offer an alternative therapy for CLE.

Lenalidomide, a thalidomide analogue, is an immunomodulatory agent with antiangiogenic and antineoplastic properties. The drug, in combination with dexamethasone, is indicated in the U.S. for the treatment of patients with multiple myeloma who have received at least one prior therapy. It is also indicated for the treatment of patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities.

An open-label phase II study was conducted in Spain to evaluate the efficacy and safety of lenalidomide in 15 patients with refractory CLE. The patients were treated with oral lenalidomide (5 mg/day) for 4 weeks. At that point, if no clinical improvement was observed, the dosage was increased to 10 mg/day; otherwise, treatment was sustained at 5 mg/day. Overall, the duration of treatment ranged from 3 to 30 months (median: 11 months), and the patients were followed for 7 to 30 months (median: 15 months). All of the patients were white and female, with a median age of 40 years (range: 28 to 53 years).

The study’s primary efficacy endpoint was the proportion of patients achieving a complete response (CR), defined as complete resolution of the inflammatory rash (Cutaneous Lupus Erythematosus Disease Area and Severity Index [CLASI] activity score = 0). Other secondary endpoints included the development of side effects, cutaneous and systemic flares, and the drug’s immunological effects.

One patient discontinued treatment because of gastrointestinal (GI) side effects. All of the remaining patients showed a clinical response, with 12 (85%) achieving CR. A significant clinical improvement (a decrease in the CLASI activity score from 11.00 to 4.13 [P = 0.0009]) was observed at 2 weeks. Of the 12 patients who achieved CR, nine (75%) relapsed within a median period of 4.4 weeks (range: 2 to 8 weeks). Only two patients, both with subacute CLE, achieved sustained disease remission after the medication was withdrawn.

Lenalidomide therapy had no effect on systemic disease, immunological parameters, or the CLASI damage score.

The drug was generally well tolerated. Only two patients (13%) developed side effects, which included insomnia, grade 2 neutropenia, and GI symptoms. These effects resolved after withdrawal of the medication. Neither polyneuropathy nor thrombosis was observed.

The authors concluded that lenalidomide appears to be safe and effective in patients with refractory CLE. Clinical relapse, however, may be expected after the drug’s withdrawal.

Lenalidomide is a Pregnancy Category X drug. If lenalidomide is used during pregnancy, it may cause birth defects or death to a developing baby. Treatment with linelidomide has also been associated with hematologic toxicity, deep-vein thrombosis, and pulmonary embolism.

Sources: Arthritis Research & Therapy ; December 7, 2012; and Revlimid PI ; May 2012.

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