The thalidomide derivative, lenalidomide, is a "safe" and effective treatment in refractory cutaneous lupus erythematosus (CLE) patients, although three-quarters of patients experience clinical relapse after the drug is withdrawn, say Spanish researchers.
Lead researcher Josep Ordi-Ros (Vall d'Hebron University Hospital Research Institute, Barcelona, Spain) commented in a press statement: "We… did not see any of the systemic lupus erythematosus (SLE) effects reported in smaller studies, even after 15 months of follow up." He suggested this may have been due to the low dose of lenalidomide used.
"Nevertheless this regime was very effective in reducing disfigurement due to CLE and was similar in effect to thalidomide but with lower toxicity," he added.
The team administered oral lenalidomide 5-10 mg/day to 15 patients with refractory CLE between 2009 and 2010, tapering the dose based on the patients' clinical response. One patient discontinued treatment after 1 week due to disabling gastrointestinal adverse effects, the researchers report in Arthritis Research and Therapy.
Over an average follow up of 15 months, all of the remaining patients demonstrated clinical response to lenalidomide, with 86% showing a complete response (CR). Of these, four had failed prior thalidomide therapy.
Interestingly, there was a difference in time to CR depending on the CLE subtype, at a median of 6 weeks and a range of 2-12 weeks in patients with discoid lupus erythematosus or subacute CLE (SCLE), and a median of 13 weeks and a range of 4-32 weeks in those with lupus profundus.
At 2 weeks, a significant clinical improvement was observed, with Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) activity scores decreasing from an average of 11.00 to 4.13. Treatment duration ranged from 3-30 months, at a median of 11 months.
Of the 12 patients who achieved a CR, 75% relapsed with 2-8 weeks, while their dosage was reduced or after lenalidomide was withdrawn. The lowest dose at which relapse occurred was 5 mg on alternate days or three times weekly. All patients responded to the introduction of lenalidomide. Only two patients, both of whom had SCLE, achieved sustained remission after medication withdrawal.
The results also show that lenalidomide had no impact on systemic diseases, immunologic parameters, or CLASI damage score. Adverse effects, which included insomnia, grade 2 neutropenia, and gastrointestinal symptoms, were seen in 13% of patients and resolved after medication withdrawal.
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