Lenalidomide may be used to treat patients with severe, treatment-refractory cutaneous lupus erythematosus, although the drug may not be advisable for patients with systemic disease, according to study results.
In an unblinded, open-label study of five adult patients, aged 35 to 47 years, the participants were assigned lenalidomide (Revlimid, Celgene), a thalidomide analog, to treat discoid lupus erythematosus (DLE) or subacute cutaneous lupus erythematosus (SCLE).
Participant eligibility was based upon diagnoses of either DLE or SCLE, having had no response to 3 months of treatment with hydroxychloroquine, and participation in RevAssist, an education program conducted by lenalidomide’s manufacturer.
During the first 6 weeks of treatment, each patient received 5 mg lenalidomide daily. All patients received a punch biopsy to an affected area of skin when the study began and at weeks 2 and 6. In addition, all received a punch biopsy on unaffected skin at the beginning of the study.
Before and after treatment, each patient’s specimen was submitted for immunotyping and analysis of mononuclear cells from peripheral blood. They also were analyzed for T-cell markers, glycosaminoglycans, and the interferon-inducible chemokine CXCL10.
Researchers said four patients saw satisfactory improvement in their skin areas affected by DLE or SCLE.
Using the Cutaneous Lupus Area and Severity Index (CLASI), the patients indicated partial response to lenalidomide (their CLASI scores decreased ≥4 points from the beginning of the study to week 6). Four of the five patients, however, were noted as “responders” because their CLASI scores fell ≥8 points.
The CLASI score of one woman with DLE showed a 5-point decrease, and she was withdrawn as a “nonresponder” at 12 weeks. Another woman’s skin lesions improved before she developed proteinuria and arthralgias, prompting her removal at week 20.
“Lenalidomide may have usefulness as therapy for severe, treatment-refractory CLE. However, our preliminary data suggest that lenalidomide may activate T cells and trigger systemic disease in some patients with CLE,” researchers said.
They also said the small study size was a limitation and that lenalidomide should perhaps not be administered to patients with systemic disease such as arthralgias.
Disclosure: See the study for a full list of relevant disclosures.