The goal of this study is to evaluate the efficacy and safety of lenalidomide in the treatment of patients with active cutaneous DM.
Dermatomyositis (DM) are systemic immune-mediated inflammatory diseases which commonly affected the skin and musculoskeletal system. The cutaneous manifestations of DM are the most important aspect of this disease. Treatment of these cutaneous manifestations is challenging and currently no universally effective drugs exists. Lenalidomide, a second-generation derivative of thalidomide, has a role as an angiogenesis inhibitor, an antineoplastic agent and an immunomodulator. Reports on refractory cutaneous manifestations of systemic lupus erythematosus have been mostly performed. The clinical trials of lenalidomide for cutaneous DM are lacking. This is a single-centre, prospective, open-label, single-arm study with Lenalidomide 5mg/day added to the background treatment of GCs and immunosuppressants in DM to evaluate the efficacy and safety of lenalidomide in the treatment of cutaneous DM.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
All subjects will be treated with lenalidomide 5mg/day with a regular follow-up of 24 weeks.
Department of Rheumatology and Clinical Immunology, Jiangxi Provincial People's Hospital
Nanchang, Jiangxi, China
Cutaneous Disease Activity Severity Index (CDASI) activity score
Change in Cutaneous Disease Activity Severity Index (CDASI) activity score (0-100), higher scores mean a worse outcome
Time frame: 24 weeks
Cutaneous Disease Activity Severity Index (CDASI) activity score
Change in Cutaneous Disease Activity Severity Index (CDASI) activity score (0-100), higher scores mean a worse outcome
Time frame: 12 weeks
International Myositis Assessment & Clinical Studies Group (IMACS) Disease Activity Core Set Measures
Change in International Myositis Assessment \& Clinical Studies Group (IMACS) Disease Activity Core Set Measures
Time frame: 12 weeks and 24 weeks
SF-36
Change in SF-36
Time frame: 12 weeks and 24 weeks
Dermatology Life Quality Index (DLQI)
Change in Dermatology Life Quality Index (DLQI)
Time frame: 12 weeks and 24 weeks
Adverse event
Adverse event monitoring
Time frame: 24 weeks
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