Proof-of-Concept Study of IVIg Efficacy in Patients With Cutaneous Lupus Erythematosus

The ultimate goal of this pilot project is to generate proof-of-concept data showing that treatment with intravenous immunoglobulin (IVIg) can replace current systemic immunosuppressive therapy in cutaneous lupus erythematosis (CLE) patients. This project has relevant clinical implications due to the severe side effects of and lack of response to current therapies. From the review of literature, it can be postulated that: the beneficial effects of IVIg for patients with CLE should be prompt, with marked improvement within a few weeks; clinical improvement should last several weeks after the last infusion; and remission may be prolonged by maintenance IVIg therapy. Although this is only a non-controlled study, the investigator expects that IVIg will improve CLE, including those resistant to standard treatments. It is anticipated that treatment with IVIg will facilitate healing of extensive cutaneous lesions and achieve rapid remission. Maintenance therapy with repeated monthly pulses of IVIg is expected to keep the disease in remission during the treatment-free follow up observational period. The results will provide the basis a multicenter randomized controlled study to identify which CLE subsets will benefit the most and which protocol will provide the optimal clinical outcome.