Evidence-based evaluation of immunomodulatory therapy for the cutaneous manifestations of lupus.

This literature review revealed an unexpected paucity of data derived from adequately powered, randomized, controlled trials to guide evidence-based treatment of the cutaneous manifestations of lupus. Lupus erythematosus is characterized by spontaneous fluctuations in disease activity. This characteristic may serve to explain some of the contradictions in published evidence and cautions us not to rely too heavily on data derived from inadequately powered studies, small uncontrolled case series, or individual case reports, which are additionally subject to publication bias. Clearly, there is a pressing need to conduct adequately powered clinical research studies to fill these gaps in our knowledge. There also is a need for controlled trials to assess drug safety in patients with SLE. Much of the data regarding side-effect profiles of the immunomodulatory drugs has been compiled in patients receiving organ transplantation or chemotherapy for malignant diseases and extrapolated to patients with lupus. Given that there is often a substantial overlap in symptoms related to drug toxicity and to lupus erythematosus, careful studies should be conducted to assess the safety and toxicities of both established and newer medical therapies, especially those whose efficacy is supported only by small trials and case reports. Table 4 summarizes the results of our literature review. For each drug, we give the highest level of data we found, both for the treatment of lupus erythematosus in general and for the treatment of the cutaneous manifestation of lupus in particular.