Abstract
In sharp contrast to the many successes in the treatment of patients with rheumatoid arthritis, the list of trial failures in systemic lupus erythematosus (SLE) is long, and unfortunately, continues to grow.1–3 The fact that drugs, apparently successful in phase 2, do not deliver successes in phase 3 frustrates patients, clinicians, and the pharmaceutical industry. The reasons are not clearcut, but inappropriate inclusion or exclusion criteria and the selection of outcome measures constitute suggested attributions, along with allowance of background medications, particularly corticosteroids.
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