To the Editor:
Controlled clinical trials have revealed modest efficacy for the use of belimumab in the treatment of systemic lupus erythematosus (SLE)1,2. Followup of these patients has been published and of the 1458 patients who have received belimumab during phase II and III clinical trials, the most frequent events leading to discontinuation were lupus nephritis and infusion-related reactions3. We report herein the status of 47 patients who received open-label belimumab from a single-site cohort of patients whose longterm followup (mean 62 mos) could be ascertained. Pregnancy was found to be an atypical and potentially important reason for drug discontinuation that bears additional scrutiny.
Study design and patient demographics for the first 52 and 76 weeks have been reviewed and published elsewhere1,2. Our initial cohort was composed of 55 patients in 2 double-blind, placebo-controlled trials: HGS-1056 and LBSL-02 (Figure 1). Twelve patients withdrew while blinded: 4 were receiving placebo and 8 withdrew because of pregnancy, flares (lupus nephritis, neuropsychiatric lupus), noncompliance, inefficacy, breast cancer, and the …
Address correspondence to Dr. M.H. Weisman, 8700 Beverly Blvd., B131, Los Angeles, California 90048, USA. E-mail: weisman{at}cshs.org
