B-cell depletion therapy and pregnancy outcome in severe, refractory systemic autoimmune diseases.

OBJECTIVE: To study the pregnancy outcome following Rituximab treatment before conception in patients with refractory autoimmune rheumatic diseases. METHODOLOGY: Five women with systemic lupus erythematosus (SLE) and 1 woman with ANCA positive vasculitis fulfilling the respective ACR classification criteria were studied retrospectively when they became pregnant following rituximab treatment for refractory disease. Rituximab was given as a 1 g infusion together with 500 mg Methylprednisolone, on day 1 and day 15 after written informed consent. RESULTS: The median age was 34 (range 32-39) years and median disease duration was 10 (range 5-16) years. All the patients achieved complete B-cell depletion < 1 cell/µL at 1 month and <5 cells/µL at 6 months with prolonged B-cell depletion. Four women had successful pregnancies with median gestational age of 38 (range 31-40) weeks; median weight of the new born was 3.25 (range1.17-3.3) kg with no documented adverse neonatal events. One patient with lupus nephritis (LN) had a premature delivery and increasing proteinuria in the third trimester. One other patient with LN had a premature delivery and the new born had oesophageal atresia. CONCLUSION: We report a child with oesophageal atresia born to a mother with lupus nephritis who had received Rituximab 12 months prior to conception, while four other pregnancies in women with SLE resulted in morphologically normal children. We also describe the first report, to our knowledge, of a successful pregnancy outcome in a woman with granulomatosis with polyangiitis treated with rituximab.