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NEW YORK (Reuters Health) Jun 23 - Results of a small retrospective study suggest that the anti-CD20 monoclonal antibody rituximab may be an effective co-therapy in children with severe systemic lupus erythematosus (SLE), especially in those with severe autoimmune cytopenia or severe lupus nephritis who fail or are intolerant to cyclophosphamide.
However, noting that severe adverse events occurred in 45% of children, the authors say larger studies of the safety and efficacy of this therapy are needed.
In The Journal of Pediatrics for May, the French Pediatric-Onset SLE Study Group reports on 11 girls with severe SLE who received 2 to 12 infusions of rituximab (350-450 mg/m/infusion) and corticosteroids, starting at a mean age of 13.9 years. They were followed for a mean of 13.2 months (range, 6-26 months).
Rituximab infusions led to complete or partial remission in 8 of 11 girls, Dr. Brigitte Bader-Meunier from Hopital de Bicetre and colleagues report. Remission was achieved in 6 of 8 girls with severe lupus nephritis and in the 2 girls with severe autoimmune cytopenia.
"This series," the authors write, "confirms that rituximab is especially efficient for treating severe autoimmune cytopenia, because early and long-lasting complete remission was observed in both children with either autoimmune hemolytic anemia or autoimmune thrombocytopenia."
Five patients who responded to treatment were able to taper steroids and one patient maintained treatment with low-dose prednisone.
Anti-double-stranded DNA antibody levels decreased in all patients who responded to rituximab and it paralleled the clinical course and the CD20 B cell depletion, "with quicker normalization" when rituximab was given with cyclophosphamide, the investigators note.
Antiphospholipid antibody levels normalized in three patients, suggesting that rituximab may be helpful for antiphospholipid syndrome, with or without SLE.
The French group points out that rituximab was less well tolerated in this trial than reported in previous series, As mentioned, severe adverse events occurred in 45% of the children severe hematologic toxicity occurred in 36%. Rituximab with immunosuppressive drugs may have contributed to the toxicity, they speculate.
There is a need, the team concludes, for large prospective trials to confirm the safety and efficacy of this treatment in children with SLE.
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