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NEW YORK (Reuters Health) May 20 - B cell depletion therapy with rituximab is effective and safe for treating children with refractory systemic lupus erythematosus (SLE), according to a report in the May issue of the Archives of Disease in Childhood.
"Rituximab actually is an impressively good treatment without major known side effects so far," Dr. Kjell Tullus told Reuters Health. "It is the new treatment that has impressed me most during my 35 years as a doctor, but formal randomized studies are needed to hopefully confirm our data."
Dr. Tullus, from the Great Ormond Street Hospital for Children NHS Trust, London, UK, and colleagues conducted a retrospective study of rituximab in 19 pediatric SLE patients treated in their hospital with two infusions, usually 14 days apart, at a dose of 750 mg/m per infusion.
More than half the children (10/19, 52%) experienced full recovery, 9 showed partial improvement, and 1 had minor symptomatic benefit after treatment, the authors report.
There was a rapid decrease in median BILAG (British Isles Lupus Assessment Group) scores from 14 to 6 within 1 month, followed by a significant decrease in BILAG scores at 6 and 12 months.
Two patients with renal failure who required renal replacement therapy experienced significant improvement in renal function within 3 months of rituximab therapy and maintained the improvement without renal replacement therapy for 18 months, the researchers note.
There were no acute adverse effects associated with rituximab treatment, though four patients developed uncomplicated herpes zoster 0.5 to 15 months after the treatment.
The investigators recommend rituximab "to everyone with a very severe, life- or organ-threatening disease and for children who have not had a full response to earlier standard treatment," Dr. Tullus said. However, "there is a huge need to do a proper international study to find the place for rituximab in childhood lupus."
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