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Mycophenolate Mofetil May Be as Effective as Cyclophosphamide in Treating Paediatric Lupus: Presented at PAS

By Bonnie Darves

SAN FRANCISCO, CA -- May 2, 2004 -- Mycophenolate Mofetil (MMF) therapy may be as effective as the standard cyclophosphamide therapy for treating childhood systemic lupus erythematosus (SLE), while offering patients less toxicity and fewer side effects.

According to a new study presented here on May 1^st at the Pediatric Academic Societies Annual Meeting, 3 years of MMF therapy resulted in stability or improvement in treating paediatric lupus, as well as manifestations of lupus nephritis. The treatment also offered young patients a decreased reliance on steroids.

MMF has long been used as an alternate treatment for adults with SLE who either don't tolerate or who fail cyclophosphamide therapy, but its use and safety has been little tested in children, said investigator Lisa Imundo, MD, Texas Scottish Rite Hospital for Children, Dallas, United States.

"[MMF] was well tolerated, and even though the [study] numbers are small, the dramatic drop in SLEDAI [Systemic Lupus Erythematosus Disease Activity Index] scores and the ability of the patients to wean off prednisone by 63% are remarkable," said Dr. Imundo, adding that the researchers were especially pleased "by the sustained response to MMF" seen in several patients.

The study involved 19 patients, with an average age of 15.3 years, who received MMF treatment for an average of 31 months. Average disease duration was 3.5 years, and 14 of the patients had received prior prolonged treatment with cyclophosphamide.

Nine months into the 3-year study, nearly half of patients reported stable or improved status, based on SLEDAI scores. The 10 patients who were able to continue the therapy for 31 months experienced a marked improvement in SLEDAI scores, from 11.6 to 4.3, and decreased their steroid use by 98% (from 1.6 mg/kg/d to 0.04 mg/kg/d). Improvement, especially in associated renal disease, was most marked in patients with severe lupus, Dr. Imundo noted.

Adverse events -- primarily leukopaenia and herpes zoster -- were relatively few, and were mild to moderate in nature. Overall, 2 patients did not tolerate MMF; 1 withdrew from all treatment; and 2 voluntarily discontinued MMF, Dr. Imundo said.

As a note of caution, Dr. Imundo noted that some patients on longer, post-study follow-up have reported an increase in flares, and that the small study numbers are also a limitation in terms of whether the treatment is safe and effective in the paediatric population. "It's clear that further study is required to determine what role MMF might play in treating childhood lupus," Dr. Imundo concluded.

Presentation title: "Three year follow-up of mycophenolate mofetil therapy in childhood SLE indicates effectiveness as a maintenance agent." Abstract #90.]

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