At baseline, 95% of patients were receiving prednisone. Of the patients treated with belimumab plus standard therapy, no difference was found in the frequency of prednisone reduction between the belimumab- and placebo-treated groups (20.0% and 21%, respectively). This study was not designed or powered to assess a steroid-sparing effect.
The probability of having an SLE disease flare was measured by the modified SELENA-SLEDAI Flare Index. The proportion of patients reporting at least one severe flare during the study was lower in patients treated with belimumab plus standard therapy (17%) than in the proportion of patients treated with placebo plus standard therapy (35%). The addition of belimumab to standard therapies resulted in a 64% lower risk of experiencing a severe disease flare during the study than patients who received placebo plus standard therapy.
Of the patients who had a severe flare, the median time to the first severe flare was 150 days in patients receiving belimumab plus standard therapy and 113 days in patients receiving placebo plus standard therapy. In the 53 patients who received belimumab, no formation of anti-belimumab antibodies occurred.
In this patient population, belimumab’s pharmacokinetics were consistent with those of the adult population with SLE. No new safety signals were identified. This FDA approval marks a significant step forward, providing treatment options for pediatric patients at risk of developing early renal damage and failure due to SLE.
Michele B. Kaufman, PharmD, BCGP, is a freelance medical writer based in New York City and a pharmacist at New York Presbyterian Lower Manhattan Hospital.
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