Support for mycophenolate sodium in patients with active SLE
medwireNews: Results of an open-label trial suggest that enteric-coated mycophenolate sodium (EC-MPS) is superior to azathioprine (AZA) in achieving remission among patients with moderate-to-severe active systemic lupus erythematosus (SLE).
Josefina Cortés-Hernández (Vall d’Hebrón University Hospital Research Institute, Barcelona, Spain) and colleagues found that 32.5% of 120 patients treated with EC-MPS at a target dose of 1440 mg per day experienced clinical remission at 3 months, compared with 19.2% of 120 patients receiving 2 mg/kg AZA, a significant difference.
And the higher rates of remission with EC-MPS were maintained throughout the study, with a respective 71.2% and 48.3% of patients experiencing remission at the 24-month follow-up. The median time to remission was 6 months in the EC-MPS group and 12 months in the AZA group.
Patients received the study drugs alongside background treatment with prednisone and antimalarial agents. After 24 months, a greater proportion of patients in the EC-MPS than the AZA group who were also taking prednisone at a dose above 7.5 mg/day at baseline had their dose reduced by month 24 (94.9 vs 83.5%).
Furthermore, the mean prednisone dose decreased over the study period for both treatment arms, from 28.6 to 4.2 mg/day in the EC-MPS group and 23.9 to 6.8 mg/day in the AZA group.
A similar proportion of patients in both groups experienced adverse events (AEs), at 59.2% in the EC-MPS group and 57.5% in the AZA group, but the percentage of patients experiencing AEs leading to treatment withdrawal was numerically lower in the EC-MPS group (2.5 vs 8.3%). The most commonly reported AEs were infections in both treatment groups.
“This is the first multicenter randomised long-term trial to demonstrate the superiority of EC-MPS over AZA in achieving better clinical remission rates in moderate-to-severe active non-renal lupus disease,” write the authors in the Annals of the Rheumatic Diseases.
However, they emphasize that “[d]espite AZA being shown to be less effective” in this study, “its safety profile during pregnancy is a significant advantage over EC-MPS.”
EC-MPS and mycophenolate mofetil are “absolutely contraindicated” during pregnancy due to their likely teratogenic effects, they stress.
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