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03-05-2017 | Rheumatology | News | Article

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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.

By Claire Barnard

medwireNews is an independent medical news service provided by Springer Healthcare. © 2017 Springer Healthcare part of the Springer Nature group