Adding mycophenolate mofetil to standard therapy may reduce the incidence of severe flare-ups and lupus nephritis in patients with new-onset systemic lupus erythematosus, according to a recent trial.

In the randomized clinical trial, published in JAMA Network Open, researchers assessed the safety and efficacy of mycophenolate mofetil (MMF) in patients with new-onset systemic lupus erythematosus, characterized by high titers of anti-double-stranded DNA (anti-dsDNA) antibodies and without major organ involvement. Conducted across three hospitals in China, the study included 130 treatment-naive participants aged 18 to 65 years. The patients were randomly assigned to receive either oral prednisone and hydroxychloroquine sulfate or these treatments in combination with MMF (500 mg twice daily) for a duration of 96 weeks.

The primary endpoint of the trial was the proportion of patients experiencing disease flare-ups, as defined by the Safety of Estrogens in Lupus Erythematosus National Assessment–Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI). Secondary outcomes included the achievement of lupus low disease activity state (LLDAS), changes in SLEDAI-2000 scores, and the incidence of adverse events.

A total of 91.5% (n = 119) patients successfully completed the study's follow-up period. The results showed a lower incidence of severe flares in the MMF group (10.8%) compared with the control group (27.7%) (P = .01). Further, MMF use was associated with a reduction in the incidence of lupus nephritis, with 1.5% of patients in the MMF group affected compared with 13.8% in the control group (P = .008). 

The incidence of adverse events was comparable between the two groups, with 23 patients (35.4%) in the control group and 30 patients (46.2%) in the MMF group (relative risk [RR] = 1.30, 95% confidence interval [CI] = 0.86–1.99, P = .20) experiencing these events. Infections were the most frequently reported adverse events, occurring in 22 patients (33.8%) in the MMF group and 20 patients (30.8%) in the control group (RR = 1.10, 95% CI = 0.67–1.81, P = .70).

The results indicated that early administration of MMF in patients with newly diagnosed lupus and high anti-dsDNA titers, in conjunction with standard therapy, was associated with reduced severe flare-ups and lupus nephritis, without an increase in adverse events. 

Full disclosures can be found in the published study.