Mycophenolate mofetil cuts flare, lupus nephritis risks in new systemic lupus erythematosus
Click Here to Manage Email Alerts
Key takeaways:
- Early mycophenolate mofetil in newly diagnosed SLE led to fewer severe flares and lower incidence of lupus nephritis.
- Rates of infection were similar to those not receiving mycophenolate mofetil.
Early treatment with mycophenolate mofetil can reduce subsequent risks for severe flares and lupus nephritis in newly diagnosed systemic lupus erythematosus, according to data published in JAMA Network Open.
“Mycophenolate mofetil (MMF) is an important disease-modifying antirheumatic drug used in SLE treatment,” Yijun You, MD, of the department of rheumatology and immunology at Ruijin Hospital, in Shanghai, China, and colleagues wrote. “MMF, a prodrug of mycophenolic acid (MPA), can inhibit inosine monophosphate dehydrogenase, which is responsible for de novo synthesis of guanosine nucleotides.
“In addition, MPA can regulate dendritic cell subsets to interrupt the harmful cascade of autoimmune disorders,” they added. “Currently, MMF is widely used for induction and maintenance treatment in LN. MMF has been reported to have a role in the treatment of patients with extrarenal involvement. In a multicenter, 24-month randomized clinical trial, MMF was superior to azathioprine in treating SLE and preventing further relapses.”
To examine the efficacy and safety adding mycophenolate mofetil to prednisone and hydroxychloroquine sulfate, vs. the latter two alone, in patients with new-onset SLE, You and colleagues conducted a multicenter, observer-blinded randomized clinical trial. The study was conducted across three hospitals in China and included 130 adults with newly diagnosed SLE (mean age, 34.5 years; 86.2% women), as well as at least 300 IU/mL of anti-dsDNA antibody and no major organ involvement.
The participants were randomly assigned to receive a 96-week course of either mycophenolate mofetil 500 mg twice per day, plus oral prednisone and hydroxychloroquine, or oral prednisone and hydroxychloroquine alone. The primary outcome was the proportion of patients who flared, assessed using the Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus Disease Activity (SELENA-SLEDAI) Flare Index.
According to the researchers, compared with the control group, patients treated with mycophenolate mofetil demonstrated significantly lower risk for severe flare (RR = 0.39; 95% CI, 0.17-0.87). Meanwhile, lupus nephritis emerged in one of 65 patients who received mycophenolate mofetil, and in nine of 65 participants in the control group (RR = 0.11; 95% CI, 0.01-0.85).
The most common serious adverse events related to the study drugs were infections, affecting 33.8% of participants treated with mycophenolate mofetil and 30.8% of those in the control group.
“The preliminary findings from this randomized clinical trial indicated that among treatment-naive patients with new-onset SLE, a high titer of anti-dsDNA antibody, and no organ involvement, early use of low-dose MMF may decrease the risk of severe flare and incidence of LN,” You and colleagues wrote. “Further investigation is warranted to assess the balance between potential benefits and harms.”
Collapse
Read more about
Click Here to Manage Email Alerts