Mycophenolate mofetil appears to limit severe flares and progression to organ damage.
Adding low-dose mycophenolate mofetil to hydroxychloroquine in lupus patients with high anti-dsDNA early in their disease may reduce severe flares and kidney involvement, according to a new study conducted in China.
The multi-site randomised controlled trial, published in JAMA Network Open, enrolled 130 patients aged 18-65 with new-onset SLE who were not yet being treated, had high titres of anti-dsDNA antibody and no major organ involvement.
Half were given prednisone (0.5mg/kg per day) and hydroxychloroquine sulfate (5mg/kg per day) plus 500mg of mycophenolate mofetil twice daily for 96 weeks. The control group received oral prednisone and hydroxychloroquine sulfate.
On the primary outcome measure of severe flares, measured using the SELENA-SLEDAI Flare Index, the MMF group did much better: seven of 65 (11%) patients had a severe flare during follow-up compared with 18 (28%) of the controls.
Nine of the controls developed lupus nephritis while only one in the MMF group did.
There was no difference between the groups in the risk of mild or moderate flares, nor in the proportion of patients in lupus low disease activity state (LLDAS) at the end of follow-up.
Twenty-three of the controls and 30 of the MMF patients reported adverse events, the most common being upper respiratory tract infection, but this difference was not statistically significant.
Severe damage across all organs, measured using the Systemic Lupus International Collaborating Clinics-American College of Rheumatology Damage Index (SDI), was recorded for five controls and two MMF patients – also not a significant difference. The authors commented that the SDI is a “relatively strict parameter” that even lupus nephritis would not satisfy.
More patients in the control group (20) discontinued treatment than in the MMF group (12).
The authors note the sample was fairly small, thanks to tight inclusion criteria, and possibly not generalisable beyond Asian populations.
