Lupus & antiphospholipid syndrome
Mycophenolate Mofetil and New-Onset Systemic Lupus Erythematosus: A Randomized Clinical Trial
Primary result · Severe flareResult — go to the resultRelative risk 0.39 95% CI 0.17–0.87Authors' conclusion
The findings of this randomized clinical trial suggest that MMF may reduce the rate of severe flare and lower the incidence of LN in patients with new-onset SLE and a high titer of anti-dsDNA antibody without major organ involvement.
Study context
- Population
- Treatment-naive patients aged 18 to 65 years with newly diagnosed systemic lupus erythematosus (SLE), a high titer of anti-dsDNA antibody and no major organ involvement, 3 hospitals across China119 (91.5%) completed follow-up
- Participants
- 130 patients
- Comparison
- Mycophenolate mofetil (MMF) plus prednisone and HCQ vs prednisone and HCQ alone for 96 weeks
- MMFn = 65
- Controln = 65reference
- Primary endpoint
- Proportion of patients with flares according to the SELENA-SLEDAI Flare Index
Methodological detailsinvestigator-initiated, multicentre, observer-blinded, Started September 1, 2018; follow-up completed September 30, 2021
- Investigator-initiated
- Multicentre
- Observer-blinded
- Started September 1, 2018; follow-up completed September 30, 2021
Primary result
Severe flare
Relative risk
0.39
95% CI 0.17–0.87
P = 0.01
Events by treatment group
MMFvs Control
RR 0.39 (95% CI 0.17–0.87); P = 0.01
As reported in the abstract
Secondary outcomes
| Outcome | MMF | Control | RR (95% CI) | P value | |
|---|---|---|---|---|---|
| LN | 1.5% | 13.8% | 0.11 (0.01–0.85) | P = 0.008 | |
| 0.050.21520Relative risk (log scale) |
Safety
Infections (most common serious study drug-related AEs)
Original publication
Mycophenolate Mofetil and New-Onset Systemic Lupus Erythematosus: A Randomized Clinical Trial. JAMA Netw Open. Published 3 September 2024. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →