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After decades of failures and setbacks, the lupus community finally had a more fruitful period marked by the successful results in two phase III and one phase II randomised controlled trials (RCTs) testing belimumab (BLM), voclosporin (VCS) and obinutuzumab (OBI), respectively, in lupus nephritis (LN), as well as of anifrolumab (ANI) in general systemic lupus erythematosus (SLE) with encouraging results in LN.1–5 These trials overcame previous drawbacks in study design, introducing new approaches in the selection of endpoints and sample size, duration of follow-up and background treatment. The new developments provide the impetus for a critical appraisal of their place in the therapeutic armamentarium of SLE. This is highly timely, since these data were published after the 2019 updates of the EULAR and EULAR-ERA/EDTA recommendations for the management of SLE and LN, respectively.6 7
Recent trials in lupus nephritis: key findings
Based on hints from previous trials (ie, BLISS-52 and BLISS-76) for the beneficial role of add-on BLM in renal parameters, a phase III trial, BLISS-LN, tested its efficacy in LN population (table 1).1 8 At the end of follow-up, significantly more patients in the BLM group met the primary endpoint of renal response (43% vs 32%; OR, 1.6; 95% CI 1.0 to 2.3). Patients who received BLM also had a lower risk of renal-related events (a composite endpoint including end-stage kidney disease (ESKD); doubling of serum creatinine; increased proteinuria or impaired kidney function or kidney disease-related treatment failure) or death (HR, 0.51; 95% CI 0.34 to 0.77) while the safety profile was similar between groups.1 Of note, the relatively high glucocorticoid (GC) dose used in this trial raises the question whether lower GC doses would allow BLM to demonstrate its true efficacy. In this regard, in a posthoc analysis of patients who remained in the study after 24 weeks—when both mycophenolate …
Handling editor Josef S Smolen
Contributors All authors contributed equally, read and approved the final manuscript.
Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.
Competing interests None declared.
Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.
Provenance and peer review Commissioned; externally peer reviewed.
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