NEW analysis of five clinical trials highlights the importance of normal serology in reducing severe and renal lupus flares.
A recent integrated analysis of five randomised clinical trials of belimumab has reinforced the significance of serological markers in treating systemic lupus erythematosus (SLE) using a treat-to-target (T2T) approach. Researchers examined over 45,000 monthly patient visits from the BLISS-52, BLISS-76, BLISS-SC, BLISS-NEA, and EMBRACE trials, evaluating how serology impacts disease control and flare risk.
The study compared two commonly used SLE treatment targets: DORIS remission, based on clinical activity, and Lupus Low Disease Activity State (LLDAS), which also incorporates serological markers like anti-dsDNA antibodies and complement levels (C3/C4). Researchers found that patients achieving DORIS or LLDAS with normal serology had significantly greater protection against severe and renal flares than those with active serology (anti-dsDNA+ or low C3/C4 levels).
Specifically, DORIS remission with negative anti-dsDNA or normal C3/C4 levels was associated with stronger flare prevention, reducing the odds of severe flares by over 95% compared to those who were not in remission. Meanwhile, patients with DORIS remission but persistent serological activity had a six-fold higher risk of renal flares than those in full clinical and serological remission. Sustained DORIS remission, particularly with normal serology, was also linked to the lowest rates of long-term organ damage.
These findings suggest that normalising serology enhances disease control, making it a valuable marker for monitoring SLE progression. The study emphasises that patients achieving clinical remission but still exhibiting serological abnormalities may remain at risk for flares and should be closely monitored. The results could lead to more refined treatment strategies, ensuring better long-term outcomes for SLE patients.
Aleksandra Zurowska, EMJ
Reference
Gomez A et al. Treat-to-target in SLE: is serology important? Results from an integrated analysis of five randomised clinical trials of belimumab. Rheumatology. 2025;DOI: 10.1093/rheumatology/keaf107.
