Effectiveness of Belimumab After Rituximab in Systemic Lupus Erythematosus: A Randomized Controlled Trial

SPS commentary:

The researchers suggest that this combination could be developed as a therapeutic strategy.

 

An editorial advises caution in interpreting these findings because of limitations in the data and study design. First, the use of a biomarker as the primary outcome differs from most similar trials, which used validated clinical end points. It notes anti-dsDNA is clinically used to assess SLE disease activity, but it is not used in isolation; levels are informative only in the context of other clinical signs and symptoms, thus the clinical significance of a reduced but persistently positive anti-dsDNA IgG level is not certain. It suggests that although the investigators showed a reduction in flares in their secondary analysis, use of a primary clinical composite end point may provide better clinical interpretability and improve the ability to compare results with those of other SLE trials. It adds that generalisability may also be compromised by the small sample size, the variation in SLE disease presentation (38% of patients had renal disease), the lack of racial diversity (only 12% of participants were Black), and the requirement for dose restriction of concomitant immunosuppressive medications, potentially ensuring that patients with more severe, refractory SLE were excluded. It concludes that data from this study may complement other trials that are under way, including the phase 3 BLISS-BELIEVE comparing the proportion of patients with SLE who achieve a validated clinical end point of disease control or remission after 104 weeks of belimumab and rituximab versus those treated with belimumab and placebo.