In a new phase 3, double-blind study, researchers explored the efficacy and safety of combination therapy using subcutaneous (SC) belimumab and rituximab for the treatment of active systemic lupus erythematosus (SLE). This study sought to evaluate if sequential belimumab and rituximab treatment might allow for rapid reduction and withdrawal of standard immunosuppressant medications, including corticosteroids, potentially minimizing side effects and long-term complications.
In the BLISS-BELIEVE study, 263 people with SLE were part of a 52-week randomized trial. Study participants were randomly assigned to receive belimumab (SC) and either intravenous (IV) placebo, or IV rituximab (1000mg) at weeks 4 and 6 while aggressively withdrawing standard of care medication. A third group of open-label participants received belimumab (SC) and standard therapy for 104 weeks.
Due to both the belimumab/rituximab and belimumab/placebo groups achieving similar levels of disease control, the study did not meet its primary endpoint showing an increased proclivity for disease control with the sequential addition of rituximab. However, study participants who received the combination therapy of belimumab and rituximab showed reductions in circulating B cells as well as improvement in serological biomarkers compared to the groups who received only belimumab or the placebo.
This study provides clinicians valuable insight to help with patient treatment decision-making. Further studies investigating combination treatment approaches with rituximab for better disease control are needed. Consult your physician before making any changes to your therapy and learn more about finding the right treatment approach.
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