Objective
Belimumab (Benlysta) is a human monoclonal antibody that inhibits soluble B-lymphocyte stimulator and was approved by the FDA for treatment of adults with systemic lupus erythematosus (SLE). This study evaluates the use and efficacy of belimumab in academic SLE practices.
Methods
Invitations to participate and complete a one-page questionnaire for each patient prescribed belimumab were sent to 16 physicians experienced in SLE Phase III clinical trials. The outcome was defined as the physician’s impression of improvement in the initial manifestation(s) being treated without worsening in other organ systems.
Results
Of 195 patients treated with belimumab at 10 academic centers, 96% were on background medications for SLE at initiation of belimumab, with 74% on corticosteroids. The main indications for initiation of belimumab were arthritis, rash, and/or worsening serologic activity, with 30% of patients unable to taper corticosteroids. Of the 120 patients on belimumab for at least 6 months, 51% responded clinically and 67% had ≥25% improvement in laboratory values. While numbers are limited, black patients showed improvement at 6 months. In a subset of 39 patients with childhood-onset SLE, 65% responded favorably at 6 months, and 35% discontinued corticosteroids.
Conclusion
Our data demonstrate favorable clinical and laboratory outcomes in patients with SLE at 6 months across all racial and ethnic groups, with similar improvement seen among patients with childhood-onset SLE.
The past decade has seen tremendous advances in both our understanding of cancer immunosuppressive microenvironments and colonic bacteria facilitated by immune checkpoint inhibitor antibodies and next generation sequencing, respectively. Because an important role of the host immune system is to communicate with and regulate the gut microbial community, it should not come as a surprise that the behavior of one is coupled to the other. In this review, we will attempt to dissect some of the studies demonstrating cancer immunotherapy modulation by specific gut microbes and discuss possible molecular mechanisms for this effect.
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