Safety and Efficacy of Belimumab to Treat Systemic Lupus Erythematosus in Academic Clinical Practices

Abstract

Objective: To evaluate the use and efficacy of belimumab in academic practices. Belimumab is a human monoclonal antibody that inhibits soluble B lymphocyte stimulator and has been approved for the treatment of adults with systemic lupus erythematosus (SLE).

Methods: Invitations to participate and complete a 1-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 taking background medications for SLE at initiation of belimumab, with 74% taking 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 taking 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.

Keywords: BELIMUMAB; CHILDHOOD-ONSET SLE; SLE TREATMENT; SYSTEMIC LUPUS ERYTHEMATOSUS.

Figure 1

Response to belimumab in all patients with lupus at 3 and 6 months after initiation of belimumab. Data were available on 158 patients at 3 months and 120 patients at 6 months of treatment. Clinical response was defined as the treating physician’s impression of ≥50% improvement in the initial manifestation(s) being treated and no worsening in other organ systems. Improvement in serology included at least 25% decrease in anti-dsDNA level from baseline.

Figure 2

Response to belimumab in patients with childhood-onset lupus at 3 and 6 months after initiation of belimumab. Data were available on 35 patients at 3 months and 26 patients at 6 months of treatment. Clinical response was defined as the treating physician’s impression of ≥50% improvement in the initial manifestation(s) being treated and no worsening in other organ systems. Improvement in serology included at least 25% decrease in anti-dsDNA level from baseline.