Background/Purpose: SLE is an autoimmune multi-system disease characterized by flares and more rarely remissions. Emerging biologic therapies for SLE are expected to change the treatment landscape. A study was conducted to: (1) review the safety and efficacy outcomes associated with treatment of SLE in the real world; (2) compare results of real-world studies with those of randomized controlled trials (RCTs) and their extension studies; (3) understand real-world patterns of medication use. Searches focused on belimumab, as it is the only biologic agent approved for the treatment of SLE.¹

Methods: A targeted literature search was conducted in MEDLINE on Jan 2, 2019, with no limitations for publication year. A total of 546 articles underwent title and abstract screening to identify English-language real-world studies of belimumab conducted in USA, UK, France, and Germany. Long-term extension studies for belimumab were identified in a separate systematic literature review of RCTs.

Results: Real-world studies showed reduced disease activity after belimumab treatment in 51% and 77% of patients with SLE at 6 months and 1 year, respectively. In comparison, RCTs of belimumab treatment showed similar efficacy for this endpoint at 6 months (44%–57%) and lower efficacy at one year (43%–58%). Reductions in disease activity were maintained over 7 years of follow-up in long-term extension studies.

The real-world studies additionally showed that belimumab treatment led to reductions in corticosteroid dosages (24%–58% at 6 months) and discontinuation of corticosteroids in up to 11% of patients with SLE. Similar reductions in corticosteroid dosages and discontinuations were seen in long-term extension studies for up to 7 years.  In contrast, claims data showed no effect of belimumab treatment on the number of patients taking corticosteroids.

Numerous reasons for discontinuation of belimumab were reported in the real-world studies, such as patient request, ineffective medication, disease progression, infection, no clinical response, adverse events (AEs), or disease persistence. In contrast, discontinuation was primarily due to AEs in RCTs and withdrawal in the long-term extension studies. Claims data showed that discontinuation of belimumab typically occurred within 6 months of treatment initiation. Rates of AEs remained stable over the course of therapy in the long-term extension studies, with infections being most common.

Conclusion: The current study found that real-world studies of belimumab show similar or better reductions in disease activity vs those observed in RCTs and that these reductions are maintained during long-term treatment. Real-world studies also showed that belimumab is associated with reductions in corticosteroid dosages and even discontinuation of corticosteroid use, two important outcomes for patients with SLE. Longer follow-up of more detailed real-world studies would further improve the understanding of outcomes of belimumab and other biologic therapies in the treatment of SLE.

¹Navarra SV, Guzman RM, Gallacher AE, et al. (2011) Efficacy and safety of belimumab in patients with active systemic lupus erythematosus: a randomised, placebo-controlled, phase 3 trial. Lancet 377 (9767): 721-731.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/real-world-evidence-associated-with-the-treatment-of-systemic-lupus-erythematosus-in-the-usa-uk-france-and-germany-a-structured-review/