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Clinical Outcomes of Patients with SLE Treated with Belimumab, Without Versus With Prior Immunosuppressant Use: a US Claims Database Study

Year: 2025

Type: article

Abstract: This study examined the benefit of belimumab as standard treatment in patients with systemic lupus erythematosus (SLE) treated without versus with immunosuppressants (IS) prior to belimumab initiation. This retrospective cohort study (GSK Study 217537) used healthcare claims from the US Komodo Health Database from January 2015 to October 2023. Eligible adults had ≥ 1 inpatient or ≥ 2 outpatient SLE diagnosis codes, ≥ 1 belimumab claim (January 2017–October 2023; index date) and 24 months continuous data pre-index. Two cohorts were defined: those with ≥ 1 claim for non-IS SLE treatment (antimalarials, oral glucocorticoids [OGC] or biologics; non-IS cohort) or ≥ 1 claim for incident IS (IS cohort) within 12 months pre-index. Cohort comparability was assessed across the 12 months before non-IS/IS treatment, applying inverse probability of treatment weighting (IPTW) to adjust for confounding. Outcomes included OGC use, SLE flare rates and healthcare resource utilisation, compared using Cox, Poisson regression and logit models, respectively. Overall, 2190 and 2533 patients were included in IPTW-adjusted non-IS and IS cohorts, respectively. The non-IS cohort had a median (95% confidence interval [CI]) time to OGC discontinuation of 9.8 (8.2, 12.2) months versus 11.7 (10.5, 13.4) for the IS cohort, and a 30% higher likelihood of OGC discontinuation (hazard ratio [95% CI] 1.30 [1.11, 1.52]). The likelihood of OGC dose reduction and discontinuation or dose reduction alone was similar between cohorts. The non-IS versus IS cohort had a lower incidence rate ratio (IRR [95% CI]) of total (0.94 [0.92, 0.96]) and moderate (0.77 [0.74, 0.80]) SLE flares, with similar odds of SLE-related inpatient stays (odds ratio [95% CI] 1.12 [0.94, 1.34]) and emergency visits (1.02 [0.82, 1.27]). In this large, retrospective, real-word study using IPTW adjustment, initiating belimumab without prior IS use was associated with OGC-sparing benefits and reduced incidence and severity of SLE flares. Biologic treatments for lupus, such as belimumab, are often only used if a patient has not responded to other treatments, such as immunosuppressants. The goal of this study was to assess whether patients would have better outcomes if they were prescribed belimumab without first taking immunosuppressants. Using patients’ healthcare data obtained between 2015 and 2023, the study compared adult patients starting belimumab treatment who either had or had not used one type of immunosuppressant within 1 year before starting belimumab. After grouping patients into those who had (2533 patients) or had not (2190 patients) received treatment with an immunosuppressant before belimumab, the study found that those who used belimumab without first using an immunosuppressant were more likely to stop using steroids (glucocorticoids) and were able to do so sooner. However, over 2 years, both groups were just as likely to reduce their glucocorticoid dose. Compared to patients who had used an immunosuppressant before starting belimumab, those who had not done so experienced milder lupus flares. Lastly, both groups had similar numbers of hospital stays or visits to emergency department in relation to lupus. To summarise, these results suggest that starting belimumab treatment without previous use of immunosuppressants may be more beneficial for patients with lupus than using belimumab after immunosuppressants.

Source: Rheumatology and Therapy

DOI: 10.1007/s40744-025-00774-6