Impact of Belimumab on Organ Damage in Systemic Lupus Erythematosus

Abstract

Organ damage is a key determinant of poor long-term prognosis and early death in patients with systemic lupus erythematosus (SLE). Prevention of damage is a key treatment goal of the 2019 update of the European Alliance of Associations for Rheumatology (EULAR) recommendations for SLE management. Belimumab is a monoclonal antibody that inhibits B lymphocyte stimulator (BLyS) and is the only therapy approved for both SLE and lupus nephritis. Here, we review the clinical trial and real-world data on the effects of belimumab on organ damage in adult patients with SLE. Across 4 phase III studies, belimumab in combination with background SLE therapy demonstrated consistent reductions in key drivers of organ damage including disease activity, risk of new severe flares, and glucocorticoid exposure compared to background therapy alone. Long-term belimumab use in SLE also reduced organ damage progression measured by the Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index, as reported in open-label extension studies, and propensity score-matched comparative analyses to background therapy alone. Results from a clinical trial showed that in patients with active lupus nephritis, belimumab treatment improved renal response, reduced the risk of renal-related events, and impacted features related to kidney damage progression compared to background therapy alone. The decrease of organ damage accumulation observed with belimumab treatment in SLE, including lupus nephritis, suggest a disease-modifying effect.

Right ventricular-pulmonary arterial coupling ratio derived from 3-dimensional echocardiography predicts outcomes in systemic lupus erythematosus-associated pulmonary arterial hypertension patients

“…4,[40][41][42][43] Studies have demonstrated that biologics such as belimumab have a favorable and reliable therapeutic effect in SLE and an acceptable safety profile in long-term studies, but it is mainly works effective in patients with lupus nephritis, and its efficacy on the cardiopulmonary system is unclear. 44 Cohort studies have confirmed that the PAH Risk Stratification Scale is a good predictor of PAH regression in patients with SLE-PAH. 45 Therefore, it is recommended that patients with CTD-PAH should agree to targeted drug monotherapy or combination therapy according to PAH risk stratification, and adjusting the treatment regimen according to PAH risk stratification during regular follow-up is needed to ultimately achieve "low-risk status."…”

“…4,40–43 Studies have demonstrated that biologics such as belimumab have a favorable and reliable therapeutic effect in SLE and an acceptable safety profile in long-term studies, but it is mainly works effective in patients with lupus nephritis, and its efficacy on the cardiopulmonary system is unclear. 44…”

Predictors of Organ Damage in Systemic Lupus Erythematosus in the Asia Pacific Region: A Systematic Review

“…In international studies, the use of belimumab in addition to standard therapy has shown promising results, with lower rates of organ damage and accrual. [68][69][70] This knowledge gap in the Asia Pacific region needs to be addressed to further understand and minimize treatment-related damage in this cohort.…”

“…Apart from glucocorticoids, knowledge regarding the impact of other treatments in the Asia Pacific region, including immunosuppression and biologic agents, is lacking. In international studies, the use of belimumab in addition to standard therapy has shown promising results, with lower rates of organ damage and accrual 68–70 . This knowledge gap in the Asia Pacific region needs to be addressed to further understand and minimize treatment‐related damage in this cohort.…”

Efficacy of lifestyle interventions in the management of systemic lupus erythematosus: a systematic review of the literature

“…During the past decades, much focus has been placed on clinical trials for pharmaceuticals. Despite considerable advances, the response rate to new biopharmaceuticals remains limited, and substantial proportions of patients still develop organ damage and experience severe pain, fatigue, and impaired quality of life [ 4 – 7 ]. The use of lifestyle changes as complementary interventions has not been thoroughly studied.…”