Organ damage in patients treated with belimumab versus standard of care: a propensity score-matched comparative analysis

Abstract

ObjectivesThe study (206347) compared organ damage progression in patients with systemic lupus erythematosus (SLE) who received belimumab in the BLISS long-term extension (LTE) study with propensity score (PS)-matched patients treated with standard of care (SoC) from the Toronto Lupus Cohort (TLC).MethodsA systematic literature review identified 17 known predictors of organ damage to calculate a PS for each patient. Patients from the BLISS LTE and the TLC were PS matched posthoc 1:1 based on their PS (±calliper). The primary endpoint was difference in change in Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index (SDI) score from baseline to 5 years.ResultsFor the 5- year analysis, of 567 (BLISS LTE n=195; TLC n=372) patients, 99 from each cohort were 1:1 PS matched. Change in SDI score at Year 5 was significantly lower for patients treated with belimumab compared with SoC (−0.434; 95% CI –0.667 to –0.201; p<0.001). For the time to organ damage progression analysis (≥1 year follow-up), the sample included 965 (BLISS LTE n=259; TLC n=706) patients, of whom 179 from each cohort were PS-matched. Patients receiving belimumab were 61% less likely to progress to a higher SDI score over any given year compared with patients treated with SoC (HR 0.391; 95% CI 0.253 to 0.605; p<0.001). Among the SDI score increases, the proportion of increases ≥2 was greater in the SoC group compared with the belimumab group.ConclusionsPS-matched patients receiving belimumab had significantly less organ damage progression compared with patients receiving SoC.

Systemic lupus erythematosus: year in review 2019

“…In 2019, a study based on 13-years’ safety and efficacy data of belimumab plus standard therapy demonstrated that belimumab was well tolerated with no new safety concerns, and efficacy was further improved. [ 46 ] A propensity score-matched comparative analysis conducted by Urowitz et al [ 47 ] revealed that belimumab-treated group experienced significantly less progression of organ damage compared with patients receiving standard therapy (harzard ratio 0.391; 95% CI 0.253–0.605; P < 0.001). These results highlighted the efficacy and tolerability of belimumab as a novel therapeutic agent for SLE.…”

BAFF inhibition in SLE—Is tolerance restored?

“…131 Nevertheless, several longer term studies have shown reduced SLE flare rates and slower progression of tissue damage in lupus patients taking belimumab. 7 Thus, continued clinical experience with belimumab and other BAFF family inhibitors will be needed to define the therapeutic role of these agents in lupus nephritis. Thus, there does not appear to be either a markedly increased infection risk or major therapeutic benefit of BAFF/APRIL blockade over BAFF inhibition alone.…”

“…Therapeutic B cell depletion is accompanied by a homeostatic increase in circulating BAFF, which could result in two potential consequences. Nevertheless, several longer term studies have shown reduced SLE flare rates and slower progression of tissue damage in lupus patients taking belimumab 7. Second, BAFF may facilitate a niche for long-lived plasma cells in secondary lymphoid organs and thereby contribute to disease relapse 129.…”

Systemic lupus erythematosus: new horizons for diagnosis and therapy

“…[51]. Длительное применение БЛМ при СКВ способствует достижению и поддержанию ремиссии (в том числе при «рефрактерном» течении заболевания), снижает риск необратимых органных повреждений, позволяет вести пациентов на минимальной поддерживающей дозе ГК [52][53][54][55].…”