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Belimumab With Standard Care Reduces Organ Damage in Lupus
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Patients with systemic lupus erythematosus treated with belimumab, plus the standard of care, demonstrated significantly less organ damage progression compared with those who received the standard of care alone, according to findings published in the Annals of the Rheumatic Diseases.
“Two long-term extension studies have previously demonstrated that long-term exposure to belimumab was safe and well tolerated, with low rates of organ damage accrual over time,” Murray B. Urowitz, MD, of the Toronto Western Hospital, told Healio Rheumatology. “As the long-term extension studies did not have comparator arms, comparison of belimumab plus standard of care with standard of care alone was not possible.”
To extend the work of the long-term extension studies — and enable a long-term comparison of belimumab (Benlysta, GlaxoSmithKline) to standard of care — Urowitz and colleagues used propensity score matching to match patients with SLE treated with belimumab in the U.S. BLISS long-term extension study with patients from an external SLE cohort, called the Toronto Lupus Cohort, who were treated with standard of care.
The researchers conducted a systematic literature review to identify 17 known predictors for organ damage, allowing them to calculate a propensity score for each participant. Each patient from the BLISS extension and the Toronto Lupus Cohort were then matched 1-to-1 based on these propensity scores. The primary endpoint was the difference in change in Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index (SDI) score from baseline to 5 years.
For this 5-year analysis, Urowitz and colleagues matched 99 participants from each cohort, out of a total of 567 patients. To evaluate the time to organ damage progression, in a follow-up of 1 year or more, the researchers’ sample included 259 patients from the BLISS extension and 706 from the Toronto cohort, of whom 179 from each were matched using propensity scores.
According to the researchers, changes in SDI score were significantly lower among patients treated with belimumab compared with standard of care at year 5 (0.434; 95% CI, –0.667 to –0.201). Regarding time to organ damage progression, patients treated with belimumab were 61% less likely to progress to a higher SDI score during any given year compared with those who received standard of care only (HR = 0.391; 95% CI, 0.253-0.605). Further, the proportion of SDI score increases equaling 2 or more were greater in the standard-of-care group compared with the belimumab group.
“The results of this study demonstrate that belimumab plus standard of care treatment results in lower rates of organ damage accrual compared with standard of care alone,” Urowitz said. “The benefits were demonstrated over a 5-year period.” – by Jason Laday
Disclosure: Urowitz reports research grants from GlaxoSmithKline. Please see the study for all other authors’ relevant financial disclosures.
Perspective
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Amanda Mixon, PA-C
Systemic lupus was first described in the literature as far back as the late 1800s. Despite this length of time and continued research, treatment options are still limited. Lupus can affect virtually every organ and can vary drastically from patient to patient. We all have patients with a very mild disease that require little therapy and then we have those “sick lupus” patients that keep us up at night.
Belimumab came to market in 2011 and was the first new lupus drug to hit the market in over 50 years. Despite that, there has been a lingering question of how well it works and if it could help prevent future end organ damage any more so than our current standard of care.
Urowitz and colleagues researched this very question using a propensity score-matched comparative analysis and found that over a 5-year period, patients treated with belimumab plus standard of care experienced less organ damage than those treated only with standard of care.
Of course, more studies are needed; however, this does give me more confidence using belimumab in addition to standard of care, especially given the additional hurdles of insurance coverage and cost for the patient. I look forward to reading future studies on this topic.
Perspective
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Alan L. Epstein, MD
It is well known that the risk of organ damage in patients with systemic lupus erythematosus is substantial — as many as 60% of adult patients with SLE may develop renal involvement. Patients with SLE have a 7.5-fold greater risk of coronary heart disease and a 7.9-fold greater risk of stroke. Unfortunately, progression to end-stage renal disease has not decreased over time.
Organ damage accrual rates have not decreased either. More than 40% of patients accrue organ damage over 3 years. Early organ damage is associated with a reduced ten-year survival; moreover, disease activity is related to future organ damage. Of interest, even patients with low disease activity are at risk for organ damage.
The efficacy of belimumab in the treatment of patients with SLE has been well established in several controlled trials. Long-term extension of these studies demonstrated continued safety and efficacy but did not allow comparison of belimumab plus standard of care to standard of care alone due to lack of a standard of care comparator arm.
The current study uses propensity score-matching to compare patients treated with belimumab plus standard of care to patients from the Toronto Lupus Cohort treated with standard of care alone. This comparison allows the assessment of damage accrual over 5 years comparing belimumab plus standard of care to standard of care alone.
The change in the SLE damage index from baseline to 5 years was significantly lower in the patients treated with belimumab plus standard of care compared to standard of care alone. A patient receiving belimumab had a 3.5% annual probability of organ damage progression compared with an 8.7% annual probability of progression in the patients receiving standard of care alone.
Given the high likelihood of organ damage accrual in patients with SLE, it is nice to know that belimumab — a relatively recent addition to our therapeutic arsenal — is able to effectively reduce the chance of the patient developing organ damage.
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