May 06, 2020
2 min read

Early belimumab use predicts favorable outcomes in lupus

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Earlier treatment with belimumab among patients with active systemic lupus erythematosus and low baseline damage predicted favorable outcomes, according to data published in Arthritis & Rheumatology.

“Belimumab has been included in the 2019 updated European League Against Rheumatism (EULAR)-endorsed recommendations on SLE management as an approved biological drug to be used in patients refractory to standard of care (SoC), which means [glucocorticoid] and hydroxychloroquine with or without a previously failed immunosuppressant,” Mariele Gatto, MD, PhD, of the University of Padova, in Italy, and colleagues wrote.

They added, “Remission and low disease activity (LDA) have recently emerged as desirable therapeutic targets in SLE, as they are associated with a decreased risk of organ damage and a better prognosis especially if achieved early during treatment and should therefore fall among the ultimate goals of any therapeutic strategy.”

To analyze predictors of remission, response and low-disease activity, as well as damage and drug discontinuation, among patients with SLE who receive belimumab (Benlysta, GlaxoSmithKline), Gatto and colleagues conducted a retrospective study of the Italian Belimumab in Real Life Setting Study (BeRLiSS). According to the researchers, BeRLiSS is a national multicenter cohort study where physicians working in the Italian reference centers were invited to participate on a free basis and without any financial support.

Earlier treatment with belimumab among patients with active SLE and low baseline damage predicted favorable outcomes, according to data.
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For their own study, Gatto and colleagues included 466 participants with active SLE, 77 of whom had a baseline disease duration of 2 years or less, who received intravenous belimumab at 24 centers. The researchers assessed the proportion of patients who achieved remission, low-disease activity and an SLE Responder Index of 4 (SRI-4). They also determined outcome predictors using multivariate logistic regression.

According to the researchers, SRI4 was achieved in 49.2%, 61.3%, 69.7%, 69.6% and 66.7% of patients at 6, 12, 24, 36 and 48 months, respectively. Baseline predictors of response at 6 months were SLEDAI2K score of 10 or greater (OR = 3.14; 95% CI, 2.033-4.86) and a disease duration of 2 years or less (OR = 1.94; 95% CI, 1.078-3.473). At 12 months, predictors included a SLEDAI2K of 10 or greater (OR = 3.48; 95% CI, 2.004-6.025) and an SDI of 0 (OR = 1.74; 95% CI, 1.0362.923).

Predictors at 24 months were SLEDAI2K of 10 or greater (OR = 4.25; 95% CI, 2.018-8.94) and a disease duration of 2 years or less (OR = 3.79; 95% CI, 1.039-13.52), while at 36 months they included a SLEDAI2K of 10 or greater (OR = 14.59; 95% CI, 3.54-59.79) and baseline smoking (OR = 0.19; 95% CI, 0.039-0.69).

Further, patients who spent 25% or more of their followup time in remission (P = .046), or at least 50% of follow-up in low-disease activity (P = .007), experienced significantly less damage. A baseline SDI of 0 independently predicted low-disease activity and remission. The lower the baseline damage, the higher the probability of remission, the researchers wrote.

Previous flares negatively predicted belimumab discontinuation due to inefficacy (P = .009).

“Our study provided novel evidence of a remarkable achievement of remission or LDA during treatment, which were also likely to persist over time, and confirmed previous results on real-life use of belimumab in terms of decrease in global and organ specific disease activity and prednisone daily dose, flare rate and damage progression,” Gatto and colleagues wrote.

“At present, belimumab is frequently used as the last option in SLE treatment,” they added. “Based on our data, we suggest that an earlier use of belimumab in patients with active SLE may maximize its efficacy, since it improves patient prognosis in terms of better response, achievement of remission/LDA and hindrance of damage accrual.” – by Jason Laday

Disclosures: The researchers report no relevant financial disclosures.