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- Title
Belimumab and antimalarials combined against renal flares in patients treated for extra-renal systemic lupus erythematosus: results from 4 phase III clinical trials.
- Authors
Gomez, Alvaro; Jägerback, Sandra; Sjöwall, Christopher; Parodis, Ioannis
- Abstract
Objectives To determine the effect of antimalarial agents (AMA) and different doses and pharmaceutical forms of belimumab on preventing renal flares in patients with SLE treated for extra-renal disease. Methods We pooled data from the BLISS-52, BLISS-76, BLISS-SC and BLISS-Northeast Asia trials of belimumab (n = 3225), that included patients with active SLE yet no severe ongoing nephritis. Participants were allocated to receive intravenous belimumab 1 mg/kg, intravenous belimumab 10 mg/kg, subcutaneous belimumab 200 mg, or placebo in addition to standard therapy. We estimated hazards of renal flare development throughout the study follow-up (52–76 weeks) using Cox regression analysis. Results In total, 192 patients developed a renal flare after a median of 197 days. Compared with placebo, the risk of renal flares was lower among patients receiving intravenous belimumab 10 mg/kg (HR: 0.62; 95% CI: 0.41, 0.92; P = 0.018) and intravenous belimumab 1 mg/kg (HR: 0.42; 95% CI: 0.22, 0.79; P = 0.007), while no significant association was found for subcutaneous belimumab 200 mg. AMA use yielded a lower hazard of renal flares (HR: 0.66; 95% CI: 0.55, 0.78; P < 0.001). The protection conferred was enhanced when belimumab and AMA were co-administered; the lowest flare rate was observed for the combination intravenous belimumab 1 mg/kg and AMA (18.5 cases per 1000 person-years). Conclusions The protection conferred from belimumab against renal flare development in patients treated for extra-renal SLE appears enhanced when belimumab was administered along with AMA. The prominent effect of low-dose belimumab warrants investigation of the efficacy of intermediate belimumab doses. Clinical trial identification BLISS-52: NCT00424476; BLISS-76: NCT00410384; BLISS-SC: NCT01484496; BLISS-NEA: NCT01345253.
- Subjects
SWEDEN; DRUG efficacy; STATISTICS; BIOMARKERS; COMBINATION drug therapy; LUPUS nephritis; INTRAVENOUS therapy; CONFIDENCE intervals; B cells; URINE; SUPPURATION; REGRESSION analysis; DISEASE relapse; SEVERITY of illness index; COMPARATIVE studies; RESEARCH funding; DESCRIPTIVE statistics; PROTEINURIA; QUESTIONNAIRES; ANTIMALARIALS; DATA analysis; HEMATURIA; DATA analysis software; PREDNISONE; IMMUNOSUPPRESSIVE agents; STATISTICAL models; BELIMUMAB; SUBCUTANEOUS injections; LONGITUDINAL method; PROPORTIONAL hazards models; CREATININE
- Publication
Rheumatology, 2024, Vol 63, Issue 2, p338
- ISSN
1462-0324
- Publication type
Article
- DOI
10.1093/rheumatology/kead253