Efficacy and safety of belimumab during maintenance therapy in patients with systemic lupus erythematosus

Author:

Miyazaki Yusuke1,Nakayamada Shingo1,Sonomoto Koshiro1ORCID,Kawabe Akio1,Inoue Yoshino1,Okubo Naoaki1,Iwata Shigeru1ORCID,Hanami Kentaro1,Tanaka Yoshiya1ORCID

Affiliation:

1. The First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, Japan

Abstract

Abstract Objectives The efficacy of belimumab (BEL) during maintenance therapy in patients with SLE remains unclear in the real-life clinical setting. This study investigated the efficacy and safety of BEL in patients with SLE during maintenance therapy. Methods In this retrospective observational study, maintenance therapy was defined as low-dose glucocorticoid (GC) therapy (prednisolone equivalent dose of ≤0.2 mg/kg/day) in patients with a Safety of Estrogens in Lupus Erythematosus National Assessment-SLE Disease Activity Index (SELENA-SLEDAI) score <10. Participants comprised patients with SLE on HCQ or MMF [standard-of-care (SoC) group: n = 103] and those on BEL plus SoC (BEL+SoC group: n = 100). Selection bias was minimized using propensity score-based inverse probability of treatment weighting (IPTW). GC dose trajectories were modelled using growth mixture modelling (GMM). The primary end point was GC dose at 52 weeks. Results No significant difference was observed in patient characteristics between the two groups after IPTW adjustment. The BEL+SoC group exhibited a significant decrease in GC dose. GC dose at 52 weeks and relapse rate were significantly lower in the BEL+SoC group than in the SoC group. The proportion of patients in one of four groups defined by GMM for which GC dose was tapered to 0 mg within 52 weeks (GC tapering-discontinuation group) was significantly higher in the BEL+SoC group than in the SoC group. In the BEL+SoC group, low SELENA-SLEDAI score and low GC dose at baseline were associated with being GC dose-tapering discontinuation. Conclusion The present study suggests that BEL is suitable for patients with SLE during maintenance therapy.

Funder

University of Occupational and Environmental Health

University of Occupational & Environmental Health, Japan (UOEH) for Advanced Research

Publisher

Oxford University Press (OUP)

Subject

Pharmacology (medical),Rheumatology

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