Data on rebound trend in individuals with any disease level of SLE who also had permanently withdrawn from further belimumab treatment (long-term discontinuation group [LTD]) were also assessed

Data on rebound trend in individuals with any disease level of SLE who also had permanently withdrawn from further belimumab treatment (long-term discontinuation group [LTD]) were also assessed. reducing disease activity and risk of severe flares, it was previously unfamiliar what the medical effects were upon treatment discontinuation. The objective of this study was to assess the effect of temporary withdrawal of intravenous (IV) belimumab in individuals with SLE. Methods This multicentre, open-label, non-randomised, 52-week study (GSK Study BEL116027; NCT02119156) recruited individuals with SLE and stable low disease activity, of whom those on belimumab 10 mg/kg IV plus standard therapy either discontinued belimumab for 24 weeks and then restarted belimumab 10 mg/kg IV every 4 weeks (q4w) for 28 weeks (treatment holiday [TH] group), or continuing on belimumab 10 mg/kg IV plus standard therapy q4w for 52 weeks (treatment continuation [TC] group). The primary endpoint was median time to first Security of Estrogens in Lupus Erythematosus National Assessment-SLE Disease Activity Index (SELENA-SLEDAI) Flare Index flare. Secondary and additional endpoints included rate of any flare, time to severe flare, time to renal flare and rebound (SELENA-SLEDAI score exceeding parent study baseline). Data on rebound trend in individuals with any disease level of SLE who experienced permanently withdrawn from further belimumab treatment (long-term discontinuation group [LTD]) were also assessed. Security was assessed. Results The primary endpoint was not evaluable in the TH (= 12) and TC (= 29) organizations as fewer than half of individuals flared. Unadjusted flare rates per patient-year were 1.0 during treatment discontinuation and 0.3 during treatment restart (0.6 overall) in the TH group and 0.6 in the TC group; there were no severe or renal flares. No TH individuals rebounded; 2 (6.9%) TC individuals rebounded; 2 (5.1%) individuals in the SGK1-IN-1 LTD group rebounded. There were no new security signals. Conclusions Twenty-four-week belimumab discontinuation did not appear to increase the risk of flares or SGK1-IN-1 rebound in individuals with low SLE disease activity; flare rates were low in both organizations. Further studies may help to fully determine the effect of belimumab discontinuation. Trial sign up ClinicalTrials.gov, NCT02119156. Registered on April 21, 2014. Supplementary Info The online version contains supplementary material available at 10.1186/s13075-022-02723-y. Keywords: Systemic lupus erythematosus and autoimmunity, B cells, Lymphocytes, Biological therapies, Biomarkers Background Systemic lupus erythematosus (SLE) is definitely a chronic, multisystem autoimmune disease characterised by autoantibody production and irregular B cell function [1]. Individuals with SLE encounter heterogeneous medical manifestations, chronic swelling and a relapsing and remitting disease pattern consisting of SLE flares alternating with periods of less severe, but prolonged, disease activity [2, 3]. Flares present a substantial burden in SLE and are associated with improved disease activity, long-term organ damage and substantial healthcare costs [3, 4]. As such, SLE treatment goals include minimising disease activity and reducing the risk of flares [5]. Belimumab is definitely a B-lymphocyte stimulator (BLyS)-specific inhibitor authorized as an add-on therapy to treat active, autoantibody-positive SLE [6]. This biologic prevents BLyS from binding to receptors on B cells, therefore inhibiting B cell survival and differentiation into immunoglobulin (Ig)-generating plasma cells [7, 8]. This action is associated with a reduction in SLE disease activity and the risk of severe flares, as founded in four phase 3, randomised, placebo-controlled tests [9C12]. Data on the effect of temporary belimumab withdrawal (treatment holiday [TH]) and the potential for rebound phenomenon are important to inform medical management of individuals with SLE, as some individuals may need temporary treatment discontinuation. In determining the effect of restarting belimumab treatment after a temporary withdrawal, it is also of medical importance to assess the risk for hypersensitivity reactions. However, it was previously SGK1-IN-1 unfamiliar what the medical effects of belimumab discontinuation were. A case series CR6 has suggested a possible SGK1-IN-1 rebound effect in three individuals following belimumab discontinuation that may be due.