Clinical outcomes in patients with systemic lupus erythematosus treated with belimumab in clinical practice settings: a retrospective analysis of results from the OBSErve study in Switzerland

Abstract

AIMS OF THE STUDY:To describe patterns of systemic lupus erythematosus (SLE) care and the clinical effectiveness of belimumab plus standard of care therapy in a realworld clinical setting in Switzerland.METHODS: This multicentre, observational, retrospective cohort study included adults with SLE who initiated belimumab as part of their usual care at least six months before data analysis. The primary outcome was the overall clinical response, assessed by a physician on a Physician's Global Assessment-like scale, to six months' treatment with belimumab. Secondary outcomes included improvement in disease activity, SLE manifestations and changes in corticosteroid use. RESULTS: 53 patients (81% female) from three hospitals were included. At index (belimumab initiation), 23 patients (43%) had mild, 23 (43%) had moderate, and 7 (13%) had severe SLE. Overall improvement in disease activity in patients receiving belimumab was: ≥80% in 6 patients (11%), ≥50% in 12 (23%), ≥20% in 31 (58%), <20% in 13 (25%), and no improvement in 9 (17%). Mean Safety of Estrogens in Lupus Erythematosus National Assessment-SLE Disease Activity Index score decreased from 8.0 at index to 3.6 at six months post index in the 27 patients assessed. In addition, a ≥50% improvement in arthritis, fatigue, rash, low complement (C3, C4 or total haemolytic complement activity), and anti-double-stranded deoxyribonucleic acid antibody levels was experienced six months post index by 10 (38%), 3 (16%), 6 (38%), 2 (12%) and 4 (16%) patients who presented the manifestations at index respectively. At index, 41 patients (77%) received oral corticosteroids at a mean dose of 11.6 mg/day, which decreased to 5.9 mg/ day at six months post index. Of the 31 patients receiving a high dose of corticosteroids (≥7.5 mg/day) at index, 18 required <7.5 mg/day and a further two discontinued corticosteroids at six months post index.CONCLUSIONS: This study provides real-world insight into belimumab use in clinical practice in Switzerland. In line with findings from other countries, Swiss patients with SLE who received belimumab demonstrated clinical and serological improvements in SLE and a reduction in corticosteroid use after six months of treatment.

Evaluation of belimumab treatment in patients with systemic lupus erythematosus in a clinical practice setting: Results from a 24-month OBSErve study in Argentina

“…28,29 A steroid-sparing effect of belimumab treatment has been suggested in post hoc analyses of a subgroup of patients from the Phase 3 belimumab clinical trials, and in the long-term continuation study of BLISS-76. 20,30 The effectiveness of belimumab demonstrated in this study supports the findings of similar studies conducted under the OBSErve programme in the USA, Canada, Germany, Spain and Switzerland, 21,[23][24][25][26] which reported dose reductions of concomitant corticosteroid medication and clinical improvements with belimumab therapy.…”

Autoantibody and Cytokine Profiles during Treatment with Belimumab in Patients with Systemic Lupus Erythematosus

“…Serum levels of IFN-α2 and IL-6 also decreased, however in a more moderate and slower fashion. The decreases in IL-10 and IL-6 levels most likely reflect the overall abatement of inflammatory activity, following the decreases in clinical markers of disease activity, as shown herein and in previous observational studies [2,4,5,[17][18][19][20][21] and clinical trials [22][23][24][25]. Although the principal functions of IL-10 were initially coupled with suppression of cytokine secretion and termination of inflammatory responses [26,27], there is evidence that IL-10 may induce and amplify autoantibody production in autoimmune conditions [28][29][30], and IL-10 levels may therefore reflect the inflammatory state in such conditions.…”

B Cell Therapy in Systemic Lupus Erythematosus: From Rationale to Clinical Practice

“…While the primary endpoint of EMBRACE was not achieved, patients with high disease activity were benefited (77). Finally, reports from several real-life clinical settings have confirmed clinical efficacy and steroid-sparing effects (61,(78)(79)(80)(81)(82)(83)(84).…”