title: Belimumab use, clinical outcomes and glucocorticoid reduction in patients with systemic lupus erythematosus receiving belimumab in clinical practice settings: results from the OBSErve Canada Study.
abstract: To describe the characteristics of patients receiving belimumab, overall patterns of systemic lupus erythematosus (SLE) care, clinical outcomes, and changes in glucocorticoid dose following 6 months of therapy with belimumab, and healthcare resource utilization in belimumab users in Canadian clinical practice settings. Retrospective multicenter medical chart review study of adult patients with SLE who were prescribed belimumab as part of usual care and who received ≥8 infusions or 6 months of treatment. Primary endpoints included physician-determined overall clinical improvement from baseline, glucocorticoid use, and physician-determined SLE disease severity at Month 6. In total, 52 patients were included in the study. At belimumab initiation, 5.8/76.9/17.3% of patients had mild/moderate/severe SLE, respectively. Oral glucocorticoids were discontinued in 11.4% of patients and 59.1% received a lower dose at Month 6. At Month 6, 80.8/57.7/17.3% of patients had a physician-determined clinical improvement of ≥20/≥50/≥80%, respectively. Sixteen patients had a SLE Disease Activity Index-2K score at both baseline and Month 6, with a mean improvement of 2.6 ± 5.3 from 8.1 ± 3.2 at baseline. No formal disease assessment tool was utilized for 42.3% of study patients at baseline. This study provides the first real-world insights into belimumab use in Canada. It demonstrates significant reduction or discontinuation of glucocorticoid dose in 70.5% of patients and clinically significant improvement following 6 months' belimumab therapy. The high number of patients with no formal disease activity assessments highlights a key care gap in SLE treatment in the real-world setting.
authors.affiliation: Centre for Prognosis Studies in the Rheumatic Diseases, Toronto Western Hospital, University of Toronto Lupus Clinic, EW, 1-412, 399 Bathurst Street, Toronto, ON, M5T 2S8, Canada. zahi.touma@uhn.ca.
authors.forename: Zahi
authors.initials: Z
authors.lastname: Touma
authors.affiliation: GlaxoSmithKline Inc., Toronto, ON, Canada.
authors.forename: Amyn
authors.initials: A
authors.lastname: Sayani
authors.affiliation: MUHC Lupus and Vasculitis Clinic, McGill University, Montreal, QC, Canada.
authors.forename: Christian A
authors.initials: CA
authors.lastname: Pineau
authors.affiliation: Centre de Rhumatologie, Quebec, Canada.
authors.forename: Isabelle
authors.initials: I
authors.lastname: Fortin
authors.affiliation: McMaster University, Hamilton, ON, Canada.
authors.forename: Mark
authors.initials: M
authors.lastname: Matsos
authors.affiliation: Dalhousie University, Halifax, Nova Scotia, Canada.|Memorial University, St. John's, Newfoundland, Canada.
authors.forename: George A
authors.initials: GA
authors.lastname: Ecker
authors.affiliation: Credit Valley Rheumatology, Canada, Mississauga, ON, Canada.
authors.forename: Andrew
authors.initials: A
authors.lastname: Chow
authors.affiliation: GlaxoSmithKline Inc., Toronto, ON, Canada.
authors.forename: Sandra
authors.initials: S
authors.lastname: Iczkovitz
mesh_terms: D000328:Adult; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage* / Q000009:adverse effects; D002170:Canada; D004359:Drug Therapy, Combination; D017723:Drug Utilization Review; D005260:Female; D005938:Glucocorticoids / Q000008:administration & dosage* / Q000009:adverse effects; D006302:Health Services Research; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage* / Q000009:adverse effects; D008180:Lupus Erythematosus, Systemic / Q000175:diagnosis / Q000188:drug therapy* / Q000276:immunology; D008297:Male; D008499:Medical Records; D008875:Middle Aged; D012074:Remission Induction; D012189:Retrospective Studies; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D005938:Glucocorticoids; D007166:Immunosuppressive Agents; C511911:belimumab
keywords: B-cell activating factor; Disease progression; Glucocorticoids; Lupus erythematosus, systemic; Observational study; Rheumatology