First Real-World Insights into Belimumab Use and Outcomes in Routine Clinical Care of Systemic Lupus Erythematosus in Germany: Results from the OBSErve Germany Study.
OBSErve Germany was the first observational study of belimumab as add-on treatment for systemic lupus erythematosus (SLE) in routine clinical care in Germany, retrospectively collecting data from 102 SLE patients, 6 months before and after belimumab initiation. Most patients had moderate or severe SLE and several SLE manifestations. After 6 months of belimumab treatment, 78% of patients showed an improvement in overall disease activity of at least 20% in their physician's judgment and for 42% of patients the improvement was at least 50%. Similar results were observed for the most common manifestations: arthritis, fatigue, rash, alopecia, increased anti-dsDNA antibody levels, and low complement. The SLE Disease Activity Index (SLEDAI/SELENA-SLEDAI) decreased from 10.6 to 5.6 (n = 65), with other indices also showing improvement. A notable dose reduction was seen for concomitant oral corticosteroids, from 13.7 to 7.6 mg/day overall (n = 91), and from 17.5 to 8.6 mg/day in patients with a high corticosteroid dose at belimumab initiation (≥7.5 mg; n = 63). Six patients discontinued belimumab therapy within 6 months. Overall, belimumab showed promising results for SLE patients in real-world settings. After 6 months of belimumab treatment, disease activity and corticosteroid use were reduced. The discontinuation rate was low and belimumab appeared to be well tolerated. Funding GlaxoSmithKline UK.
Department of Rheumatology and Clinical Immunology, University Medical Centre of the Johannes Gutenberg-University Mainz, ACURA Center for Rheumatic Diseases Bad Kreuznach, Mainz, Germany. schwarting@uni-mainz.de.
Andreas
A
Schwarting
Department of Internal Medicine 1, University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany.
Johann O
JO
Schroeder
Department of Rheumatology and Clinical Immunology, Charité-University Medicine Berlin, Berlin, Germany.
Tobias
T
Alexander
Department of Internal Medicine 2, University Hospital, Würzburg, Germany.
Marc
M
Schmalzing
ACURA Center for Rheumatic Diseases, Baden-Baden, Germany.
Christoph
C
Fiehn
Department of Rheumatology and Clinical Immunology, University Hospital, Essen, Germany.
Christof
C
Specker
GF Immuno Inflammation/ID Franchise, GlaxoSmithKline, Brentford, UK.
Alessandra
A
Perna
Public Health, Kantar Health, Munich, Germany.
Constanze
C
Cholmakow-Bodechtel
GF Immuno Inflammation/ID Franchise, GlaxoSmithKline, Brentford, UK.
Volker B
VB
Koscielny
Medical Department, Immunology and Rare Diseases Business Unit, GlaxoSmithKline, Hamburg, Germany.
Heike
H
Carnarius
B cell targeted therapy; Belimumab; Observational study; SLE; Systemic lupus erythematosus