Efficacy and Safety of Belimumab and Azathioprine for Maintenance of Remission in Antineutrophil Cytoplasmic Antibody–Associated Vasculitis: A...
Jayne D., Blockmans D., Luqmani R., Moiseev S. V., Ji B., Green Y., Hall L., Roth D., Henderson R. B., Merkel P. A.
Arthritis and Rheumatology
Vol.71, Issue6, P. 952-963
Опубликовано: 2019
Тип ресурса: Статья
Аннотация:
Objective: To evaluate the safety and efficacy of belimumab as adjunctive therapy to maintain remission in antineutrophil cytoplasmic antibody (ANCA)–associated vasculitis (AAV). Methods: In this multicenter, double-blind, placebo-controlled study, patients with AAV (ages ≥18 years) were randomized 1:1 to receive azathioprine (2 mg/kg/day), low-dose oral glucocorticoids (≤10 mg/day), and either intravenous belimumab (10 mg/kg) or placebo, following remission induction with rituximab or cyclophosphamide along with glucocorticoids. The primary end point was time to first protocol-specified event (PSE), with first PSE defined as a Birmingham Vasculitis Activity Score (BVAS) of ≥6, presence of ≥1 major BVAS item, or receipt of prohibited medications for any reason, resulting in treatment failure (adjusted for ANCA type [proteinase 3 (PR3) or myeloperoxidase (MPO)], disease stage at induction, and induction regimen). Vasculitis relapse was defined as the PSE of either a BVAS activity score
Ключевые слова:
azathioprine; belimumab; cyclophosphamide; glucocorticoid; immunoglobulin G; methotrexate; myeloblastin; myeloperoxidase; neutrophil cytoplasmic antibody; placebo; rituximab; azathioprine; belimumab; cyclophosphamide; glucocorticoid; immunoglobulin; immunosuppressive agent; monoclonal antibody; neutrophil cytoplasmic antibody; rituximab; adult; aged; ANCA associated vasculitis; anus cancer; Article; benign neoplasm; birmingham vasculitis activity score; brain ischemia; concentration at steady-state; controlled study; corticosteroid therapy; disease duration; double blind procedure; drug efficacy; drug intoxication; drug megadose; drug pulse therapy; drug safety; drug withdrawal; evaluation study; female; hematologic disease; human; immunoglobulin blood level; immunopathology; infestation; intention to treat analysis; low drug dose; lymphatic system disease; maintenance therapy; major clinical study; male; malignant neoplasm; mediastinum disease; middle aged; multicenter study; multiple
Язык текста: Английский
ISSN: 2326-5205
Jayne D.
Blockmans D.
Luqmani R.
Moiseev S. V. Sergej Valentinovich 1960-
Ji B.
Green Y.
Hall L.
Roth D.
Henderson R. B.
Merkel P. A.
Йайне Д.
Блоcкманс Д.
Луqмани Р.
Моисеев С. В. Сергей Валентинович 1960-
Йи Б.
Греен Y.
Халл Л.
Ротх Д.
Хендерсон Р. Б.
Меркел П. А.
Efficacy and Safety of Belimumab and Azathioprine for Maintenance of Remission in Antineutrophil Cytoplasmic Antibody–Associated Vasculitis: A Randomized Controlled Study
Efficacy and Safety of Belimumab and Azathioprine for Maintenance of Remission in Antineutrophil Cytoplasmic Antibody–Associated Vasculitis: A...
Текст визуальный непосредственный
Arthritis and Rheumatology
John Wiley & Sons
Vol.71, Issue6 P. 952-963
2019
Статья
azathioprine belimumab cyclophosphamide glucocorticoid immunoglobulin G methotrexate myeloblastin myeloperoxidase neutrophil cytoplasmic antibody placebo rituximab azathioprine belimumab cyclophosphamide glucocorticoid immunoglobulin immunosuppressive agent monoclonal antibody neutrophil cytoplasmic antibody rituximab adult aged ANCA associated vasculitis anus cancer Article benign neoplasm birmingham vasculitis activity score brain ischemia concentration at steady-state controlled study corticosteroid therapy disease duration double blind procedure drug efficacy drug intoxication drug megadose drug pulse therapy drug safety drug withdrawal evaluation study female hematologic disease human immunoglobulin blood level immunopathology infestation intention to treat analysis low drug dose lymphatic system disease maintenance therapy major clinical study male malignant neoplasm mediastinum disease middle aged multicenter study multiple
Objective: To evaluate the safety and efficacy of belimumab as adjunctive therapy to maintain remission in antineutrophil cytoplasmic antibody (ANCA)–associated vasculitis (AAV). Methods: In this multicenter, double-blind, placebo-controlled study, patients with AAV (ages ≥18 years) were randomized 1:1 to receive azathioprine (2 mg/kg/day), low-dose oral glucocorticoids (≤10 mg/day), and either intravenous belimumab (10 mg/kg) or placebo, following remission induction with rituximab or cyclophosphamide along with glucocorticoids. The primary end point was time to first protocol-specified event (PSE), with first PSE defined as a Birmingham Vasculitis Activity Score (BVAS) of ≥6, presence of ≥1 major BVAS item, or receipt of prohibited medications for any reason, resulting in treatment failure (adjusted for ANCA type [proteinase 3 (PR3) or myeloperoxidase (MPO)], disease stage at induction, and induction regimen). Vasculitis relapse was defined as the PSE of either a BVAS activity score