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

被引:53
|
作者
Touma, Zahi [1 ]
Sayani, Amyn [2 ]
Pineau, Christian A. [3 ]
Fortin, Isabelle [4 ]
Matsos, Mark [5 ]
Ecker, George A. [6 ,7 ]
Chow, Andrew [8 ]
Iczkovitz, Sandra [2 ]
机构
[1] Univ Toronto, Toronto Western Hosp, Ctr Prognosis Studies Rheumat Dis, Lupus Clin, EW,1-412,399 Bathurst St, Toronto, ON M5T 2S8, Canada
[2] GlaxoSmithKline Inc, Toronto, ON, Canada
[3] McGill Univ, MUHC Lupus & Vasculitis Clin, Montreal, PQ, Canada
[4] Ctr Rhumatol, Quebec City, PQ, Canada
[5] McMaster Univ, Hamilton, ON, Canada
[6] Dalhousie Univ, Halifax, NS, Canada
[7] Mem Univ, St John, NF, Canada
[8] Credit Valley Rheumatol, Mississauga, ON, Canada
关键词
Lupus erythematosus; systemic; B-cell activating factor; Observational study; Glucocorticoids; Disease progression; Rheumatology; MONOCLONAL-ANTIBODY;
D O I
10.1007/s00296-017-3682-9
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
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.
引用
收藏
页码:865 / 873
页数:9
相关论文
共 22 条
  • [11] Early and Late Response and Glucocorticoid-Sparing Effect of Belimumab in Patients with Systemic Lupus Erythematosus with Joint and Skin Manifestations: Results from the Belimumab in Real Life Setting Study-Joint and Skin (BeRLiSS-JS']JS)
    Zen, Margherita
    Gatto, Mariele
    Depascale, Roberto
    Regola, Francesca
    Fredi, Micaela
    Andreoli, Laura
    Franceschini, Franco
    Urban, Maria Letizia
    Emmi, Giacomo
    Ceccarelli, Fulvia
    Conti, Fabrizio
    Bortoluzzi, Alessandra
    Govoni, Marcello
    Tani, Chiara
    Mosca, Marta
    Ubiali, Tania
    Gerosa, Maria
    Bozzolo, Enrica P.
    Canti, Valentina
    Cardinaletti, Paolo
    Gabrielli, Armando
    Tanti, Giacomo
    Gremese, Elisa
    De Marchi, Ginevra
    De Vita, Salvatore
    Fasano, Serena
    Ciccia, Francesco
    Pazzola, Giulia
    Salvarani, Carlo
    Negrini, Simone
    Di Matteo, Andrea
    De Angelis, Rossella
    Orsolini, Giovanni
    Rossini, Maurizio
    Faggioli, Paola
    Laria, Antonella
    Piga, Matteo
    Cauli, Alberto
    Scarpato, Salvatore
    Rossi, Francesca Wanda
    De Paulis, Amato
    Brunetta, Enrico
    Ceribelli, Angela
    Selmi, Carlo
    Prete, Marcella
    Racanelli, Vito
    Vacca, Angelo
    Bartoloni, Elena
    Gerli, Roberto
    Zanatta, Elisabetta
    JOURNAL OF PERSONALIZED MEDICINE, 2023, 13 (04):
  • [12] Combination of clinical factors predicts successful glucocorticoid withdrawal in systemic lupus erythematosus (SLE): results from a multicentre, retrospective cohort study
    Katechis, Spyridon
    Pitsigavdaki, Sofia
    Nikoloudaki, Myrto
    Silvagni, Ettore
    Repa, Argyro
    Marangoni, Antonio
    Flouri, Irini
    Avgoustidis, Nestor
    Parperis, Konstantinos
    Govoni, Marcello
    Sidiropoulos, Prodromos
    Boumpas, Dimitrios T.
    Fanouriakis, Antonis
    Bertsias, George
    Bortoluzzi, Alessandra
    RMD OPEN, 2025, 11 (01):
  • [13] Low-dose belimumab for patients with systemic lupus erythematosus at low disease activity: protocol for a multicentre, randomised, double-blind, placebo-controlled clinical trial
    Sun, Fangfang
    Huang, Wenyan
    Chen, Jie
    Zhao, Liling
    Zhang, Danting
    Wang, Xiaodong
    Wan, Weiguo
    Dai, Sheng-Ming
    Chen, Sheng
    Li, Ting
    Ye, Shuang
    LUPUS SCIENCE & MEDICINE, 2022, 9 (01):
  • [14] Long-term open-label continuation study of the safety and efficacy of belimumab for up to 7 years in patients with systemic lupus erythematosus from Japan and South Korea
    Tanaka, Yoshiya
    Bae, Sang-Cheol
    Bass, Damon
    Curtis, Paula
    Chu, Myron
    DeRose, Kathleen
    Ji, Beulah
    Kurrasch, Regina
    Lowe, Jenny
    Meizlik, Paige
    Roth, David A.
    RMD OPEN, 2021, 7 (02):
  • [15] Burden of systemic lupus erythematosus in clinical practice: baseline data from the SLE Prospective Observational Cohort Study (SPOCS) by interferon gene signature
    Arnaud, Laurent
    Furie, Richard
    Morand, Eric F.
    Aringer, Martin
    Peschken, Christine
    Desta, Barnabas
    Rapsomaniki, Eleni
    Hedberg, Jonatan
    Knagenhjelm, Jacob
    Seo, Caroline
    Een, Tina Gruenfeld
    Sorrentino, Alessandro
    Tummala, Raj
    Stirnadel-Farrant, Heide A.
    Ding, Bo
    LUPUS SCIENCE & MEDICINE, 2023, 10 (02):
  • [16] Characteristics and clinical outcomes of patients with systemic lupus erythematosus initiating anifrolumab in a real-world setting in Spain (AZAHAR study): an observational study protocol
    Galindo-Izquierdo, Maria
    Bahamontes-Rosa, Noemi
    Sarto-Ferres, Berta
    Galvez-Fernandez, Marta
    Cortes-Hernandez, Josefina
    LUPUS SCIENCE & MEDICINE, 2025, 12 (01):
  • [17] Effects of belimumab, a B lymphocyte stimulator-specific inhibitor, on disease activity across multiple organ domains in patients with systemic lupus erythematosus: combined results from two phase III trials
    Manzi, Susan
    Sanchez-Guerrero, Jorge
    Merrill, Joan T.
    Furie, Richard
    Gladman, Dafna
    Navarra, Sandra V.
    Ginzler, Ellen M.
    D'Cruz, David P.
    Doria, Andrea
    Cooper, Simon
    Zhong, Z. John
    Hough, Douglas
    Freimuth, William
    Petri, Michelle A.
    ANNALS OF THE RHEUMATIC DISEASES, 2012, 71 (11) : 1833 - 1838
  • [18] Preconception clinical factors related to adverse pregnancy outcomes in patients with systemic lupus erythematosus or primary Sjogren's syndrome: a retrospective cohort study
    Fierro, Juan J.
    Prins, Jelmer R.
    Verstappen, Gwenny M.
    Bootsma, Hendrika
    Westra, Johanna
    de Leeuw, Karina
    RMD OPEN, 2023, 9 (03):
  • [19] HIV Treatment Outcomes Among HIV-Infected, Opioid-Dependent Patients Receiving Buprenorphine/Naloxone Treatment within HIV Clinical Care Settings: Results From a Multisite Study
    Altice, Frederick L.
    Bruce, R. Douglas
    Lucas, Gregory M.
    Lum, Paula J.
    Korthuis, P. Todd
    Flanigan, Timothy P.
    Cunningham, Chinazo O.
    Sullivan, Lynn E.
    Vergara-Rodriguez, Pamela
    Fiellin, David A.
    Cajina, Adan
    Botsko, Michael
    Nandi, Vijay
    Gourevitch, Marc N.
    Finkelstein, Ruth
    JAIDS-JOURNAL OF ACQUIRED IMMUNE DEFICIENCY SYNDROMES, 2011, 56 : S22 - S32
  • [20] Clinical and Demographic Profile of Patients Receiving Fingolimod in Clinical Practice in Germany and the Benefit–Risk Profile of Fingolimod After 1 Year of Treatment: Initial Results From the Observational, Noninterventional Study PANGAEA
    Tjalf Ziemssen
    Michael Lang
    Björn Tackenberg
    Stephan Schmidt
    Holger Albrecht
    Luisa Klotz
    Judith Haas
    Christoph Lassek
    Jennie Medin
    Christian Cornelissen
    Neurotherapeutics, 2018, 15 : 190 - 199