Abstract
BASELINE PROFILE OF SYSTEMIC LUPUS ERYTHEMATOSUS PATIENTS ON TREATMENT WITH BELIMUMAB OF A SPANISH MULTICENTER COHORT
Full text
I. Altabás González, J. M. Pego-Reigosa, A. Hernández-Martín, J. Font, I. Casafont-Solé, J. A. Román Ivorra, M. DE LA Rubia Navarro, M. Galindo, T. C. Salman Monte, J. Narváez, P. Vidal Montal, M. J. Garcia Villanueva, C. Marras Fernandez Cid, M. M. Piqueras Garcia, J. Martínez-Barrio, M. Sánchez Lucas, J. Cortés-Hernández, E. Penzo, J. Calvo-Alén, J. R. De Dios, E. Tomero Muriel, R. Menor-Almagro, M. Gandia Martinez, J. A. Gómez-Puerta, B. Frade-Sosa, C. Ramos Giráldez, C. Trapero, A. Muñoz Jimenez, C. Moriano, E. Diez Alvarez, N. Jiménez, I. Rua-FigueroaComplejo Hospitalario Universitario de Vigo, Rheumatology, Vigo, Spain
IRIDIS Group, IISGS, Vigo, Spain
Hospital Universitario de Gran Canaria Dr. Negrín, Rheumatology, Las Palmas de Gran Canaria, Spain
Hospital Universitario Germans Trias i Pujol, Rheumatology, Badalona, Spain
Hospital Universitario y Politécnico de la Fe, Rheumatology, Valencia, Spain
Hospital 12 de octubre, Rheumatology, Madrid, Spain
Hospital del Mar, Rheumatology, Barcelona, Spain
Hospital Universitario de Bellvitge, Rheumatology, Barcelona, Spain
Hospital Universitario Ramón y Cajal, rheumatology, madrid, Spain
Hospital Virgen de la Arrixaca de Murcia, Rheumatology, Murcia, Spain
Hospital General Universitario Gregorio Marañón, Rheumatology, Madrid, Spain
Hospital Universitario Valle de Hebrón, Rheumatology, Barcelona, Spain
Hospital Universitario Araba, Rheumatology, Vitoria, Spain
Hospital Universitario de La Princesa, Rheumatology, Madrid, Spain
Hospital Universitario de Jerez, Rheumatology, Cádiz, Spain
Hospital Clinic de Barcelona, Rheumatology, Barcelona, Spain
Hospital Universitario Nuestra Señora de Valme, Rheumatology, Sevilla, Spain
Hospital Universitario Virgen del Rocío, Rheumatology, Sevilla, Spain
Hospital Universitario de León, Rheumatology, León, Spain
Background Belimumab (BLM) is a recombinant human IgG-1λ monoclonal antibody that inhibits B-cell activating factor. It is commonly used for treatment of systemic lupus erythematosus (SLE) patients with inadequate control to first-line treatments and inability to taper GC daily dose to acceptable levels. More recently it has been approved for patients with active lupus nephritis.
Objectives To report baseline profile of SLE patients treated with BLM enrolled in a SLE Spanish registry.
Methods Multicenter retrospective and longitudinal cohort study including SLE patients treated with BLM in 18 Spanish rheumatology units. Demographic, clinical data and treatments were collected at baseline, 6, 12 months and in the last visit available. Patients starting BLM in different periods (2010-2015 and 2016-2021) were compared regarding the reason of prescription of the drug.
Results 324 patients (91% female, 84,8% caucasian) were enrolled. Mean (±SD) age at diagnosis: 31.8 years (±11.9); mean disease duration of 8.7 years (±9.07) and mean follow-up 3.8 (±2.7). A total of 319 (98.45%) subjects met SLE 1997 ACR or SLICC 2012 criteria; 217 (68.2%) were anti-dsDNA positive and 224 (69.8%) had low complement levels. At baseline, the mean SLEDAI-2K score was 10.4 (±5.25); 152 (47.5%) of patients had damage with a mean SDI score of 0.83 (±1.2). A total of 289 patients (89.2%) had received disease modifying anti-rheumatic drugs (DMARDs) before BLM: conventional (cDMARDS) in 282 patients (87%) and biologic DMARDs (bDMARDs) in 74 patients (22.8%); 164 (51.9%) had received more than one cDMARDs, methotrexate being the most frequently used (44.4%). Other cDMARDs used were: mycophenolate mofetil in 104 (37.01%), azathioprine in 91 (32.38%), leflunomide in 29 (10.32%), cyclophosphamide in 28 (9.92%) and calcineurin inhibitors in 13 (4.6%) of patients. The most frequent bDMARDs used was Rituximab in 80%. Most patients were receiving antimalarials (83,2%) and glucocorticoids (GC) (91.2%), with a mean dose of 12.3 mg/day. A total of 209 (67.9%) patients were receiving more than 5 mg/day and 180 (58.4%) more than 7.5 mg/day of prednisone.
BLM was used in monotherapy in 99 (30.5%) subjects. It was initiated due to disease activity in 307 patients (95%) and/or as a GC sparing agent in 191 patients (59%). Most patients initiated BLM for several concurrent reason; only a few patients received BLM just for maintenance (4/322) or save GC (8/322). At baseline, only 6 patients (1.9%) were in DORIS-21-remission and LLDAS. The main reasons of prescription for ongoing activity were arthritis (65.4%), cutaneous (40.7 %) or both (81%). There were no statistically significant differences in any of the prescription reasons when comparing the periods 2010-2015 and 2016-2021.
Table 1. Type and reasons of prescription of Belimumab
N (%) or mean (± SD) (n = 324 patients)
Age at prescription of Belimumab (years)
42.3 (± 12.9)
Intravenous Belimumab
215 (66.35%)
Subcutaneous Belimumab
110 (33%)
Reasons of prescription* (multiple response allowed)
Disease activity
307 (95%)
Maintenance
197 (61%)
Glucocorticoid sparing
191 (59 %)
Activity
Cutaneous
132 (40.7 %)
Articular
212 (65.4%)
Renal
58 (17,9%)
Hematological
60 (18.5%)
Serosal
47 (14.5%)
Other
29 (8.82%)
Conclusion In the majority of patients, belimumab was prescribed after the use of other DMARDs and more than 50% of patients had received at least 2 DMARDs and were receiving GC at medium doses. One third of patients received BLM as monotherapy. It was prescribed due to active disease in the vast majority of patients and/or as GC sparing agent. Activity in articular and cutaneous domains were the main reasons of indication. No changes in prescription habits were identified over time.
REFERENCES:
NIL.
Acknowledgements: NIL.
Disclosure of Interests None Declared.
Keywords: bDMARD, Systemic lupus erythematosus, Descriptive Studies
DOI: 10.1136/annrheumdis-2023-eular.3003Citation: , volume 82, supplement 1, year 2023, page 1461Session: SLE, Sjön’s and APS - treatment
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19 organizations
Organization
IRIDIS Group, IISGS, Vigo, SpainOrganization
Hospital Universitario de Gran Canaria Dr. Negrín, Rheumatology, Las Palmas de Gran Canaria, SpainOrganization
Hospital del Mar, Rheumatology, Barcelona, Spain