0604: Is Belimumab Dose Optimization Possible in Patients with Systemic Lupus Erythematosus?: Analysis of This Therapeutic Strategy in a Large Multicenter Cohort of Patients from Spanish Rheumatology Departments

Irene Altabas Gonzalez¹, Jose-Maria Pego-Reigosa², CORAL Mourino Rodriguez³, Norman Jiménez⁴, Andrea Hernández-Martín⁵, Judit Font⁶, Ivette Casafont-Sole⁷, Jose Andres Roman Ivorra⁸, Marta De la Rubia Navarro⁹, Maria Galindo¹⁰, TAREK CARLOS SALMAN MONTE¹¹, Javier Narvaez¹², Paola Vidal-Montal¹³, Maria J. García-Villanueva¹⁴, Sandra Garrote Corral¹⁴, María Ángeles Blázquez Cañamero¹⁵, carlos Marras Fernández-Cid¹⁶, María Piqueras García¹⁷, JULIA MARTINEZ BARRIO¹⁸, Marina Sánchez-Lucas¹⁹, Josefina Cortés Hernández²⁰, Eleonora Penzo²¹, Jaime Calvo Alén²², Juan Ramón de Dios Jiménez de Aberásturi²³, Belén Álvarez Rodríguez²⁴, Margarida Rocha²⁵, Eva Tomero Muriel²⁶, Raúl Menor-Almagro²⁷, Myriam Gandía Martínez²⁸, Jose A Gomez-Puerta²⁹, Beatriz Frade³⁰, Consuelo Ramos-Giráldez³¹, Carmen Trapero Pérez³², MARIA ELVIRA DIEZ ALVAREZ³³, Clara Moriano Morales³³, Alejandro Muñoz³⁴ and Iñigo Rúa-Figueroa³⁵, ¹Complejo Hospitalario Universitario de Vigo, IRIDIS (Investigation in Rheumatology and Immune-Mediated Diseases) Group, Galicia Sur Health Research Institute, Vigo, Spain, ²Rheumatology, Hospital do Meixoeiro, Vigo, Spain, ³Complejo Hospitalario Universitario de Vigo. IRIDIS (Investigation in Rheumatology and Immune-Mediated Diseases) Group, Galicia Sur Health Research Institute, Vigo, Spain, ⁴IIRIDIS (Investigation in Rheumatology and Immune-Mediated Diseases) Group, Galicia Sur Health Research Institute., Vigo, Spain, ⁵Hospital Universitario de Gran Canaria Dr. Negrin, Las Palmas de Gran Canaria, Spain, ⁶Hospital Universitario Germans Trias i Pujol, Badalona, Spain, ⁷Hospital Universitari Germans Trias i Pujol, Badalona, Spain, ⁸Hospital Universitari i Politècnic la Fe, Valencia, Spain, ⁹Hospital Universitario y Politécnico de la Fe, Valencia, Spain, ¹⁰Hospital Universitario 12 de Octubre, Madrid, Spain, ¹¹Hospital del Mar/Parc de Salut Mar-IMIM, Barcelona, Spain, ¹²Hospital Universitario de Bellvitge, Barcelona, Spain, ¹³Department of Rheumatology. Hospital Universitario de Bellvitge, Barcelona, Spain, ¹⁴Hospital Ramón y Cajal, Madrid, Spain, ¹⁵Rheumatology Department Hospital Ramon y Cajal, Madrid, Spain, ¹⁶Rheumatology, Hospital Virgen Arrixaca, Murcia, Spain, ¹⁷Hospital Virgen de la Arrixaca de Murcia, Murcia, Spain, ¹⁸Rheumatology, Gregorio Marañon University Hospital, Madrid, Spain, ¹⁹Hospital General Universitario Gregorio Marañón, Madrid, Spain, ²⁰Lupus Unit, Rheumatology Department, Vall d’Hebron Hospitals, Barcelona, Spain, ²¹Hospital Universitario Valle d´ Hebrón, Barcelona, Spain, ²²Hospital Universitario Araba, Vitoria, Spain, ²³Hospital Universitario Araba, Álava, Spain, ²⁴Hospital de Araba, Vitoria, Spain, ²⁵Osakidetza, Bilbo, Spain, ²⁶Rheumatology, Hospital La Princesa, Madrid, Spain, ²⁷Rheumatology, Hospital Jerez, Puerto De Santa María, Spain, ²⁸Hospital de Jerez, Jerez, Spain, ²⁹Department of Rheumatology, Hospital Clinic of Barcelona, Barcelona, Spain, ³⁰Hospital Clinic, Barcelona, Spain, ³¹Rheumatology Department Hospital Universitario Virgen de Valme, Sevilla, Spain, ³²Hospital Universitario Nuestra Señora de Valme, Sevilla, Spain, ³³Rheumatology, Hospital Universitario de León, León, Spain, ³⁴Hospital universitario Virgen del Rocío, El Viso de Alcor, Spain, ³⁵Rheumatology, Hospital de Gran Canaria Doctor Negrin, Las Palmas de Gran Canaria, Spain

Background/Purpose: Belimumab (BLM) is an IgG-1l anti-BAFF monoclonal antibody effective in patients with systemic lupus erythematosus (SLE), being used increasingly. However, there are no published data on dose optimization in responder patients.

Aim: to assess the prevalence of dose optimization in patients with SLE treated with BLM in our country, its modalities and its impact on disease activity control.

Methods: Retrospective longitudinal and multicenter study of SLE patients, treated with

BLM in Spanish rheumatology departments. Demographic and clinical features, activity (SLEDAI), treatments and outcomes (remission (DORIS -2021) and low disease activity (LLDAS) were collected at baseline (pre-optimization) (VB), at 6 (V6M) and at 12 months (V12M) post-optimization. A comparative analysis was performed pre- and post-optimization.

Results: 324 patients with SLE (98%, ACR-97 or SLICC-12 criteria) treated with BLM were included; 91% women; mean age (±DS): 42.4 (±12.9) years. Median follow-up follow-up: 3.2 years (p25-p75) (1.4-5.9). A total of 29 patients (8.9%) were optimized. Median time to optimization 2.7 (1.77-4.48) years. Mean time on optimization: 11.36 (±2.5) months. Optimization modalities: increase of the interval in 9 patients with subcutaneous BLM (from 7 days to 10-21 days of interval between doses) and in 6 patients with intravenous (ivBLM) (from a 4-week to a 5- 6-weeks). Dose reduction per administration (all ivBLM) in 16 patients (from 10mg/kg to 5-9 mg/kg).

Pre-optimization status (VB): 15/26 (57.7%) in DORIS-21 remission and 23/26 (88.5%) in LLDAS. LLDAS. Only 1 patient had lupus nephritis. Detailed description of other baseline characteristics are displayed in Table 1. After optimization, 2/24 (8.3%) and 3/22(13.6%) patients lost remission-DORIS in V6M and V12M, respectively, but with no statistically significant differences with respect to VB; regarding to LLDAS, 2/23(8.7%) and 2/21(9.5%) did so in V6M and V12M, respectively, but also without statistically significant differences with respect to VB. Out of 11/23(47.8%) and 9/21(42.9%) moved from SLEDAI 0 to SLEDAI >0 in V6M and V12M, respectively. In terms of disease activity, no significant differences were found pre- and post-optimization in any of the measures, except for hypocomplementemia (p = 0.0276) (Table 1). Changes in activity did not lead to relevant changes in treatment, thus only one patient returned to the baseline dose of BLM and only one patient started DMARD. Significantly fewer patients received GC in V12M, even though the median dose of GC was higher in V12M (5 (0.62-8.75) vs. 2.5 (0-5) in VB) (Table 1).

Conclusion: It is possible to optimize doses of BLM without relevant changes in disease activity, at least in the short term, in a significant percentage of patients, and the most of them maintain the optimized dose. However, the increased clinical or serologic activity is possible in some patients. This makes a tighter post-optimization follow-up advisable.

More studies, with a larger number of patients and longer follow-up time, will be required to confirm these results and to analyse more robust outcomes.




I. Altabas Gonzalez: None; J. Pego-Reigosa: None; C. Mourino Rodriguez: None; N. Jiménez: None; A. Hernández-Martín: None; J. Font: None; I. Casafont-Sole: None; J. Roman Ivorra: None; M. De la Rubia Navarro: None; M. Galindo: None; T. SALMAN MONTE: None; J. Narvaez: None; P. Vidal-Montal: None; M. García-Villanueva: AstraZeneca, 6, GSK, 6, Otsuka, 1; S. Garrote Corral: None; M. Blázquez Cañamero: Gedeon Richter, 6, GlaxoSmithKlein(GSK), 6, UCB, 6; c. Marras Fernández-Cid: None; M. Piqueras García: None; J. MARTINEZ BARRIO: None; M. Sánchez-Lucas: None; J. Cortés Hernández: GSK, 6; E. Penzo: None; J. Calvo Alén: None; J. de Dios Jiménez de Aberásturi: None; B. Álvarez Rodríguez: None; M. Rocha: None; E. Tomero Muriel: None; R. Menor-Almagro: None; M. Gandía Martínez: None; J. Gomez-Puerta: AstraZeneca, 6, Eli Lilly, 6, Galapagos, 6, GSK, 6, Janssen, 6, Pfizer, 6, Sanofi, 2; B. Frade: None; C. Ramos-Giráldez: None; C. Trapero Pérez: None; M. DIEZ ALVAREZ: None; C. Moriano Morales: None; A. Muñoz: None; I. Rúa-Figueroa: AstraZeneca, 5, GSK, 1, 6.