Author Of 2 Presentations
P0324 - Effect of ocrelizumab treatment in peripheral blood leukocyte subsets of Primary Progressive Multiple Sclerosis patients (ID 1613)
- J. Fernandez-Velasco
- J. Kuhle
- E. Monreal
- V. Meca-Lallana
- J. Meca-Lallana
- G. Izquierdo
- F. Gascón Giménez
- S. Sainz de la Maza
- P. Walo Delgado
- A. Maceski
- E. Rodríguez-Martin
- E. Roldán
- N. Villarrubia
- A. Saiz
- Y. Blanco
- P. Sánchez
- E. Carreón Guarnizo
- Y. Aladro
- L. Brieva
- C. Íñiguez
- I. González-Suárez
- L. Rodríguez De Antonio
- J. Masjuan
- L. Costa-Frossard
- L. Villar
Abstract
Background
Ocrelizumab is the first drug approved as disease modifying treatment for primary progressive (PP) multiple sclerosis (MS). As a humanized monoclonal antibody targeting CD20 cells, it is widely known that ocrelizumab treatment results in B cells depletion, but less is known about the effects of this drug in other blood leukocyte subsets of PPMS patients.
Objectives
To explore the changes induced by ocrelizumab in blood immune cells of PPMS patients to further understand their effects in the abnormal inflammatory response.
Methods
Multi-centre prospective longitudinal study including fifty‐three PPMS patients who initiated ocrelizumab treatment. Effector, memory, and regulatory cells were analyzed by flow cytometry at baseline and after 6 months of treatment. To assess differences between baseline and after 6 months, Wilcoxon matched paired tests were used and p values were corrected using Bonferroni test.
Results
Ocrelizumab decreased numbers of naïve and memory B cells (p<0.0001) and those of B cells producing interleukin (IL)-6, IL-10, granulocyte-macrophage colony-stimulating factor and tumor necrosis factor-alpha (p<0.0001 in all cases). A reduction of CD20+ T cell numbers (p=0.02) and percentages (p<0.0001) was also observed. We also detected a clear remodelation of the T cell compartment characterized by relative increases of the naïve/effector ratio in CD4+ (p=0.002) and CD8+ (p=0.002) T cells, and relative decreases of CD4+ (p=0.03) and CD8+ (p=0.004) T cells producing interferon-gamma. Total monocyte numbers increased (p=0.002), with no changes in those producing inflammatory cytokines. All these changes resulted in a reduction of serum neurofilament light chain (sNfL) levels (p=0.009).
Conclusions
Effector B cell depletion by ocrelizumab treatment induces changes in the T cell response of PPMS patients towards a low inflammatory profile. This resulted in a decrease of sNfL levels.
P1024 - Economic impact of the Secondary Progressive Multiple Sclerosis in Spain: Interim analysis of the DISCOVER study (ID 1595)
- C. Oreja-Guevara
- J. Río
- J. Ara Callizo
- M. Hernández Pérez
- J. Gracia Gil
- L. Ramió I Torrentà
- B. Pilo De La Fuente
- A. Alonso Torres
- S. Martínez-Yélamos
- F. Gascón Giménez
- S. Eichau Madueño
- B. Casanova-Estruch
- M. Martínez Ginés
- M. Aguado Valcárcel
- J. Martínez Rodríguez
- A. López Real
- C. López De Silanes
- V. González Quintanilla
- Y. El Berdei Montero
- A. Labiano
- M. Garcés Redondo
- L. Costa-Frossard
- J. García Merino
- F. Castellanos Pinedo
- C. Muñoz Fernández
- V. Meca-Lallana
- T. Castillo-Trivino
- A. Ródríguez-Antiguedad
- J. Peña Martínez
- J. Prieto González
- D. Solar Sánchez
- I. Pérez Molina
- E. Agüera Morales
- N. Herrera Varo
- J. Meca-Lallana
Abstract
Background
Multiple Sclerosis (MS) is a chronic, inflammatory, autoimmune, neurodegenerative disease. Around 19% of treated patients with relapsing-remitting MS progress to Secondary Progressive MS (SPMS) 15 years after disease onset, representing the most severe stage of the disease. MS symptoms lead to a general disability, impacting the quality of life of patients and also being related with an important economic burden on the National Health System, the patients, their caregivers and the whole society.
Objectives
There are limited published data on the economic impact of SPMS. The main objective of the study was to estimate the economic impact of SPMS in Spain.
Methods
DISCOVER (CBAF312AES01) is an observational, non-interventional, cross-sectional, retrospective and multicenter study, including 297 SPMS patients ≥18 years treated and monitored according to routine clinical practice in Spain in 34 public hospitals. All data was collected in one single visit. Primary endpoint: total annual cost per patient, including direct healthcare and non-healthcare costs and indirect costs. Interim results from 99 patients are presented.
Results
62.6% females; mean (SD) age 53.1 (9.3) years; 40.4% with higher education; 86.9% living with a relative. Mean (SD) time since first MS diagnosis was 17.5 (8.9) years and since progression to SPMS 5.2 (4.3) years. At diagnosis, mean (SD) EDSS was 2.0 (1.1), being 5.0 (1.1) at the time of progression and 5.9 (0.8) at the study visit, 47.5% patients reaching EDSS>6. 12.8% of patients presented relapses between 12-24 months before the study. According to EQ-5D-5L, mean (SD) utility (<1) was 0.48 (0.27) for patients with Gd+ lesions and/or relapses 2 years before. According to EQ-5D-5L, mean (SD) utility (<1) for patients with cognitive impairment was 0.45 (0.29) vs 0.51 (0.21) for those without it. Mean (SD) utility for Spanish general population was 0.897 (0.21). EDSS score showed a significative effect (P=0.0074) on the economic burden of the disease, with total costs increasing from 14,546€ (EDSS 4-4.5) to 21,918€ (EDSS 5-5.5) and 26,832€ (EDSS=6). Costs related to patients with EDSS=6 from the societal, patient and healthcare system were 6,441€, 8,450€ and 11,941€, respectively.
Conclusions
Interim results of the DISCOVER study revealed a significant economic impact of MS progression, highlighting the importance of implementing therapeutic strategies specific to the SPMS patient within the early stages of progression.