Author Of 2 Presentations
P0172 - The prognostic value of lipid-specific IgM oligoclonal bands versus IgM index in patients with a clinical isolated syndrome: a comparative study. (ID 1114)
Abstract
Background
The value of intrathecal IgM synthesis (ITMS) is increasingly recognized as a prognostic biomarker in patients with a clinically isolated syndrome (CIS). However, no comparative studies between different methods to assess ITMS have been described previously evaluating the prognosis of patients with CIS.
Objectives
To compare the predictive value of IgM Reibergram (IR) and the presence of lipid-specific IgM oligoclonal bands (LS-OCMB) in CSF to predict conversion to clinically defined multiple sclerosis (CDMS), and the onset of EDSS of 3, 6 and a secondary progressive MS (SPMS).
Methods
An observational single-center study with CIS patients with at least 2 years of follow-up attended at Hospital Universitario Ramón y Cajal was performed. Demographics, clinical, radiological and immunological variables were collected.
Results
196 patients were included, 131 (66.8%) women, with a median (range) age of 31 (12–63) years and mean (SD) follow-up of 13.2 (±7.0) years. Overall, positive LS-OCMB was observed in 52 (26.5%) patients and IR in 32/193 (16.6%), reaching a concordance of 59.4% between both. The risk of CDMS was significantly higher exclusively among LS-OCMB (adjusted HR 1.80 (95%CI 1.24-2.62), p=0.002), but not for IR. In addition, LS-OCMB predicted a higher risk of reaching an EDSS of 3 (OR 1.97, p=0.044), an EDSS of 6 (OR 3.82, p=0.001) and a SPMS (OR 2.67, p=0.013) among MS patients. No significant differences were observed with IR.
Conclusions
LS-OCMB are a more sensitive and reliable CSF biomarker to predict the natural history of CIS patients compare to semi-quantitative IR.
P0327 - Effectiveness and safety profile of the Natalizumab extended interval dosing in a Spanish cohort (ID 1815)
Abstract
Background
Previous Biogen analyses of the US TOUCH Registry showed that the risk of developing natalizumab-associated progressive multifocal leukoencephalopathy (PML) among anti-JCV antibody positive natalizumab-treated patients was significantly lower with extended interval dosing (EID) compared with standard interval dosing (SID). However, the efficacy of EID was not evaluated in these analyses. Real-world studies and modelling data suggest that a patient population stable on natalizumab SID who is then switched to EID is more likely to maintain efficacy with EID as compared to a population who initiates natalizumab on EID.
Objectives
The main objective of the study is to evaluate the effectiveness (measured by the annualized relapse rate - ARR) of natalizumab EID in subjects who have been previously treated with natalizumab SID during the 12-month list, in relation to continuous SID treatment.
Methods
Observational, open-label study with retrospective analysis of a prospective cohort of patients with relapsing-remitting multiple sclerosis (RRMS) treated at Hospital Ramón y Cajal (Madrid) with natalizumab for 12 months using SID (Infusion every month). All patients were transferred after a period of initial treatment at standard interval doses to a 6-week EID, according to hospital protocol, eliminating a potential selection bias for assigning less active patients to the EID group Demographic, clinical, radiological and immunological variables were collected.
Results
61 patients were included, 33 (54%) women, with a median (range) age at treatment initiation of 35 (17-55) years. Median (range) treatment duration was 5,2 years (2-11,3), 3,47 years (1,4-7,8) in SID, 1,7 years (0,5-4,1) in EID. There was no difference in ARR, mean [95% confidence interval (CI)], (SID: 0.05 [0,01-0,1]; EID: 0.02 [0,02-0,05]; P=0.558), or EDSS (SID: 2,35 [1,9-2,7], EID: 2,67 [2,2-3,9]; p=0,42).
Conclusions
This study does not demonstrate significant differences in relapse outcomes between SID and EID periods of patients who switched to EID from natalizumab after ≥1 year on SID. These results are consistent with previous analyzes without comparison that concluded that efficacy is maintained after switching to EID. Consistent MRI and EDSS results will be shown in the final poster. An ongoing prospective randomized trial of EID versus SID will provide a more complete understanding of the effectiveness of natalizumab EID.