Author Of 3 Presentations
LB1193 - The Framingham cardiovascular risk score and 5-year progression of multiple sclerosis (ID 2012)
Abstract
Background
Cardiovascular risk factors and comorbidities can affect the prognosis of multiple sclerosis (MS). The Framingham risk score is an algorithm that can estimate the 10-year risk of developing macrovascular disease.
Objectives
To evaluate possible association between the Framingham risk score at baseline, and MS relapses, disability and disease-modifying therapy choices over 5-year follow-up.
Methods
This is a retrospective cohort study including 251 MS subjects. At baseline, we calculated the Framingham risk score considering the following variables: age, sex, diabetes, smoking, systolic blood pressure, and body mass index. MS outcomes including relapses, disability and treatments were collected over 5 years. Cox proportional regression models were employed to estimate hazard ratios (HR).
Results
1-point increase in the Framingham risk score was associated with 31% higher risk of relapse (HR=1.31; 95%CI=1.03, 1.68), 19% higher risk of reaching of EDSS 6.0 (HR=1.19; 95%CI=1.05, 3.01), and 62% higher risk of disease modifying treatment escalation (HR=1.62; 95%CI=1.22, 3.01).
Conclusions
Higher cardiovascular risk was associated with higher risk of relapses, disability, and treatment escalation in MS. Early identification, correction and treatment of cardiovascular comorbidities should be carefully considered within MS management.
P0344 - Injectable versus oral first-line disease-modifying therapies: results from Italian MS register (ID 1384)
Abstract
Background
The advent of oral first-line disease-modifying therapies (DMTs) for relapsing-remitting multiple sclerosis (RRMS) has expanded considerably the therapeutic landscape. However, here is an important need to gather real-world evidence data regarding long-term treatment effectiveness and safety in comparison to the old first-line injectables DMTs.
Objectives
To compare old injectable and oral first line DMTs for time to first relapse, time to confirmed disability progression (CDP), and time to discontinuation in a cohort of RRMS patients extracted from the Italian MS Registry.
Methods
Multicentre, observational, retrospectively acquired and propensity-adjusted cohort study of RRMS-naïve patients in the Italian MS Register starting injective or oral first line DMTs between 1 January 2010 and 31 December 2017 to evaluate their impact on disability outcomes in patients. Enrolled patients were divided into two groups: injectable group (IG) and oral group (OG).
Results
From a cohort of 11,416 patients, 4,602 were enrolled (3,919 on IG and 683 on OG). IG had higher rate of women (67.3% vs 63.4%, p<.05) and a lower mean age (36.1±10.9 vs 38.9±11.8, p<.001). For the event time to first relapse, Cox models after PS adjustment revealed a lower risk for OG patients (HR 0.58 CI95% 0.47-0.70, p<0.001). About the risk of CDP, no differences were found in the two groups (HR 1.14 CI95% 0.88-1.48, p=0.306). About the risk of DMT discontinuation, OG patients showed lower risk (HR 0.70 CI95% 0.57-0.86 p=0.001) than IG patients.
Conclusions
Real-world data from the Italian MS registry suggest that first line oral DMTs are associated to lower risks of experiencing a new relapse and of therapy discontinuation in comparison to injectable DMTs.
P0883 - MRI activity and extended interval of Natalizumab dosing: a multicenter Italian study (ID 1269)
- M. Clerico
- S. De Mercanti
- A. Signori
- M. Iudicello
- C. Cordioli
- E. Signoriello
- G. Lus
- S. Bonavita
- L. Lavorgna
- G. Maniscalco
- E. Curti
- L. Lorefice
- E. Cocco
- V. Nociti
- M. Mirabella
- D. Baroncini
- G. Mataluni
- D. Landi
- M. Petruzzo
- R. Lanzillo
- I. Gandoglia
- A. Laroni
- R. Frangiamore
- A. Sartori
- P. Cavalla
- G. Costantini
- M. Sormani
- R. Capra
Abstract
Background
Extending the natalizumab interval after the 24th administration could reduce the risk of progressive multifocal leukoencephalopathy (PML) without efficacy reduction.
Objectives
To evaluate the non-inferiority of the efficacy of an extended interval dosing (EID) regimen compared with the standard interval dosing (SID) of natalizumab regarding the multiple sclerosis (MS) MRI activity.
Methods
It is an observational, multicenter (14 Italian centers), retrospective cohort study, starting from the 24th natalizumab infusion to the loss of follow-up or 2 years after baseline. Patients were grouped in 2 categories according to the mean number of weeks between doses: < 5 weeks, SID; ≥ 5 weeks, EID. Three hundred and eight patients were enrolled. Median dose interval (MDI) following 24th infusion was 5 weeks, with a bimodal distribution (modes at 4 and 6 weeks).
Results
Two hundred and sixteen patients were in the SID group (MDI = 4.4 weeks) and 144 in the EID group (MDI 6 weeks). The risk to develop active lesions on MRI is similar in SID and EID groups during the 6 and 12 months after the 24th natalizumab infusion, respectively 2.98% (95% CI: 0.56-5.40) vs 3.32% (95% CI: 0.00-6.65%) [p=0.88] and 6.65% (95% CI: 3.02-10.29) vs 5.67% (95% CI: 1.76-9.58%) [p=0.73]. The EID regimen does not increase the occurrence of MRI activity after 6 and 12 months.
Conclusions
There is no evidence of a reduced efficacy of natalizumab in an EID setting regarding the MRI activity. This observation confirms previous clinical results and together with the increasing evidence of a reduced risk of PML associated to an EID regimen, supports the need of a bigger randomized study to assess the need to change the standard of the natalizumab dosing schedule, in order to better manage JCV-positive patients after 24 doses of natalizumab.