The Italian Multiple Sclerosis Database Network (MSDN): the risk of worsening according to IFNβ exposure in multiple sclerosis

2006 ◽  
Vol 12 (5) ◽  
pp. 578-585 ◽  
Author(s):  
Maria Trojano ◽  
Pierluigi Russo ◽  
Aurora Fuiani ◽  
Damiano Paolicelli ◽  
Elisabetta Di Monte ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Propensity Score ◽  
Relapse Rate ◽  
Cox Regression ◽  
Response To Treatment ◽  
Disability Progression ◽  
Proportion Of Days Covered ◽  
Clinical Stabilization ◽  
Multiple Sclerosis Patients

We evaluated the risk of worsening according to the length of exposure to interferon beta (IFNβ)ina large cohort of 2090 multiple sclerosis patients collected by the Italian MS Database Network. Overall 44-140 patient-visits with a follow-up of 22-143 patient-years were evaluated. Forty-one per cent of patients were exposed to IFNβ for up to 2 years, 39% for 2- 4 years and 20% for more than 4 years. A Cox regression model was used to analyse two clinical outcomes: disability progression and worsening of relapse rate. The technique of propensity score was applied to reduce bias in the comparison of non-randomized groups. The risks of disability progression (HR=0.23; 95% CI: 0.17 - 0.30) and worsening of relapse rate (HR=0.19; 95% CI: 0.14 - 0.27) were reduced by about 4- 5- fold in patients exposed to IFNβ for more than four years, compared with patients exposed for up to two years. The propensity score technique confirmed the findings. The proportion of days covered by IFNβ treatment was lower ( P<0.0001) in patients exposed to IFNβ for up to two years than in other groups. A clinical stabilization over two years of IFNβ exposure may predict a subsequent good clinical response to treatment.

scholarly journals Brain atrophy and disability progression in multiple sclerosis patients: a 10-year follow-up study

2014 ◽  
Vol 85 (10) ◽  
pp. 1109-1115 ◽  
Author(s):  
Cecilie Jacobsen ◽  
Jesper Hagemeier ◽  
Kjell-Morten Myhr ◽  
Harald Nyland ◽  
Kirsten Lode ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Brain Atrophy ◽  
Disability Progression ◽  
Follow Up Study ◽  
Multiple Sclerosis Patients

Impact of natural menopause on multiple sclerosis: a multicentre study

2019 ◽  
Vol 90 (11) ◽  
pp. 1201-1206 ◽  
Author(s):  
Damiano Baroncini ◽  
Pietro Osvaldo Annovazzi ◽  
Nicola De Rossi ◽  
Giulia Mallucci ◽  
Valentina Torri Clerici ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Cigarette Smoking ◽  
Relapse Rate ◽  
Disability Progression ◽  
Natural Menopause ◽  
Multicentre Cohort Study ◽  
Disability Status ◽  
Speed Up ◽  
Multicentre Cohort

ObjectiveTo study the effect of natural menopause on multiple sclerosis clinical course.MethodsThis was an observational, retrospective, multicentre, cohort study. Menopause onset was defined by the final menstrual period (FMP) beyond which no menses occurred for 12 months. We included multiple sclerosis (MS) patients with FMP occurred after 2005 and a recorded follow-up of at least 2 years pre-FMP and post-FMP. We excluded patients with primary progressive course, iatrogenic menopause and with other confounders that could mask menopause onset. We compared relapse-rate and expanded disability status scale (EDSS) scores pre-FMP and post-FMP, searching for possible interactions with age, disease duration, cigarette smoking and nulliparity status.Results148 patients were included (mean observation: 3.5 years pre-FMP and post-FMP). Most patients (92%) received disease-modifying therapies, mainly first-lines. After menopause the annualised relapse rate (ARR) significantly decreased (from 0.21±0.31 to 0.13± 0.24; p=0.005), while disability worsened (increase of mean 0.4 vs 0.2 points after menopause; p<0.001). Older age and long-lasting disease were associated with ARR reduction (p=0.013), but not with disability worsening. Cigarette smokers showed a trend to a higher disability accumulation after menopause (p=0.059).ConclusionNatural menopause seems to be a turning point to a more progressive phase of MS. Relapse rate is also reduced after menopause, but this effect could be driven most by ageing and shifting to progressive phase in patients with long-lasting disease. Cigarette smoking could speed up disability progression after menopause.

Response to interferon in multiple sclerosis is related to lipid-specific oligoclonal IgM bands

2010 ◽  
Vol 16 (7) ◽  
pp. 810-815 ◽  
Author(s):  
I. Bosca ◽  
LM Villar ◽  
F. Coret ◽  
MJ Magraner ◽  
M. Simó-Castelló ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Relapse Rate ◽  
Brain Mri ◽  
Biological Marker ◽  
Response To Treatment ◽  
First Year ◽  
Interferon Treatment ◽  
Secondary Endpoints ◽  
Relapsing Remitting Multiple Sclerosis

The objective of this study was to investigate whether the presence of lipid-specific oligoclonal IgM bands (LS-OCMB) in cerebrospinal fluid (CSF) influences the response to treatment with beta-interferon in relapsing—remitting multiple sclerosis (RRMS) patients. We performed a collaborative prospective study including RRMS patients with brain MRI and LS-OCMB studies performed before starting interferon treatment. The primary endpoint was the risk of having a relapse after treatment initiation. Secondary endpoints included relapse rate, relapse-rate reduction, proportion of relapse-free patients and proportion of patients with sustained disability increase during follow-up. One-hundred and two patients were included. After a mean follow-up of 37.4 months, the risk of suffering a relapse was two-fold higher in patients with LS-OCMB (hazard ratio 2.0, 95% confidence interval 1.1—3.8). LS-OCMB+ patients showed lower reduction in relapse rate (51.8% versus 80.8%; p < 0.0001), higher relapse rate in the first year (0.8 versus 0.2; p = 0.001), lower proportion of relapse-free patients (25% versus 61.3%; p = 0.003), and higher proportion of patients with sustained 1.0 increase in the Expanded Disability Status Score (45% versus 12.9%; p = 0.0003). In conclusion, LS-OCMB can have an influence on the response to interferon treatment in RRMS patients. They could be used as a biological marker to predict high inflammatory activity after treatment.

Disability progression in relapse-free multiple sclerosis patients on fingolimod versus interferon-beta/glatiramer acetate

2020 ◽  
pp. 135245852091848
Author(s):  
Viktor von Wyl ◽  
Pascal Benkert ◽  
André Moser ◽  
Johannes Lorscheider ◽  
Bernhard Décard ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Regression Analysis ◽  
Confidence Interval ◽  
Glatiramer Acetate ◽  
Interferon Beta ◽  
Cox Regression ◽  
Hazard Ratio ◽  
Disability Progression ◽  
Cox Regression Analysis ◽  
Multiple Sclerosis Patients

Background: Disability progression independent of relapses (PIRA) has been described as a frequent phenomenon in relapsing-remitting multiple sclerosis (RRMS). Objective: To compare the occurrence of disability progression in relapse-free RRMS patients on interferon-beta/glatiramer acetate (IFN/GA) versus fingolimod. Methods: This study is based on data from the Swiss association for joint tasks of health insurers. Time to relapse and 12-month confirmed disability progression were compared between treatment groups using multivariable Cox regression analysis with confounder adjustment. Inverse-probability weighting was applied to correct for the bias that patients on fingolimod have a higher chance to remain relapse-free than patients on IFN/GA. Results: We included 1640 patients (64% IFN/GA, 36% fingolimod, median total follow-up time = 4–5 years). Disease-modifying treatment (DMT) groups were well balanced with regard to potential confounders. Disability progression was observed in 155 patients (8.8%) on IFN/GA and 51 (7.6%) on fingolimod, of which 44 and 23 were relapse-free during the initial DMT, respectively. Adjusted standard regression analysis on all patients indicated that those on fingolimod experience less frequently disability progression compared with IFN/GA (hazard ratio = 0.53 (95% confidence interval = 0.37–0.76)). After bias correction, this was also true for patients without relapses (hazard ratio=0.56 (95% confidence interval = 0.32–0.98). Conclusion: Our analysis indicates that fingolimod is superior to IFN/GA in preventing disability progression in both relapsing and relapse-free, young, newly diagnosed RRMS patients.

scholarly journals Safety and Efficacy of Rituximab in Multiple Sclerosis: A Retrospective Observational Study

2018 ◽  
Vol 2018 ◽  
pp. 1-9 ◽  
Author(s):  
Bassem I. Yamout ◽  
Nabil K. El-Ayoubi ◽  
Johny Nicolas ◽  
Yehya El Kouzi ◽  
Samia J. Khoury ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Relapse Rate ◽  
Perianal Abscess ◽  
Disability Progression ◽  
Surgical Interventions ◽  
Disability Status ◽  
Relapsing Remitting ◽  
Clinical Practice Setting ◽  
Magnetic Resonance Imaging Mri

Objective. To evaluate the efficacy and safety of rituximab in multiple sclerosis in a clinical practice setting. Methods. Clinical data for all adult patients with multiple sclerosis (MS) treated with off-label rituximab at a single MS center in Lebanon between March 2008 and April 2017 were retrospectively collected from medical charts. The main efficacy outcomes assessed were annualized relapse rate (ARR) and proportion of patients free from relapses, disability progression, or magnetic resonance imaging (MRI) activity. Results. A total of 89 rituximab-treated patients were included: 59 relapsing-remitting MS (RRMS) and 30 progressive MS (PMS). Patients were treated with 1000 or 2000 mg rituximab IV every 6–12 months for a mean duration of 22.2 ± 24.8 months. The subjects were 65.2% females with a mean age of 40.5 ± 12.3 years and a mean disease duration of 7.9 ± 6.2 years. During treatment, the ARR decreased from 1.07 at baseline to 0.11 in RRMS (p<0.0001) and from 0.25 to 0.16 in PMS patients (p=0.593). The mean Expanded Disability Status Scale (EDSS) remained unchanged in both RRMS and PMS patients. Between baseline and the last follow-up, the percent of patients free from any new MRI lesions increased from 18.6% to 92.6% in the RRMS group and from 43.3% to 82% in the PMS group. No evidence of disease activity (NEDA) was achieved in 74% of patients at 1 year of treatment. A total of 64 adverse events (AEs) (71.9%) were recorded with the most common being infusion-related reactions in 25.8% of patients, all mild in nature. Two of our rituximab-treated patients experienced serious AEs requiring surgical interventions: pyoderma gangrenosum vaginalis with perianal abscess and fistula and an increase in the size of a meningioma. No case of progressive multifocal leukoencephalopathy (PML) was detected. Conclusion. In our real-world cohort, rituximab was well-tolerated and effective in reducing relapse rate and disability progression in relapsing-remitting and progressive MS patients.

Effect of relapses over early progression of disability in multiple sclerosis patients treated with beta-interferon

2008 ◽  
Vol 14 (5) ◽  
pp. 636-639 ◽  
Author(s):  
I Bosca ◽  
F Coret ◽  
C Valero ◽  
AM Pascual ◽  
MJ Magraner ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Cox Regression ◽  
Statistical Significance ◽  
Interferon Treatment ◽  
Disability Progression ◽  
Cox Regression Analysis ◽  
Beta Interferon ◽  
Kaplan Meier ◽  
Early Progression ◽  
Multiple Sclerosis Patients

Observational study designed to explore the effect of demographical variables and number of relapses over the disability progression in the two first years of beta-interferon treatment for multiple sclerosis. One hundred and sixty two patients treated with beta-interferon for at least two years were included, 70.9% females, mean age 33.4 years, mean disease duration 75.1 months, mean EDSS 2.4, previous year relapse rate 1.3. Main end-point was defined as a sustained EDSS increase (1.5 if previous EDSS 0-2.0; 1.0 if previous EDSS 2.5-4.0; 0.5 if previous EDSS 4.5 or higher). 62.3% of patients presented one or more relapses and 32.7% patients reached sustained disability increase. The univariate and multivariate Cox regression analysis only showed statistical significance for the relapses in the two first years after the treatment (HR 1 relapse: 3.4, p = 0.05; HR ≥ 2 relapses: 4.3, p < 0.001). The Kaplan-Meier survival analysis showed a higher probability of EDSS progression for patients with one relapse (log rank 10.9, p = 0.02) and with ≥ 2 relapses (log rank 17.7, p < 0.001), with no differences between them ( p = 0.38). In conclusion, patients with one or more relapses in the first two years of interferon treatment developed an earlier sustained progression of the disability.

scholarly journals Rituximab versus mitoxantrone: comparing effectiveness and safety in advanced relapsing multiple sclerosis

2021 ◽  
Vol 12 ◽  
pp. 204062232110243
Author(s):  
Zrzavy Tobias ◽  
Daniels Esther ◽  
Stuka Niklas ◽  
Weber Dennis ◽  
Winkelmann Alexander ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Propensity Score ◽  
Adverse Events ◽  
Lower Probability ◽  
Disability Progression ◽  
Treatment Groups ◽  
Off Label ◽  
Favorable Safety ◽  
Relapsing Multiple Sclerosis

Background: Rituximab (RTX), a CD20 depleting agent, is a frequently used off-label treatment for multiple sclerosis (MS), while mitoxantrone (MTX) is approved, albeit rarely used for active relapsing MS (RMS). However, observational data comparing RTX and MTX effectiveness and safety are scarce. Objective: We aimed to compare effectiveness and safety of MTX and RTX in patients with active RMS. Methods: From combined retrospective clinical data of three MS centers, we selected patients who had received at least one infusion of RTX or MTX and had at least a 6-month clinical follow-up available. Treatment groups were compared by propensity score (PS)-adjusted regression and inverse PS-weighted generalized estimated equation models regarding disability progression, relapse activity, and adverse events (AEs). Results: We included 292 RMS patients (mean age 41.8 years, 71.6% female) who received RTX (119 patients, mean age 36.8 years, 74.8% female) or MTX (173 patients mean age 45.3 years, 69.4% female). Using both PS methods, we did not find a significant effect favoring RTX or MTX treatment regarding the probability of disability worsening or relapse occurrence. However, RTX treatment was associated with a significantly lower probability of severe AEs and AEs. Conclusions: RTX shows comparable effectiveness but a favorable safety profile compared with MTX in active RMS.

scholarly journals Long-term comparative analysis of no evidence of disease activity (NEDA-3) status between multiple sclerosis patients treated with natalizumab and fingolimod for up to 4 years

2021 ◽  
Author(s):  
Tommaso Guerra ◽  
Francesca Caputo ◽  
Bianca Orlando ◽  
Damiano Paolicelli ◽  
Maria Trojano ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Disease Activity ◽  
Cox Regression ◽  
First Line ◽  
Chi Square ◽  
Relapsing Remitting ◽  
Chi Square Test ◽  
Multiple Sclerosis Patients ◽  
Relapsing Remitting Multiple Sclerosis

Abstract Background Comparative effectiveness of natalizumab and fingolimod over a follow-up longer than 2 years has been not addressed yet. Objectives To compare the effect on no evidence of disease activity (NEDA-3) in relapsing-remitting multiple sclerosis (RRMS) patients treated with natalizumab or fingolimod for at least 4 years. Methods We included RRMS patients switched from first-line agents to natalizumab or fingolimod. Patients were propensity score (PS)-matched on a 1-to-1 basis. Percentages of patients reaching NEDA-3 status at 2 and 4 years of follow-up were compared using the chi-square test. The risk of not achieving NEDA-3 at 4 years was explored in matched samples by Cox regression models. Results We evaluated 174 PS-matched patients. Patients receiving natalizumab reached a NEDA-3 status at 2 and 4 years more frequently than those exposed to fingolimod (63% vs 44%, p=0.037; 45.7% vs 25.8%, p=0.015, respectively). Patients receiving natalizumab were at a significant lower risk of not achieving the NEDA-3 status at 4 years compared to those exposed to fingolimod (hazard ratio (95% confidence interval): 0.54 (0.36–0.80), p=0.002). Conclusions Although both medications were effective in patients non-responding to first-line agents, natalizumab seems to be superior to fingolimod in RRMS in obtaining NEDA-3 status at 4 years.

scholarly journals Assessment of Disability Progression Independent of Relapse and Brain MRI Activity in Patients with Multiple Sclerosis in Poland

2021 ◽  
Vol 10 (4) ◽  
pp. 868
Author(s):  
Katarzyna Kapica-Topczewska ◽  
François Collin ◽  
Joanna Tarasiuk ◽  
Agata Czarnowska ◽  
Monika Chorąży ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Brain Activity ◽  
Brain Mri ◽  
Disability Progression ◽  
Program Monitoring ◽  
Therapeutic Program ◽  
Relapsing Remitting ◽  
Second Year ◽  
Multiple Sclerosis Patients ◽  
Relapsing Remitting Multiple Sclerosis

The aim of the study was to verify the association of clinical relapses and brain activity with disability progression in relapsing/remitting multiple sclerosis patients receiving disease-modifying treatments in Poland. Disability progression was defined as relapse-associated worsening (RAW), progression independent of relapse activity (PIRA), and progression independent of relapses and brain MRI Activity (PIRMA). Data from the Therapeutic Program Monitoring System were analyzed. Three panels of patients were identified: R0, no relapse during treatment, and R1 and R2 with the occurrence of relapse during the first and the second year of treatment, respectively. In the R0 panel, we detected 4.6% PIRA patients at 24 months (p < 0.001, 5.0% at 36 months, 5.6% at 48 months, 6.1% at 60 months). When restricting this panel to patients without brain MRI activity, we detected 3.0% PIRMA patients at 12 months, 4.5% at 24 months, and varying from 5.3% to 6.2% between 36 and 60 months of treatment, respectively. In the R1 panel, RAW was detected in 15.6% patients at 12 months and, in the absence of further relapses, 9.7% at 24 months and 6.8% at 36 months of treatment. The R2 group was associated with RAW significantly more frequently at 24 months compared to the R1 at 12 months (20.7%; p < 0.05), but without a statistical difference later on. In our work, we confirmed that disability progression was independent of relapses and brain MRI activity.

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