Intravenous immunoglobulin in primary and secondary chronic progressive multiple sclerosis: a randomized placebo controlled multicentre study

2007 ◽  
Vol 13 (9) ◽  
pp. 1107-1117 ◽  
Author(s):  
D. Pöhlau ◽  
H. Przuntek ◽  
M. Sailer ◽  
F. Bethke ◽  
J. Koehler ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Placebo Group ◽  
Relapse Rate ◽  
Fine Motor ◽  
Ivig Treatment ◽  
Ivig Infusion ◽  
Progression Of Disease ◽  
Secondary Endpoints ◽  
Edss Score ◽  
The Difference

In patients with relapsing-remitting multiple sclerosis (MS), IVIG was shown to reduce the relapse rate and progression of disability. In patients with chronic progressive MS, a beneficial effect of IVIG was not documented in placebo controlled studies. This trial investigated the influence of IVIG in primary (PPMS) and secondary (SPMS) chronic progressive MS. Two-hundred and thirty-one patients stratified for PPMS ( n = 34) and SPMS ( n = 197) were randomly assigned to IVIG 0.4 g/kg per month or to placebo for 24 months. Primary endpoints were 1) the time to sustained progression of disease identified as worsening of the expanded disability status scale (EDSS) sustained for 3 months, and 2) the improvement of neurological functions defined by a patient's best EDSS score. Secondary endpoints were the proportion of patients with sustained progression, the relapse rate, the assessment of fine motor skills, visual evoked potentials, contrast sensitivity, depression and quality of life. Analysis of the intention-to-treat (ITT) population of combined PPMS and SPMS patients showed that the mean time to sustained progression was 74 weeks in the IVIG compared with 62 weeks in the placebo group ( P = 0.0406). When PPMS and SPMS patients were analysed separately, the time to sustained progression was also longer in the IVIG group, but the difference was not significant. There was no IVIG-mediated improvement in neurological functions. In the combined per protocol (PP) treated patients, IVIG treatment prolonged time to sustained progression by 13 weeks ( P = 0.0396). PPMS patients, but not SPMS patients showed a slight favourable IVIG effect on the best EDSS score. In the combined ITT population there were less patients with sustained progression in the IVIG than in the placebo group ( P = 0.028). The difference was significant in PPMS ( P = 0.016), but not in SPMS patients. In the combined PP population, there was a trend for a favorable IVIG effect on the rates of patients with sustained progression. In patients with PPMS, this IVIG effect reached significance ( P = 0.036). Other secondary endpoints did not show significant differences between treatment groups. Eighteen patients with PPMS and 102 patients with SPMS withdrew from the study for various reasons. Treatment was generally well tolerated. It was concluded that monthly IVIG infusion could delay progression of disease in patients with PPMS, and that there was a trend in favour of IVIG treatment in patients with SPMS. Multiple Sclerosis 2007; 13: 1107—1117. http://msj.sagepub.com

scholarly journals Effects of Fatigue on Balance and Mobility in Subjects with Multiple Sclerosis: A Brief Report

2012 ◽  
Vol 2012 ◽  
pp. 1-4 ◽  
Author(s):  
Elisa Gervasoni ◽  
Davide Cattaneo ◽  
Angelo Montesano ◽  
Johanna Jonsdottir
Keyword(s):  
Multiple Sclerosis ◽  
Berg Balance Scale ◽  
Balance Performance ◽  
Before And After ◽  
Increase Risk ◽  
Risk Of Falls ◽  
Edss Score ◽  
The Difference ◽  
Dynamic Gait Index ◽  
Dynamic Gait

Purpose. People with Multiple Sclerosis (PwMS) tent to have increased levels of fatigue which can impact on their balance and increase risk of falls. However, the relationship between fatigue and balance is poorly understood. The aim of the present study was to assess if an experimentally induced fatigue had an immediate effect on balance. Methods. 37 inpatients with multiple sclerosis were recruited; the mean age (standard deviation) was 48.7 (9.6) years. The average onset of the pathology was 15.3 (9.8) years before the start of the study. The median (1°–3° quartile) Expanded Disability Status Scale (EDSS) score was 5.5 (4.5–6.0). Before and after a fatiguing treadmill, session, subjects were assessed with the Berg Balance Scale and Dynamic Gait Index. Results. After the treadmill, no statistically significant differences were found in balance before and after a treadmill session (monopodalic stance: before 5.3s (10.3) and after 7.7s (13.9); walk with horizontal head turns: before 11.6 (6.9) seconds and after 11.3 (7.7)). There was no correlation between the EDSS score and the difference in balance skills before and after treadmill. Conclusion. After treadmil PwMS were mentally and physically fatigued; however, their balance performance did not change, indicating no increase in risk of falling with fatigue.

Association of vitamin D metabolite levels with relapse rate and disability in multiple sclerosis

2008 ◽  
Vol 14 (9) ◽  
pp. 1220-1224 ◽  
Author(s):  
J Smolders ◽  
P Menheere ◽  
A Kessels ◽  
J Damoiseaux ◽  
R Hupperts
Keyword(s):  
Multiple Sclerosis ◽  
Vitamin D ◽  
Relapse Rate ◽  
Serum Levels ◽  
Cross Sectional Study ◽  
Vitamin D Supplementation ◽  
Biologically Active ◽  
Serum Samples ◽  
Cross Sectional ◽  
Edss Score

Background Multiple Sclerosis is associated with low serum levels of 25-hydroxyvitamin D (25(OH)D). We investigated the association between serum levels of 25(OH)D and 1,25-dihydroxyvitamin D (1,25(OH)2D), the biologically active metabolite, and clinical MS severity as expressed by EDSS-score and relapse rate. Study-design Cross-sectional study. Patients and Methods Serum samples from 267 MS patients were collected for 25(OH)D and 1,25(OH)2D measurement. Clinical MS parameters at the date of serum sampling were determined. Results: Both metabolite levels were significantly lower in the progressive forms compared to the relapsing remitting (RR)MS phenotype. In RRMS patients (disease course ≤ 5 years), high 25(OH)D levels were associated with a high chance of remaining relapse-free. Low 25(OH)D levels were associated with high EDSS-scores. 1,25(OH)2D was not directly associated with relapse rate or EDSS-score, and was dependent of age and 25(OH)D level. Conclusion Serum levels of 25(OH)D were associated with both relapse rate and disability in MS patients. These results are suggestive for a disease modulating effect of the serum concentrations of 25(OH)D on MS. The low circulating 1,25(OH)2D levels in progressive MS are due to older age and lower 25(OH)D levels. The potential consequences for vitamin D supplementation in MS will be discussed.

scholarly journals The Role of Postpartum Intravenous Corticosteroids in the Prevention of Relapses in Multiple Sclerosis

2011 ◽  
Vol 13 (2) ◽  
pp. 91-93 ◽  
Author(s):  
Jose Avila-Ornelas ◽  
Mirla Avila ◽  
Milena Stosic ◽  
Liliana Robles ◽  
Pilar Guillermo Prieto ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Retrospective Study ◽  
Relapse Rate ◽  
Women Of Childbearing Age ◽  
Childbearing Age ◽  
Intravenous Methylprednisolone ◽  
Secondary Progressive ◽  
Relapsing Remitting ◽  
The Difference

Multiple sclerosis (MS) is most prevalent in women of childbearing age. It is well established that the relapse rate decreases during pregnancy but increases significantly during the first postpartum trimester. The objective of this retrospective study was to evaluate the effectiveness of the administration of 1 g of intravenous methylprednisolone (IVMP) after delivery in the prevention of MS relapses. The study involved 47 women with one or more documented pregnancies; each pregnancy was treated as a separate case. There were 50 cases with relapsing-remitting MS and 2 with secondary progressive MS. The cases were divided into two groups: the IVMP group (those who received 1 g of IVMP after delivery) and the no-IVMP group (those who did not receive IVMP after delivery). There were 39 cases in the IVMP group and 13 in the no-IVMP group. During the first postpartum trimester, relapses occurred in 17.9% of the IVMP group, compared with 46.2% of the no-IVMP group (P = .0448). The difference in relapse percentage between the two groups during the second and third postpartum trimesters was not statistically significant. Our study shows a statistically significant benefit of postpartum IVMP administration in reducing MS relapses.

How similar are commonly combined criteria for EDSS progression in multiple sclerosis?

2006 ◽  
Vol 12 (6) ◽  
pp. 782-786 ◽  
Author(s):  
J J Kragt ◽  
J M Nielsen ◽  
F AH van der Linden ◽  
B MJ Uitdehaag ◽  
C H Polman
Keyword(s):  
Multiple Sclerosis ◽  
Neurological Impairment ◽  
Point Change ◽  
Perceived Disability ◽  
Number Of Patients ◽  
Sum Score ◽  
Disability Status ◽  
Edss Score ◽  
The Difference ◽  
Quantitative Scoring

Introduction Measuring disease progression is an important aspect of multiple sclerosis (MS) clinical trials. Commonly applied disability endpoints include time to clinically meaningful Expanded Disability Status Scale (EDSS) change, or the number of patients in whom such a change has occurred. Typically, clinically meaningful EDSS change has been defined as a change of 1.0 point on Kurtzke’s EDSS in patients with an entry EDSS score of 5.5 or lower, or 0.5 point in patients with a higher EDSS score. Our goal was to evaluate whether these changes can be considered as similar. Therefore, we compared EDSS changes to corresponding changes in the Guy’s Neurological Disability Scale (GNDS), which is a measure of patient perceived disability, and the Multiple Sclerosis Functional Composite (MSFC), which is an examination-based quantitative scoring of neurological impairment. Methods From a large longitudinal database, we selected two groups of patients with a clinically meaningful change in EDSS score according to the usual criteria: patients with EDSS change]/1.0 for baseline EDSS 5/5.5 and patients with EDSS change]/0.5 for baseline EDSS]/6.0. We compared changes in GNDS sum score and in MSFC score between both groups. Results In the group with baseline EDSS]/6.0, GNDS and MSFC changes were higher than in patients with baseline EDSS 5/5.5. The difference in change was 1.00 (95% confidence interval (CI): / 0.35 to 2.36) for the GNDS and 0.412 (95% CI: 0.300-0.525) for the MSFC. Conclusion Our results indicate that a 0.5 point EDSS change in patients with baseline EDSS / 6.0 cannot be considered equal to a 1.0 point change in patients with baseline EDSS 5/5.5.

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.

scholarly journals Factors Influencing the Degree of Disability in Patients With Multiple Sclerosis

2021 ◽  
Vol 12 ◽  
Author(s):  
Huiru Xue ◽  
Zhenzhen Yang ◽  
Li Wang ◽  
Yayun Jiang ◽  
Jiayang Li ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Drug Use ◽  
Univariate Analysis ◽  
Multivariate Logistic Regression Analysis ◽  
Clinical Intervention ◽  
Prognostic Evaluation ◽  
Factors Influencing ◽  
Degree Of Disability ◽  
Edss Score ◽  
The Difference

Objective: To explore the factors influencing the degree of disability in patients with multiple sclerosis (MS), and to provide evidence for its early diagnosis, prognostic evaluation and clinical intervention.Methods: This retrospective observational study included 72 patients with relapsing-remitting multiple sclerosis (RRMS) at the First Hospital of Shanxi Medical University. All patients completed craniocerebral and spinal cord MRI (with or without Gd enhancement) and were evaluated for Expanded Disability Status Score (EDSS) scores before receiving treatment.Results: Among 72 patients with RRMS, 45 (62.5%) had an EDSS score ≤3; A total of 27 patients (37.5%) had an EDSS score &gt;3 points. Univariate analysis showed that age, annual recurrence rate (ARR), drug use, albumin (ALB), triglycerides (TG), and total number of lesions in groups with EDSS score ≤3 were significantly different from those with an EDSS score &gt; 3 points (P &lt; 0.05). Multivariate logistic regression analysis showed that ALB, total number of lesions, and drug use were independent influencing factors of the degree of disability in patients with MS, and the difference was statistically significant (P &lt; 0.05). An ROC curve was constructed using ALB and the total number of lesions. The AUC of ALB was 0.681, P &lt; 0.05, and the best cut-off value was 44.2 g/L. Its sensitivity to predict the degree of disability in patients with multiple sclerosis was 85.2%, while its specificity was 51.1%. The AUC of the total number of lesions was 0.665 (P &lt; 0.05) and the best cut-off value was 5.5. Its sensitivity to predict the degree of disability in patients with multiple sclerosis was 70.4%, while its specificity was 64.4%. The AUC of the combined ALB, total number of lesions, and drug use was 0.795 (P &lt; 0.05), sensitivity was 77.8, and specificity was 73.3%. The optimal diagnostic cut-off value of the regression equation for the EDSS score of patients with multiple sclerosis was 0.420.Conclusion: Serum ALB, total number of lesions, and drug use in patients with multiple sclerosis were independent factors influencing the degree of disability. These findings provide clinical evidence for the prognostic evaluation and early intervention of patients with multiple sclerosis.

Relapse rates and enhancing lesions in a phase II trial of natalizumab in multiple sclerosis

2005 ◽  
Vol 11 (5) ◽  
pp. 568-572 ◽  
Author(s):  
Paul O'Connor ◽  
David Miller ◽  
Katherine Riester ◽  
Minhua Yang ◽  
Michael Panzara ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Phase Ii ◽  
Relapse Rate ◽  
Phase Ii Study ◽  
Treatment Phase ◽  
Inflammatory Cells ◽  
Lower Proportion ◽  
Phase Iii ◽  
Study Entry ◽  
The Difference

Background: Natalizumab, a humanized monoclonal IgG4 antibody, is an a4-integrin antagonist, which inhibits the migration of inflammatory cells into the central nervous system, a key pathogenic mechanism in multiple sclerosis (MS). In a six month, phase II clinical trial of patients with relapsing MS, natalizumab significantly reduced the formation of new gadolinium-enhanced (Gd +) lesions and the number of clinical relapses. Objective: To investigate the relationship of historical relapse rate and new Gd+ lesion number with subsequent MS disease activity and natalizumab treatment in the phase II study. Methods: Patients who participated in the phase II study were stratified into subgroups according to: (i) the number of relapses in the two years prior to entry into the study: 2 relapses (n=108), 3 relapses (n=57), and-3 relapses (n=48); (ii) the number of new Gd+ lesions at baseline (Month 0): 0 (n=129), 1-2(n=50), and >2(n=33). Relapses and new Gd+ lesions during the treatment phase of the trial were determined and compared for each subgroup. Results: Both the prestudy relapse rate and number of new Gd+ lesions at baseline were related to the subsequent risk of a relapse; baseline number of Gd+ lesions was related to the likelihood of subsequent new Gd+ lesion formation. There was a lower proportion of subjects with an on-study relapse and fewer new Gd+ lesions in all natalizumab-treated subgroups when compared with their placebo counterpart; the difference was most apparent in the subgroups of patients with >3 relapses in the two years prior to study entry and >2 new Gd+ lesions at Month 0. Conclusions: There was a lower proportion of subjects with an on-study relapse in natalizumab-treated patients, particularly in those with a more active disease at study entry. Larger ongoing phase III studies will allow more definitive investigation of these preliminary subgroup findings.

scholarly journals Kinematic Analysis of Lower Limb Joint Asymmetry during Gait in People with Multiple Sclerosis

Symmetry ◽  
2021 ◽  
Vol 13 (4) ◽  
pp. 598
Author(s):  
Massimiliano Pau ◽  
Bruno Leban ◽  
Michela Deidda ◽  
Federica Putzolu ◽  
Micaela Porta ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Lower Limb ◽  
Sagittal Plane ◽  
Cross Sectional Study ◽  
Camera Motion ◽  
Cross Sectional ◽  
Temporal Parameters ◽  
Wide Range ◽  
Edss Score ◽  
Spatio Temporal

The majority of people with Multiple Sclerosis (pwMS), report lower limb motor dysfunctions, which may relevantly affect postural control, gait and a wide range of activities of daily living. While it is quite common to observe a different impact of the disease on the two limbs (i.e., one of them is more affected), less clear are the effects of such asymmetry on gait performance. The present retrospective cross-sectional study aimed to characterize the magnitude of interlimb asymmetry in pwMS, particularly as regards the joint kinematics, using parameters derived from angle-angle diagrams. To this end, we analyzed gait patterns of 101 pwMS (55 women, 46 men, mean age 46.3, average Expanded Disability Status Scale (EDSS) score 3.5, range 1–6.5) and 81 unaffected individuals age- and sex-matched who underwent 3D computerized gait analysis carried out using an eight-camera motion capture system. Spatio-temporal parameters and kinematics in the sagittal plane at hip, knee and ankle joints were considered for the analysis. The angular trends of left and right sides were processed to build synchronized angle–angle diagrams (cyclograms) for each joint, and symmetry was assessed by computing several geometrical features such as area, orientation and Trend Symmetry. Based on cyclogram orientation and Trend Symmetry, the results show that pwMS exhibit significantly greater asymmetry in all three joints with respect to unaffected individuals. In particular, orientation values were as follows: 5.1 of pwMS vs. 1.6 of unaffected individuals at hip joint, 7.0 vs. 1.5 at knee and 6.4 vs. 3.0 at ankle (p < 0.001 in all cases), while for Trend Symmetry we obtained at hip 1.7 of pwMS vs. 0.3 of unaffected individuals, 4.2 vs. 0.5 at knee and 8.5 vs. 1.5 at ankle (p < 0.001 in all cases). Moreover, the same parameters were sensitive enough to discriminate individuals of different disability levels. With few exceptions, all the calculated symmetry parameters were found significantly correlated with the main spatio-temporal parameters of gait and the EDSS score. In particular, large correlations were detected between Trend Symmetry and gait speed (with rho values in the range of –0.58 to –0.63 depending on the considered joint, p < 0.001) and between Trend Symmetry and EDSS score (rho = 0.62 to 0.69, p < 0.001). Such results suggest not only that MS is associated with significantly marked interlimb asymmetry during gait but also that such asymmetry worsens as the disease progresses and that it has a relevant impact on gait performances.

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