Comparison of 24 month changes in brain volume among long term users of fingolimod versus glatiramer acetate in patients with multiple sclerosis

2018 ◽  
Author(s):  
Justin Honce
Keyword(s):  
Multiple Sclerosis ◽  
Glatiramer Acetate ◽  
Brain Volume

scholarly journals Brain Atrophy Rates for Stable Multiple Sclerosis Patients on Long-Term Fingolimod versus Glatiramer Acetate

2020 ◽  
Vol 11 ◽  
Author(s):  
Justin M. Honce ◽  
Kavita V. Nair ◽  
Brian D. Hoyt ◽  
Rebecca A. Seale ◽  
Stefan Sillau ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Glatiramer Acetate ◽  
Brain Atrophy ◽  
Multiple Sclerosis Patients

scholarly journals Long-term efficacy and safety of three times weekly dosing regimen of glatiramer acetate in relapsing multiple sclerosis patients: Seven-year results of the Glatiramer Acetate Low-frequency Administration (GALA) open-label extension study

2021 ◽  
Vol 7 (4) ◽  
pp. 205521732110615
Author(s):  
Peter Rieckmann ◽  
Robert Zivadinov ◽  
Alexey Boyko ◽  
Krzysztof Selmaj ◽  
Jessica K. Alexander ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Glatiramer Acetate ◽  
Low Frequency ◽  
Exposure Period ◽  
Similar Efficacy ◽  
Open Label ◽  
Open Label Extension ◽  
Multiple Sclerosis Patients ◽  
Relapsing Multiple Sclerosis

Objective Describe the long-term outcomes of early-start (ES) and delayed-start (DS) glatiramer acetate 40 mg/mL treatment three times weekly (GA40) for up to seven years in the Glatiramer Acetate Low-frequency Administration (GALA) study in patients with relapsing multiple sclerosis (RMS). Methods Patients were evaluated every three to six months. The primary efficacy endpoint was annualized relapse rate (ARR); additional endpoints were exploratory or post hoc. For efficacy, data from the entire exposure period were used for the ES and DS cohorts. For safety, exposure only under GA40 was considered. Results Of the patients who continued into the open-label extension (OLE), 580/834 (70%) ES and 261/419 (62%) DS completed the OLE. For the entire placebo-controlled and OLE study period, ARR was 0.26 for ES and 0.31 for DS patients (risk ratio = 0.83; 95% confidence interval [CI]: 0.70–0.99). ES prolonged median time to first relapse versus DS (4.9 versus 4.3 years; hazard ratio = 0.82; 95% CI: 0.6–0.96). OLE-only results showed DS patients experienced similar efficacy for relapse and disability outcomes as ES patients. Adverse events were consistent with the well-established GA safety profile. Conclusions GA40 treatment conferred clinical benefit up to seven years, resulting in sustained efficacy and was generally well tolerated in RMS patients.

Long-term follow-up for multiple sclerosis patients initially treated with interferon-beta and glatiramer acetate

2018 ◽  
Vol 394 ◽  
pp. 127-131 ◽  
Author(s):  
Brian C. Healy ◽  
Bonnie I. Glanz ◽  
Jonathan D. Zurawski ◽  
Maria Mazzola ◽  
Tanuja Chitnis ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Glatiramer Acetate ◽  
Interferon Beta ◽  
Long Term Follow Up ◽  
Multiple Sclerosis Patients

scholarly journals Prognostic factors for long-term outcomes in relapsing–remitting multiple sclerosis

2016 ◽  
Vol 2 ◽  
pp. 205521731666640 ◽  
Author(s):  
Anthony L Traboulsee ◽  
Peter Cornelisseª ◽  
Magnhild Sandberg-Wollheim ◽  
Bernard MJ Uitdehaag ◽  
Ludwig Kappos ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Prognostic Factors ◽  
Regression Models ◽  
Brain Volume ◽  
Univariate Analysis ◽  
Medication Possession Ratio ◽  
Stepwise Multiple Regression ◽  
Long Term Outcomes ◽  
Edss Score

Objective The objective of this article is to investigate potential clinical and MRI predictors of long-term outcomes in multiple sclerosis (MS). Methods This was a post hoc analysis using data from all 382 patients in the PRISMS long-term follow-up (LTFU) study collected up to eight years after randomisation. An additional analysis was performed including only those patients originally randomised to receive early subcutaneous interferon (IFN) β-1a ( n = 259). Baseline/prestudy variables, indicators of early clinical and MRI activity (baseline to month 24), and indicators of IFN β-1a treatment exposure (including medication possession ratio (MPR)) were investigated as candidate prognostic factors for outcomes measured from baseline and from month 24 to LTFU. Explanatory variables identified from univariate regression models ( p ≤ 0.15) were selected for inclusion in stepwise multiple regression models. Results Candidate prognostic factors selected by the univariate analysis ( p ≤ 0.15) included age, MS duration, baseline brain volume, EDSS score, and log(T2 burden of disease (BOD)). In most of the multivariate regression models applied, higher baseline brain volume and MPR predicted better long-term clinical outcomes, while higher baseline and greater early increase in EDSS score predicted worse outcomes. Conclusion Identification of markers that may be prognostic for long-term disability could help identify MS patients at higher risk of disability progression.

Long-term (up to 22 years), open-label, compassionate-use study of glatiramer acetate in relapsing—remitting multiple sclerosis

2008 ◽  
Vol 14 (4) ◽  
pp. 494-499 ◽  
Author(s):  
Aaron Miller ◽  
Vincent Spada ◽  
Dorothy Beerkircher ◽  
Rivka Riven Kreitman
Keyword(s):  
Multiple Sclerosis ◽  
Adverse Events ◽  
Glatiramer Acetate ◽  
Open Label ◽  
Disability Status ◽  
Relapsing Remitting ◽  
Remitting Multiple Sclerosis ◽  
Relapsing Remitting Multiple Sclerosis ◽  
Pretreatment Score

To evaluate the safety and efficacy of long-term glatiramer acetate (GA) therapy, 46 patients with relapsing—remitting multiple sclerosis (RRMS) were treated for up to 22 years in an ongoing, open-label study. Kurtzke expanded disability status scale (EDSS) was measured every six months, relapses were reported at occurrence and patients self-reported adverse events (AEs). At GA initiation, disease durations ranged from 0—20 years (median 6.0 years) and at data cut-off (October 2004), GA therapy duration ranged from 1—22 years (median 12.0 years). Mean EDSS score increased 0.9 ± 1.9 from the pretreatment score (3.0 ± 1.8; P = 0.076). Only 10/28 (36%) patients with baseline EDSS <4.0 had a last observed value ≥ 4.0 and 8/34 (24%) with entry EDSS < 6.0 reached EDSS ≥ 6.0. A majority (57%) maintained improved or unchanged EDSS scores. Annualized relapse rate decreased to 0.1 ± 0.2 from 2.9 ± 1.4 prestudy ( P < 0.0001). Of the 18 remaining patients in October 2004 (average disease duration 23 years), 17% with baseline EDSS scores < 4.0 reached EDSS ≥ 4.0 and 28% with baseline scores < 6.0 reached EDSS ≥ 6.0. Adverse events were similar to those reported in short-term clinical trials. This study shows a low rate of relapses and EDSS progression in RRMS patients on GA for up to 22 years. Multiple Sclerosis 2008; 14: 494—499. http://msj.sagepub.com

Glatiramer acetate antibodies, gene expression and disease activity in multiple sclerosis

2011 ◽  
Vol 18 (3) ◽  
pp. 305-313 ◽  
Author(s):  
F Sellebjerg ◽  
CJ Hedegaard ◽  
M Krakauer ◽  
D Hesse ◽  
H Lund ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Transcription Factors ◽  
Disease Activity ◽  
Glatiramer Acetate ◽  
Immunological Response ◽  
Term Treatment ◽  
Pcr Analysis ◽  
Enhanced Mri ◽  
Long Term Treatment

Background: Glatiramer acetate (GA) treatment suppresses disease activity in multiple sclerosis (MS). The immunological response to treatment may differ in patients who are stable on GA therapy and patients with breakthrough disease activity, but the results of previous studies are inconsistent. Objectives: We studied the immunological response to GA and its relationship with disease activity. Methods: Anti-GA antibodies in plasma and the expression of genes encoding cytokines and T-cell-polarizing transcription factors in blood cells were analysed by flow cytometric bead array and polymerase chain reaction (PCR) analysis in 39 untreated and 29 GA-treated relapsing–remitting MS patients. Definition of breakthrough disease was based on the occurrence of relapses, disability progression, or gadolinium (Gd)-enhanced MRI. Results: The expression of T helper type 1 (Th1) and Th17 cytokines and transcription factors was reduced during long-term treatment, but there was no relationship between the expression of cytokines and transcription factors and anti-GA antibodies. High expression of mRNA encoding GATA3 and lymphotoxin-β (LT-β) was associated with low disease activity in Gd-enhanced MRI studies. None of the variables studied were associated with clinical disease activity. GA treatment resulted in the development of IgG and IgG4 anti-GA antibodies during the first months of treatment, persisting during long-term treatment. Conclusions: The observed relationship between the expression of mRNA encoding GATA3 and LT-β expression and MRI disease activity deserves further analysis in future studies. The development of anti-GA antibodies was observed in all patients treated with GA, but this was not related with measures of cellular immunity, clinical or MRI disease activity.

scholarly journals Long-term follow-up of a randomized study of combination interferon and glatiramer acetate in multiple sclerosis: Efficacy and safety results up to 7 years

2017 ◽  
Vol 18 ◽  
pp. 95-102 ◽  
Author(s):  
Fred D. Lublin ◽  
Stacey S. Cofield ◽  
Gary R. Cutter ◽  
Tarah Gustafson ◽  
Stephen Krieger ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Glatiramer Acetate ◽  
Randomized Study ◽  
Efficacy And Safety ◽  
Long Term Follow Up
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