scholarly journals Natalizumab in Early Relapsing-Remitting Multiple Sclerosis: A 4-Year, Open-Label Study

2021 ◽  
Author(s):  
Jai Perumal ◽  
Roumen Balabanov ◽  
Ray Su ◽  
Roger Chang ◽  
Laura Balcer ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Open Label ◽  
Open Label Study ◽  
Label Study ◽  
Relapsing Remitting ◽  
Remitting Multiple Sclerosis ◽  
Relapsing Remitting Multiple Sclerosis

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

scholarly journals A standardised frankincense extract reduces disease activity in relapsing-remitting multiple sclerosis (the SABA phase IIa trial)

2017 ◽  
Vol 89 (4) ◽  
pp. 330-338 ◽  
Author(s):  
Klarissa Hanja Stürner ◽  
Jan-Patrick Stellmann ◽  
Jan Dörr ◽  
Friedemann Paul ◽  
Tim Friede ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Disease Activity ◽  
Treatment Period ◽  
Gastrointestinal Symptoms ◽  
Study Drug ◽  
Open Label ◽  
Clinical Trial Registration ◽  
Relapsing Remitting ◽  
Remitting Multiple Sclerosis ◽  
Relapsing Remitting Multiple Sclerosis

ObjectiveTo investigate whether oral administration of a standardised frankincense extract (SFE) is safe and reduces disease activity in patients with relapsing-remitting multiple sclerosis (RRMS).MethodsWe performed an investigator-initiated, bicentric phase IIa, open-label, baseline-to-treatment pilot study with an oral SFE in patients with RRMS (NCT01450124). After a 4-month baseline observation phase, patients were treated for 8 months with an option to extend treatment for up to 36 months. The primary outcome measures were the number and volume of contrast-enhancing lesions (CEL) measured in MRI during the 4-month treatment period compared with the 4-month baseline period. Eighty patients were screened at two centres, 38 patients were included in the trial, 28 completed the 8-month treatment period and 18 of these participated in the extension period.ResultsThe SFE significantly reduced the median number of monthly CELs from 1.00 (IQR 0.75–3.38) to 0.50 (IQR 0.00–1.13; difference −0.625, 95% CI −1.25 to −0.50; P<0.0001) at months 5–8. We observed significantly less brain atrophy as assessed by parenchymal brain volume change (P=0.0081). Adverse events were generally mild (57.7%) or moderate (38.6%) and comprised mainly gastrointestinal symptoms and minor infections. Mechanistic studies showed a significant increase in regulatory CD4+ T cell markers and a significant decrease in interleukin-17A-producing CD8+ T cells indicating a distinct mechanism of action of the study drug.InterpretationThe oral SFE was safe, tolerated well and exhibited beneficial effects on RRMS disease activity warranting further investigation in a controlled phase IIb or III trial.Clinical trial registrationNCT01450124; Results.

Glatiramer acetate (Copaxone): comparison of continuous versus delayed therapy in a six-year organized multiple sclerosis trial

2003 ◽  
Vol 9 (6) ◽  
pp. 585-591 ◽  
Author(s):  
K P Johnson ◽  
B R Brooks ◽  
C C Ford ◽  
A D Goodman ◽  
R P Lisak ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Glatiramer Acetate ◽  
Open Label ◽  
Open Label Study ◽  
Label Study ◽  
Neurological Improvement ◽  
Disability Status ◽  
Relapsing Remitting ◽  
Neurologic Disability

The aim of this study was to assess the long-term safety and efficacy of glatiramer acetate (GA) for patients with multiple sclerosis (MS) who received active treatment versus those on placebo for approximately 30 months (24-35 months) before receiving GA during a six-year organized, prospective open label study. Entry required two relapses in the previous two years and an Expanded Disability Status Scale (EDSS) score of 0-5. Patients (251) were equally randomized to daily subcutaneous G A, 20 mg, or to placebo. A fter approximately 30 months, 208 patients continued in an open label study: 101 continued on G A and 107 switched from placebo to active drug. Groups were well matched at randomization and entry to the open label study. Patients always on G A showed a steady decline in relapses: a mean of 1.5 per year at entry, a mean of 0.42 over the entire six years (95% C I=0.34-0.51), a 72% reductio n (P =0.0001). They averaged a relapse every four+ years (yearly rate 0.23 in year six) and 26/101 remain relapse free. Patients did less well if on placebo for 30 months, but relapses then declined, and by year six the rates were similar. O f patients always on GA, 69% showed neurological improvement of > 1 EDSS steps or remained stable compared with 57% if G A treatment was delayed. O f relapse-free patients always on G A over six years, only three of 26 (11%) were worse by]-1 EDSS steps, whereas nine of 21 (43%) in the placebo/active group were worse (P B-0.03). Disability, measured every six months, showed that the group of patients always on G A was relatively stable over the six years, while the group who received placebo for the first two-and-a-half years did significantly less well. Daily injections of GA were well tolerated. This longest ever organized MS treatment trial shows that delaying therapy with GA increases the risk of neurologic disability, reinforcing the rationale for using G A as a first-line treatment early in the course of relapsing-remitting MS.

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