Peginterferon beta-1a reduces the number of black holes evolved from acute MRI lesions in newly diagnosed patients with relapsing-remitting multiple sclerosis: A post hoc analysis ADVANCE

2019 ◽  
Vol 175 ◽  
pp. S96
Author(s):  
Douglas Arnold ◽  
Oksana Mokliatchouk ◽  
Maria L. Naylor
Keyword(s):  
Multiple Sclerosis ◽  
Black Holes ◽  
Newly Diagnosed ◽  
Post Hoc Analysis ◽  
Relapsing Remitting ◽  
Remitting Multiple Sclerosis ◽  
Post Hoc ◽  
Relapsing Remitting Multiple Sclerosis

scholarly journals Efficacy and safety of delayed-release dimethyl fumarate in patients newly diagnosed with relapsing–remitting multiple sclerosis (RRMS)

2014 ◽  
Vol 21 (1) ◽  
pp. 57-66 ◽  
Author(s):  
Ralf Gold ◽  
Gavin Giovannoni ◽  
J Theodore Phillips ◽  
Robert J Fox ◽  
Annie Zhang ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Dimethyl Fumarate ◽  
Newly Diagnosed ◽  
Efficacy And Safety ◽  
Delayed Release ◽  
Disease Modifying Therapy ◽  
Relapsing Remitting ◽  
Remitting Multiple Sclerosis ◽  
Post Hoc ◽  
Relapsing Remitting Multiple Sclerosis

Background: Delayed-release dimethyl fumarate (DMF) demonstrated efficacy and safety in the Phase 3 DEFINE and CONFIRM trials. Objective: To evaluate delayed-release DMF in newly diagnosed relapsing–remitting multiple sclerosis (RRMS) patients, in a post-hoc analysis of integrated data from DEFINE and CONFIRM. Methods: Patients included in the analysis were diagnosed with RRMS within 1 year prior to study entry and naive to MS disease-modifying therapy. Results: The newly diagnosed population comprised 678 patients treated with placebo ( n = 223) or delayed-release DMF 240 mg BID ( n = 221) or TID ( n = 234). At 2 years, delayed-release DMF BID and TID reduced the annualized relapse rate by 56% and 60% (both p < 0.0001), risk of relapse by 54% and 57% (both p < 0.0001), and risk of 12-week confirmed disability progression by 71% ( p < 0.0001) and 47% ( p = 0.0085) versus placebo. In a subset of patients (MRI cohort), delayed-release DMF BID and TID reduced the mean number of new or enlarging T2-hyperintense lesions by 80% and 81%, gadolinium-enhancing lesion activity by 92% and 92%, and mean number of new non-enhancing T1-hypointense lesions by 68% and 70% (all p < 0.0001 versus placebo). Flushing and gastrointestinal events were associated with delayed-release DMF. Conclusion: Delayed-release DMF improved clinical and neuroradiological outcomes relative to placebo in newly diagnosed RRMS patients.

scholarly journals Analysis of frequency and severity of relapses in multiple sclerosis patients treated with cladribine tablets or placebo: The CLARITY and CLARITY Extension studies

2021 ◽  
pp. 135245852110102
Author(s):  
Nicola De Stefano ◽  
Maria Pia Sormani ◽  
Gavin Giovannoni ◽  
Kottil Rammohan ◽  
Thomas Leist ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Lower Risk ◽  
Steroid Treatment ◽  
Post Hoc Analysis ◽  
Relapsing Remitting ◽  
Remitting Multiple Sclerosis ◽  
Multiple Sclerosis Patients ◽  
Post Hoc ◽  
Relapsing Remitting Multiple Sclerosis ◽  
Multiple Sclerosis Treatment

Background: In the CLARITY (CLAdRIbine Tablets treating multiple sclerosis orallY) study of patients with relapsing-remitting multiple sclerosis, treatment with cladribine tablets 3.5 mg/kg (CladT) significantly reduced the annualised relapse rate (ARR) versus placebo; this effect was sustained in CLARITY Extension, without further treatment. Objective: To assess the frequency and severity of relapses in patients treated with CladT versus placebo in CLARITY over 2 years and evaluate the durability of effect in patients who received no further treatment for 2 years in CLARITY Extension. Methods: In this post hoc analysis, ARRs were calculated for qualifying and all relapses, and qualifying and all severe relapses (i.e. requiring steroid treatment or leading to hospitalisation) in patients treated with CladT ( n = 433) and placebo ( n = 437) in CLARITY, and those from the CladT group who received placebo in CLARITY Extension ( n = 98). Results: At Month 6, Year 1 and Year 2, patients receiving CladT had a significantly lower risk of qualifying or all relapses (all p < 0.0001), and qualifying or all severe relapses (all p < 0.005), compared with placebo. This effect was sustained in CLARITY Extension without further treatment. Conclusion: The results show durable efficacy of cladribine tablets 3.5 mg/kg for reducing frequency and severity of relapses in patients with relapsing-remitting multiple sclerosis. CLARITY: NCT00213135; CLARITY Extension: NCT00641537

scholarly journals Efficacy of alemtuzumab over 6 years in relapsing–remitting multiple sclerosis patients who relapsed between courses 1 and 2: Post hoc analysis of the CARE-MS studies

2019 ◽  
Vol 26 (13) ◽  
pp. 1719-1728 ◽  
Author(s):  
Bart Van Wijmeersch ◽  
Barry A Singer ◽  
Aaron Boster ◽  
Simon Broadley ◽  
Óscar Fernández ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Post Hoc Analysis ◽  
Brain Volume Loss ◽  
Disability Status ◽  
Relapsing Remitting ◽  
Remitting Multiple Sclerosis ◽  
Magnetic Resonance Imaging Mri ◽  
Multiple Sclerosis Patients ◽  
Post Hoc ◽  
Relapsing Remitting Multiple Sclerosis

Background: Alemtuzumab is administered as two annual courses for relapsing–remitting multiple sclerosis (MS). Patients may relapse before completing the two-course regimen. Objective: The objective was to evaluate 6-year outcomes in patients who relapsed between alemtuzumab Courses 1 and 2 (early relapsers). Methods: Post hoc analysis of patients from the Comparison of Alemtuzumab and Rebif® Efficacy in Multiple Sclerosis (CARE-MS) studies who enrolled in the extension. Results: Early relapsers (CARE-MS I: 15%; CARE-MS II: 24%) had more relapses in 1–2 years pre-alemtuzumab and higher mean baseline Expanded Disability Status Scale score than patients without relapse. Their annualized relapse rate declined from Year 1 (CARE-MS I: 1.3; CARE-MS II: 1.2) to Year 2 following Course 2 (0.3; 0.5) and remained low thereafter. Over 6 years, 60% remained free of 6-month confirmed disability worsening; 24% (CARE-MS I) and 34% (CARE-MS II) achieved 6-month confirmed disability improvement. During Year 6, 69% (CARE-MS I) and 68% (CARE-MS II) were free of magnetic resonance imaging (MRI) disease activity. Median percent yearly brain volume loss (Year 1: −0.67% (CARE-MS I); −0.47% (CARE-MS II)) declined after Course 2 (Year 6: −0.24%; −0.13%). Conclusion: Early relapsers’ outcomes improved after completing the second alemtuzumab course. These findings support administering the approved two-course regimen to maximize clinical benefit. ClinicalTrials.gov registration numbers: CARE-MS I, II, extension: NCT00530348, NCT00548405, NCT00930553.

scholarly journals Subcutaneous interferon β-1a three times weekly and the natural evolution of gadolinium-enhancing lesions into chronic black holes in relapsing and progressive multiple sclerosis: Analysis of PRISMS and SPECTRIMS trials

2017 ◽  
Vol 3 (4) ◽  
pp. 205521731774534
Author(s):  
A Traboulsee ◽  
DKB Li ◽  
R Tam ◽  
G Zhao ◽  
A Riddehough ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Black Holes ◽  
Progressive Multiple Sclerosis ◽  
Repair Capacity ◽  
Relapsing Remitting ◽  
Mri Scans ◽  
History Of ◽  
Lesion Level ◽  
Post Hoc ◽  
Relapsing Remitting Multiple Sclerosis

Background Evolution of gadolinium-enhancing lesions into chronic black holes (CBH) may be reduced by interferon (IFN) therapy. Objective The objective of this paper is to assess the effect of IFN β-1a and placebo on CBH evolution and disability in patients with relapsing–remitting multiple sclerosis (RRMS), as well as CBH evolution in patients with secondary progressive multiple sclerosis (SPMS). Methods A post hoc, exploratory analysis of patients with RRMS and SPMS with monthly MRI scans (months –1 to 9) from two separate placebo-controlled clinical trials of IFN β-1a was conducted. Results In RRMS patients, the risk of ≥1 evolved CBH was lower for IFN β-1a versus placebo (odds ratio 0.42; p = 0.024); volume of newly evolved CBH was numerically reduced. A numerically higher proportion of patients with ≥1 evolving CBH vs no evolving CBH had confirmed three-month disability progression (four-year rate 55.8% vs 43.1%, respectively). Proportion of lesions evolving into CBH (patient level: 34.7% vs 12.6%, p < 0.0001; lesion level: 28.8% vs 11.0%, p < 0.0001) and evolved CBH volume (median 33.5 mm3 (Quartile 1, 0.0; Quartile 3, 173.4) vs 0.0 mm3 (0.0; 52.4); p = 0.0008) was higher for SPMS than RRMS patients treated with IFN β-1a. Conclusion In RRMS, IFN β-1a significantly decreased the proportion of new T1 Gd+ lesions evolving into CBH and the risk of developing a CBH. In patients with SPMS, more lesions develop to CBH, indicating reduced repair capacity, and the natural history of lesion development appears to be unaffected by IFN β-1a treatment.

Rapid benefits of a new formulation of subcutaneous interferon beta-1a in relapsing—remitting multiple sclerosis

2010 ◽  
Vol 16 (7) ◽  
pp. 888-892 ◽  
Author(s):  
Nicola De Stefano ◽  
François Curtin ◽  
Bettina Stubinski ◽  
Gregg Blevins ◽  
Jelena Drulovic ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Brain Mri ◽  
Cumulative Number ◽  
Beneficial Effects ◽  
Relapsing Remitting ◽  
The Mean ◽  
Remitting Multiple Sclerosis ◽  
New Formulation ◽  
Post Hoc ◽  
Relapsing Remitting Multiple Sclerosis

This study evaluated the efficacy of a new formulation of subcutaneous (sc) interferon (IFN)-β1a in relapsing—remitting multiple sclerosis (RRMS). Patients ( n = 180) were randomized (2 : 1) to IFN-β1a or placebo for 16 weeks; all patients then received IFN-β1a for 24 weeks. Monthly brain MRI was performed. At week 16, the mean number of combined unique active (CUA) lesions was lower with IFN-β1a than with placebo ( p < 0.001; 69% fewer lesions). The mean cumulative number of CUA lesions was already lower with IFN-β1a by week 4 (post hoc analysis; p = 0.015). The new formulation of sc IFN-β1a has rapid beneficial effects on MRI outcomes in RRMS.

Subclinical cochlear dysfunction in newly diagnosed relapsing-remitting multiple sclerosis

2019 ◽  
Vol 33 ◽  
pp. 55-60 ◽  
Author(s):  
Roberta Di Mauro ◽  
Stefano Di Girolamo ◽  
Massimo Ralli ◽  
Marco de Vincentiis ◽  
Nicola Mercuri ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Newly Diagnosed ◽  
Relapsing Remitting ◽  
Remitting Multiple Sclerosis ◽  
Relapsing Remitting Multiple Sclerosis ◽  
Cochlear Dysfunction
Sign in / Sign up

Export Citation Format

Share Document