Efficacy and safety of alemtuzumab treatment in a real-world cohort of patients with multiple sclerosis

Background: Evidence suggests that efficacy and safety of disease-modifying treatments for multiple sclerosis may differ with age. We evaluate efficacy and safety of teriflunomide across age subgroups of patients from pooled clinical trials and real-world studies. Methods: Post hoc analyses of patients who received teriflunomide 14 mg in the pooled phase II and III TEMSO, TOWER, TENERE, and TOPIC core and extension studies (n = 1978), and the real-world Teri-PRO (n = 928) and TAURUS-MS I (n = 1126) studies were conducted. Data were stratified by age at study entry: ⩽25, >25 to ⩽35, >35 to ⩽45, and >45 years. In Teri-PRO and TAURUS-MS I, an additional group, >55 years, was assessed. Results: In the pooled core studies, teriflunomide reduced annualized relapse rate (ARR) versus placebo across all ages. Unadjusted ARRs remained low across age groups in pooled extensions (0.18-0.30), Teri-PRO (0.10-0.35), and TAURUS-MS I (0.14-0.35). Baseline Expanded Disability Status Scale scores were higher with age, but stable through core and extension studies (mean increases over 7 years: ⩽25 years, +0.59; >25 to ⩽35 years, +0.46; >35 to ⩽45 years, +0.35; >45 years, +0.81). Across age groups, adverse event (AE) incidences were 78.4% to 90.7% in pooled core and extension studies and Teri-PRO, and 29.2% to 37.7% in TAURUS-MS I; serious AE incidences were ⩽21.3% in all studies. In pooled phase III and Teri-PRO studies, lymphocyte count decreases over 1 year after initiating teriflunomide, and proportions of patients developing lymphopenia, were small across age groups. Conclusions: Teriflunomide efficacy was demonstrated regardless of age. Safety was generally consistent across age groups.

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Real-world Fingolimod Efficacy and Safety in Emirati Patients with Multiple Sclerosis

Multiple Sclerosis and Related Disorders ◽

10.1016/j.msard.2018.10.085 ◽

2018 ◽

Vol 26 ◽

pp. 257-258

Author(s):

A. Ceccarelli ◽

R.Y.G. Elhennawy ◽

V.A. Mifsud ◽

B. Benedetti ◽

S.I. Hussain ◽

...

Keyword(s):

Multiple Sclerosis ◽

Real World ◽

Efficacy And Safety

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Short term real-world Fingolimod efficacy and safety in Emirati patients with multiple sclerosis

Journal of Clinical Neuroscience ◽

10.1016/j.jocn.2019.11.010 ◽

2020 ◽

Vol 71 ◽

pp. 39-42 ◽

Cited By ~ 1

Author(s):

Antonia Ceccarelli ◽

Victoria Mifsud ◽

Eslam Abusamra ◽

Syed Irteza Hussain

Keyword(s):

Multiple Sclerosis ◽

Real World ◽

Efficacy And Safety ◽

Short Term

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Real-World Effectiveness of Natalizumab in Korean Patients With Multiple Sclerosis

Frontiers in Neurology ◽

10.3389/fneur.2021.714941 ◽

2021 ◽

Vol 12 ◽

Author(s):

Ki Hoon Kim ◽

Su-Hyun Kim ◽

Na Young Park ◽

Jae-Won Hyun ◽

Ho Jin Kim

Keyword(s):

Multiple Sclerosis ◽

Adverse Events ◽

Real World ◽

Brain Magnetic Resonance Imaging ◽

Clinical Relapse ◽

Efficacy And Safety ◽

Serious Adverse Events ◽

Korean Patients ◽

Relapsing Remitting ◽

The Mean

Background and Purpose: Natalizumab is a highly efficacious disease-modifying therapy for relapsing-remitting multiple sclerosis (MS). Data on the efficacy and safety profile of natalizumab in Asian patients with MS are limited. This study assessed the efficacy and safety of natalizumab in Korean patients with MS in a real-world setting.Methods: This study enrolled consecutive Korean patients with active relapsing-remitting MS who were treated with natalizumab for at least 6 months between 2015 and 2021. To evaluate the therapeutic outcome of natalizumab, we used the Expanded Disability Status Scale (EDSS) scores and brain magnetic resonance imaging; adverse events were assessed at regular intervals. No evidence of disease activity (NEDA) was defined as no clinical relapse, no worsening of EDSS score, and no radiological activities.Results: Fourteen subjects with MS were included in the study. The mean age at initiation of natalizumab therapy was 32 years. All patients were positive for anti-John Cunningham virus antibodies before natalizumab administration. The mean annual relapse rate was markedly reduced from 2.7 ± 3.2 before natalizumab therapy to 0.1 ± 0.4 during natalizumab therapy (p = 0.001). Disability was either improved or stabilized after natalizumab treatment in 13 patients (93%). During the 1st year and 2 years after initiating natalizumab, NEDA-3 was achieved in 11/12 (92%) and 9/11 (82%) patients, respectively. No progressive multifocal leukoencephalopathy or other serious adverse events leading to the discontinuation of natalizumab were observed.Conclusions: Natalizumab therapy showed high efficacy in treating Korean patients with active MS, without unexpected safety problems.

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Safety and efficacy of direct acting oral anticoagulants and vitamin K antagonists in nonvalvular atrial fibrillation – a network meta-analysis of real-world data

VASA ◽

10.1024/0301-1526/a000746 ◽

2019 ◽

Vol 48 (2) ◽

pp. 134-147 ◽

Cited By ~ 8

Author(s):

Mirko Hirschl ◽

Michael Kundi

Keyword(s):

Real World ◽

Meta Analysis ◽

Vitamin K Antagonists ◽

Oral Anticoagulants ◽

Efficacy And Safety ◽

Nonvalvular Atrial Fibrillation ◽

Real World Data ◽

Hazard Ratios ◽

Direct Acting ◽

Event Rates

Abstract. Background: In randomized controlled trials (RCTs) direct acting oral anticoagulants (DOACs) showed a superior risk-benefit profile in comparison to vitamin K antagonists (VKAs) for patients with nonvalvular atrial fibrillation. Patients enrolled in such studies do not necessarily reflect the whole target population treated in real-world practice. Materials and methods: By a systematic literature search, 88 studies including 3,351,628 patients providing over 2.9 million patient-years of follow-up were identified. Hazard ratios and event-rates for the main efficacy and safety outcomes were extracted and the results for DOACs and VKAs combined by network meta-analysis. In addition, meta-regression was performed to identify factors responsible for heterogeneity across studies. Results: For stroke and systemic embolism as well as for major bleeding and intracranial bleeding real-world studies gave virtually the same result as RCTs with higher efficacy and lower major bleeding risk (for dabigatran and apixaban) and lower risk of intracranial bleeding (all DOACs) compared to VKAs. Results for gastrointestinal bleeding were consistently better for DOACs and hazard ratios of myocardial infarction were significantly lower in real-world for dabigatran and apixaban compared to RCTs. By a ranking analysis we found that apixaban is the safest anticoagulant drug, while rivaroxaban closely followed by dabigatran are the most efficacious. Risk of bias and heterogeneity was assessed and had little impact on the overall results. Analysis of effect modification could guide the clinical decision as no single DOAC was superior/inferior to the others under all conditions. Conclusions: DOACs were at least as efficacious as VKAs. In terms of safety endpoints, DOACs performed better under real-world conditions than in RCTs. The current real-world data showed that differences in efficacy and safety, despite generally low event rates, exist between DOACs. Knowledge about these differences in performance can contribute to a more personalized medicine.

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