Background: Alemtuzumab is a disease-modifying therapy for highly active relapsing-remitting multiple sclerosis (RRMS). Sustained efficacy up to 9 years was observed in the phase IIIb/IV open-label TOPAZ clinical trial and assessed in the real-world retrospective and prospective study, TREAT-MS.
Objectives: To examine long-term efficacy and safety of alemtuzumab in participants with multiple sclerosis (MS) and highly active disease (HAD) by combining up to 13 years of TOPAZ data and TREAT-MS interim data.
Design: TOPAZ: Randomized participants completing core CARE-MS I and II could receive additional alemtuzumab (12 mg/day, 3 consecutive days; ⩾12 months apart) for 11-13 years after initiating treatment. TREAT-MS: Participants from German MS clinics were observed for 4 years after last alemtuzumab treatment phase.
Methods: Efficacy outcomes (annualized relapse rate (ARR), change in Expanded Disability Status Scale (EDSS), 6-month confirmed disability worsening/improvement, magnetic resonance imaging), and adverse events (AEs) were examined. Primary HAD definition (⩾2 relapses in the year prior to baseline and ⩾1 gadolinium-enhancing lesion at baseline), and two alternative HAD definitions were assessed.
Results: More participants from CARE-MS I (28%) and II (24%) met primary HAD criteria than TREAT-MS (~14%). Mean ARR for alemtuzumab-treated HAD participants was significantly reduced in CARE-MS I and II (0.14 and 0.15, respectively, Years 3-13) and in TREAT-MS (0.24, 2 years). Stable/improved EDSS scores were achieved by 74% of HAD participants in CARE-MS I, 67% in CARE-MS II (both Year 11), and 79% in TREAT-MS (Year 3.6), with 6-month CDI achieved by about half at Year 11 (CARE-MS I, II). Annual treatment-emergent AE incidences declined in TOPAZ and were lower in TREAT-MS.
Conclusion: Sustained efficacy of alemtuzumab was observed for clinical and radiological outcomes in participants with HAD in the TOPAZ clinical trial and real-world TREAT-MS study with no new safety signals.
Trial Registration: ClinicalTrials.gov (CARE-MS I, NCT00530348; CARE-MS II, NCT00548405; CARE-MS Extension Study, NCT00930553; TOPAZ, NCT02255656). Paul-Ehrlich-Institut (TREAT-MS, NIS 281).
Download full-text PDF |
Source |
|---|---|
| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC11811979 | PMC |
| http://dx.doi.org/10.1177/17562864241306575 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
Metal-Free Electrochemical C-H Chlorination of Terminal Alkanes.
Angew Chem Int Ed Engl
March 2025
Nanjing University of Chinese Medicine, College of Pharmacy, 138, 210023, Nanjing, CHINA.
Although research on the activation of C-H bonds in alkanes has been ongoing for decades, there are still few strategies that are both highly selective and suitable for industrial production. Here, we report a highly selective method for chlorination of terminal C-H bonds in alkanes by combining electrochemistry and organocatalysis. The specific cavity size of organic molecular catalysts ensures high regioselectivity, while the use of inexpensive and easily reusable graphite felt electrodes, simple electrochemical device and mild conditions enables the reaction to maintain good efficiency even when scaled up to kilogram level production.
View Article and Find Full Text PDFAnalyte heterogeneity analysis as a possible potency parameter for MSC.
Best Pract Res Clin Haematol
December 2024
Mellen Center, Neurological Institute, Cleveland Clinic Foundation, United States.
Mesenchymal stem/stromal cells (MSC) have been transplanted for therapeutic purposes with inconsistent results. MSC preparations are heterogeneous, and this person-to-person heterogeneity may account for the variable clinical outcomes. Additionally, the mechanisms of therapeutic action for MSC are unclear which confounds attempts to understand and identify factors that may account for variable clinical results.
View Article and Find Full Text PDFIn-situ quantitative detection of hypochlorous acid in food samples by employing a near-infrared fluorescent probe in association with a portable optical data acquisition system.
Anal Chim Acta
May 2025
School of Chemistry and Chemical Engineering, Jiangsu University, Zhenjiang, Jiangsu, 212013, PR China; Key Laboratory of Modern Agricultural Equipment and Technology (Ministry of Education), Jiangsu University, Zhenjiang, Jiangsu, 212013 PR China. Electronic address:
Background: Hypochlorous acid (HClO) is a crucial disinfectant in the food industry. It can be used to soak perishable foods like vegetables, fruits, eggs, fish, and raw meat before processing and storage, eliminating microorganisms, bacteria, fungi, and pathogens to ensure food safety. HClO also helps preserve vegetables and fruits by reducing ethylene production, delaying rotting, decreasing cell membrane permeability, inhibiting polyphenol oxidase activity, and postponing discoloration.
View Article and Find Full Text PDFMechanisms of cognitive impairment associated with cerebral infarction.
Zhong Nan Da Xue Xue Bao Yi Xue Ban
October 2024
Department of Neurology, Second Xiangya Hospital, Central South University, Changsha 410011, China.
Cerebral infarction is a common type of stroke with high incidence and disability rates, and most patients experience varying degrees of cognitive impairment. The manifestations and severity of post-infarction cognitive impairment are influenced by multiple interacting factors, and its pathophysiological mechanisms are highly complex, involving pericyte degeneration, excessive generation of reactive oxygen species (ROS), overproduction of glutamate, and overactivation of autophagy. After cerebral infarction, abnormal pericyte function activates neuroinflammation and facilitates the entry of inflammatory mediators into the brain; detachment of pericytes from blood vessels disrupts the integrity of the blood-brain barrier.
View Article and Find Full Text PDFSynergistic antibacterial effects of pinaverium bromide and oxacillin against .
Zhong Nan Da Xue Xue Bao Yi Xue Ban
October 2024
Department of Laboratory Medicine, Third Xiangya Hospital, Central South University, Changsha 410013, China.
Objectives: () adheres to the surface of medical devices, forming highly drug-resistant biofilms, which has made the development of novel antibacterial agents against and its biofilms a key research focus. By drug repurposing, this study aims to explore the combinational antimicrobial effects between pinaverium bromide (PVB), a -type calcium channel blocker, and oxacillin (OXA) against .
Methods: Clinical isolates of were collected from January to September 2022 at the Department of Clinical Laboratory of the Third Xiangya Hospital, Central South University.
Want AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!