Λεπτομέρειες βιβλιογραφικής εγγραφής
| Τίτλος: |
Stability in Cognition and Employment in People with Relapsing Multiple Sclerosis Treated with Cladribine Tablets: Two-year Phase IV CLARIFY-MS Study. |
| Συγγραφείς: |
Brochet, Bruno1 (AUTHOR) bruno.brochet@u-bordeaux.fr, Langdon, Dawn2 (AUTHOR), Havrdova, Eva Kubala3 (AUTHOR), Lechner-Scott, Jeanette4,5 (AUTHOR), Montalban, Xavier6 (AUTHOR), Patti, Francesco7 (AUTHOR), Piehl, Fredrik8 (AUTHOR), Solari, Alessandra9 (AUTHOR), Hupperts, Raymond10 (AUTHOR), Alexandri, Nektaria11 (AUTHOR), Lehn, Annette11 (AUTHOR), Smyk, Andrzej11 (AUTHOR), Selmaj, Krzysztof12,13 (AUTHOR) |
| Πηγή: |
Neurology & Therapy. Aug2026, Vol. 15 Issue 4, p1491-1507. 17p. |
| Θεματικοί όροι: |
*Cognitive processing speed, *Employment, *Multiple sclerosis, *Clinical trials, *Size of brain, *Cognitive ability, *Drugs |
| Περίληψη: |
Introduction: Cognitive impairment can affect people with multiple sclerosis (MS) at all stages, negatively impacting their work performance and quality of life. This study aimed to report the cognitive function and employment status data for participants with highly active relapsing MS (RMS) treated with cladribine tablets (CladT) during the 2-year, prospective, open-label, exploratory, single-arm, multicentre, phase IV CLARIFY-MS study. Methods: In this post hoc analysis, changes in cognitive function at month (M)12 and M24 (vs baseline) were measured using the Brief International Cognitive Assessment for MS (BICAMS) battery. Additional analyses were conducted to assess clinically meaningful 4- and 8-point changes in Symbol Digit Modalities Test (SDMT) scores. The employment status of participants was determined through a survey at baseline and M24. Results: BICAMS parameter scores remained stable over 2 years in CladT-treated participants. As determined by a 4- and 8-point change, a high proportion of participants had increased or stable SDMT scores at M24 versus baseline. The mean annualised percentage brain volume change (PBVC) in participants was low. No correlation was found between changes in BICAMS parameter scores and annualised PBVC. Furthermore, no major differences in the employment status of participants were observed over 2 years, with > 40% of participants being in full-time employment during the study. Conclusions: Most CLARIFY-MS participants had increased or stable information processing speed at M24 (vs baseline), as determined using clinically meaningful 4- and 8-point changes in SDMT scores. Overall, the cognitive function and employment status of CladT-treated participants with highly active RMS remained stable over 2 years. Trial Registry Details: URL: https://clinicaltrials.gov/ct2/show/NCT03369665; ClinicalTrials.gov Identifier: NCT03369665. Plain Language Summary: Multiple sclerosis (MS) is an autoimmune condition where the immune system (the body's natural defence system) mistakenly attacks myelin, a protective layer found around the nerve cells in the brain and spinal cord. These attacks may contribute to cognitive decline, which impacts the ability of people with MS to think, learn, and remember, causing problems in daily life and work. Cognitive decline often appears as slower information processing speed and difficulties with memory and verbal fluency. Cladribine tablets are an oral medication for treating relapsing forms of MS, taken in two short courses over two consecutive years. Each treatment course consists of two treatment weeks, one at the beginning of the first month and one at the beginning of the second month. Relapses are periods where new MS symptoms appear or existing symptoms worsen over 24 h or longer. In the CLARIFY-MS study, researchers studied the changes in cognitive function and employment status over 2 years in people with highly active relapsing MS treated with cladribine tablets. The majority of participants in CLARIFY-MS showed increased or stable information processing speed at 24 months compared to the start of the study. Overall, cognitive function, including verbal learning and visual memory, remained stable over 2 years. Most participants who were employed full-time at the start of the study retained their employment status even after 2 years. The stability in cognitive function and employment status observed during CLARIFY-MS supports previously reported positive quality-of-life findings in people with highly active relapsing MS treated with cladribine tablets. [ABSTRACT FROM AUTHOR] |
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