Alemtuzumab in a Large Real-Life Cohort: Interim Baseline Data of the TREAT-MS Study DOI Creative Commons
Tjalf Ziemssen,

Frank Hoffmann,

Stephan Richter

и другие.

Frontiers in Neurology, Год журнала: 2021, Номер 12

Опубликована: Авг. 5, 2021

The non-interventional long-Term study foR obsErvAtion of Treatment with alemtuzumab in active relapsing–remitting MS (TREAT-MS) collects the so far largest real-life cohort regarding utilization, long-term effectiveness, and safety alemtuzumab, a humanized monoclonal antibody directed against cell surface glycoprotein CD52, adult patients multiple sclerosis (RRMS). An interim analysis baseline parameters at inclusion real-world about Germany including previous (MS) medication activity, severity, duration, as well comorbidities was performed. Of 883 patients, 71.6% were women. Mean age 35.7 ± 9.2 years, time since first symptoms (=disease duration) is 8.0 6.8 Expanded Disability Status Scale (EDSS) 2.7 1.8 points (range, 0.0–7.5 points). number relapses 12 24 months prior to 1.6 1.2 2.2 1.8, respectively. 14.4% treatment naive, while for majority, wide spectrum disease-modifying treatments (DMTs) sequences documented. Overall, interferon beta (IFN-beta) reported most frequently (52.4%), followed by fingolimod (35.2%), natalizumab (34.9%), glatiramer acetate (28.9%). Patients longer disease duration higher EDSS had DMTs. Compared pivotal phase 2/3 studies, RRMS starting conditions. There variety different before final switch alemtuzumab. In future, linking these or other characteristics effectiveness outcomes might be useful support decisions. Registered Paul-Ehrlich-Institut under NIS 281.

Язык: Английский

Early use of high-efficacy disease‑modifying therapies makes the difference in people with multiple sclerosis: an expert opinion DOI Creative Commons
Massimo Filippi, Maria Pia Amato, Diego Centonze

и другие.

Journal of Neurology, Год журнала: 2022, Номер 269(10), С. 5382 - 5394

Опубликована: Май 24, 2022

Abstract Multiple sclerosis (MS) is a chronic and progressive neurological disease that characterized by neuroinflammation, demyelination neurodegeneration occurring from the earliest phases of may be underestimated. MS patients accumulate disability through relapse-associated worsening or progression independent relapse activity. Early intervention with high-efficacy disease-modifying therapies (HE-DMTs) represent best window opportunity to delay irreversible central nervous system damage MS-related hindering underlying heterogeneous pathophysiological processes contributing progression. In line this, growing evidence suggests early use HE-DMTs associated significant greater reduction not only inflammatory activity (clinical relapses new lesion formation at magnetic resonance imaging) but also progression, in terms accumulation clinical compared delayed HE-DMT escalation strategy. These beneficial effects seem acceptable long-term safety risks, thus configuring this treatment approach as most positive benefit/risk profile. Accordingly, it should mandatory treat people case prognostic factors suggestive aggressive disease, advisable offer an after diagnosis, taking into account drug profile, severity, and/or radiological activity, patient-related factors, including possible comorbidities, family planning, patients’ preference agreement EAN/ECTRIMS AAN guidelines. Barriers for include concerns safety, challenges management initiation monitoring, negative preferences, restricted access according guidelines regulatory rules, sustainability. However, these barriers do apply each none appear insuperable.

Язык: Английский

Процитировано

103

The Disease-Modifying Therapies of Relapsing-Remitting Multiple Sclerosis and Liver Injury: A Narrative Review DOI Creative Commons
Marco Biolato, Assunta Bianco, Matteo Lucchini

и другие.

CNS Drugs, Год журнала: 2021, Номер 35(8), С. 861 - 880

Опубликована: Июль 28, 2021

In this narrative review, we analyze pre-registration and post-marketing data concerning hepatotoxicity of all disease-modifying therapies (DMTs) available for the treatment relapsing-remitting multiple sclerosis, including beta interferon, glatiramer acetate, fingolimod, teriflunomide, dimethyl fumarate, cladribine, natalizumab, alemtuzumab, ocrelizumab. We review proposed causal mechanisms described in literature also address issues like use DMTs patients with viral hepatitis or liver cirrhosis. Most emerged phase by reports to national pharmacovigilance agencies published case series. Serious adverse events are rare, but exact incidence is largely unknown, as predictive factors. Unfortunately, none currently sclerosis free potential hepatic toxic effects. Cases acute failure have been reported beta-interferon, ocrelizumab different (idiosyncratic reaction, autoimmune hepatitis, reactivation). Patients should be informed about possible side effects their treatment. cases injury idiosyncratic unpredictable. The specific monitoring schedule each DMT has reviewed clinician ready recognize clinical symptoms suggestive injury. Not indicated cirrhotic patients. For some DMTs, screening B virus C required before starting a antiviral prophylaxis established. Beta alemtuzumab relatively contraindicated due risk disease exacerbation.

Язык: Английский

Процитировано

38

Alemtuzumab: A Review in Relapsing Remitting Multiple Sclerosis DOI

Yahiya Y. Syed

Drugs, Год журнала: 2020, Номер 81(1), С. 157 - 168

Опубликована: Дек. 24, 2020

Язык: Английский

Процитировано

35

A five-year observational prospective mono-center study of the efficacy of alemtuzumab in a real-world cohort of patients with multiple sclerosis DOI Creative Commons
Sofia Sandgren, Lenka Novakova, Anna Nordin

и другие.

Frontiers in Neurology, Год журнала: 2023, Номер 14

Опубликована: Сен. 21, 2023

Alemtuzumab (ALZ) is a pulsed immune reconstitution therapy for multiple sclerosis (MS).To assess basic characteristics, therapeutic effects, and prognostic biomarkers on clinical imaging parameters of disease activity relapsing-remitting MS (RRMS) patients selected ALZ, in real-world long-term setting.Fifty-one RRMS [female = 31; mean age 36 (standard deviation 7.1) years; median expanded disability status scale (EDSS) 2 (interquartile range (IQR) 1.5)] initiating ALZ treatment, were consecutively included. Patients assessed at baseline thereafter annually 5 years with measures, symbol digit modality test (SDMT), magnetic resonance (MRI). Concentrations glial fibrillary acidic protein (GFAP), reflecting astrogliosis, neurofilament light (NfL), axonal damage, measured cerebrospinal fluid (CSF) serum samples collected after CSF, serum. Control subjects symptomatic controls (SCs, n 27), who examined without evidence neurological disease.While the annualized relapse rate was significantly reduced from each year follow-up, essentially maintained EDSS 1.5 IQR between 1.13 2.25. New MRI recorded 26 (53%) over years. The proportion achieved no (NEDA-3), 6-months confirmed worsening (CDW), improvement (CDI) 33, 31, 31%, respectively. SDMT score (p < 0.001), but unchanged SCs. treatment did not change GFAP levels, whereas there significant decrease CSF NfL levels follow-up [CSF month 24: 456 pg./mL (IQR 285.4) 0.05); 6.7 pg/mL 4.7) 0.01); 60: 7.2 0.01)], compared to [CSF: 1014 2832.5); 8.6 17.4)].In this mono-center population, we observed progression-free survival 69%, cumulative NEDA-3 33%, five-year follow-up. This confirms as an effective that reduces neuro loss, therefore has potential reduce disability. appear affect astrogliosis.

Язык: Английский

Процитировано

13

A real-world single-centre analysis of alemtuzumab and cladribine for multiple sclerosis DOI Open Access
Gauruv Bose,

Carolina Rush,

Harold Atkins

и другие.

Multiple Sclerosis and Related Disorders, Год журнала: 2021, Номер 52, С. 102945 - 102945

Опубликована: Апрель 14, 2021

Язык: Английский

Процитировано

26

The immunological bases of alemtuzumab as induction-therapy in pediatric-onset multiple sclerosis DOI Creative Commons
Marco Puthenparampil,

Marta Gaggiola,

Francesca Rinaldi

и другие.

Frontiers in Immunology, Год журнала: 2025, Номер 15

Опубликована: Янв. 8, 2025

Pediatric-Onset Multiple Sclerosis (POMS) is characterized by both white and grey matter inflammation, as well a higher risk of long-term physical cognitive disability. The peculiar immunopathogenic mechanisms POMS suggests that the use induction therapies, including alemtuzumab (ALTZ), might be promising approach, at least for postpuberal (> 11 yo) POMS. Although no data on therapies in are available from clinical trials currently, case series or reports effect (ALTZ) have been recently published. In this review we briefly revised features POMS, how ALTZ impact them, reporting its efficacy observed different cohorts.

Язык: Английский

Процитировано

0

Assessment of the impact of reconstitution therapies—cladribine tablets and alemtuzumab—on the atrophy progression among patients with relapse-remitting multiple sclerosis DOI Creative Commons
Aleksandra Pogoda-Wesołowska,

Irene Stachura,

Arkadiusz Żegadło

и другие.

Frontiers in Neuroscience, Год журнала: 2025, Номер 19

Опубликована: Фев. 27, 2025

Immune reconstitution therapies (IRT) are highly effective for multiple sclerosis (MS). Among IRT, we can distinguish partially selective such as cladribine in tablets (CLAD) and non-selective therapies, which include alemtuzumab (ALEM). Today, it is known that these controlling the relapse activity of disease progression clinical disability, has been proven both trials real world evidence (RWE). However, there a lack data assessing effect IRT on neurodegenerative process, intensified patients with MS. The aim study was to assess treatment degree pattern brain atrophy MS during 3 years observation. Patients relapsing-remitting (RRMS) treated CLAD ALEM were retrospectively recruited study. Demographic, clinical, magnetic resonance imaging (MRI) collected at 4 time points: before one, two, three after treatment. MRI examinations analyzed volumetrically using Freesurfer software. Global regional changes assessed by calculating percentage volume between points. Results drug groups compared each other. After follow-up, statistically significant differences observed hippocampus [p < 0.01] amygdala 0.01]. Ventral diencephalon noted groups. On other hand, groups, no white grey matter noted. In addition, an increase thalamus observed. studied shown slow down process similar extent. These may play neuroprotective role increasing hippocampus. limited small number Therefore, further studies needed fully processes RRMS.

Язык: Английский

Процитировано

0

The epidemiology, pathology and pathogenesis of MS: Therapeutic implications DOI Creative Commons
Douglas S. Goodin

Neurotherapeutics, Год журнала: 2025, Номер unknown, С. e00539 - e00539

Опубликована: Фев. 1, 2025

Язык: Английский

Процитировано

0

Estudio abierto retrospectivo multicéntrico sobre la utilización de alemtuzumab en esclerosis múltiple remitente-recurrente en práctica clínica habitual. Seguimiento durante 4 años. DOI Creative Commons

Antonio Pato Pato,

Pablo Gabeiras Araujo,

Marta E. García

и другие.

Neurology Perspectives, Год журнала: 2025, Номер unknown, С. 100192 - 100192

Опубликована: Апрель 1, 2025

Процитировано

0

Use of disease-modifying drugs during pregnancy and breastfeeding DOI
Ruth Dobson, Kerstin Hellwig

Current Opinion in Neurology, Год журнала: 2021, Номер 34(3), С. 303 - 311

Опубликована: Март 11, 2021

The fact that multiple sclerosis (MS) predominantly affects women has been recognized for many years. As the age at diagnosis is decreasing, and treatment options are becoming more complex, increasing numbers of facing decisions about use disease modifying therapy (DMT) in around pregnancy.New data rapidly available, particularly regarding safety therapies both pregnancy breastfeeding. Effective suppression relapses key to ensuring good outcomes longer term woman, however this must be balanced against individual risk relapse risks fetus. Women should advised it possible breastfeed while taking selected DMT.In review, we discuss evidence surrounding DMTs breastfeeding, knowledge suggest approaches family planning with MS.

Язык: Английский

Процитировано

22