Preliminary Results of the FASM Study, an On-Going Italian Active Pharmacovigilance Project

Maniscalco, Giorgia Teresa; Morra, Vincenzo Brescia; Florio, Ciro; Lus, Giacomo; Tedeschi, Gioacchino; Cianfrani, M.; Docimo, Renato; Miniello, Stefania; Romano, Felice; Sinisi, L; Spitaleri, Daniele; Longo, Giuseppe; Trama, Ugo; Triassi, Maria; Scavone, Cristina; Capuano, Annalisa

doi:10.3390/ph13120466

Cited by 9 publications

(4 citation statements)

References 67 publications

(28 reference statements)

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Indeed, their prompt recognition and treatment are essential in order to achieve good clinical outcomes. Many risk factors for acute relapse were identified, including female sex (women are more likely to experience relapses throughout the course of the disease), smoking status and the discontinuation of highly effective therapy (3)(4)(5).…”

Section: Discussionmentioning

confidence: 99%

Severe Multiple Sclerosis Relapse After COVID-19 Vaccination: A Case Report

et al. 2021

Self Cite

View full text Add to dashboard Cite

We describe a case of acute relapse in a woman with Multiple Sclerosis (MS) shortly after the mRNA COVID-19 vaccination. The patient received a diagnosis of MS in November 2016 at the MS Centre of the A. Cardarelli Hospital (South of Italy). Since that moment, her clinical conditions and pharmacological therapies have been managed at this MS centre where, according to national recommendations, in April 2021, the patient received the BNT162b2 vaccine. Almost 48 h after receiving the vaccine, the patient developed paraesthesia and weakness in her left arm and limbs. The neurological examination revealed walking difficulties while the MRI showed three new voluminous enhancing lesions. After having received methylprednisolone iv for 5 days, the patient's neurological symptoms fully recovered. Along with the implementation of COVID-19 vaccination programmes among vulnerable population, further studies are needed in order to improve our knowledge on the benefit/risk ratio of COVID-19 vaccines.

show abstract

Section: Discussionmentioning

confidence: 99%

Severe Multiple Sclerosis Relapse After COVID-19 Vaccination: A Case Report

et al. 2021

Self Cite

View full text Add to dashboard Cite

show abstract

“…The safety profiles of DMDs are under constant scrutiny, with ongoing pharmacovigilance studies being pivotal in understanding the adverse drug reactions (ADRs) associated with these therapies. This knowledge is crucial for optimising the use of DMDs and minimising potential risks, including ICH [ 66 ].…”

Section: Discussion and Future Prospectsmentioning

confidence: 99%

Intracerebral haemorrhage in multiple sclerosis: assessing the impact of disease-modifying medications

Ou Yong,

Awuah,

Shah

et al. 2024

Eur J Med Res

View full text Add to dashboard Cite

Multiple Sclerosis (MS) is a complex autoimmune disorder that significantly impacts the central nervous system, leading to a range of complications. While intracranial haemorrhage (ICH) is a rare but highly morbid complication, more common CNS complications include progressive multifocal leukoencephalopathy (PML) and other CNS infections. This severe form of stroke, known for its high morbidity and mortality rates, presents a critical challenge in the management of MS. The use of disease-modifying drugs (DMDs) in treating MS introduces a nuanced aspect to patient care, with certain medications like Dimethyl Fumarate and Fingolimod showing potential in reducing the risk of ICH, while others such as Alemtuzumab and Mitoxantrone are associated with an increased risk. Understanding the intricate relationship between these DMDs, the pathophysiological mechanisms of ICH, and the individualised aspects of each patient's condition is paramount. Factors such as genetic predispositions, existing comorbidities, and lifestyle choices play a crucial role in tailoring treatment approaches, emphasising the importance of a personalised, vigilant therapeutic strategy. The necessity for ongoing and detailed research cannot be overstated. It is crucial to explore the long-term effects of DMDs on ICH occurrence and prognosis in MS patients, aiming to refine clinical practices and promote patient-centric, informed therapeutic decisions. This approach ensures that the management of MS is not only comprehensive but also adaptable to the evolving understanding of the disease and its treatments.

show abstract

“…The pharmacological management of MS foresees the use of disease-modifying therapies (DMTs) that are able to reduce the number of relapses and delay disease’s progression ( 8 ). These drugs, which act on different biological pathways and show distinct efficacy/safety profiles, are classified as low/moderate- or high-efficacy treatment.…”

Section: Introductionmentioning

confidence: 99%

Disease-modifying therapies and hematological disorders: a systematic review of case reports and case series

Scavone,

Liguori,

Adungba

et al. 2024

Front. Neurol.

Self Cite

View full text Add to dashboard Cite

IntroductionDisease modifying therapies (DMTs) used to treat multiple sclerosis (MS) can be associated to the occurrence of hematological disorders. This systematic review aims to provide an overview of these events occurring in real-life conditions, by describing case reports and series published in the literature.MethodsA literature search of all publications up to January 5th 2024 on the Medline and Embase databases was carried out. The results were presented both in the text and in tables.ResultsSixty-seven case reports/series were included in this review, of which more than half related to alemtuzumab, natalizumab and ocrelizumab. The publication date of included studies ranged from 2006 to 2024. The majority of case reports and series described the occurrence of late-onset hematological disorders (events that occurred more than 30 days after the first DMT administration), mainly represented by case of neutropenia, autoimmune hemolytic anemia and immune thrombocytopenia. All cases reported a favorable outcome, apart one case report that described a fatal case. Among included cases, 4 articles, all related to natalizumab, described the occurrence of myeloid disorders in 13 newborns from mother receiving the DMT.DiscussionConsidering the limitations identified in the majority of included studies, further ad hoc studies are strongly needed to better evaluate the hematological disorders of DMTs. Meantime, the strict monitoring of treated patients for the occurrence of these toxicities should be highly recommended.

show abstract

Preliminary Results of the FASM Study, an On-Going Italian Active Pharmacovigilance Project

Cited by 9 publications

References 67 publications

Severe Multiple Sclerosis Relapse After COVID-19 Vaccination: A Case Report

Severe Multiple Sclerosis Relapse After COVID-19 Vaccination: A Case Report

Intracerebral haemorrhage in multiple sclerosis: assessing the impact of disease-modifying medications

Disease-modifying therapies and hematological disorders: a systematic review of case reports and case series

Contact Info

Product

Resources

About