Neutropenia with fatal outcome in a multiple sclerosis patient 23 days after alemtuzumab infusion

Yiannopoulou, Konstantina G.; Papadimitriou, Dimitra; Anastasiou, Aikaterini; Siakantaris, Marina P.

doi:10.1016/j.msard.2018.04.014

Cited by 21 publications

(23 citation statements)

References 5 publications

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“…Four of these cases (No. 2 and 6–8) have previously been published or reported on meetings [4, 7, 16, 17], whereas six have not been published. Our results were shared with the Pharmacovigilance Risk Assessment Committee in EMA before EMA initiated an article 20 review of Lemtrada on April 12 2019.…”

Section: Discussionmentioning

confidence: 99%

“…Prophylactic treatment with antibiotics has been suggested in addition to the antiviral therapy that is generally used [23], and could perhaps prevent listeriosis more effectively than diet advice alone. Weekly hematological screening the first period following treatment could possibly limit the consequences of early agranulocytosis [7], and monitoring of blood pressure could possibly prevent early cerebral hemorrhages [14]. Early adverse effects due to hyperinflammation can, however, at present neither be predicted nor fully prevented.…”

Section: Discussionmentioning

confidence: 99%

“…Following regulatory approval of alemtuzumab for relapsing remitting MS in 2013 by the European Medicines Agency (EMA) and in 2014 by the U.S. Food and Drug Administration (FDA), there have been reports of severe and even fatal suspected adverse effects. These include listeriosis [4, 5], alveolar hemorrhage [6], neutropenia with staphylococcus infection [7], autoimmune hemolytic anemia with necrotizing leukoencephalopathy [8], and hemophagocytic lymphohistiocytosis [9].…”

Section: Introductionmentioning

confidence: 99%

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Adverse events with fatal outcome associated with alemtuzumab treatment in multiple sclerosis

et al. 2019

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Objective Sporadic fatal adverse events have been reported during treatment of multiple sclerosis with alemtuzumab. To provide a systematic overview, we searched the centralized European Medicines Agency database of suspected adverse reactions related to medicinal products (EudraVigilance) for fatal adverse events associated with treatment with alemtuzumab (Lemtrada®) for multiple sclerosis. Four independent reviewers with expertise on MS, clinical immunology, infectious diseases and clinical pharmacology reviewed the reports, and scored the likelihood for causality. Results We identified nine cases with a probable and one case with a possible causal relationship between alemtuzumab treatment and a fatal adverse event. Six of these patients died within one month after treatment; one from intracerebral hemorrhage, two from acute multiple organ failure and septic shock, one from listeriosis, one from pneumonia and one from agranulocytosis. Four patients died several months after administration of alemtuzumab from either autoimmune hepatitis, immune-mediated thrombocytopenia, autoimmune hemolytic anemia or agranulocytosis. Four of the 10 cases had been published previously in case reports or congress abstracts. Fatal adverse events related to treatment with alemtuzumab occur more frequently than previously published in the literature. A significant proportion occurs in the first month after treatment.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Adverse events with fatal outcome associated with alemtuzumab treatment in multiple sclerosis

et al. 2019

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“…A case of early neutropenia with fatal outcomes in a 47-year-old PwMS patient 23 days after AI infusion was described. Weekly blood tests for the first 2 months after the first infusion could prevent major infections 64. This “early neutropenia after alemtuzumab infusion” is to be distinguished from a “neutropenia as a result of alemtuzumab-induced secondary autoimmunity” which occurs much later in the context of immune reconstitution 65…”

Section: Vds As a Further Prevention Measure Of Rare Side Effects Of mentioning

confidence: 99%

<p>Vitamin D supplementation for the prevention or depletion of side effects of therapy with alemtuzumab in multiple sclerosis</p>

Goischke¹

2019

TCRM

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Purpose of review: Not only the multiple sclerosis specialist but also the general neurologist and primary care practitioner are increasingly aware of possible adverse events (AEs) by treatment with alemtuzumab (over 47% risk of secondary autoimmune-mediated diseases). Vitamin D supplementation's effect (VDS) to reduce these autoimmune AEs is poorly performed in routine practice. This article seeks to justify why this simple, inexpensive, patient-friendly therapy should be seriously discussed. Recent findings: Patients who have developed autoimmunity also show a high basal level of IL-21, a cytokine which increases the growth of auto-reactive T-cells. For side effects such as thyroid dysfunction, autoimmune thrombocytopenia, autoimmune hemolytic anemia, autoimmune hepatitis, diabetes mellitus type 1, and alopecia areata/alopecia totalis, VDS may have an impact on the immunological mechanism, in particular lowering levels of IL-17 and IL-21. Summary: The potential role of vitamin D in influencing autoimmune diseases is evident. If a life-threatening side-effect can be prevented by high-dose VDS, it is ethical to initiate this add-on therapy despite contradictory results in studies on the effectiveness of VDS.

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“…Even though alemtuzumab is generally considered safe, serious adverse reactions have been identified, including infections, immune-mediated thrombocytopenia and thyroiditis [3] Following regulatory approval of alemtuzumab for relapsing remitting MS in 2013 by the European Medicines Agency (EMA) and in 2014 by the U.S. Food and Drug Administration (FDA), there have been reports of severe and even fatal suspected adverse effects. These include listeriosis [4,5], alveolar hemorrhage [6], neutropenia with staphylococcus infection [7], autoimmune hemolytic anemia with necrotizing leukoencephalopathy [8], and hemofagocytic lymphohistocytosis [9]. These concerns led us to perform a systematic search for information on fatal cases following treatment with alemtuzumab in MS, retrieving data from the European database of suspected adverse drug reaction reports (EudraVigilance).…”

Section: Introductionmentioning

confidence: 99%

Adverse events with fatal outcome associated with alemtuzumab treatment in multiple sclerosis

Holmøy

Fevang²,

Olsen

et al. 2019

Preprint

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Neutropenia with fatal outcome in a multiple sclerosis patient 23 days after alemtuzumab infusion

Cited by 21 publications

References 5 publications

Adverse events with fatal outcome associated with alemtuzumab treatment in multiple sclerosis

Adverse events with fatal outcome associated with alemtuzumab treatment in multiple sclerosis

<p>Vitamin D supplementation for the prevention or depletion of side effects of therapy with alemtuzumab in multiple sclerosis</p>

Adverse events with fatal outcome associated with alemtuzumab treatment in multiple sclerosis

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