Severe Anaemia during Natalizumab Treatment: Case Presentation with Literature Review (original) (raw)
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Severe anemia in a patient with multiple sclerosis treated with natalizumab
Neurology, 2014
We prescribed natalizumab (NAT) treatment in July 2009 for a 51-year-old woman with a 16-year history of relapsing-remitting multiple sclerosis (RRMS), but no other notable medical history, because of disease progression observed on MRI. Previous treatment consisted of azathioprine (1997-2003) and interferon-b-1a (2003-2009), with no adverse events reported. The patient was free of further clinical relapses during NAT treatment and MRI lesion load remained stable. In August 2012, after 34 NAT infusions, the patient developed severe symptomatic anemia (Hgb, 7.3 g/dL) and a blood reticulocyte rate at the lower limit of normal (0.020 mL/mcL, normal 0.018-0.114 mL/mcL, and 0.66%, normal 0.38%-2.13%), but with no abnormalities in lymphocytes. Parvovirus serology was negative. Bone marrow aspirate showed anemia with maturation arrest of the red cell line (figure, A). Findings were negative for splenomegaly and mass lesions based on total body CT scans. We immediately discontinued NAT treatment and treated with blood transfusions (in August and September 2012). Trephine bone marrow biopsy (BMB, September 2012) showed high cellularity (80%-85%) with moderate fibrosis, erythroid hyperplasia, and increased (.2% but ,5%, figure, B) CD341 cells and negative results for the JAK2V617F mutation. Follow-up BMB 2 months later showed decreased cellularity (20%) and fibrosis with normal erythropoiesis, megakaryocytes, and granulocytopoiesis (figure, C). Hemoglobin values at that time were normal (14.3 g/dL). We therefore ruled out myeloproliferative disease and diagnosed severe anemia from possible drug toxicity (NAT).
Asymptomatic progressive multifocal leukoencephalopathy associated with natalizumab
Journal of Neurology, 2012
Background: We report the development of asymptomatic progressive multifocal leukoencephalopathy in a patient with multiple sclerosis on natalizumab therapy. Progressive multifocal leukoencephalopathy often presents with debilitating neurologic symptoms. Very few cases have documented a completely asymptomatic course of the disease. Case presentation: A 26-year-old white woman with multiple sclerosis was treated with natalizumab. She was diagnosed as having progressive multifocal leukoencephalopathy based on characteristic magnetic resonance imaging lesions after 27 infusions of natalizumab. She had no neurologic deficits at the time of diagnosis and John Cunningham virus in cerebrospinal fluid was detected at 15 copies/ml. She was initially treated with mefloquine and mirtazapine and remained asymptomatic for 3 months. She later developed worsening magnetic resonance imaging lesions related to immune reconstitution inflammatory syndrome. At that time, she received intravenously administered immunoglobulin and high-dose intravenously administered methylprednisolone with radiologic improvement of the lesions. Conclusions: Our case report illustrates that early detection of asymptomatic progressive multifocal leukoencephalopathy and its subsequent treatment resulted in a benign clinical course. In consideration of the additional small number of cases of asymptomatic progressive multifocal leukoencephalopathy that have been reported, we conclude that routine magnetic resonance imaging surveillance is important for patients with multiple sclerosis who are at high risk for developing natalizumab-associated progressive multifocal leukoencephalopathy.
Archives of Neurology, 2010
atalizumab (Tysabri) was the first monoclonal antibody approved for the treatment of relapsing forms of multiple sclerosis (MS). After its initial approval, 3 patients undergoing natalizumab therapy in combination with other immunoregulatory and immunosuppressive agents were diagnosed with progressive multifocal leukoencephalopathy (PML). The agent was later reapproved and its use restricted to monotherapy in patients with relapsing forms of MS. Since reapproval in 2006, additional cases of PML were reported in patients with MS receiving natalizumab monotherapy. Thus, there is currently no convincing evidence that natalizumab-associated PML is restricted to combination therapy with other diseasemodifying or immunosuppressive agents. In addition, recent data indicate that risk of PML might increase beyond 24 months of treatment.
2021
Background Progressive multifocal leukoencephalopathy (PML) is one of the most serious treatment-related complications that is encountered in patients with multiple sclerosis (MS). PML is a serious complication of MS treatment which is most commonly related to natalizumab. Case presentation We report clinical course of progressive multifocal leukoencephalopathy (PML) in a 40-year-old man who was on treatment for highly active relapsing-remitting multiple sclerosis with natalizumab (Nz). He was treated with steroids, cidofovir, and mirtazapine and went on to develop long-term disability. The case describes the evolution of PML from diagnosis up till 5 months with changes on sequential brain scans and clinical symptoms in our patient. Conclusion Patients who are on natalizumab should be aware and consented for the risk of PML. They should be periodically re-assessed for their relative PML risk. There is a growing body of evidence that suggests switching patients from natalizumab who h...
Journal of Neuroimmunology, 2007
Natalizumab (Tysabri®) (anti-VLA4) is a novel agent for treatment of relapsing multiple sclerosis (MS) . A randomized, placebo-controlled trial of natalizumab for relapsing multiple sclerosis. N. Engl. J. Med. 354,[899][900][901][902][903][904][905][906][907][908][909][910]. Controlled trials have shown considerable efficacy in preventing relapses, in excess of that seen for other EMEA-approved disease modulating drugs. While well-tolerated and generally safe, three cases of progressive multifocal leukoencephalopathy (PML) occurred in the context of 3 clinical trials encompassing some 3300 patients using this drug in multiple sclerosis and Crohn's disease. Immune compromised patients, such as those receiving immunosuppressive medications, are at a higher risk of developing PML. Natalizumab was recently approved for the treatment of relapsing forms of MS. This includes patients who had an inadequate response to other therapies and some of these patients will have already received immunosuppressants. These agents have the potential to cause prolonged effects on the immune system, even after dosing has been discontinued. Determining that these patients are not immunocompromised will be an important safety issue to consider prior to the initiation of natalizumab therapy. This short report summarizes interdisciplinary practical recommendations from specialists in neuroimmunology, rheumatology, transplantation medicine and clinical immunology.
Natalizumab adverse events are rare in patients with multiple sclerosis
Arquivos de Neuro-Psiquiatria, 2013
ObjectiveTo assess the prevalence and the profile of adverse events (AE) of natalizumab in patients with multiple sclerosis (MS).MethodsData collection from neurologists attending to patients with MS at specialized units in Brazil.ResultsData from 103 patients attending the infusion centers of 16 MS units in 9 Brazilian states were included in the study. The total number of infusions was 1,042. Seventy-nine patients (76.7%) did not present any AE. Twenty-four patients (23.3%) presented only mild AE. There were three major AE, including two deaths. These three occurrences, although not necessarily being drug-related, must be taken into consideration.ConclusionThe profile of AEs for natalizumab shows that 97% of patients have none or only mild AE. However, still due to safety worries, the use of this medication should be restricted to MS units under the care of specialized neurologists.
Immunologic, clinical, and radiologic status 14 months after cessation of natalizumab therapy
Neurology, 2009
Natalizumab is a humanized recombinant monoclonal antibody against very late activation antigen-4 approved for the treatment of patients with multiple sclerosis (MS). A phase II study failed to demonstrate a difference between natalizumab treatment groups and the placebo group with regard to gadolinium enhancing lesions on MRI 3 months after discontinuation of therapy. The objective of this study was to assess clinical MS disease activity, surrogate disease markers on MRI, immunologic parameters in peripheral blood and CSF, as well as safety in patients with MS after discontinuation of natalizumab therapy.