Natalizumab adverse events are rare in patients with multiple sclerosis

Abstract

Objective: To assess the prevalence and the profile of adverse events (AE) of natalizumab in patients with multiple sclerosis (MS). Methods: Data collection from neurologists attending to patients with MS at specialized units in Brazil. Results: Data 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. Conclusion: The 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.Key words: multiple sclerosis, natalizumab, adverse events, antibodies, monoclonal. RESUMOObjetivo: Avaliar a prevalência e o perfil dos eventos adversos (EA) por natalizumabe em pacientes com esclerose múltipla (EM). Métodos: Coleta de dados fornecidos por neurologistas de unidades especializadas em EM no Brasil. Resultados: No estudo, foram incluídos dados de 103 pacientes em tratamento em centros de infusão de 16 unidades de EM em 9 estados brasileiros. O número total de infusões foi 1.042. Setenta e nove pacientes (76,7%) não apresentaram nenhum EA. Vinte e quatro pacientes (23,3%) apresentaram apenas EA leves. Foram relatados três importantes EA, incluindo duas mortes. Embora não necessariamente ligadas à droga, estas EA devem ser levadas em consideração. Conclusão: O perfil de EA para natalizumabe mostrou que em 97% dos pacientes não houve EA ou houve apenas EA leves. No entanto, dadas as preocupações com segurança da droga, o uso deste medicamento deve continuar restrito às unidades de EM sob os cuidados de neurologistas especializados.Palavras-Chave: esclerose múltipla, natalizumabe, eventos adversos, anticorpos monoclonais.

Natalizumab treatment in multiple sclerosis: the experience from two Brazilian MS centers

“…Indeed, most patients (57.1%) decided to interrupt treatment due to PML risk, but 85% of our patients never experienced any adverse events. Similar results were found by Fragoso et al in a recent paper analyzing natalizumab safety and tolerability reports during over more than 1000 infusions 13 . It is important to note that the only PML case happened after 60 infusions in a patient who has been treated with immunosuppressant previously.…”

Nearly one-half of Brazilian patients with multiple sclerosis using natalizumab are DNA-JC virus positive

“…With the patient's agreement, they are nonetheless prescribing natalizumab in patients who have had therapeutic failure with immunomodulatory drugs. It is imperative that continuous medical education programs and pharmacovigilance databases are maintained in Brazil since the use of natalizumab has become more frequent 11 .…”

Developing a Model of Care for Home Infusions of Natalizumab for People With Multiple Sclerosis

“… 4 Acute hypersensitivity reactions (eg, urticaria) occur in 3% to 4% of patients, with serious hypersensitivity anaphylaxis reactions occurring in 1% of patients. 2 , 5 Infusion-related reactions are typically nonspecific and, in addition to fatigue and nausea, may also include weakness, dizziness, sweating, fever, rash, rigors, diaphoresis, slow pulse, and/or a moderate drop in blood pressure, dyspnea, chest pain, and leg bruising. 3 , 6 , 7 …”