RESUMO
BACKGROUND: Sugammadex hypersensitivity is an emerging safety concern. We aimed to describe the clinical and diagnostic features of perioperative hypersensitivity to sugammadex, and secondarily to provide an estimate of perioperative sugammadex hypersensitivity incidence in Australia. METHODS: We retrospectively analysed cases of hypersensitivity to sugammadex diagnosed by positive intradermal or skin prick testing at six perioperative allergy clinics in Australia. We included all grades of hypersensitivity and compared life-threatening with non-life-threatening presentations. Incidence of hypersensitivity events was estimated relative to the estimated number of sugammadex administrations across two health services between January 1, 2010 and June 30, 2023. RESULTS: Thirty cases were included (15 life-threatening and 15 non-life-threatening). The most common clinical signs were hypotension (n=25, 83.3%) and flushing/erythema (n=21, 70%). The median time to recognition of hypersensitivity was 5 (interquartile range 2-7.5) min. Five cases were recognised 10-30 min after administration. Serum tryptase was measured in 28 (93.3%) patients. Tryptase was positive in 15 (100%) life-threatening cases and nine (69.2%) non-life-threatening cases. The estimated incidence of sugammadex hypersensitivity was 0.004% (95% confidence interval 0.002-0.008%). CONCLUSIONS: Sugammadex hypersensitivity presents similarly to other causes of perioperative hypersensitivity, however recognition can be delayed. The combination of positive serum tryptase and positive skin tests suggests an IgE-mediated mechanism of hypersensitivity. The estimated incidence of sugammadex hypersensitivity in Australia is lower than earlier reports.
Assuntos
Proteínas Adaptadoras de Transdução de Sinal/genética , Autoimunidade , Proteínas do Citoesqueleto/genética , Inflamação/diagnóstico , Proteinúria/diagnóstico , Colchicina/uso terapêutico , Feminino , Heterozigoto , Humanos , Inflamação/tratamento farmacológico , Inflamação/genética , Rim/metabolismo , Complexo Antígeno L1 Leucocitário/sangue , Complexo Antígeno L1 Leucocitário/metabolismo , Complexo Antígeno L1 Leucocitário/urina , Fígado/metabolismo , Pessoa de Meia-Idade , Mutação , Proteinúria/sangue , Proteinúria/tratamento farmacológico , Proteinúria/urina , SíndromeRESUMO
BACKGROUND: Myasthenia gravis is an autoimmune disorder of the neuromuscular junction. Rituximab (RTX), a monoclonal antibody to CD20, leads to B lymphocyte depletion and has been used in some autoimmune disorders, including small case series of myasthenia gravis patients. METHODS: A retrospective analysis was performed of all patients with acetylcholine receptor (AChR) (11 subjects) or muscle specific kinase antibody (MuSK) positive myasthenia gravis (three subjects), who had been treated with RTX in Brisbane, Australia. In most patients 1 g of RTX, in two divided doses, was given. Patients were monitored by serial clinical assessments, flow cytometry of peripheral blood B lymphocytes and antibody testing. RESULTS: RTX led to a significant improvement in symptoms in 11 of 14 patients. Doses of immunosuppressive medications were able to be reduced in 12 of 14 patients but medications could be completely ceased in only one patient. A demonstrable reduction of autoantibody levels was found in only three AChR positive patients and one MuSK positive patient, independent of clinical improvement. Peripheral blood B lymphocyte depletion was achieved in 13 out of 14 patients. B lymphocyte recovery occurred between 9 and 30 months post RTX (median 12.3 months) and was consistently associated with worsening of clinical symptoms. CONCLUSION: Rituximab at a dose of 1 g appears to be beneficial in the treatment of patients with severe myasthenia gravis. Serial monitoring of peripheral blood B lymphocytes appears to be useful in guiding the need for further RTX therapy.