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Fluticasone-propionate/mepolizumab/omalizumab Lack of efficacy, anaphylaxis to excipient polysorbate-20 and cross reactivity: case report

A 27-year-old woman developed anaphylaxis during treatment with mepolizumab and omalizumab containing excipient polysorbate-20. She also exhibited lack of efficacy during treatment with fluticasone propionate for allergic asthma. Additionally, cross-reactivity between mepolizumab and omalizumab was noted [not all routes and dosages stated]. The woman had a childhood history of allergic asthma. In 2016 (approximately 12 months before starting mepolizumab), she experienced four serious asthma exacerbations despite treatment with high-dose inhaled fluticasone propionate 1500µg, unspecified long-acting β mimetic, muscarinic antagonist and a leukotriene receptor antagonist. On 01 November 2017, the woman started receiving mepolizumab injection 100 mg/month. Her corticosteroids were discontinued. On 12 December 2018 (around 30 minutes after the mepolizumab injection), she developed dry cough, dyspnoea, decreased BP, increased heart rate and respiratory distress. Her FEV1 was low and she hyperventilated. She was treated with prednisolone, salbutamol and ipratropium bromide. She was hospitalised with a presumed diagnosis of status asthmaticus and treated with adrenaline, terbutaline and noninvasive intermittent ventilation. Her physician suspected asthma exacerbation and not a reaction to mepolizumab. After three weeks, a prick test with undiluted mepolizumab was performed. The test was negative at 20 minutes. She then received SC mepolizumab 0.3mL injection. Thirty minutes later, she developed dry cough, dyspnoea and wheezing, with a decrease in blood pressure. She received prednisolone, terbutaline, salbutamo and oxygen again. She recovered within 20 minutes. She then underwent skin prick tests with mepolizumab, benralizumab, omalizumab and polysorbate (all undiluted), all of which were negative at 15 minutes. Hence, she received SC omalizumab injection omalizumab 0.1mL. Howeverm after 10 minutes, her earlier skin test with polysorbate became positive with a wheal of 4mm, whereas the test with omalizumab became positive after about 45 minutes. Around 20 minutes after the omalizumab injection, she developed dyspnoea, dry cough, dizziness and obstruction with no signs of hyperventilation or any other stress-induced reaction. She was treated with salbutamol and terbutaline. Her dyspnoea resolved and breathing returned to normal. It was concluded that polysorbate-20, an excipient in omalizumab and mepolizumab, was the most likely cause of these reactions. Additionally, cross reactivity between mepolizumab and omalizumab was concluded. Bergmann KC, et al. Anaphylaxis to mepolizumab and omalizumab in a single patient: Is polysorbate the culprit?. Journal of Investigational Allergology and Clinical Immunology 30: 285-287, No. 4, 2020. Available from: URL: http://doi.org/10.18176/jiaci.0492

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