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Rapid loss of efficacy of biosimilar infliximab in three patients with Behçet’s disease after switching from infliximab originator

机译:从英夫利昔单抗治疗者切换后三名贝塞特氏病患者的生物仿制药英夫利昔单抗疗效迅速丧失

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摘要

Three patients affected by Behçet’s disease (BD) with severe uveitis and neurological involvement in stable clinical remission and who rapidly relapsed after switching from reference infliximab (re-IFX) to biosimilar infliximab (bio-IFX) are reported. In order to observe the rules of local health authorities, two males and one female (38, 26, and 40 years old, respectively) with BD complicated by severe uveitis and neuro-Behçet and who were in prolonged remission, were switched from re-IFX to bio-IFX, with the same dosing regimen of 5 mg/kg intravenous infusions every 8 weeks. All three patients experienced disease flare-ups, with recurrence of uveoretinitis in the first patient, neuro-Behçet in the second, and uveitis and neuro-Behçet in the third after 1, 3, and 2 infusions, respectively. After appropriate washout of re-IFX, all three patients were administered subcutaneous adalimumab, with a dosing regimen of 40 mg/fortnight, and a good response was achieved. Our three patients with BD experienced a rapid disease relapse after switching from re-IFX to bio-IFX, possibly due to cross-reaction of anti-IFX antibodies. This outcome suggests the necessity to exercise caution regarding the automatic substitution of re-IFX with bio-IFX in patients achieving remission with re-IFX.
机译:据报道,三名受贝塞特氏病(BD)感染的患者患有严重的葡萄膜炎和神经系统疾病,临床症状稳定,并且从参考英夫利昔单抗(re-IFX)改为生物仿制药英夫利昔单抗(bio-IFX)后迅速复发。为了遵守当地卫生主管部门的规定,将两名男性和一名女性(分别为38岁,26岁和40岁)并发BD并伴有严重葡萄膜炎和神经性Behçet且长期缓解的患者改行从IFX到bio-IFX,每8周以5 mg / kg静脉输注的相同剂量方案。所有三名患者均经历疾病发作,在分别输注1、3和2次后,第一例患者出现葡萄膜视网膜炎复发,第二例患者复发神经-贝塞特,第三例患者发生葡萄膜炎和神经贝塞特。适当冲洗re-IFX后,所有三名患者均接受皮下注射阿达木单抗治疗,给药方案为40 mg /两周,并取得了良好的疗效。我们的三名BD患者在从re-IFX切换到bio-IFX后经历了疾病的快速复发,这可能是由于抗IFX抗体的交叉反应所致。该结果表明,对于通过re-IFX缓解的患者,将re-IFX自动替换为bio-IFX时要保持谨慎。

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