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三名白塞病患者从英夫利昔单抗原研药换用生物类似药英夫利昔单抗后疗效迅速丧失。

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

作者信息

Cantini Fabrizio, Niccoli Laura, Nannini Carlotta, Cassarà Emanuele, Kaloudi Olga

机构信息

Division of Rheumatology, Azienda USL Toscana Centro, Hospital of Prato, Italy.

出版信息

Eur J Rheumatol. 2017 Dec;4(4):288-290. doi: 10.5152/eurjrheum.2017.16112. Epub 2017 Oct 25.

Abstract

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.

摘要

报告了3例白塞病(BD)患者,他们患有严重葡萄膜炎且有神经受累,临床处于稳定缓解期,但在从参比英夫利昔单抗(re-IFX)换用生物类似药英夫利昔单抗(bio-IFX)后迅速复发。为遵守当地卫生当局的规定,2名男性和1名女性(分别为38岁、26岁和40岁)患有BD并伴有严重葡萄膜炎和神经白塞病,且处于长期缓解期,他们从re-IFX换用bio-IFX,采用相同的给药方案,即每8周静脉输注5 mg/kg。所有3例患者均出现病情复发,第1例患者在输注1次后葡萄膜视网膜炎复发,第2例患者在输注3次后神经白塞病复发,第3例患者在输注2次后葡萄膜炎和神经白塞病复发。在适当洗脱re-IFX后,所有3例患者均接受皮下注射阿达木单抗,给药方案为每两周40 mg,取得了良好疗效。我们的3例BD患者在从re-IFX换用bio-IFX后病情迅速复发,可能是由于抗IFX抗体的交叉反应。这一结果表明,对于使用re-IFX实现缓解的患者,在用bio-IFX自动替代re-IFX时需谨慎。

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