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比较英夫利昔单抗与英夫利昔单抗-abda 治疗化脓性汗腺炎患者的有效性和安全性。

Comparing the Effectiveness and Safety Associated With Infliximab vs Infliximab-abda Therapy for Patients With Hidradenitis Suppurativa.

机构信息

University of North Carolina School of Medicine, Chapel Hill.

University of North Carolina Gillings School of Public Health, Chapel Hill.

出版信息

JAMA Dermatol. 2021 Jun 1;157(6):708-711. doi: 10.1001/jamadermatol.2021.0220.

Abstract

IMPORTANCE

Although limited effective and affordable treatment options exist for hidradenitis suppurativa, recent studies describe the effectiveness of a medical therapy, infliximab, for the treatment of hidradenitis suppurativa. Cost-saving biosimilar alternatives have recently become available, but no data currently exist on their safety and effectiveness.

OBJECTIVE

To evaluate the effectiveness of infliximab-abda vs infliximab administration associated with the treatment of hidradenitis suppurativa.

DESIGN, SETTING, AND PARTICIPANTS: This retrospective cohort study identified patients treated with infliximab or infliximab-abda between 2016 and 2020 at the dermatology clinic at the University of North Carolina at Chapel Hill. The study population included patients who met the clinical criteria for hidradenitis suppurativa and had received a continuous dose of infliximab or infliximab-abda for at least 10 weeks. In total, 62 potential participants were identified using clinical tracking lists on the electronic medical records, and 34 participants were included in the final analysis.

EXPOSURES

Patients who started receiving infliximab or infliximab-abda were clinically tracked for a minimum of 10 weeks using the electronic medical record system, beginning at the time of drug initiation. Patients received loading doses of 10 mg/kg at weeks 0, 2, and 6, and then treatment was continued with a maintenance dose administered every 4 to 8 weeks.

MAIN OUTCOMES AND MEASURES

The primary outcome measure was Hidradenitis Suppurativa Clinical Response, defined as at least 50% decrease in inflammatory nodule count without any increase in number of abscesses or draining sinuses.

RESULTS

Of 34 participants, 20 comprised the infliximab treatment group (mean [SD] age, 42.2 [13.2] years; 17 women [85%]), and 14 comprised the infliximab-abda treatment group (mean [SD] age, 35.5 [10.9] years; 13 women [93%]). The proportions of patients achieving a Hidradenitis Suppurativa Clinical Response were 71% (10 patients) in the infliximab-abda and 60% (12 patients) in the infliximab treatment group, which were not significantly different (P = .47).

CONCLUSIONS AND RELEVANCE

This cohort study found that both infliximab administration and infliximab-abda administration were associated with similar and significant improvement in disease as measured by the Hidradenitis Suppurativa Clinical Response. Infliximab-abda is likely a reasonable treatment option for hidradenitis suppurativa, and further research is warranted.

摘要

重要性:尽管目前已有一些有限的有效且负担得起的治疗选择用于治疗化脓性汗腺炎,但最近的研究描述了一种医学疗法英夫利昔单抗治疗化脓性汗腺炎的有效性。最近出现了节省成本的生物类似物替代品,但目前尚无关于其安全性和有效性的数据。

目的:评估英夫利昔单抗-abda 与英夫利昔单抗联合治疗化脓性汗腺炎的有效性。

设计、地点和参与者:这项回顾性队列研究在北卡罗来纳大学教堂山分校皮肤科诊所确定了 2016 年至 2020 年期间接受英夫利昔单抗或英夫利昔单抗-abda 治疗的患者。研究人群包括符合化脓性汗腺炎临床标准且至少连续接受英夫利昔单抗或英夫利昔单抗-abda 治疗 10 周的患者。共使用电子病历的临床跟踪列表确定了 62 名潜在参与者,其中 34 名参与者纳入最终分析。

暴露:患者在开始使用药物时开始通过电子病历系统接受英夫利昔单抗或英夫利昔单抗-abda 治疗,至少接受 10 周的临床跟踪。患者在第 0、2 和 6 周接受 10mg/kg 的负荷剂量,然后每 4 至 8 周继续维持剂量治疗。

主要结局和测量:主要结局测量是化脓性汗腺炎临床应答,定义为炎症性结节计数至少减少 50%,且脓肿或窦道数量无增加。

结果:在 34 名参与者中,20 名患者接受英夫利昔单抗治疗(平均[标准差]年龄 42.2[13.2]岁;17 名女性[85%]),14 名患者接受英夫利昔单抗-abda 治疗(平均[标准差]年龄 35.5[10.9]岁;13 名女性[93%])。英夫利昔单抗-abda 组和英夫利昔单抗组的患者达到化脓性汗腺炎临床应答的比例分别为 71%(10 例)和 60%(12 例),差异无统计学意义(P = .47)。

结论和相关性:这项队列研究发现,英夫利昔单抗给药和英夫利昔单抗-abda 给药都与疾病的显著改善相关,这可以通过化脓性汗腺炎临床应答来衡量。英夫利昔单抗-abda 可能是化脓性汗腺炎的合理治疗选择,需要进一步研究。

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