ixekizumab治疗中重度斑块性银屑病的有效性和安全性

Mdp Briceño Casado, Gil-Sierra, B. D. L. C. Riaguas, M. Domínguez-Cantero
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Effectiveness was measured by the psoriasis area severity index (PASI): PASI-75 (≥75% reduction in baseline PASI), PASI-90 (≥90% reduction) and PASI-100 (total clearance of lesions) at weeks 12 and 36. Failure to achieve PASI-75 was considered no response. Safety was evaluated according to adverse events (AE) and discontinuations of treatment. Results 46 patients were included, 27 (59%) were men. Mean age was 49 (23–74) years. Previous treatments: methotrexate (n=33), cyclosporine (n=29) and biological therapy (n=35). Mean number of prior biological drugs was 3 (1–5), including anti-TNF (etanercept, n=23; adalimumab, n=22; infliximab, n=3), anti-IL-12-23 (ustekinumab, n=16) and anti-IL-17A (secukinumab, n=7). All patients received ixekizumab with an induction dose of 160 mg at week 0 and then 80 mg at weeks 2, 4, 6, 8, 10 and 12. Maintenance dose was 80 mg every 4 weeks in 34 (74%) patients and every 6 weeks in 12 (26%). Mean duration of ixekizumab therapy was 17 (3–44) months. 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引用次数: 1

摘要

背景和重要性Ixekizumab是一种高亲和力的抗白细胞介素17A单克隆抗体。它用于治疗中重度斑块型银屑病(MTSPP)。目的和目的评价ixekizumab治疗MTSPP的临床有效性和安全性。材料与方法采用描述性、回顾性、多中心研究。纳入了2017年1月1日至2020年9月30日期间接受ixekizumab治疗的MTSPP患者。使用电子临床病史和处方程序Farmatools记录数据:性别、年龄、既往治疗、剂量和治疗持续时间。有效性通过银屑病区域严重程度指数(PASI)来衡量:第12周和第36周时,PASI-75(基线PASI降低≥75%),PASI-90(降低≥90%)和PASI-100(病变总清除率)。未能达到PASI-75被认为没有响应。根据不良事件(AE)和停药情况评估安全性。结果纳入46例患者,其中男性27例(59%)。平均年龄49岁(23-74岁)。既往治疗:甲氨蝶呤(n=33)、环孢素(n=29)和生物治疗(n=35)。在先生物药物平均为3个(1-5),其中抗tnf(依那西普,n=23;adalimumab n = 22;英夫利昔单抗,n=3),抗il -12-23 (ustekinumab, n=16)和抗il - 17a (secukinumab, n=7)。所有患者均接受ixekizumab治疗,诱导剂量在第0周为160 mg,然后在第2、4、6、8、10和12周为80 mg。34例(74%)患者维持剂量为每4周80mg, 12例(26%)患者维持剂量为每6周80mg。ixekizumab治疗的平均持续时间为17(3-44)个月。所有患者的基线PASI为bb50, 37例(80%)患者的基线PASI为bb10。由于缺乏信息,5例(11%)患者在第12周和8例(17%)患者在第36周未进行有效性评估。在第12周:1例(2%)患者出现PASI-75, 12例(26%)出现PASI-90, 23例(50%)出现PASI-100, 5例(11%)无反应。在第36周:1例(2%)患者达到PASI-75, 15例(33%)达到PASI-90, 16例(35%)达到PASI-100, 6例(13%)无反应。安全性方面,3例(7%)患者出现AE:脱发、嗜酸性粒细胞增多和注射部位反应。没有停止治疗的报告。Ixekizumab是有效的,并且在第12周时为一半的患者提供MTSPP病变的完全清除,在第36周时超过三分之一的患者有相当大的反应。Ixekizumab耐受性良好,AE发生率低。参考文献和/或致谢利益冲突无利益冲突
本文章由计算机程序翻译,如有差异,请以英文原文为准。
4CPS-324 Effectiveness and safety of ixekizumab in moderate-to-severe plaque psoriasis
Background and importance Ixekizumab is a high affinity monoclonal antibody against interleukin 17A. It is used for the treatment of moderate-to-severe plaque psoriasis (MTSPP). Aim and objectives To assess the effectiveness and safety of ixekizumab in MTSPP in clinical practice. Material and methods A descriptive, retrospective, multicentre study was conducted. Patients with MTSPP receiving ixekizumab between 1 January 2017 and 30 September 2020 were included. Electronic clinical history and the prescription programme Farmatools were used to record data: sex, age, previous treatment, dosage and duration of therapy. Effectiveness was measured by the psoriasis area severity index (PASI): PASI-75 (≥75% reduction in baseline PASI), PASI-90 (≥90% reduction) and PASI-100 (total clearance of lesions) at weeks 12 and 36. Failure to achieve PASI-75 was considered no response. Safety was evaluated according to adverse events (AE) and discontinuations of treatment. Results 46 patients were included, 27 (59%) were men. Mean age was 49 (23–74) years. Previous treatments: methotrexate (n=33), cyclosporine (n=29) and biological therapy (n=35). Mean number of prior biological drugs was 3 (1–5), including anti-TNF (etanercept, n=23; adalimumab, n=22; infliximab, n=3), anti-IL-12-23 (ustekinumab, n=16) and anti-IL-17A (secukinumab, n=7). All patients received ixekizumab with an induction dose of 160 mg at week 0 and then 80 mg at weeks 2, 4, 6, 8, 10 and 12. Maintenance dose was 80 mg every 4 weeks in 34 (74%) patients and every 6 weeks in 12 (26%). Mean duration of ixekizumab therapy was 17 (3–44) months. Baseline PASI was >5 in all patients and >10 in 37 (80%) cases. Effectiveness was not evaluated in 5 (11%) patients at week 12 and in 8 (17%) patients at week 36 due to lack of information. At week 12: 1 (2%) patient presented PASI-75, 12 (26%) PASI-90, 23 (50%) PASI-100 and 5 (11%) no response. At week 36: 1 (2%) patient achieved PASI-75, 15 (33%) PASI-90, 16 (35%) PASI-100 and 6 (13%) no response. Regarding the safety profile, 3 (7%) patients presented AE: alopecia, eosinophilia and injection site reaction. No discontinuations of treatment were reported. Conclusion and relevance Ixekizumab was effective and provided total clearance of MTSPP lesions to half of the patients by week 12, with this considerable response in more than a third of patients at week 36. Ixekizumab was well tolerated, with a low frequency of AE. References and/or acknowledgements Conflict of interest No conflict of interest
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