Background/Aims Interleukin (IL)-17 plays a role in host defense against common extracellular pathogens, including fungi. Treatment with IL-17 inhibitors has been associated with fungal infections. Ixekizumab (IXE) is an anti-IL-17A monoclonal antibody approved for the treatment of psoriasis (PsO) in adults and children, psoriatic arthritis (PsA) in adults, and axial spondyloarthritis (axSpA) in adults. This integrated post-hoc analysis investigates treatment-emergent fungal infections in IXE-treated patients across the approved indications. Methods Safety data on fungal infections were pooled from the IXE paediatric and adult clinical trial programs, comprising 26 clinical studies. Here, we describe the types of fungal infections, number of infections, recurrence (defined by at least two separate events irrespective of location), severity (defined at the investigator’s discretion), events that lead to discontinuation, and anti-fungal medications. Data are presented as frequency or incidence rate per 100 person-years (IR). Results Fungal infections were reported in patients with PsO (IR = 4.0), PsA (IR = 4.1), and axSpA (IR = 2.7). Across indications, most fungal infections were not recurrent and were classified as mild or moderate in severity. There were few severe fungal infections in patients with PsO (IR = 0.1), PsA (IR = 0.0), and axSpA (IR = 0.0). Most fungal infections in patients with PsO, PsA, and axSpA were candidiasis (IR = 1.9, IR = 2.5, IR = 1.4, respectively) and superficial dermatophytosis (IR = 1.5, IR = 1.0, IR = 1.0, respectively). No cases of subcutaneous and systemic mycosis infections were reported. The proportions of patients with PsO, PsA, and axSpA who received a topical vs systemic anti-fungal medication were 53.6% vs 1.1%, 47.8% vs 0.0%, and 45.6% vs 3.5%, respectively (Table 1). Most fungal infections did not lead to discontinuation of IXE (Table 1). Conclusion Consistent with previously disclosed IXE data, the majority of treatment-emergent fungal infections observed in patients with PsO, PsA, or axSpA treated with IXE were: (i) not recurrent; (ii) mild or moderate in severity, (iii) associated with candidiasis and superficial dermatophytosis, (iv) managed with topical anti-fungal medications or no treatment reported, and (v) not leading to drug discontinuation. Disclosure S. Schwartzman: Corporate appointments; SS reports being a board member of the National Psoriasis Foundation. Consultancies; S. Schwartzman has served as a speaker and/or consultant for AbbVie, Janssen, Eli Lilly and Company, Pfizer, UCB, Myriad, Novartis, Regeneron, Sanofi, Stelexis, Jubilant, Teijin. L. Puig: Corporate appointments; Board member of the International Psoriasis Council. Consultancies; AbbVie, Almirall, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Janssen, Leo Pharma, Eli Lilly and Company, Novartis, Pfizer, Sandoz, Sanofi, UCB. Honoraria; Boehringer Ingelheim, Janssen, Eli Lilly and Company, Novartis, UCB, travel support from Janssen, Eli Lilly and Company, Pfizer, UCB. Grants/research support; L. Puig reports receiving grants from AbbVie, Almirall, Amgen, Boehringer Ingelheim, Leo Pharma, Eli Lilly and Company, Novartis, Pfizer, Sanofi, UCB. A.D. Cohen: Honoraria; AbbVie, Amgen, Boehringer Ingelheim, Dexcel Pharma; Janssen, Eli Lilly and Company, Neopharm, Novartis, Perrigo, Pfizer, Rafa. Grants/research support; A. D. Cohen has served on advisory board for Samsung, and reports receiving grants from AbbVie, Janssen, Novartis, Pfizer, travel support from AbbVie. S. Khattri: Consultancies; S. Khattri reports being part of Eli Lilly and Company speaker’s bureau, receiving consulting fees and honoraria from Eli Lilly and Company, AbbVie, UCB, Janssen, BI, Regeneron, Leo Pharma. C. Jossart: Shareholder/stock ownership; C. Jossart is a stockholder of Eli Lilly and Company and was an employee of Eli Lilly and Company when this study was conducted. C. Diaz: Shareholder/stock ownership; C. Diaz is employee and stockholder of Eli Lilly and Company. A. Garrelts: Shareholder/stock ownership; A. Garrelts is employee and stockholder of Eli Lilly and Company. D. Zhu: Shareholder/stock ownership; D. Zhu is employee and stockholder of Eli Lilly and Company. N. Eberhart: Shareholder/stock ownership; N. Eberhart is employee and stockholder of Eli Lilly and Company. A. Eleftheriadi: Shareholder/stock ownership; A. Eleftheriadi is employee and stockholder of Eli Lilly and Company. N. Tangsirisap: Shareholder/stock ownership; N. Tangsirisap is employee and stockholder of Eli Lilly and Company. C. Schuster: Shareholder/stock ownership; C. Schuster is an employee and stockholder of Eli Lilly and Company. A.B. Gottlieb: Consultancies; Xbiotech (stock options for an RA project). Honoraria; Amgen, AnaptysBio, Avotres Therapeutics, Boehringer Ingelheim, Bristol Myers Squibb, Dice Therapuetics, Dermavant, Lilly, Janssen, Leo, Pharma, Novartis, Pfizer, Sanofi, Sun Pharma, UCB Pharma. Grants/research support; AnaptysBio, Moonlake Immunotherapeutics, Novartis, BMS, and UCB Pharma; all funds go to the Icahn School of Medicine at Mount Sinai. M. Sheesh: Shareholder/stock ownership; MS is a full-time employee and minor share holder of Eli-Lilly and Company.

中文翻译：

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P172 对接受 ixekizumab 治疗的银屑病、银屑病关节炎或中轴型脊柱关节炎患者治疗中出现的真菌感染进行的综合安全性分析，来自 26 项临床研究

背景/目标 白细胞介素 (IL)-17 在宿主防御常见细胞外病原体（包括真菌）中发挥作用。 IL-17 抑制剂治疗与真菌感染有关。 Ixekizumab (IXE) 是一种抗 IL-17A 单克隆抗体，被批准用于治疗成人和儿童银屑病 (PsO)、成人银屑病关节炎 (PsA) 和成人中轴型脊柱关节炎 (axSpA)。这项综合事后分析调查了接受 IXE 治疗的患者在已批准的适应症中出现的治疗中出现的真菌感染。方法 真菌感染的安全性数据来自 IXE 儿童和成人临床试验项目，包括 26 项临床研究。在这里，我们描述了真菌感染的类型、感染数量、复发（由至少两个单独的事件定义，无论位置如何）、严重程度（由研究者自行决定）、导致停药的事件和抗真菌药物。数据以每 100 人年 (IR) 的频率或发病率表示。结果 PsO (IR = 4.0)、PsA (IR = 4.1) 和 axSpA (IR = 2.7) 患者均报告有真菌感染。在各种适应症中，大多数真菌感染不会复发，并且严重程度被归类为轻度或中度。 PsO (IR = 0.1)、PsA (IR = 0.0) 和 axSpA (IR = 0.0) 患者中很少有严重真菌感染。 PsO、PsA 和 axSpA 患者的大多数真菌感染为念珠菌病（分别为 IR = 1.9、IR = 2.5、IR = 1.4）和浅表皮肤癣菌病（分别为 IR = 1.5、IR = 1.0、IR = 1.0）。未报告皮下和全身性真菌病感染病例。接受局部与全身抗真菌药物治疗的 PsO、PsA 和 axSpA 患者的比例分别为 53.6% vs 1.1%、47.8% vs 0.0% 和 45.6% vs 3.5%（表 1）。大多数真菌感染不会导致 IXE 的终止（表 1）。结论 与之前披露的 IXE 数据一致，在接受 IXE 治疗的 PsO、PsA 或 axSpA 患者中观察到的大多数治疗中出现的真菌感染是：(i) 不复发； (ii) 严重程度为轻度或中度，(iii) 与念珠菌病和浅表皮肤癣菌病相关，(iv) 使用局部抗真菌药物治疗或未报告治疗，以及 (v) 不会导致停药。披露 S. Schwartzman：公司任命； SS 自称是国家银屑病基金会的董事会成员。咨询； S. Schwartzman 曾担任 AbbVie、Janssen、Eli Lilly and Company、Pfizer、UCB、Myriad、Novartis、Regeneron、Sanofi、Stelexis、Jubilant、Teijin 的演讲者和/或顾问。 L. Puig：公司任命；国际银屑病理事会董事会成员。咨询；艾伯维、Almirall、安进、勃林格殷格翰、百时美施贵宝、杨森、Leo Pharma、礼来公司、诺华、辉瑞、山德士、赛诺菲、UCB。酬金；勃林格殷格翰、杨森、礼来公司、诺华、UCB、来自杨森、礼来公司、辉瑞、UCB 的差旅支持。赠款/研究支持； L. Puig 报告获得了艾伯维 (AbbVie)、Almirall、安进 (Amgen)、勃林格殷格翰 (Boehringer Ingelheim)、Leo Pharma、礼来制药 (Eli Lilly and Company)、诺华 (Novartis)、辉瑞 (Pfizer)、赛诺菲 (Sanofi)、UCB 等机构的资助。 AD科恩：酬金；艾伯维、安进、勃林格殷格翰、Dexcel Pharma；杨森、礼来公司、Neopharm、诺华、Perrigo、辉瑞、Rafa。赠款/研究支持； AD Cohen 曾在三星顾问委员会任职，并报告获得艾伯维 (AbbVie)、杨森 (Janssen)、诺华 (Novartis)、辉瑞 (Pfizer) 的资助以及艾伯维 (AbbVie) 的旅行支持。 S. Khattri：咨询； S. Khattri 报告说，他是礼来公司发言人办公室的一员，接受礼来公司、艾伯维、UCB、杨森、BI、Regeneron、Leo Pharma 的咨询费和酬金。 C. Jossart：股东/股权； C. Jossart 是礼来公司的股东，并且在进行本研究时是礼来公司的员工。 C. Diaz：股东/股权； C. Diaz 是礼来公司的员工和股东。 A. Garrelts：股东/股权； A. Garrelts 是礼来公司的员工和股东。 D. Zhu：股东/股权； D. Zhu 是礼来公司的员工和股东。 N. Eberhart：股东/股权； N. Eberhart 是礼来公司的员工和股东。 A. Eleftheriadi：股东/股权； A. Eleftheriadi 是礼来公司的员工和股东。 N. Tangsirisap：股东/股权； N. Tangsirisap 是礼来公司的员工和股东。 C. Schuster：股东/股权； C. Schuster 是礼来公司的员工和股东。 AB Gottlieb：咨询； Xbiotech（RA 项目的股票期权）。酬金；安进、AnaptysBio、Avotres Therapeutics、勃林格殷格翰、百时美施贵宝、Dice Therapuetics、Dermavant、礼来、杨森、Leo、Pharma、诺华、辉瑞、赛诺菲、Sun Pharma、UCB Pharma。赠款/研究支持； AnaptysBio、Moonlake Immuntherapeutics、诺华、BMS 和 UCB Pharma；所有资金都捐给西奈山伊坎医学院。 M. Sheesh：股东/股权； MS 是 Eli-Lilly and Company 的全职员工和小股东。BI、再生元、利奥制药。 C. Jossart：股东/股权； C. Jossart 是礼来公司的股东，并且在进行本研究时是礼来公司的员工。 C. Diaz：股东/股权； C. Diaz 是礼来公司的员工和股东。 A. Garrelts：股东/股权； A. Garrelts 是礼来公司的员工和股东。 D. Zhu：股东/股权； D. Zhu 是礼来公司的员工和股东。 N. Eberhart：股东/股权； N. Eberhart 是礼来公司的员工和股东。 A. Eleftheriadi：股东/股权； A. Eleftheriadi 是礼来公司的员工和股东。 N. Tangsirisap：股东/股权； N. Tangsirisap 是礼来公司的员工和股东。 C. Schuster：股东/股权； C. Schuster 是礼来公司的员工和股东。 AB Gottlieb：咨询； Xbiotech（RA 项目的股票期权）。酬金；安进、AnaptysBio、Avotres Therapeutics、勃林格殷格翰、百时美施贵宝、Dice Therapuetics、Dermavant、礼来、杨森、Leo、Pharma、诺华、辉瑞、赛诺菲、Sun Pharma、UCB Pharma。赠款/研究支持； AnaptysBio、Moonlake Immuntherapeutics、诺华、BMS 和 UCB Pharma；所有资金都捐给西奈山伊坎医学院。 M. Sheesh：股东/股权； MS 是礼来公司的全职员工和小股东。BI、再生元、利奥制药。 C. Jossart：股东/股权； C. Jossart 是礼来公司的股东，并且在进行本研究时是礼来公司的员工。 C. Diaz：股东/股权； C. Diaz 是礼来公司的员工和股东。 A. Garrelts：股东/股权； A. Garrelts 是礼来公司的员工和股东。 D. Zhu：股东/股权； D. Zhu 是礼来公司的员工和股东。 N. Eberhart：股东/股权； N. Eberhart 是礼来公司的员工和股东。 A. Eleftheriadi：股东/股权； A. Eleftheriadi 是礼来公司的员工和股东。 N. Tangsirisap：股东/股权； N. Tangsirisap 是礼来公司的员工和股东。 C. Schuster：股东/股权； C. Schuster 是礼来公司的员工和股东。 AB Gottlieb：咨询； Xbiotech（RA 项目的股票期权）。酬金；安进、AnaptysBio、Avotres Therapeutics、勃林格殷格翰、百时美施贵宝、Dice Therapuetics、Dermavant、礼来、杨森、Leo、Pharma、诺华、辉瑞、赛诺菲、Sun Pharma、UCB Pharma。赠款/研究支持； AnaptysBio、Moonlake Immuntherapeutics、诺华、BMS 和 UCB Pharma；所有资金都捐给西奈山伊坎医学院。 M. Sheesh：股东/股权； MS 是 Eli-Lilly and Company 的全职员工和小股东。股东/股权； MS 是 Eli-Lilly and Company 的全职员工和小股东。股东/股权； MS 是 Eli-Lilly and Company 的全职员工和小股东。