Introduction Preserving fertility is crucial when managing male patients with spondyloarthritis (SpA) and/or psoriasis (PsO), especially in young men. Chronic inflammation, hormonal dysregulation, and immunosuppressive therapies can negatively impact male fertility. Over the past decades, positive data have emerged regarding the reproductive safety of various therapies in men. Ixekizumab (IXE), a high-affinity monoclonal antibody targeting IL-17A, has shown a safe profile for male fertility in small studies. This pilot study assesses the impact of IXE treatment on sperm parameters in SpA and/or PsO patients in a real-world setting. Methods Consecutive adult male SpA and/or PsO patients eligible for or undergoing IXE treatment were prospectively enrolled. Demographic data, disease characteristics, laboratory assessments, comorbidities, and previous treatments were recorded. Sperm analysis was conducted after a minimum of 6 months of IXE treatment, and also before treatment inititation in a subgroup of patients. Parallel sperm evaluations were performed in a control group of healthy donors. Results Ten patients were enrolled: 8 with SpA and 2 with PsO. After 6 months of IXE treatment, all patients had normal sperm parameters. One SpA and PsO patient with baseline oligozoospermia showed normal parameters at follow-up and achieved a successful pregnancy post-treatment. Compared with controls, IXE-treated patients had lower sperm concentrations but higher vitality. Conclusion In our limited size pilot study on SpA and PsO patients, Ixekizumab exposure did not impair male fertility. Sperm parameters remained within normal ranges after a minimum of 6 months of treatment. Early Ixekizumab treatment may preserve or potentially reverse fertility impairment.

中文翻译：

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ixekizumab 治疗后保留了男性生育能力——一项现实生活中的试点研究


简介 在管理患有脊柱关节炎 （SpA） 和/或银屑病 （PsO） 的男性患者时，保持生育能力至关重要，尤其是在年轻男性中。慢性炎症、荷尔蒙失调和免疫抑制疗法会对男性生育能力产生负面影响。在过去的几十年里，出现了关于各种疗法在男性中的生殖安全性的积极数据。Ixekizumab （IXE） 是一种靶向 IL-17A 的高亲和力单克隆抗体，在小型研究中显示出对男性生育能力的安全特征。这项初步研究在真实环境中评估了 IXE 治疗对 SpA 和/或 PsO 患者精子参数的影响。方法 前瞻性纳入符合或接受 IXE 治疗的连续成年男性 SpA 和/或 PsO 患者。记录人口统计数据、疾病特征、实验室评估、合并症和既往治疗。精子分析是在 IXE 治疗至少 6 个月后进行的，并且在治疗开始前对一个亚组患者进行。在健康供体的对照组中进行平行精子评估。结果 共纳入 10 例患者： SpA 8 例，PsO 2 例。IXE 治疗 6 个月后，所有患者的精子参数均正常。1 例基线少精症 SpA 和 PsO 患者在随访中参数正常，并在治疗后成功怀孕。与对照组相比，IXE 治疗的患者精子浓度较低，但活力较高。结论 在我们关于 SpA 和 PsO 患者的有限规模试点研究中，Ixekizumab 暴露不会损害男性生育能力。治疗至少 6 个月后，精子参数保持在正常范围内。早期 Ixekizumab 治疗可能会保留或可能逆转生育能力损害。