Netherlands Pharmacovigilance Centre Lareb, Goudsbloemvallei 7, 5237 MH, 's-Hertogenbosch, The Netherlands.
Department of Pharmacy, Radboud University Medical Center, Nijmegen, The Netherlands.
BioDrugs. 2023 Jul;37(4):541-550. doi: 10.1007/s40259-023-00592-8. Epub 2023 Apr 3.
Fatigue is a common problem in immune-mediated inflammatory disease (IMID) patients, significantly impacting their quality of life.
In this study, we describe the pattern and characteristics of fatigue as a patient-reported adverse drug reaction (ADR) of biologics, and compared patient and treatment characteristics with patients reporting other ADRs or no ADRs.
In this cohort event monitoring study, the description and characteristics of fatigue reported as a possible ADR in the Dutch Biologic Monitor were assessed and analysed for commonly recurring themes or patterns. Baseline and treatment characteristics of patients with fatigue and patients reporting other ADRs or no ADRs were compared.
Of 1382 participating patients, 108 patients (8%) reported fatigue as an ADR of a biologic. Almost half of these patients (50 patients, 46%) described episodes of fatigue during or shortly after biologic injection, which often recurred following subsequent injections. Patients with fatigue were significantly younger than patients with other ADRs or patients without ADRs (median age for patients with fatigue, 52 years; median age for patients with other ADRs, 56 years; and median age for patients without ADRs, 58 years); significantly more often smoked (25% vs. 16% and 15%); used infliximab (22% vs. 9% and 13%), rituximab (9% vs. 3% and 1%) or vedolizumab (6% vs. 2% and 1%); and significantly more often had Crohn's disease (28% vs. 13% and 13%) and other comorbidities (31% vs. 20% and 15%). Patients with fatigue significantly less frequently used etanercept (12% vs. 29% and 34%) or had rheumatoid arthritis (30% vs. 45% and 43%).
IMID patients may experience fatigue as a postdosing effect of biologics.
疲劳是免疫介导的炎症性疾病（IMID）患者的常见问题，显著影响其生活质量。
本研究描述了生物制剂作为不良反应（ADR）的疲劳模式和特征，并比较了报告疲劳和其他 ADR 或无 ADR 的患者的患者和治疗特征。
在这项队列事件监测研究中，评估并分析了荷兰生物监测报告的可能生物制剂 ADR 中的疲劳描述和特征，并分析了常见的反复出现的主题或模式。比较了有疲劳、有其他 ADR 或无 ADR 的患者的基线和治疗特征。
在 1382 名参与患者中，108 名患者（8%）报告生物制剂的疲劳为 ADR。这些患者中有近一半（50 名，46%）描述了生物制剂注射期间或之后不久出现疲劳发作，随后注射后经常复发。有疲劳的患者明显比有其他 ADR 或无 ADR 的患者年轻（疲劳患者的中位年龄为 52 岁；有其他 ADR 的患者的中位年龄为 56 岁；无 ADR 的患者的中位年龄为 58 岁）；吸烟的比例明显更高（25%比 16%和 15%）；使用英夫利昔单抗（22%比 9%和 13%）、利妥昔单抗（9%比 3%和 1%）或维得利珠单抗（6%比 2%和 1%）的比例明显更高；患有克罗恩病（28%比 13%和 13%）和其他合并症（31%比 20%和 15%）的比例明显更高。有疲劳的患者使用依那西普（12%比 29%和 34%）或患有类风湿关节炎（30%比 45%和 43%）的比例明显更低。
IMID 患者可能会经历生物制剂的给药后效应引起的疲劳。
