Jette A van Lint, Naomi T Jessurun, Sander W Tas, Harald E Vonkeman, Martijn B A van Doorn, Frank Hoentjen, Michael T Nurmohamed, Eugene P van Puijenbroek, Bart J F van den Bemt
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Baseline and treatment characteristics of patients with fatigue and patients reporting other ADRs or no ADRs were compared.</p><p><strong>Results: </strong>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%). 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Baseline and treatment characteristics of patients with fatigue and patients reporting other ADRs or no ADRs were compared.</p><p><strong>Results: </strong>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%). 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引用次数: 0
摘要
背景:疲劳是免疫介导炎性疾病(IMID)患者的常见问题，严重影响其生活质量。目的:在本研究中，我们描述了疲劳作为一种患者报告的生物制剂不良反应(ADR)的模式和特征，并将患者和治疗特征与报告其他ADR或无ADR的患者进行了比较。方法:在这项队列事件监测研究中，对荷兰生物监测中报告的疲劳的描述和特征进行评估和分析，以确定常见的反复出现的主题或模式。比较疲劳患者和报告其他不良反应或无不良反应患者的基线和治疗特征。结果:在1382名参与研究的患者中，108名患者(8%)报告疲劳是一种生物制剂的不良反应。这些患者中几乎有一半(50名患者，46%)描述了在生物注射期间或注射后不久的疲劳发作，这种情况经常在后续注射后复发。疲劳患者明显比其他不良反应患者或无不良反应患者年轻(疲劳患者的中位年龄，52岁;其他不良反应患者的中位年龄为56岁;无不良反应患者的中位年龄为58岁);吸烟频率明显增加(25% vs. 16%和15%);使用英夫利昔单抗(22%对9%和13%)、利妥昔单抗(9%对3%和1%)或维多单抗(6%对2%和1%);患克罗恩病(28%对13%和13%)和其他合并症(31%对20%和15%)的几率明显更高。疲劳患者使用依那西普的频率明显降低(12%对29%和34%)或类风湿关节炎患者(30%对45%和43%)。结论:IMID患者可能会因生物制剂的给药后效应而感到疲劳。
Recurring Fatigue After Biologic Administration: Patient-Reported Data from the Dutch Biologic Monitor.
Background: Fatigue is a common problem in immune-mediated inflammatory disease (IMID) patients, significantly impacting their quality of life.
Objectives: 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.
Methods: 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.
Results: 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%).
Conclusions: IMID patients may experience fatigue as a postdosing effect of biologics.
期刊介绍：
An essential resource for R&D professionals and clinicians with an interest in biologic therapies.
BioDrugs covers the development and therapeutic application of biotechnology-based pharmaceuticals and diagnostic products for the treatment of human disease.
BioDrugs offers a range of additional enhanced features designed to increase the visibility, readership and educational value of the journal’s content. Each article is accompanied by a Key Points summary, giving a time-efficient overview of the content to a wide readership. Articles may be accompanied by plain language summaries to assist patients, caregivers and others in understanding important medical advances. The journal also provides the option to include various other types of enhanced features including slide sets, videos and animations. All enhanced features are peer reviewed to the same high standard as the article itself. Peer review is conducted using Editorial Manager®, supported by a database of international experts. This database is shared with other Adis journals.
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