van Lint Jette A, Vriezekolk Johanna E, Jessurun Naomi T, den Broeder Alfons A, van den Bemt Bart J F, Huiskes Victor J B
Pharmacy, Radboudumc, Nijmegen, NL, Netherlands.
Netherlands Pharmacovigilance Centre Lareb, Goudsbloemvallei 7, 's-Hertogenbosch, 5237 MH, Netherlands.
Rheumatol Int. 2025 Jan 11;45(1):24. doi: 10.1007/s00296-024-05779-y.
This study investigated severity, course and patterns of fatigue surrounding subcutaneous biological disease-modifying antirheumatic drug (bDMARD) injection in inflammatory rheumatic disease (IRD) patients using ecological momentary assessments and investigated self-reported adverse drug reactions (ADRs). In this prospective cohort study, IRD patients completed fatigue severity numeric rating scales (0-10) in web-based ecological momentary assessments in three waves of five days surrounding bDMARD injection. The course of fatigue was measured by the change in fatigue from pre-dosing to post-dosing scores and was classified as: worsening, improving or no clinically relevant change. A pattern was defined as a course of worsening, improving or no clinically relevant change in fatigue in at least two out of three waves for patients completing assessments across all three waves. ADRs could be reported on day five of each wave. In total 609 participants completed ecological momentary assessments surrounding 1541 bDMARD injections. Overall average fatigue severity across all three waves was 4.5 (± SD 2.4) and 78% experienced severe fatigue in at least one assessment. Of 398 patients completing all three waves, 61% had no clinically relevant change in fatigue in at least two out of three waves, 13% had a pattern of worsening fatigue and 18% had a pattern of improving fatigue. Of 398 patients, 36% had a consistent pattern in all three waves. IRD patients using a bDMARD may consistently experience specific fatigue patterns surrounding bDMARD administration. These patterns provide insights for clinical practice and could be used to inform patients properly.
本研究使用生态瞬时评估法，调查了炎症性风湿病（IRD）患者皮下注射生物性改善病情抗风湿药物（bDMARD）前后疲劳的严重程度、病程及模式，并调查了自我报告的药物不良反应（ADR）。在这项前瞻性队列研究中，IRD患者在围绕bDMARD注射的三个为期五天的阶段中，通过基于网络的生态瞬时评估完成疲劳严重程度数字评定量表（0 - 10）。疲劳病程通过给药前至给药后分数的疲劳变化来衡量，并分类为：恶化、改善或无临床相关变化。对于完成所有三个阶段评估的患者，一种模式被定义为在三个阶段中至少两个阶段出现疲劳恶化、改善或无临床相关变化的病程。在每个阶段的第五天可报告ADR。共有609名参与者完成了围绕1541次bDMARD注射的生态瞬时评估。所有三个阶段的总体平均疲劳严重程度为4.5（±标准差2.4），78%的患者在至少一次评估中经历了严重疲劳。在398名完成所有三个阶段评估的患者中，61%在三个阶段中的至少两个阶段疲劳无临床相关变化，13%有疲劳恶化模式，18%有疲劳改善模式。在398名患者中，36%在所有三个阶段都有一致的模式。使用bDMARD的IRD患者在bDMARD给药前后可能会持续经历特定的疲劳模式。这些模式为临床实践提供了见解，并可用于对患者进行适当的告知。
