Internistische Gemeinschaftspraxis Für Verdauungs- Und Stoffwechselkrankheiten Leipzig Und Schkeuditz, Nordstraße 21, 04105, Leipzig, Sachsen, Germany.
Praxis Für Innere Medizin/Gastroenterologie, Allee Nach Sanssouci 7, 14471, Potsdam, Germany.
BMC Gastroenterol. 2021 Apr 12;21(1):161. doi: 10.1186/s12876-021-01747-z.
Ulcerative colitis (UC) is a chronic inflammatory bowel disease with recurrent episodes of debilitating symptoms negatively affecting work productivity and health-related quality of life (HRQoL). The use of biologics in UC treatment improves work and HRQoL but prospective long-term data concerning the treatment with TNFα inhibitor golimumab in UC patients are still rare. Therefore, our study aimed to evaluate the change in work productivity, capacity for daily activities and HRQoL in UC patients treated with golimumab in Germany.
Using the Work Productivity and Activity Impairment questionnaire, the change in work productivity and in capacity for daily activities after 3 months and over the whole observational period of 24 months were assessed (both primary endpoints). Disease-specific and health-related quality of life (QoL) were analyzed with the Inflammatory Bowel Disease Questionnaire (IBDQ), the Short-Form 12 Health Survey Questionnaire (SF-12), and the Partial Mayo Score (secondary endpoints). Further, disease-related hospitalization rates were assessed.
This prospective non-interventional study included 286 patients. Thereof, 212 patients were employed at baseline (modified intention to treat analysis set employed at baseline, mITTe). 61.3% of the mITTe patients had moderate and 17.0% had severe UC. Three months after initiation of golimumab therapy, total work productivity impairment (TWPI) score and activity impairment score improved significantly from baseline with a mean change of - 17.3% (p < 0.0001) and - 14.4% (p < 0.0001), respectively. Results persisted over 24 months (mean change TWPI score: - 24.5%, mean change activity impairment score: - 30.0%). Disease- and health-related QoL also improved significantly under golimumab treatment as indicated by increased IBDQ [mean change: 28.0 (SD: ± 36.1, month 3), 42.1 (SD: ± 39.5, month 24)] and SF-12 scores [PCS-12: 45.9 (SD: ± 8.5), MCS-12: 4.9 (SD: ± 10.6, month 3), PCS-12: 5.9 (SD: ± 9.0), MCS-12: 6.4 (SD: ± 11.1, month 24)]. Disease-related hospitalization rate decreased from 16.0% (BL) to 4.3% at month 24 and the mean number of missed working days due to UC decreased from 8.2 (SD: 17.6, BL) to 0.7 (SD: 2.1) after golimumab induction.
Golimumab leads to notable long-term improvements in work productivity, daily activity, HRQoL, and disease-related hospitalization rates in patients with moderate to severe UC.
PEI (Paul-Ehrlich-Institute, Langen, Germany) Registration Nr: NIS#255 ( https://www.pei.de/SharedDocs/awb/nis-0201-0300/0255.html ).
溃疡性结肠炎（UC）是一种慢性炎症性肠病，反复发作的衰弱症状会对工作生产力和健康相关生活质量（HRQoL）产生负面影响。生物制剂在 UC 治疗中的应用改善了工作和 HRQoL，但关于 TNFα 抑制剂戈利木单抗在 UC 患者中的长期治疗数据仍然很少。因此，我们的研究旨在评估德国接受戈利木单抗治疗的 UC 患者的工作生产力、日常活动能力和 HRQoL 的变化。
使用工作生产力和活动障碍问卷，评估 3 个月和整个 24 个月观察期后的工作生产力和日常活动能力变化（均为主要终点）。使用炎症性肠病问卷（IBDQ）、短表单 12 健康调查问卷（SF-12）和部分 Mayo 评分（次要终点）分析疾病特异性和健康相关生活质量（QoL）。此外，还评估了与疾病相关的住院率。
这是一项前瞻性非干预性研究，纳入了 286 名患者。其中，212 名患者在基线时有工作（改良意向治疗分析集在基线时有工作，mITTe）。mITTe 患者中有 61.3%为中度 UC，17.0%为重度 UC。戈利木单抗治疗 3 个月后，总工作生产力障碍（TWPI）评分和活动障碍评分与基线相比显著改善，平均变化分别为-17.3%（p<0.0001）和-14.4%（p<0.0001）。结果在 24 个月内持续（TWPI 评分平均变化：-24.5%，活动障碍评分平均变化：-30.0%）。在戈利木单抗治疗下，疾病和健康相关的 QoL 也显著改善，IBDQ[平均变化：28.0（SD：±36.1，第 3 个月），42.1（SD：±39.5，第 24 个月）]和 SF-12 评分[PCS-12：45.9（SD：±8.5），MCS-12：4.9（SD：±10.6，第 3 个月），PCS-12：5.9（SD：±9.0），MCS-12：6.4（SD：±11.1，第 24 个月）]也有所增加。与疾病相关的住院率从 16.0%（BL）下降到第 24 个月的 4.3%，UC 导致的平均旷工天数从 8.2（SD：17.6，BL）减少到戈利木单抗诱导后的 0.7（SD：2.1）。
戈利木单抗可显著改善中重度 UC 患者的工作生产力、日常活动、HRQoL 和与疾病相关的住院率。
PEI（Paul-Ehrlich-Institute，德国朗根）注册编号：NIS#255（https://www.pei.de/SharedDocs/awb/nis-0201-0300/0255.html）。
