University of Liège and CHU, Liège, Belgium.
J Crohns Colitis. 2013 Feb;7(1):34-43. doi: 10.1016/j.crohns.2012.02.017. Epub 2012 Apr 4.
Crohn's disease negatively affects patients' quality of life and ability to work. We investigated the impact of adalimumab on work productivity, daily activities, and quality of life in an open-label trial (N=945). The population comprised both infliximab-naïve and -exposed patients, including infliximab primary non-responders.
Patients received adalimumab induction therapy (160 mg/80 mg at Weeks 0/2), followed by adalimumab 40 mg every other week for up to 20 weeks (patients with flares/non-response could receive 40 mg weekly at/after Week 12). The Work Productivity and Activity Impairment Questionnaire and Short Inflammatory Bowel Disease Questionnaire were assessed. Indirect cost savings were estimated based on the average work productivity improvements at Week 20.
Mean baseline scores indicated severe productivity impairment and poor quality of life. At Week 20, 60% of infliximab-naïve and 47% of infliximab primary non-responders achieved clinically important improvements (≥9 points) on the Short Inflammatory Bowel Disease Questionnaire, and 51% and 43%, respectively, achieved the minimum clinically important difference (improvement ≥7 percentage points) for total work productivity impairment (non-responder imputation). At Week 20, 64% of infliximab-naïve and 55% of infliximab primary non-responders achieved clinically important improvements in total activity impairment. Estimated 20-week total indirect productivity-related cost savings were €3070 per infliximab-naïve patient and €2059 per infliximab-exposed patient.
Adalimumab therapy significantly improved work productivity and disease-specific quality of life for patients with moderate to severe Crohn's disease. Patients who failed prior infliximab therapy and patients naïve to infliximab benefited from adalimumab, with potentially greater benefits for infliximab-naïve patients (NCT00409617).
克罗恩病对患者的生活质量和工作能力有负面影响。我们在一项开放性试验（N=945）中调查了阿达木单抗对工作生产力、日常活动和生活质量的影响。该人群包括英夫利昔单抗初治和经治患者，包括英夫利昔单抗原发性无应答者。
患者接受阿达木单抗诱导治疗（第 0 周和第 2 周给予 160 mg/80 mg），然后每 2 周给予阿达木单抗 40 mg，最多 20 周（出现 flares/无应答的患者可在第 12 周后每周给予 40 mg）。使用工作生产力和活动障碍问卷和简短炎症性肠病问卷进行评估。根据第 20 周的平均工作生产力改善情况，估算间接成本节约。
基线平均评分表明生产力严重受损和生活质量较差。在第 20 周时，60%的英夫利昔单抗初治患者和 47%的英夫利昔单抗原发性无应答者在简短炎症性肠病问卷上取得了临床重要改善（≥9 分），分别有 51%和 43%在总工作生产力障碍方面达到了最小临床重要差异（改善≥7 个百分点）（无应答者推断）。在第 20 周时，64%的英夫利昔单抗初治患者和 55%的英夫利昔单抗原发性无应答者在总活动障碍方面取得了临床重要改善。估计第 20 周的总间接生产力相关成本节约为每例英夫利昔单抗初治患者 3070 欧元，每例英夫利昔单抗经治患者 2059 欧元。
阿达木单抗治疗显著改善了中重度克罗恩病患者的工作生产力和疾病特异性生活质量。先前英夫利昔单抗治疗失败的患者和英夫利昔单抗初治患者均从阿达木单抗治疗中获益，英夫利昔单抗初治患者的获益可能更大（NCT00409617）。
