Danielle Bargo, Theo Tritton, Joseph C Cappelleri, Marco DiBonaventura, Timothy W Smith, Takanori Tsuchiya, Sean Gardiner, Irene Modesto, Tim Holbrook, Daniel Bluff, Taku Kobayashi
{"title":"日本溃疡性结肠炎患者:生物学持久性和保健资源利用。","authors":"Danielle Bargo, Theo Tritton, Joseph C Cappelleri, Marco DiBonaventura, Timothy W Smith, Takanori Tsuchiya, Sean Gardiner, Irene Modesto, Tim Holbrook, Daniel Bluff, Taku Kobayashi","doi":"10.1159/000519123","DOIUrl":null,"url":null,"abstract":"<p><strong>Objective: </strong>The aim of the study was to improve understanding of adherence and persistence to biologics, and their association with health-care resource utilization (HCRU), in Japanese patients with moderate to severe ulcerative colitis (UC).</p><p><strong>Methods: </strong>Data were from Medical Data Vision, a secondary care administrative database. A retrospective, longitudinal cohort analysis was conducted of data from UC patients initiating biologic therapy between August 2013 and July 2016. Data collected for 2 years prior (baseline) and 2 years after (follow-up) the index date were evaluated. Patients completing biologic induction were identified, and adherence/persistence to biologic therapy calculated. HCRU, steroid, and immunosuppressant use during baseline and follow-up were assessed. Biologic switching during the follow-up was evaluated. Descriptive statistics (e.g., means and proportions) were obtained and inferential analyses (from Student's <i>t</i> tests, Fisher's exact tests, χ<sup>2</sup> tests, the Cox proportional hazard model, and negative binomial regression) were performed.</p><p><strong>Results: </strong>The analysis included 649 patients (adalimumab: 265; infliximab: 384). Biologic induction was completed by 80% of patients. Adherence to adalimumab was higher than that to infliximab (<i>p</i> < 0.001). Persistence at 6, 12, 18, and 24 months was higher with infliximab than with adalimumab (<i>p</i> < 0.05). Overall, gastroenterology outpatient visits increased, and hospitalization frequency and duration decreased, from baseline to follow-up. UC-related hospitalizations were fewer and shorter, and endoscopies fewer, in persistent than in nonpersistent patients, although persistent patients made more outpatient visits than nonpersistent patients. Hospitalization duration was lower in persistent than nonpersistent patients. Approximately 50% of patients received an immunosuppressant during biologic therapy; 5% received a concomitant steroid during biologic therapy. Overall, 17% and 3% of patients, respectively, received 2nd line and 3rd line biologics.</p><p><strong>Conclusions: </strong>Poor biologic persistence was associated with increased non-medication-associated HCRU. 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A retrospective, longitudinal cohort analysis was conducted of data from UC patients initiating biologic therapy between August 2013 and July 2016. Data collected for 2 years prior (baseline) and 2 years after (follow-up) the index date were evaluated. Patients completing biologic induction were identified, and adherence/persistence to biologic therapy calculated. HCRU, steroid, and immunosuppressant use during baseline and follow-up were assessed. Biologic switching during the follow-up was evaluated. Descriptive statistics (e.g., means and proportions) were obtained and inferential analyses (from Student's <i>t</i> tests, Fisher's exact tests, χ<sup>2</sup> tests, the Cox proportional hazard model, and negative binomial regression) were performed.</p><p><strong>Results: </strong>The analysis included 649 patients (adalimumab: 265; infliximab: 384). Biologic induction was completed by 80% of patients. Adherence to adalimumab was higher than that to infliximab (<i>p</i> < 0.001). Persistence at 6, 12, 18, and 24 months was higher with infliximab than with adalimumab (<i>p</i> < 0.05). Overall, gastroenterology outpatient visits increased, and hospitalization frequency and duration decreased, from baseline to follow-up. UC-related hospitalizations were fewer and shorter, and endoscopies fewer, in persistent than in nonpersistent patients, although persistent patients made more outpatient visits than nonpersistent patients. Hospitalization duration was lower in persistent than nonpersistent patients. Approximately 50% of patients received an immunosuppressant during biologic therapy; 5% received a concomitant steroid during biologic therapy. Overall, 17% and 3% of patients, respectively, received 2nd line and 3rd line biologics.</p><p><strong>Conclusions: </strong>Poor biologic persistence was associated with increased non-medication-associated HCRU. 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引用次数: 2
摘要
目的:本研究的目的是提高对日本中重度溃疡性结肠炎(UC)患者对生物制剂的依从性和持久性及其与卫生保健资源利用(HCRU)的关系的理解。方法:数据来自二级医疗管理数据库Medical Data Vision。对2013年8月至2016年7月间开始生物治疗的UC患者的数据进行回顾性纵向队列分析。对指标日期前2年(基线)和后2年(随访)收集的数据进行评估。确定完成生物诱导的患者,并计算对生物治疗的依从性/持久性。评估基线和随访期间HCRU、类固醇和免疫抑制剂的使用情况。评估随访期间的生物转换。获得描述性统计数据(如均值和比例),并进行推理分析(来自Student's t检验、Fisher精确检验、χ2检验、Cox比例风险模型和负二项回归)。结果:分析纳入649例患者(阿达木单抗:265例;英夫利昔单抗:384)。80%的患者完成了生物诱导。阿达木单抗的依从性高于英夫利昔单抗(p < 0.001)。英夫利昔单抗组6、12、18和24个月的持续时间高于阿达木单抗组(p < 0.05)。总体而言,从基线到随访,胃肠病学门诊就诊增加,住院频率和持续时间减少。与非持续性患者相比,持续性患者与uc相关的住院次数更少,时间更短,内窥镜检查次数更少,尽管持续性患者比非持续性患者就诊次数更多。顽固性患者住院时间低于非顽固性患者。大约50%的患者在生物治疗期间接受了免疫抑制剂;5%的患者在生物治疗期间同时使用类固醇。总体而言,分别有17%和3%的患者接受了二线和三线生物制剂。结论:生物持续性差与非药物相关HCRU增加有关。UC需要高持续性和有限相关HCRU的有效治疗。
Living with Ulcerative Colitis in Japan: Biologic Persistence and Health-Care Resource Use.
Objective: The aim of the study was to improve understanding of adherence and persistence to biologics, and their association with health-care resource utilization (HCRU), in Japanese patients with moderate to severe ulcerative colitis (UC).
Methods: Data were from Medical Data Vision, a secondary care administrative database. A retrospective, longitudinal cohort analysis was conducted of data from UC patients initiating biologic therapy between August 2013 and July 2016. Data collected for 2 years prior (baseline) and 2 years after (follow-up) the index date were evaluated. Patients completing biologic induction were identified, and adherence/persistence to biologic therapy calculated. HCRU, steroid, and immunosuppressant use during baseline and follow-up were assessed. Biologic switching during the follow-up was evaluated. Descriptive statistics (e.g., means and proportions) were obtained and inferential analyses (from Student's t tests, Fisher's exact tests, χ2 tests, the Cox proportional hazard model, and negative binomial regression) were performed.
Results: The analysis included 649 patients (adalimumab: 265; infliximab: 384). Biologic induction was completed by 80% of patients. Adherence to adalimumab was higher than that to infliximab (p < 0.001). Persistence at 6, 12, 18, and 24 months was higher with infliximab than with adalimumab (p < 0.05). Overall, gastroenterology outpatient visits increased, and hospitalization frequency and duration decreased, from baseline to follow-up. UC-related hospitalizations were fewer and shorter, and endoscopies fewer, in persistent than in nonpersistent patients, although persistent patients made more outpatient visits than nonpersistent patients. Hospitalization duration was lower in persistent than nonpersistent patients. Approximately 50% of patients received an immunosuppressant during biologic therapy; 5% received a concomitant steroid during biologic therapy. Overall, 17% and 3% of patients, respectively, received 2nd line and 3rd line biologics.
Conclusions: Poor biologic persistence was associated with increased non-medication-associated HCRU. Effective treatments with high persistence levels and limited associated HCRU are needed in UC.