Treatment Patterns, Complications, and Disease Relapse in a Real-world Population of Patients with Moderate-to-severe Ulcerative Colitis Initiating Immunomodulator Therapy
Treatment Patterns, Complications, and Disease Relapse in a Real-world Population of Patients with Moderate-to-severe Ulcerative Colitis Initiating Immunomodulator Therapy
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DOI：
10.1097/mib.0000000000000089
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发表时间：
2014-08-01
影响因子：
4.9
通讯作者：
Luo, Allison
中科院分区：
文献类型：
--
作者：
Loftus, Edward V., Jr.;Davis, Keith L.;Luo, Allison
背景：免疫调节剂(IM)治疗溃疡性结肠炎(UC)不能治愈，并且增加了并发症的风险，有时会导致治疗方法的改变，减少治疗效益，并最终复发。我们评估了一组中到重度UC患者的IM使用和治疗变化、并发症和疾病复发的模式。方法：对大量商业保险美国人群的索赔数据进行了回顾分析。纳入标准是(1)&>=2个UC诊断索赔(ICD-9-CM 556.xx)，(2)&>=1个IM索赔，其中第一个IM索赔定义了索引日期，(3)&>=索引前12个月的健康计划投保(基线)，以及(4)&>=索引后的24个月投保(后续)。描述性地评估了IM治疗的特点和在随访期间指数的变化，以及并发症和疾病复发。结果：共有2136名患者入选(年龄，平均[SD]，46[16]岁，54%女性)。硫唑嘌呤是最常见的IM指标(46%的患者)，其次是6-巯基嘌呤(28%)。从索引IM切换到另一个治疗类别是常见的(21%的患者)，其中5-ASA(48%的转换者)、口服皮质类固醇(21%)和生物制剂(17%)是最频繁使用的下一种药物。增强也很常见(25%的患者)，到目前为止，5-ASA是添加到IM指数中最常见的药物(72%的增强者)。30%的患者经历了并发症，73%的患者复发，其中大部分复发发生在指数IM暴露期间。结论：对IM治疗UC的评估表明，患者经常改变治疗方法，并有较高的下游并发症和复发率。
Background: Immunomodulator (IM) treatments in ulcerative colitis (UC) are not curative and carry increased risk of complications, sometimes leading to therapy changes, reduced treatment benefits, and eventual relapse. We assessed patterns of IM utilization and therapy changes, complications, and disease relapse in a real-world population of patients with moderate-to-severe UC.Methods: Claims data from a large commercially insured U. S. population were retrospectively analyzed. Inclusion criteria were (1) >= 2 UC diagnosis claims (ICD-9-CM 556.xx) between January 2005 and July 2010, (2) >= 1 IM claim, where first IM claim defined the index date, (3) >= 12 months preindex health plan enrollment (baseline), and (4) >= 24 months postindex plan enrollment (follow-up). Characteristics of and changes to the index IM therapy during follow-up were descriptively assessed, as were complications and disease relapses.Results: A total of 2136 patients were identified for inclusion (age, mean [SD], 46 [16] years, 54% female). Azathioprine was the most common index IM (46% of patients), followed by 6-mercaptopurine (28%). Switching from the index IM to another therapy class was common (21% of patients), with 5-ASAs (48% of switchers), oral corticosteroids (21%), and biologics (17%) being the most frequent next agents used. Augmentation was also common (25% of patients), with 5-ASA being, by far, the most frequent agent added to the index IM (72% of augmenters). Thirty percent of patients experienced a complication, and 73% of patients relapsed, with the majority of relapses occurring during index IM exposure.Conclusions: This assessment of IM treatments for UC demonstrated frequent changes to therapy and high downstream complication and relapse rates.