Switching and Discontinuation Patterns Among Patients Stable on Originator Infliximab Who Switched to an Infliximab Biosimilar or Remained on Originator Infliximab.

IF 5.3 Q1 MEDICINE, RESEARCH & EXPERIMENTAL
Biologics : Targets & Therapy Pub Date : 2021-01-06 eCollection Date: 2021-01-01 DOI:10.2147/BTT.S285610
Timothy Fitzgerald, Richard Melsheimer, Marie-Hélène Lafeuille, Patrick Lefebvre, Laura Morrison, Kimberly Woodruff, Iris Lin, Bruno Emond
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引用次数: 0

Abstract

Objective: To compare switching and discontinuation patterns of patients stable on originator infliximab (IFX) who switched to an IFX biosimilar (switchers) or remained on originator IFX (continuers) in the United States.

Methods: Symphony Health Solutions' Patient Transactional Datasets (10/2012-03/2019) were used to identify adults with ≥2 claims for either rheumatoid arthritis (RA), psoriatic arthritis, plaque psoriasis, ankylosing spondylitis, or inflammatory bowel disease (IBD); and ≥1 claim for originator or biosimilar IFX. The index date was the first IFX biosimilar claim for switchers or a random originator IFX claim for continuers. All patients were required to have ≥5 originator IFX claims during the 12 months pre-index (prevalent population). The subset of patients with ≥12 months of observation prior to the first originator IFX claim was also analyzed (incident population). Switchers were matched 1:3 to continuers. Discontinuation was defined as having ≥120 days between 2 consecutive index treatment claims.

Results: Prevalent switchers (N=1109) were 3.57-times more likely than continuers (N=3327) to switch to another originator biologic (hazard ratio [HR]=3.57, p<0.001). Of 249 prevalent switchers who switched to another originator biologic, 200 (80.3%) switched back to originator IFX. Incident switchers (N=571) were 2.55-times more likely than continuers (N=1713) to switch to another originator biologic (HR=2.55, p<0.001). Of 118 incident switchers who switched to another originator biologic, 90 (76.3%) switched back to originator IFX. Prevalent switchers were 1.25-times more likely than continuers to discontinue index therapy (HR=1.25, p<0.001). Similar results were observed in RA (prevalent population; switching: HR=3.49, p<0.001; discontinuation: HR=1.23, p=0.009) and IBD (prevalent population; switching: HR=3.82, p<0.001; discontinuation: HR=1.29, p=0.003) subgroups.

Conclusion: Patients switching from originator to biosimilar IFX were more likely to switch to another originator biologic (notably back to originator IFX) and discontinue index treatment than those remaining on originator IFX; however, reasons for switching are unknown.

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稳定使用原研英夫利西单抗的患者转用英夫利西单抗生物仿制药或继续使用原研英夫利西单抗的转药和停药模式。
目的比较美国稳定使用原研药英夫利西单抗(IFX)的患者转用 IFX 生物仿制药(转换者)或继续使用原研药 IFX(继续者)的转换和停药模式:使用 Symphony Health Solutions 的患者交易数据集(10/2012-03/2019)来识别有≥2 次类风湿性关节炎 (RA)、银屑病关节炎、斑块状银屑病、强直性脊柱炎或炎症性肠病 (IBD) 治疗申请;且有≥1 次原研药或生物仿制药 IFX 治疗申请的成年人。对于转换者,指标日期为首次 IFX 生物仿制药索赔日期;对于持续者,指标日期为随机的原研 IFX 索赔日期。要求所有患者在指数前的 12 个月内(流行人群)有≥5 次原研 IFX 治疗申请。此外,还分析了在首次申请 IFX 之前观察时间≥12 个月的患者子集(事件人群)。转换者与继续者的配对比例为 1:3。中断治疗的定义是在 2 次连续的指数治疗索赔之间间隔≥120 天:结果:普遍的转换者(N=1109)转换到另一种原研生物制剂的可能性是继续治疗者(N=3327)的3.57倍(危险比[HR]=3.57,pConclusion):与继续使用原研 IFX 的患者相比,从原研 IFX 转为使用生物仿制药 IFX 的患者更有可能转为使用另一种原研生物制剂(尤其是转回原研 IFX)并停止指数治疗;然而,转药原因尚不清楚。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Biologics : Targets & Therapy
Biologics : Targets & Therapy MEDICINE, RESEARCH & EXPERIMENTAL-
CiteScore
8.30
自引率
0.00%
发文量
22
审稿时长
16 weeks
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