PERFUSE研究:接受Adalimumab生物类似物SB5的患者的经验
Yoram Bouhnik1, Franck Carbonnel2, Mathurin Fumery3
1Paris IBD Center, Groupe hospitalier privé Ambroise Paré - Hartmann, 25 Boulevard Victor Hugo, 92200 Neuilly sur Seine, France.
概括
患者报告的SB5的结果,阿达利穆马布生物类似剂,表明治疗持续时间更高. 早期的患者反可以识别有停止治疗风险的个体,改善长期坚持治疗.
科学领域:
- 胃肠病学 胃肠病学
- 药物经济学 药物经济学
- 患者报告的结果
背景情况:
- SB5是一种经EMA批准的阿达利穆马布生物相似剂,具有已确定的生物等价性.
- 它的疗效,安全性和免疫性与参考产品具有可比性.
研究的目的:
- 通过患者报告的结果指标 (PROMs) 评估患者对SB5的培训和满意度.
- 评估PROMs对SB5在炎症性肠病中的12个月治疗持久性的影响.
主要方法:
- 观察性PERFUSE研究在法国招募了318名克罗恩病和88名性结肠炎患者.
- 患者报告的结果是通过在线问卷 (ePRO) 在基线后一个月收集的.
- 治疗持续性被监测了长达15个月,分析基于先前的生物经验和培训的数据.
主要成果:
- 所有子组的患者满意度得分都很高.
- 与非响应者相比,对ePRO反应的患者在SB5的12个月持续时间显著更高 (68.0%与52.3%相比).
- 患者对疾病的更好认识与治疗持续时间的增加有关 (OR=1.02).
结论:
- 早期收集患者报告的结果可能有助于识别患有中止治疗风险的患者.
- 使用PROM可能会改善对SB5治疗的长期坚持.
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