Abstract：
BACKGROUND: SB5 is an EMA-approved adalimumab biosimilar, having demonstrated bioequivalence, equivalent efficacy, and similar safety and immunogenicity to the reference product.
OBJECTIVE: Describe patient training and satisfaction using patient-reported outcome measures (PROMs) and assess their impact on 12-month persistence on SB5.
METHODS: The observational PERFUSE study included 318 Crohn\'s disease (CD) patients and 88 ulcerative colitis (UC) patients in 27 sites across France between October 2018 and December 2020. PROMs were collected at 1-month post-baseline using an online questionnaire (ePRO) designed with patient associations. Treatment persistence was collected during routine visits (up to 15 months post-initiation). Results are presented by prior experience with subcutaneous biologics and training in proper use of the injection device.
RESULTS: 57.1% (n = 145) and 44.1% (n = 67) of naïve and pre-treated patients, respectively, answered the ePRO. Naïve patients were offered training more often (86.9% vs 31.3% respectively, p < 0.05), with disparities between sites. All subgroups\' satisfaction scores were high. 12-month persistence on SB5 was significantly higher for respondents than for non-respondents (68.0% [60.9; 74.1] vs 52.3% [44.5; 59.6]; p < 0.05) and in patients with a better perception of their illness (OR=1.02, [1.0; 1.05]; p < 0.05).
CONCLUSIONS: Early patient questionnaires may be useful to identify patients at higher risk of treatment discontinuation.
OBJECTIVE: Describe patient training and satisfaction using patient-reported outcome measures (PROMs) and assess their impact on 12-month persistence on SB5.
METHODS: The observational PERFUSE study included 318 Crohn\'s disease (CD) patients and 88 ulcerative colitis (UC) patients in 27 sites across France between October 2018 and December 2020. PROMs were collected at 1-month post-baseline using an online questionnaire (ePRO) designed with patient associations. Treatment persistence was collected during routine visits (up to 15 months post-initiation). Results are presented by prior experience with subcutaneous biologics and training in proper use of the injection device.
RESULTS: 57.1% (n = 145) and 44.1% (n = 67) of naïve and pre-treated patients, respectively, answered the ePRO. Naïve patients were offered training more often (86.9% vs 31.3% respectively, p < 0.05), with disparities between sites. All subgroups\' satisfaction scores were high. 12-month persistence on SB5 was significantly higher for respondents than for non-respondents (68.0% [60.9; 74.1] vs 52.3% [44.5; 59.6]; p < 0.05) and in patients with a better perception of their illness (OR=1.02, [1.0; 1.05]; p < 0.05).
CONCLUSIONS: Early patient questionnaires may be useful to identify patients at higher risk of treatment discontinuation.
摘要：
背景：SB5是EMA批准的阿达木单抗生物仿制药，证明了生物等效性，等效功效，以及与参考产品相似的安全性和免疫原性。
目的：使用患者报告的结果指标（PROMs）描述患者的培训和满意度，并评估其对SB512个月持久性的影响。
方法：观察性PERFUSE研究包括2018年10月至2020年12月在法国27个地点的318名克罗恩病（CD）患者和88名溃疡性结肠炎（UC）患者。使用与患者关联设计的在线问卷(ePRO)在基线后1个月收集PROM。在常规访视期间(开始后长达15个月)收集治疗持久性。结果由皮下生物制剂的先前经验和正确使用注射装置的培训提供。
结果：57.1％（n=145）和44.1％（n=67）初治和治疗前的患者，分别,回答了EPRO。初治患者接受培训的频率更高(分别为86.9%和31.3%，p<0.05)，网站之间的差异。所有亚组的满意度得分均较高。12个月的SB5持久性显着高于非受访者（68.0％[60.9;74.1]vs52.3％[44.5;59.6];p<0.05），并且患者对自己的疾病有更好的感知（OR=1.02，[1.0;1.05];p<0.05）。
结论：早期患者问卷调查可能有助于识别具有更高治疗中止风险的患者。
目的：使用患者报告的结果指标（PROMs）描述患者的培训和满意度，并评估其对SB512个月持久性的影响。
方法：观察性PERFUSE研究包括2018年10月至2020年12月在法国27个地点的318名克罗恩病（CD）患者和88名溃疡性结肠炎（UC）患者。使用与患者关联设计的在线问卷(ePRO)在基线后1个月收集PROM。在常规访视期间(开始后长达15个月)收集治疗持久性。结果由皮下生物制剂的先前经验和正确使用注射装置的培训提供。
结果：57.1％（n=145）和44.1％（n=67）初治和治疗前的患者，分别,回答了EPRO。初治患者接受培训的频率更高(分别为86.9%和31.3%，p<0.05)，网站之间的差异。所有亚组的满意度得分均较高。12个月的SB5持久性显着高于非受访者（68.0％[60.9;74.1]vs52.3％[44.5;59.6];p<0.05），并且患者对自己的疾病有更好的感知（OR=1.02，[1.0;1.05];p<0.05）。
结论：早期患者问卷调查可能有助于识别具有更高治疗中止风险的患者。
