PDF(Pubmed)
Abstract：
BACKGROUND: Wearable sensors in digital health may pose a risk for skin irritation through the use of wearable patches. Little is known about how patient- and product-related factors impact the risk of skin irritation. Aripiprazole tablets with sensor (AS, Abilify MyCite; Otsuka America Pharmaceutical, Inc) is a digital medicine system indicated for the treatment of patients with schizophrenia, bipolar I disorder, and major depressive disorder. AS includes aripiprazole tablets with an embedded ingestible event marker, a wearable sensor attached to the skin through a wearable patch, a smartphone app, and a web-based portal. To continuously improve the final product, successive iterations of wearable patches were developed, including raisin patch version 4 (RP4), followed by disposable wearable sensor version 5 (DW5), and then reusable wearable sensor version 2 (RW2).
OBJECTIVE: This analysis pooled safety data from clinical studies in adult participants using the RP4, DW5, and RW2 wearable patches of AS and evaluated adverse events related to the use of wearable patches.
METHODS: Safety data from 12 studies in adults aged 18-65 years from May 2010 to August 2020 were analyzed. All studies evaluated safety, with studies less than 2 weeks also specifically examining human factors associated with the use of the components of AS. Healthy volunteers or patients with schizophrenia, bipolar I disorder, or major depressive disorder were enrolled; those who were exposed to at least 1 wearable patch were included in the safety analysis. Adverse events related to the use of a wearable patch were evaluated. Abrasions, blisters, dermatitis, discoloration, erythema, irritation, pain, pruritus, rash, and skin reactions were grouped as skin irritation events (SIEs). All statistical analyses were descriptive.
RESULTS: The analysis included 763 participants (mean [SD] age 42.6 [12.9] years; White: n=359, 47.1%; and male: n=420, 55%). Participants were healthy volunteers (n=269, 35.3%) or patients with schizophrenia (n=402, 52.7%), bipolar I disorder (n=57, 7.5%), or major depressive disorder (n=35, 4.6%). Overall, 13.6% (104/763) of the participants reported at least 1 SIE, all of which were localized to the wearable patch site. Incidence of ≥1 patch-related SIEs was seen in 18.1% (28/155), 14.2% (55/387), and 9.2% (28/306) of participants who used RP4, DW5, and RW2, respectively. Incidence of SIE-related treatment discontinuation was low, which is reported by 1.9% (3/155), 3.1% (12/387), and 1.3% (4/306) of participants who used RP4, DW5, and RW2, respectively.
CONCLUSIONS: The incidence rates of SIEs reported as the wearable patch versions evolved from RP4 through RW2 suggest that information derived from reported adverse events may have informed product design and development, which could have improved both tolerability and wearability of successive products.
BACKGROUND: Clinicaltrials.gov NCT02091882, https://clinicaltrials.gov/study/NCT02091882; Clinicaltrials.gov NCT02404532, https://clinicaltrials.gov/study/NCT02404532; Clinicaltrials.gov NCT02722967, https://clinicaltrials.gov/study/NCT02722967; Clinicaltrials.gov NCT02219009, https://clinicaltrials.gov/study/NCT02219009; Clinicaltrials.gov NCT03568500, https://clinicaltrials.gov/study/NCT03568500; Clinicaltrials.gov NCT03892889, https://clinicaltrials.gov/study/NCT03892889.
OBJECTIVE: This analysis pooled safety data from clinical studies in adult participants using the RP4, DW5, and RW2 wearable patches of AS and evaluated adverse events related to the use of wearable patches.
METHODS: Safety data from 12 studies in adults aged 18-65 years from May 2010 to August 2020 were analyzed. All studies evaluated safety, with studies less than 2 weeks also specifically examining human factors associated with the use of the components of AS. Healthy volunteers or patients with schizophrenia, bipolar I disorder, or major depressive disorder were enrolled; those who were exposed to at least 1 wearable patch were included in the safety analysis. Adverse events related to the use of a wearable patch were evaluated. Abrasions, blisters, dermatitis, discoloration, erythema, irritation, pain, pruritus, rash, and skin reactions were grouped as skin irritation events (SIEs). All statistical analyses were descriptive.
RESULTS: The analysis included 763 participants (mean [SD] age 42.6 [12.9] years; White: n=359, 47.1%; and male: n=420, 55%). Participants were healthy volunteers (n=269, 35.3%) or patients with schizophrenia (n=402, 52.7%), bipolar I disorder (n=57, 7.5%), or major depressive disorder (n=35, 4.6%). Overall, 13.6% (104/763) of the participants reported at least 1 SIE, all of which were localized to the wearable patch site. Incidence of ≥1 patch-related SIEs was seen in 18.1% (28/155), 14.2% (55/387), and 9.2% (28/306) of participants who used RP4, DW5, and RW2, respectively. Incidence of SIE-related treatment discontinuation was low, which is reported by 1.9% (3/155), 3.1% (12/387), and 1.3% (4/306) of participants who used RP4, DW5, and RW2, respectively.
CONCLUSIONS: The incidence rates of SIEs reported as the wearable patch versions evolved from RP4 through RW2 suggest that information derived from reported adverse events may have informed product design and development, which could have improved both tolerability and wearability of successive products.
BACKGROUND: Clinicaltrials.gov NCT02091882, https://clinicaltrials.gov/study/NCT02091882; Clinicaltrials.gov NCT02404532, https://clinicaltrials.gov/study/NCT02404532; Clinicaltrials.gov NCT02722967, https://clinicaltrials.gov/study/NCT02722967; Clinicaltrials.gov NCT02219009, https://clinicaltrials.gov/study/NCT02219009; Clinicaltrials.gov NCT03568500, https://clinicaltrials.gov/study/NCT03568500; Clinicaltrials.gov NCT03892889, https://clinicaltrials.gov/study/NCT03892889.
摘要：
背景：数字健康中的可穿戴传感器可能会通过使用可穿戴贴片对皮肤造成刺激的风险。关于患者和产品相关因素如何影响皮肤刺激的风险知之甚少。带传感器的阿立哌唑片(AS，AbilifyMyCite;OtsukaAmericaPharmaceutical,Inc）是一种数字医疗系统，用于治疗精神分裂症患者，I型双相情感障碍,和重度抑郁症.AS包括阿立哌唑片剂，带有嵌入的可摄取事件标记，通过可穿戴贴片附着在皮肤上的可穿戴传感器，一个智能手机应用程序，和基于Web的门户。不断改进最终产品，开发了可穿戴补丁的连续迭代，包括葡萄干补丁版本4(RP4)，其次是一次性可穿戴传感器版本5(DW5)，然后可重复使用的可穿戴传感器版本2（RW2）。
目的：本分析汇集了使用RP4、DW5和RW2可穿戴式AS贴片的成年参与者临床研究的安全性数据，并评估了与使用可穿戴贴片相关的不良事件。
方法：分析了2010年5月至2020年8月在18-65岁成年人中进行的12项研究的安全性数据。所有研究都评估了安全性，在不到2周的研究中，还特别检查了与AS组件使用相关的人为因素。健康的志愿者或精神分裂症患者，I型双相情感障碍,纳入或重度抑郁症;暴露于至少1个可穿戴贴片的患者被纳入安全性分析.评估与使用可穿戴贴片相关的不良事件。磨损,水泡,皮炎,变色,红斑,刺激,疼痛,瘙痒,皮疹,和皮肤反应被分组为皮肤刺激事件（SIE）。所有统计分析均为描述性。
结果：分析包括763名参与者（平均[SD]年龄42.6[12.9]岁；白人：n=359，47.1％；男性：n=420，55％）。参与者是健康志愿者（n=269，35.3%）或精神分裂症患者（n=402，52.7%），双相I型障碍（n=57，7.5％），或重度抑郁障碍（n=35，4.6％）。总的来说,13.6%(104/763)的参与者报告至少1个SIE，所有这些都位于可穿戴贴片站点。≥1个斑块相关SIE的发生率为18.1%(28/155)，14.2%（55/387），和9.2%(28/306)的参与者分别使用RP4、DW5和RW2。SIE相关治疗中止的发生率较低，1.9%(3/155)报告，3.1%（12/387），使用RP4、DW5和RW2的参与者分别为1.3%(4/306)。
结论：从RP4到RW2的可穿戴贴片版本报告的SIE发生率表明，从报告的不良事件中获得的信息可能为产品设计和开发提供了信息，这可以提高连续产品的耐受性和耐磨性。
背景：Clinicaltrials.govNCT02091882,https://clinicaltrials.gov/study/NCT02091882;Clinicaltrials.govNCT02404532,https://clinicaltrials.gov/NCT0585/CTtrigoal91928/
目的：本分析汇集了使用RP4、DW5和RW2可穿戴式AS贴片的成年参与者临床研究的安全性数据，并评估了与使用可穿戴贴片相关的不良事件。
方法：分析了2010年5月至2020年8月在18-65岁成年人中进行的12项研究的安全性数据。所有研究都评估了安全性，在不到2周的研究中，还特别检查了与AS组件使用相关的人为因素。健康的志愿者或精神分裂症患者，I型双相情感障碍,纳入或重度抑郁症;暴露于至少1个可穿戴贴片的患者被纳入安全性分析.评估与使用可穿戴贴片相关的不良事件。磨损,水泡,皮炎,变色,红斑,刺激,疼痛,瘙痒,皮疹,和皮肤反应被分组为皮肤刺激事件（SIE）。所有统计分析均为描述性。
结果：分析包括763名参与者（平均[SD]年龄42.6[12.9]岁；白人：n=359，47.1％；男性：n=420，55％）。参与者是健康志愿者（n=269，35.3%）或精神分裂症患者（n=402，52.7%），双相I型障碍（n=57，7.5％），或重度抑郁障碍（n=35，4.6％）。总的来说,13.6%(104/763)的参与者报告至少1个SIE，所有这些都位于可穿戴贴片站点。≥1个斑块相关SIE的发生率为18.1%(28/155)，14.2%（55/387），和9.2%(28/306)的参与者分别使用RP4、DW5和RW2。SIE相关治疗中止的发生率较低，1.9%(3/155)报告，3.1%（12/387），使用RP4、DW5和RW2的参与者分别为1.3%(4/306)。
结论：从RP4到RW2的可穿戴贴片版本报告的SIE发生率表明，从报告的不良事件中获得的信息可能为产品设计和开发提供了信息，这可以提高连续产品的耐受性和耐磨性。
背景：Clinicaltrials.govNCT02091882,https://clinicaltrials.gov/study/NCT02091882;Clinicaltrials.govNCT02404532,https://clinicaltrials.gov/NCT0585/CTtrigoal91928/
