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Early Identification and Management of Chronic Kidney Disease: A Narrative Review of the Crucial Role of Primary Care Practitioners 慢性肾病的早期识别和管理:对初级保健医生关键作用的叙述性回顾。
IF 3.4 3区 医学 Q2 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2024-08-20 DOI: 10.1007/s12325-024-02957-z
Pamela Kushner, Kamlesh Khunti, Ana Cebrián, Gary Deed

Early-stage (stage 1–3) chronic kidney disease (CKD) has an asymptomatic presentation such that most people with CKD are unaware of their disease status and remain undiagnosed. CKD is associated with multiple long-term conditions (MLTC), or multimorbidity, the most common of these being cardiovascular disease, hypertension, and type 2 diabetes. Primary care practitioners (PCPs) are crucial in the early identification and management of patients with CKD. For individuals at high risk of CKD, measurements of estimated glomerular filtration rate, urine albumin–creatinine ratio, and blood pressure should be obtained regularly and recorded in a timely manner. The importance of lifestyle changes in the prevention and management of CKD should also be highlighted. A recent addition to the treatment of CKD in people with and without type 2 diabetes has been the recommendation by clinical practice guidelines of a sodium–glucose co-transporter 2 (SGLT2) inhibitor alongside a renin–angiotensin–aldosterone system inhibitor as foundational therapy. SGLT2 inhibitors prevent CKD progression and reduce fatal and non-fatal kidney and cardiovascular events, hospitalization for heart failure, and all-cause mortality, and they have a favorable safety and tolerability profile. However, uptake has been slow, particularly in people with CKD without type 2 diabetes. A multifaceted approach is required to ensure that people with CKD receive optimal kidney protection. Measures to raise awareness of the importance of early identification and intervention include local/national campaigns via social media and practice-based education; clinical education programs; integration of clinical decision support tools into electronic health records; detection programs built around electronic health records; and good interdisciplinary communication. PCPs at the forefront of multidisciplinary care are best placed to implement the evidence-based clinical practice CKD guidelines for lifestyle modification and guideline-directed medical therapy.

早期(1-3 期)慢性肾脏病(CKD)表现为无症状,因此大多数慢性肾脏病患者都不知道自己的疾病状况,一直未得到诊断。慢性肾脏病与多种长期疾病(MLTC)或多病共存有关,其中最常见的是心血管疾病、高血压和 2 型糖尿病。初级保健医生(PCP)对于早期识别和管理慢性肾脏病患者至关重要。对于慢性肾脏病高危人群,应定期测量肾小球滤过率、尿白蛋白-肌酐比值和血压,并及时记录。还应强调改变生活方式对预防和治疗慢性肾脏病的重要性。最近,临床实践指南建议将钠-葡萄糖共转运体 2(SGLT2)抑制剂与肾素-血管紧张素-醛固酮系统抑制剂一起作为基础疗法,用于治疗 2 型糖尿病患者和非 2 型糖尿病患者的慢性肾脏病。SGLT2 抑制剂可预防慢性肾脏病进展,减少致命和非致命肾脏和心血管事件、心力衰竭住院治疗以及全因死亡率,而且具有良好的安全性和耐受性。然而,这种药物的吸收速度一直很慢,尤其是在患有慢性肾脏病但没有 2 型糖尿病的人群中。要确保慢性肾脏病患者获得最佳的肾脏保护,需要采取多方面的措施。提高对早期识别和干预重要性认识的措施包括:通过社交媒体和实践教育开展地方/全国性宣传活动;临床教育计划;将临床决策支持工具整合到电子健康记录中;围绕电子健康记录制定检测计划;以及良好的跨学科沟通。处于多学科护理前沿的初级保健医生最适合实施以循证医学为基础的慢性肾功能衰竭临床实践指南,以调整生活方式和指导药物治疗。
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引用次数: 0
Real-World Long-Term Persistence and Surgical Procedure-Free Period Among Bio-naïve Patients with Crohn’s Disease and Fistula Initiated on Ustekinumab 克罗恩病和瘘管的生物无效患者开始使用乌司替库单抗后的长期疗效和无手术期的实际情况。
IF 3.4 3区 医学 Q2 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2024-08-20 DOI: 10.1007/s12325-024-02963-1
Maryia Zhdanava, Sumesh Kachroo, Porpong Boonmak, Sabree Burbage, Aditi Shah, Patrick Lefebvre, Caroline Kerner, Dominic Pilon

Introduction

Fistula is a common complication of Crohn’s disease (CD). Treatment with biologics has been associated with fistula healing. Long-term persistence is an important factor for a chronic inflammatory process such as fistula. This study described 24-month persistence and time-to-surgery endpoints among bio-naïve patients with CD and intestinal fistula who were initiated on ustekinumab.

Methods

Adults with CD and any enteric or perianal fistula initiated on ustekinumab (index date) between September 23, 2016, and March 2, 2022, were selected from the IQVIA PharMetrics® Plus database and followed up to 24 months. Persistence on ustekinumab (no gaps in days of supply of > 120 days) and composite endpoints of being persistent while on monotherapy and persistent while corticosteroid free were also assessed. The date of surgery was defined as the date of first claim for any CD-related surgeries. Persistence and time-to-surgery endpoints were assessed from the index date until the earliest of discontinuation (event), immunomodulator or other biologic use (event), corticosteroid use (event), date of surgery (event), 24-month follow-up or data end (censoring) using Kaplan-Meier analyses.

Results

The sample included 445 patients (mean age: 42.8 years; 56.6% female). The most common type of fistula was anal fistula (36.0%). At 24 months after ustekinumab initiation, 64.2% of patients remained persistent (95% confidence interval [CI] 55.8–71.4). Furthermore, 53.3% of patients were persistent while on monotherapy (95% CI 45.1–60.7), and 45.6% of patients were persistent while being corticosteroid free (95% CI 36.9–53.8). At 24 months, 22.8% (95% CI 17.0–30.3) of patients underwent any CD-related surgery.

Conclusion

This study quantified long-term persistence on ustekinumab among bio-naïve patients with CD and fistula. Over half of patients initiated on ustekinumab were persistent and persistent while on monotherapy 24 months after initiation. Time-to-surgery estimate was comparable to existing evidence. These findings support ustekinumab as a treatment option for long-term management of CD with fistula.

简介:瘘管是克罗恩病(CD)的常见并发症:瘘管是克罗恩病(CD)的常见并发症。使用生物制剂治疗与瘘管愈合有关。长期持续性是瘘管等慢性炎症过程的一个重要因素。本研究描述了开始使用乌司替尼的CD和肠瘘患者24个月的持续性和手术时间终点:从IQVIA PharMetrics® Plus数据库中选取2016年9月23日至2022年3月2日期间开始使用乌司替库单抗(指标日期)的CD合并任何肠瘘或肛周瘘的成人患者,随访24个月。此外,还评估了持续服用乌司替库单抗的情况(供应天数间隔未超过 120 天),以及持续服用单药和持续服用无皮质类固醇药物的复合终点。手术日期定义为首次申请 CD 相关手术的日期。采用卡普兰-梅耶尔分析法评估了从指数日期到停药(事件)、使用免疫调节剂或其他生物制剂(事件)、使用皮质类固醇(事件)、手术日期(事件)、24 个月随访或数据结束(剔除)最早日期的持续性和手术时间终点:样本包括 445 名患者(平均年龄:42.8 岁;56.6% 为女性)。最常见的瘘管类型是肛瘘(36.0%)。在开始使用乌司替库单抗 24 个月后,64.2% 的患者瘘管仍然存在(95% 置信区间 [CI] 55.8-71.4)。此外,53.3%的患者在接受单药治疗时病情仍在持续(95% 置信区间 [CI] 45.1-60.7),45.6%的患者在不使用皮质类固醇时病情仍在持续(95% 置信区间 [CI] 36.9-53.8)。24个月时,22.8%(95% CI 17.0-30.3)的患者接受了任何与CD相关的手术:这项研究对CD合并瘘管的生物无效患者长期服用乌司替尼的情况进行了量化。在开始使用乌司替库单抗的患者中,超过半数的患者在开始使用单药治疗 24 个月后仍在坚持使用乌司替库单抗。估计的手术时间与现有证据相当。这些研究结果支持将乌司替库单抗作为CD合并瘘管长期治疗的一种治疗选择。
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引用次数: 0
Clinical and Humanistic Burden of Non-inhibitor Haemophilia A in Five European Countries: Insights from the CHESS II Study 欧洲五国非抑制剂血友病 A 的临床和人文负担:CHESS II 研究的启示
IF 3.4 3区 医学 Q2 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2024-08-17 DOI: 10.1007/s12325-024-02956-0
Enrico Ferri Grazzi, Tobias Becker, Stephanie Brandt, Gaetan Duport, Daniel-Anibal Garcia Diego, Angelo Lupi, William McKeown, Debra Morgan, Charlotte Camp, Charles Hawes, Tom Blenkiron, Jamie O’Hara, Tom Burke

Introduction

Haemophilia A (HA) is a congenital bleeding disorder caused by a deficiency/absence of factor VIII (FVIII) and characterised by frequent, acute and prolonged spontaneous or traumatic bleeding events, often leading to haemophilic arthropathy and progressive joint deterioration. HA severity is characterized by endogenous FVIII activity: mild (> 5–40%), moderate (1–5%), or severe (< 1%). HA poses a substantial clinical and socioeconomic burden on people with HA (PWHA), their caregivers, and society. This analysis evaluates clinical and patient-centric outcomes of a cohort of individuals with non-inhibitor HA sampled from France, Germany, Italy, Spain, and the UK in the ‘Cost of Haemophilia in Europe: A Socioeconomic Survey II’ (CHESS II) study.

Methods

CHESS II was a cross-sectional burden-of-illness study collecting clinical and socioeconomic data on adult (≥ 18 years) individuals with haemophilia A or B of any severity with or without inhibitors from eight European countries. Descriptive analyses were conducted examining physician-reported demographics, clinical and health resource utilisation information. PWHA-reported health-related quality of life (HRQoL) using the EQ-5D-5L and Work Productivity and Activity Impairment (WPAI) were also examined. Outcomes were stratified by HA severity and reported at country level.

Results

Demographics and clinical characteristics of the cohort (N = 880) were generally consistent across countries. Individuals with severe HA experienced more frequent bleeding events and joint disease despite broad use of factor replacement therapy long-term prophylaxis. A minority of those with mild or moderate HA also experienced such challenges. HRQoL and workforce participation diminished, and chronic pain increased, with increasing HA severity.

Conclusion

This analysis provides up-to-date insights on the impact of HA across five European countries. Increasing HA severity was generally associated with worse clinical outcomes, HRQoL and workforce participation. These findings suggest a place for continued evidence-based tailored treatment and clinical management approaches in addressing the residual burden of HA.

导言:甲型血友病(HA)是一种先天性出血性疾病,由第八因子(FVIII)缺乏/缺失引起,其特征是频繁、急性和长期的自发性或创伤性出血事件,通常会导致血友病性关节病和进行性关节恶化。HA 的严重程度取决于内源性 FVIII 的活性:轻度(> 5-40%)、中度(1-5%)或重度(方法:CHESS II 是一项横断面疾病负担研究,收集了来自八个欧洲国家的成年(≥ 18 岁)血友病 A 或血友病 B 患者的临床和社会经济数据,这些患者的严重程度不一,有的患有抑制剂,有的没有。对医生报告的人口统计学、临床和医疗资源利用信息进行了描述性分析。此外,还研究了 PWHA 使用 EQ-5D-5L 和工作效率与活动障碍 (WPAI) 报告的健康相关生活质量 (HRQoL)。研究结果按HA严重程度进行了分层,并在国家层面进行了报告:结果:各国研究组(N = 880)的人口统计学和临床特征基本一致。尽管广泛使用因子替代疗法进行长期预防,但重度HA患者的出血事件和关节疾病更为频繁。少数轻度或中度HA患者也遇到了这些问题。随着HA严重程度的增加,HRQoL和劳动力参与度降低,慢性疼痛增加:这项分析提供了有关欧洲五国 HA 影响的最新见解。HA严重程度的增加通常与更差的临床结果、HRQoL和劳动力参与度相关。这些研究结果表明,以证据为基础的定制治疗和临床管理方法在解决HA残余负担方面仍有用武之地。
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引用次数: 0
The Broader Effects of Delayed Progression to End-Stage Kidney Disease: Delaying the Inevitable or a Meaningful Change? 延迟发展为终末期肾病的更广泛影响:推迟不可避免的情况还是有意义的改变?
IF 3.4 3区 医学 Q2 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2024-08-14 DOI: 10.1007/s12325-024-02950-6
Ricardo Correa-Rotter, David C. Wheeler, Phil McEwan

A global rise in the prevalence of patients with chronic kidney disease (CKD) with end-stage kidney disease (ESKD) has led to a considerable and increasing burden to health systems, patients, and society. Sodium–glucose cotransporter 2 (SGLT2) inhibitors are proven to reduce incidence of cardio-renal outcomes, including onset of ESKD. Recent post hoc analyses of SGLT2 inhibitor trials extrapolate substantial delays in the average time to ESKD over a patient’s lifetime. In this article, we explore the possible real-world effects of such a delay by considering the available evidence reporting outcomes following onset of ESKD. From the patient perspective, a delay in reaching ESKD could substantially improve health-related quality of life and result in additional life years without the need for kidney replacement therapies, a target relevant to all CKD subpopulations. Furthermore, should a patient initiate dialysis at an older age as a result of CKD progression, the time spent in receipt of dialysis, and therefore associated healthcare costs, may also be reduced. A delay in progression may also lead to changes in the management of ESKD, such as increased election of conservative care in preference to dialysis, particularly in elderly populations. For younger patients with CKD, those who reach ESKD while employed face considerable work impairment and productivity loss, as may families and care partners of working age. Therefore, a delay to the onset of ESKD will reduce the proportion of their working lives affected by productivity losses or unemployment due to medical reasons. In conclusion, optimised treatment of CKD may lead to a shift in treatment options, but proper and timely implementation is essential for the realisation of improved outcomes.

全球慢性肾脏病(CKD)和终末期肾脏病(ESKD)患者的发病率不断上升,给医疗系统、患者和社会带来了巨大且日益沉重的负担。事实证明,钠-葡萄糖共转运体 2(SGLT2)抑制剂可降低心肾衰竭的发病率,包括 ESKD 的发病率。最近对 SGLT2 抑制剂试验进行的事后分析推断,在患者的一生中,发生 ESKD 的平均时间将大大推迟。在本文中,我们通过考虑现有证据报告的 ESKD 发病后的结果,探讨了这种延迟可能在现实世界中产生的影响。从患者的角度来看,推迟达到 ESKD 的时间可以大大改善与健康相关的生活质量,并在不需要肾脏替代疗法的情况下延长生命年限,这与所有 CKD 亚群都息息相关。此外,如果患者因 CKD 进展而在年龄较大时开始透析,那么接受透析所花费的时间以及相关的医疗费用也会减少。病情进展的延迟还可能导致 ESKD 的治疗方法发生变化,例如,更多地选择保守治疗而不是透析,尤其是在老年人群中。对于年轻的慢性肾功能衰竭患者来说,在就业期间达到 ESKD 的患者会面临相当大的工作障碍和生产力损失,工作年龄的家人和护理伙伴也会面临同样的问题。因此,推迟 ESKD 的发病时间将减少他们因医疗原因导致的生产力损失或失业而影响工作生活的比例。总之,对慢性肾脏病的优化治疗可能会导致治疗方案的转变,但要实现更好的治疗效果,适当和及时的实施是必不可少的。
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引用次数: 0
Real-World Treatment Persistence Among Advanced Therapy-Naïve or -Experienced Patients with Ulcerative Colitis Initiated on Ustekinumab or Adalimumab 开始使用 Ustekinumab 或 Adalimumab 的晚期治疗无效或有经验的溃疡性结肠炎患者的实际治疗持续率。
IF 3.4 3区 医学 Q2 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2024-08-14 DOI: 10.1007/s12325-024-02942-6
Maryia Zhdanava, Sumesh Kachroo, Porpong Boonmak, Sabree Burbage, Aditi Shah, Jill Korsiak, Patrick Lefebvre, Caroline Kerner, Dominic Pilon

Introduction

Persistence on advanced therapies in ulcerative colitis (UC) is a useful real-world treatment performance measure. This study compared real-world persistence during the maintenance phase among advanced therapy-naïve and -experienced patients with UC initiated on ustekinumab or adalimumab.

Methods

Claims data from the IQVIA PharMetrics® Plus de-identified database (01/01/2015–06/30/2022) were used to select adult patients with UC treated with ustekinumab or adalimumab based on the agent first initiated (index date) after 10/21/2019. Inverse probability of treatment weighting was used to balance cohorts on baseline characteristics. Persistence on the index agent (no gaps in days of supply of > 120 days for ustekinumab or > 60 days for adalimumab), persistence while corticosteroid-free, while on monotherapy, and persistence on the US labeled dose were described and compared during the 12-month period post-index using Kaplan–Meier analysis and Cox proportional hazards models. Outcomes were analyzed separately among advanced therapy-naïve and advanced therapy-experienced patients.

Results

At 12 months post-index, advanced therapy-naïve patients receiving ustekinumab (n = 371) had higher persistence on the index agent [83.8% vs. 57.6%, hazard ratio (95% confidence interval) = 3.09 (2.29–4.16); p < 0.001), persistence while corticosteroid-free [2.00 (1.63–2.45); p < 0.001], persistence while on monotherapy [2.67 (2.07–3.44); p < 0.001], and persistence on the labeled dose [4.21 (2.76–6.44); p < 0.001] versus those receiving adalimumab (n = 1726). At 12 months post-index, advanced therapy-experienced patients receiving ustekinumab (n = 693) had higher persistence on the index agent [78.1% vs. 59.2%, 2.44 (1.82–3.26); p < 0.001], persistence while corticosteroid-free [1.24 (1.01–1.54); p = 0.0447], persistence while on monotherapy [2.53 (2.00–3.21); p < 0.001], and persistence on the labeled dose [4.77 (3.09–7.35); p < 0.001] versus those receiving adalimumab (n = 254).

Conclusion

This claims-based analysis demonstrated significantly higher treatment persistence, including persistence while corticosteroid-free, persistence while on monotherapy, and persistence on the labeled dose, among both advanced therapy-naïve and advanced therapy-experienced patients with UC initiated on ustekinumab compared to adalimumab.

简介:溃疡性结肠炎(UC)晚期疗法的持续性是衡量真实世界治疗效果的一个有用指标。本研究比较了未接受过晚期疗法和有过晚期疗法治疗经验的 UC 患者在维持治疗阶段的实际坚持率:采用IQVIA PharMetrics® Plus去标识数据库(01/01/2015-06/30/2022)中的索赔数据,根据2019年10月21日之后首次启用的药剂(索引日期)选择接受乌司替尼或阿达木单抗治疗的成年UC患者。治疗的反概率加权用于平衡基线特征上的队列。使用 Kaplan-Meier 分析和 Cox 比例危险模型描述并比较了指数后 12 个月内指数药物的持续使用情况(乌斯特库单抗的供应天数间隔不超过 120 天,阿达木单抗的供应天数间隔不超过 60 天)、无皮质类固醇时的持续使用情况、单药治疗时的持续使用情况以及美国标注剂量的持续使用情况。对未接受过晚期治疗和接受过晚期治疗的患者的结果进行了分别分析:在指数后 12 个月,接受乌司替单抗治疗的晚期治疗无效患者(n = 371)对指数药物的持续耐受性更高[83.8% vs. 57.6%,危险比(95% 置信区间)= 3.09 (2.29-4.16);p 结论:这项基于索赔的分析表明,接受乌司替单抗治疗的晚期治疗无效患者对指数药物的持续耐受性更高:这项基于索赔的分析表明,与阿达木单抗相比,晚期治疗无效和晚期治疗经验丰富的UC患者的治疗持续率(包括无皮质类固醇时的持续率、单药治疗时的持续率和标注剂量的持续率)明显更高。
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引用次数: 0
Effects of Glucagon-Like Peptide 1 Receptor Agonists on Atrial Fibrillation Recurrence After Catheter Ablation: A Systematic Review and Meta-analysis 胰高血糖素样肽 1 受体激动剂对导管消融术后心房颤动复发的影响:系统回顾与元分析》。
IF 3.4 3区 医学 Q2 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2024-08-14 DOI: 10.1007/s12325-024-02959-x
Paschalis Karakasis, Nikolaos Fragakis, Dimitrios Patoulias, Panagiotis Theofilis, George Kassimis, Theodoros Karamitsos, Mohamed El-Tanani, Manfredi Rizzo

Introduction

Despite the technological advancements in catheter ablation strategies, the recurrence of atrial fibrillation (AF) post-ablation remains a concern that requires further investigation. Glucagon-like peptide 1 (GLP-1) receptor agonists have shown a significant effect on weight reduction, which in turn is associated with freedom from AF recurrence in both patients who are obese and not obese undergoing ablation. Therefore, we aimed to summarize the available evidence on the efficacy of GLP-1 receptor agonists in maintaining sinus rhythm post-ablation.

Methods

Medline, Cochrane Library, and Scopus were searched until June 9, 2024. Double-independent study selection, data extraction, and quality assessment were performed. Evidence was pooled using DerSimonian-Laird random effects meta-analysis.

Results

Three propensity score-matched studies (n = 6031 participants) were analyzed. Over a 12-months follow-up, the use of GLP-1 receptor agonists was associated with a significant reduction in AF recurrence compared to controls, hazard ratio (HR) = 0.549, 95% confidence interval (CI) = [0.315, 0.956], P = 0.034; I2 = 57%. No significant heterogeneity was observed (Q statistic = 4.6, heterogeneity P = 0.1).

Conclusion

The use of GLP-1 receptor agonists is associated with a lower risk of AF recurrence in patients receiving AF ablation therapy. Further large-scale randomized trials are necessary to explore the efficacy of GLP-1 receptor agonists in maintaining ablation outcomes over the long term.

导言:尽管导管消融策略的技术不断进步,但消融后心房颤动(房颤)的复发仍然是一个需要进一步研究的问题。胰高血糖素样肽 1(GLP-1)受体激动剂对减轻体重有显著效果,而减轻体重又与接受消融术的肥胖和非肥胖患者不再复发房颤有关。因此,我们旨在总结有关 GLP-1 受体激动剂在消融术后维持窦性心律方面疗效的现有证据:方法:检索 Medline、Cochrane Library 和 Scopus,直至 2024 年 6 月 9 日。进行了双重独立的研究筛选、数据提取和质量评估。使用 DerSimonian-Laird 随机效应荟萃分析对证据进行汇总:对三项倾向得分匹配研究(n = 6031 名参与者)进行了分析。在12个月的随访中,与对照组相比,使用GLP-1受体激动剂可显著降低房颤复发率,危险比(HR)= 0.549,95%置信区间(CI)= [0.315,0.956],P = 0.034;I2 = 57%。未观察到明显的异质性(Q统计量=4.6,异质性P=0.1):结论:在接受房颤消融治疗的患者中,使用 GLP-1 受体激动剂可降低房颤复发风险。有必要进一步开展大规模随机试验,探讨 GLP-1 受体激动剂在长期保持消融疗效方面的功效。
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引用次数: 0
Adherence, Persistence, Healthcare Resource Use, and Costs in Tofacitinib-Treated Patients with Psoriatic Arthritis: Data from Two United States Claims Databases 托法替尼治疗银屑病关节炎患者的依从性、持续性、医疗资源使用和成本:来自两个美国索赔数据库的数据。
IF 3.4 3区 医学 Q2 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2024-08-14 DOI: 10.1007/s12325-024-02904-y
Philip J. Mease, Eros Papademetriou, Ravi Potluri, Ekta Agarwal, Joseph C. Cappelleri, You-Li Ling

Introduction

Associations between increased functional disability and higher healthcare resource utilization (HCRU) and costs were reported in patients with psoriatic arthritis (PsA). We assessed characteristics/outcomes of patients with PsA receiving tofacitinib monotherapy vs combination therapy with conventional synthetic disease-modifying antirheumatic drugs.

Methods

Claims data from Optum® Clinformatics® Data Mart (OC) and Merative™ MarketScan® (MS) databases between December 2017 and February 2020 were analyzed. Outcomes assessed were adherence/persistence by therapy type (monotherapy/combination therapy); HCRU/costs (per patient per month) by periods on-treatment (sum time on tofacitinib) and off-treatment (sum time off tofacitinib [gap of > 60 days]) plus therapy type.

Results

This analysis included 274 and 395 tofacitinib-treated patients in OC (70.4% female, mean age 54.4 years) and MS (68.9% female, mean age 51.4 years), respectively. Percentages of patients with a proportion of days covered ≥ 0.8 at 12 months for monotherapy vs combination therapy were OC, 44.5% vs 53.8%; MS, 36.4% vs 45.7%. Generally similar trends were seen over 24 months and for medication possession ratio ≥ 0.8. Median (95% confidence interval) times to treatment discontinuation for monotherapy vs combination therapy were OC, 10.1 (7.4–11.8) vs 16.7 (8.3–26.6) months; MS, 6.9 (5.6–9.4) vs 11.0 (6.1–13.9) months. During off-treatment vs on-treatment periods, numerical decreases were observed for all-cause (OC, $5383 vs $6149; MS, $4145 vs $5180) and PsA-related costs (OC, $3237 vs $4515; MS, $2703 vs $3907) regardless of therapy type. During off-treatment vs on-treatment periods, numerical increases in outpatient visits for all-cause (OC, 2.37 vs 2.05; MS, 2.15 vs 1.99) and PsA-related visits (OC, 0.60 vs 0.46; MS, 0.47 vs 0.44) were observed, and PsA-related medications numerically decreased (OC, 1.21 vs 1.53; MS, 1.05 vs 1.48).

Conclusion

In this USA-based claims analysis, tofacitinib adherence was numerically lower for patients with PsA receiving monotherapy vs combination therapy. Costs numerically decreased off-treatment vs on-treatment, irrespective of therapy type, driven by lower medication costs.

导言:据报道,银屑病关节炎(PsA)患者的功能障碍增加与医疗资源利用率(HCRU)和费用增加之间存在关联。我们评估了接受托法替尼单药治疗与传统合成改善病情抗风湿药联合治疗的 PsA 患者的特征/结果:分析了 Optum® Clinformatics® Data Mart (OC) 和 Merative™ MarketScan® (MS) 数据库中 2017 年 12 月至 2020 年 2 月期间的索赔数据。评估的结果包括按治疗类型(单一疗法/联合疗法)划分的依从性/持久性;按治疗期间(服用托法替尼的时间总和)和非治疗期间(停用托法替尼的时间总和[间隙>60天])加治疗类型划分的HCRU/费用(每位患者每月):该分析分别纳入了274例和395例接受过托法替尼治疗的OC(70.4%为女性,平均年龄54.4岁)和MS(68.9%为女性,平均年龄51.4岁)患者。12个月时,单一疗法与联合疗法覆盖天数比例≥0.8的患者比例分别为:OC,44.5% vs 53.8%;MS,36.4% vs 45.7%。在 24 个月内,药物持有率≥ 0.8 的趋势基本相似。单一疗法与联合疗法停药时间的中位数(95% 置信区间)分别为:OC,10.1(7.4-11.8)个月 vs 16.7(8.3-26.6)个月;MS,6.9(5.6-9.4)个月 vs 11.0(6.1-13.9)个月。在非治疗与治疗期间,观察到全因费用(OC,5383 美元 vs 6149 美元;MS,4145 美元 vs 5180 美元)和 PsA 相关费用(OC,3237 美元 vs 4515 美元;MS,2703 美元 vs 3907 美元)均有所下降,与治疗类型无关。在非治疗与治疗期间,观察到全因(OC,2.37 vs 2.05;MS,2.15 vs 1.99)和PsA相关门诊就诊人数增加(OC,0.60 vs 0.46;MS,0.47 vs 0.44),PsA相关药物治疗人数减少(OC,1.21 vs 1.53;MS,1.05 vs 1.48):结论:在这项基于美国的索赔分析中,接受单一疗法与联合疗法的PsA患者对托法替尼的依从性较低。无论治疗类型如何,非治疗与治疗期间的费用在数字上都有所下降,原因是药物费用较低。
{"title":"Adherence, Persistence, Healthcare Resource Use, and Costs in Tofacitinib-Treated Patients with Psoriatic Arthritis: Data from Two United States Claims Databases","authors":"Philip J. Mease,&nbsp;Eros Papademetriou,&nbsp;Ravi Potluri,&nbsp;Ekta Agarwal,&nbsp;Joseph C. Cappelleri,&nbsp;You-Li Ling","doi":"10.1007/s12325-024-02904-y","DOIUrl":"10.1007/s12325-024-02904-y","url":null,"abstract":"<div><h3>Introduction</h3><p>Associations between increased functional disability and higher healthcare resource utilization (HCRU) and costs were reported in patients with psoriatic arthritis (PsA). We assessed characteristics/outcomes of patients with PsA receiving tofacitinib monotherapy vs combination therapy with conventional synthetic disease-modifying antirheumatic drugs.</p><h3>Methods</h3><p>Claims data from Optum<sup>®</sup> Clinformatics<sup>®</sup> Data Mart (OC) and Merative™ MarketScan<sup>®</sup> (MS) databases between December 2017 and February 2020 were analyzed. Outcomes assessed were adherence/persistence by therapy type (monotherapy/combination therapy); HCRU/costs (per patient per month) by periods on-treatment (sum time on tofacitinib) and off-treatment (sum time off tofacitinib [gap of &gt; 60 days]) plus therapy type.</p><h3>Results</h3><p>This analysis included 274 and 395 tofacitinib-treated patients in OC (70.4% female, mean age 54.4 years) and MS (68.9% female, mean age 51.4 years), respectively. Percentages of patients with a proportion of days covered ≥ 0.8 at 12 months for monotherapy vs combination therapy were OC, 44.5% vs 53.8%; MS, 36.4% vs 45.7%. Generally similar trends were seen over 24 months and for medication possession ratio ≥ 0.8. Median (95% confidence interval) times to treatment discontinuation for monotherapy vs combination therapy were OC, 10.1 (7.4–11.8) vs 16.7 (8.3–26.6) months; MS, 6.9 (5.6–9.4) vs 11.0 (6.1–13.9) months. During off-treatment vs on-treatment periods, numerical decreases were observed for all-cause (OC, $5383 vs $6149; MS, $4145 vs $5180) and PsA-related costs (OC, $3237 vs $4515; MS, $2703 vs $3907) regardless of therapy type. During off-treatment vs on-treatment periods, numerical increases in outpatient visits for all-cause (OC, 2.37 vs 2.05; MS, 2.15 vs 1.99) and PsA-related visits (OC, 0.60 vs 0.46; MS, 0.47 vs 0.44) were observed, and PsA-related medications numerically decreased (OC, 1.21 vs 1.53; MS, 1.05 vs 1.48).</p><h3>Conclusion</h3><p>In this USA-based claims analysis, tofacitinib adherence was numerically lower for patients with PsA receiving monotherapy vs combination therapy. Costs numerically decreased off-treatment vs on-treatment, irrespective of therapy type, driven by lower medication costs.</p></div>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":"41 10","pages":"3850 - 3867"},"PeriodicalIF":3.4,"publicationDate":"2024-08-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11399223/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141981515","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
The Economic Burden of Childhood Ocular Morbidity in Bangladesh 孟加拉国儿童眼部疾病的经济负担。
IF 3.4 3区 医学 Q2 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2024-08-10 DOI: 10.1007/s12325-024-02958-y
A. H. M. Enayet Hussain, Labida Islam, Saidur Rahman Mashreky, Eija Viitasara, Koustuv Dalal

Introduction

Childhood eye morbidity is a great public health problem, especially in low-income countries. This study aimed to determine the economic burden of childhood ocular morbidity on attending tertiary hospitals in Bangladesh. This study also assessed the catastrophic health expenditure (CHE) for childhood ocular morbidity in Bangladesh.

Methods

A cross-sectional mixed method was used for this study from April to October 2023 at two tertiary hospitals in Bangladesh, one government-funded and one private. Face-to-face interviews using a semi-structured quantitative questionnaire with the caregivers/parents and in-depth interviews (IDIs) were conducted among the same respondents of these two hospitals, and a workshop was conducted with the stakeholders during the study period.

Results

This was the first study in Bangladesh to determine the cost of pediatric ocular morbidity. Among 335 patients, the total median direct cost at a single time was 3740 ± 18,285 BDT (34 ± 166.2 USD) at the government hospital and 7300 ± 40,630 BDT (66.36 ± 369.36 USD) at the private hospital. The disease-specific median overall cost from diagnosis of the disease was 65,000 BDT (591 USD) for squint, 50,000 BDT (454.54 USD) for cataract, and 30,000 BDT (272.72 USD) for eye injury. Almost 90% of the caregivers/parents faced CHE due to different pediatric ocular morbidity.

Conclusions

These cost estimates can be used as an initial basis for financial decisions that aim to enhance access to care, management, and follow-up of children with ocular morbidity. These cost estimates also offer helpful information for organizational and financial sustainability initiatives. Policymakers can consider serious immediate interventions for securing ocular health services in Bangladesh and prevent families from CHE.

导言:儿童眼病是一个严重的公共卫生问题,尤其是在低收入国家。本研究旨在确定在孟加拉国三级医院就诊的儿童眼部疾病所造成的经济负担。本研究还评估了孟加拉国儿童眼病的灾难性医疗支出(CHE):本研究采用横断面混合方法,于 2023 年 4 月至 10 月在孟加拉国的两家三级医院(一家政府资助医院和一家私立医院)进行。使用半结构化定量问卷对这两家医院的护理人员/家长进行了面对面访谈,并对相同的受访者进行了深度访谈(IDI),在研究期间还与利益相关者开展了一次研讨会:这是孟加拉国首次对小儿眼部疾病的成本进行研究。在 335 名患者中,公立医院的单次直接费用中位数为 3740 ± 18285 孟加拉塔卡(34 ± 166.2 美元),私立医院的单次直接费用中位数为 7300 ± 40630 孟加拉塔卡(66.36 ± 369.36 美元)。斜视患者从确诊疾病起的总费用中位数为 65,000 BDT(591 美元),白内障患者为 50,000 BDT(454.54 美元),眼外伤患者为 30,000 BDT(272.72 美元)。近 90% 的护理人员/家长因不同的小儿眼部疾病而需要花费不同的费用:这些成本估算可作为财务决策的初步依据,旨在提高眼部疾病患儿获得护理、管理和随访的机会。这些成本估算还为组织和财务的可持续发展举措提供了有用的信息。政策制定者可以考虑立即采取严肃的干预措施,以确保孟加拉国的眼部健康服务,并防止家庭因眼部疾病而陷入困境。
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引用次数: 0
Comparative Efficacy and Safety of Upadacitinib vs. Vedolizumab, Ustekinumab, and Tofacitinib After Induction and Maintenance for Ulcerative Colitis: Three Matching-Adjusted Indirect Comparisons 乌达帕替尼与韦多珠单抗、乌斯特库单抗和托法替尼在溃疡性结肠炎诱导和维持治疗后的疗效和安全性比较:三项匹配调整间接比较。
IF 3.4 3区 医学 Q2 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2024-08-10 DOI: 10.1007/s12325-024-02912-y
Walter Reinisch, Gil Y. Melmed, Hiroshi Nakase, Jakob Seidelin, Christopher Ma, Si Xuan, Jacinda Tran, Valencia Remple, Lani Wegrzyn, Gweneth Levy, Yuri Sanchez Gonzalez, Remo Panaccione

Introduction

Evidence on the comparative efficacy and safety of approved therapies for ulcerative colitis (UC) during induction and maintenance, including upadacitinib (UPA), vedolizumab (VEDO), ustekinumab (UST), and tofacitinib (TOFA), is limited.

Methods

Using data from phase 3 trials, three placebo (PBO)-anchored matching-adjusted indirect comparisons of the efficacy and safety of UPA versus VEDO, UST, and TOFA (U-ACHIEVE and U-ACCOMPLISH, GEMINI-1, UNIFI, and OCTAVE induction and maintenance trials) have been conducted. Baseline characteristics from UPA trials were weighted separately to match each comparator trial. Induction responders were re-randomized to oral UPA 15 or 30 mg, VEDO 300 mg intravenously every 8 weeks (Q8W), UST 90 mg SC Q8W, or oral TOFA 5 mg, or PBO in maintenance. Treat-through efficacy outcomes at weeks 44(UST)/46(VEDO)/52(UPA/TOFA) were adjusted by the likelihood of induction response and included clinical response, clinical remission, and endoscopic improvement. Safety outcomes included adverse events (AEs), serious AEs (SAEs), and AEs leading to discontinuation (except UPA vs. VEDO). Benefit–risk was assessed by numbers needed to treat (NNT)/harm, calculated as the inverse of the difference in proportions of patients achieving each efficacy/safety outcome for UPA versus comparator.

Results

The proportions of patients who demonstrated clinical response or endoscopic improvement was greater with UPA 15 mg versus VEDO and TOFA (p < 0.05). The proportions of patients demonstrating all treat-through efficacy outcomes were significantly greater with UPA 30 mg versus VEDO, UST, or TOFA with NNTs 3.2–8.7. No significant differences in proportions of AEs, SAEs, and AEs leading to discontinuation were observed between the two doses of UPA and comparators.

Conclusion

In patients with active UC, greater clinical efficacy, and similar safety after 1 year of maintenance were observed with UPA versus VEDO, UST, and TOFA, suggesting a favorable benefit-risk profile for UPA. Despite matched baseline characteristics, differences in trial design and endpoints may persist.

导言:有关已获批准的溃疡性结肠炎(UC)诱导和维持治疗方法(包括乌达替尼(UPA)、维多珠单抗(VEDO)、乌斯特库单抗(UST)和托法替尼(TOFA))的疗效和安全性比较的证据十分有限:方法:利用3期试验的数据,对UPA与VEDO、UST和TOFA(U-ACHIEVE和U-ACCOMPLISH、GEMINI-1、UNIFI和OCTAVE诱导和维持试验)的疗效和安全性进行了三次安慰剂(PBO)锚定匹配调整间接比较。对来自 UPA 试验的基线特征进行了单独加权,以与每项参照试验相匹配。诱导应答者被重新随机分配到口服 UPA 15 或 30 毫克、每 8 周静脉注射 VEDO 300 毫克(Q8W)、UST 90 毫克(SC Q8W)或口服 TOFA 5 毫克或 PBO 维持治疗。第44周(UST)/第46周(VEDO)/第52周(UPA/TOFA)的疗效结果根据诱导应答的可能性进行调整,包括临床应答、临床缓解和内镜改善。安全性结果包括不良事件(AE)、严重不良事件(SAE)和导致停药的不良事件(UPA vs. VEDO除外)。疗效风险通过治疗所需人数(NNT)/危害进行评估,计算方法是UPA与对比药在每项疗效/安全性结果上达到的患者比例差异的倒数:结果:UPA 15 毫克与 VEDO 和 TOFA 相比,获得临床应答或内镜改善的患者比例更高(p 结论:UPA 15 毫克与 VEDO 和 TOFA 相比,获得临床应答或内镜改善的患者比例更高:在活动性UC患者中,UPA与VEDO、UST和TOFA相比,临床疗效更高,且维持1年后安全性相似,这表明UPA具有良好的收益风险特征。尽管基线特征匹配,但试验设计和终点的差异可能依然存在。
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引用次数: 0
Matched Comparison Examining the Effect of Obesity on Clinical, Economic, and Humanistic Outcomes in Patients with Bipolar I Disorder 研究肥胖对双相情感障碍 I 患者的临床、经济和人文结果的影响的匹配比较。
IF 3.4 3区 医学 Q2 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2024-08-08 DOI: 10.1007/s12325-024-02953-3
Michael J. Doane, Adam Jauregui, Hemangi R. Panchmatia

Introduction

Bipolar I disorder (BD-I) is associated with an increased risk of obesity, but few studies have evaluated the real-world clinical, humanistic, and economic effects associated with obesity in people with BD-I.

Methods

This was a retrospective, cross-sectional analysis of responses to the 2016 and 2020 National Health and Wellness surveys. Respondents (18–64 years) with a self-reported physician diagnosis of BD-I were matched to controls without BD-I based on demographic and health characteristics. Respondents were categorized by body mass index as underweight/normal weight (< 25 kg/m2), overweight (25 to < 30 kg/m2), or obese (≥ 30 kg/m2). Multivariable regression models were used to compare obesity-related comorbidities, healthcare resource utilization (HCRU), health-related quality of life (HRQoL), work productivity, and indirect and direct costs.

Results

Before matching, the BD-I cohort was younger than the non-BD-I cohort and included more female and white respondents and a greater proportion covered by Medicaid or Medicare. After matching, the BD-I and non-BD-I cohorts had similar characteristics. A total of 5418 respondents (BD-I, n = 1806; matched controls, n = 3612) were analyzed. Obese respondents with BD-I reported the highest adjusted prevalences of high blood pressure (50%), high cholesterol (35%), sleep apnea (27%), osteoarthritis (17%), type 2 diabetes (12%), and liver disease (4%). Obesity in respondents with BD-I was associated with the lowest HRQoL scores. Measures of work impairment were highest in respondents with BD-I and obesity, as was HCRU. Respondents with BD-I and obesity had the highest associated total indirect and direct medical costs ($25,849 and $44,482, respectively).

Conclusion

Obese respondents with BD-I had greater frequencies of obesity-related comorbidities, higher HCRU, lower HRQoL, greater work impairments, and higher indirect and direct medical costs. These findings highlight the real-world burden of obesity in people with BD-I and the importance of considering treatments that may reduce this burden.

导言:双相情感障碍(BD-I)与肥胖风险增加有关,但很少有研究对双相情感障碍(BD-I)患者肥胖相关的临床、人文和经济影响进行评估:这是一项对 2016 年和 2020 年全国健康与保健调查回复的回顾性横断面分析。根据人口统计学和健康特征,将自述经医生诊断为 BD-I 的受访者(18-64 岁)与未患有 BD-I 的对照者进行配对。受访者按体重指数分为体重不足/正常体重(2)、超重(25 至 2)或肥胖(≥ 30 kg/m2)。多变量回归模型用于比较与肥胖相关的并发症、医疗资源利用率(HCRU)、与健康相关的生活质量(HRQoL)、工作效率以及间接和直接成本:匹配前,BD-I 组群比非 BD-I 组群更年轻,女性和白人受访者更多,享受医疗补助或医疗保险的比例更高。匹配后,BD-Ⅰ 组群和非 BD-I 组群的特征相似。共对 5418 名受访者(BD-Ⅰ,n = 1806;匹配对照,n = 3612)进行了分析。患有 BD-I 的肥胖受访者报告的高血压(50%)、高胆固醇(35%)、睡眠呼吸暂停(27%)、骨关节炎(17%)、2 型糖尿病(12%)和肝病(4%)的调整后患病率最高。患有 BD-I 的受访者中肥胖者的 HRQoL 得分最低。患有 BD-I 和肥胖症的受访者的工作障碍程度最高,HCRU 也是如此。患有 BD-I 和肥胖症的受访者的相关间接和直接医疗总费用最高(分别为 25,849 美元和 44,482 美元):结论:患有 BD-I 的肥胖受访者患有肥胖相关合并症的频率更高、HCRU 更高、HRQoL 更低、工作损伤更大,间接和直接医疗费用也更高。这些发现凸显了肥胖给 BD-I 患者带来的实际负担,以及考虑可减轻这一负担的治疗方法的重要性。
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Advances in Therapy
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