首页 > 最新文献

Rheumatology and Therapy最新文献

英文 中文
Projected Health and Economic Burden of Comorbid Gout and Chronic Kidney Disease in a Virtual US Population: A Microsimulation Study. 虚拟美国人口中痛风和慢性肾病并发症的健康和经济负担预测:微观模拟研究
IF 2.9 3区 医学 Q2 RHEUMATOLOGY Pub Date : 2024-08-01 Epub Date: 2024-06-05 DOI: 10.1007/s40744-024-00681-2
Joshua Card-Gowers, Lise Retat, Ada Kumar, Brad A Marder, Lissa Padnick-Silver, Brian LaMoreaux, Laura Webber

Introduction: Gout, a common comorbidity of chronic kidney disease (CKD), is associated with high morbidity and healthcare utilization. However, a large proportion of gout remains undermanaged or untreated which may lead to worse patient outcomes and greater healthcare costs. This study estimates the present and future health and economic burden of controlled and uncontrolled gout in a virtual United States (US) CKD population.

Methods: A validated microsimulation model was used to project the burden of gout in patients with CKD in the USA through 2035. Databases were utilized to build a virtual CKD population of "individuals" with controlled or uncontrolled gout. Modelling assumptions were made on the basis of the literature, which was sparse in some cases. Health and economic outcomes with the current care (baseline) scenario were evaluated, along with potential benefits of urate-lowering intervention scenarios.

Results: The prevalence of comorbid gout and CKD in the USA was projected to increase by 29%, from 7.9 million in 2023 to 9.6 million in 2035 in the baseline scenario. Gout flares, tophi, and comorbidity development were also projected to increase markedly through 2035, with the economic burden of gout in the CKD population subsequently increasing from $38.9 billion in 2023 to $47.3 billion in 2035. An increased use of oral urate-lowering therapies in undermanaged patients, and pegloticase use in patients refractory to oral urate-lowering therapies were also project to result in 744,000 and 353,000 fewer uncontrolled gout cases, respectively, by 2035. Marked reductions in complications and costs ensued.

Conclusions: This study projected a substantial increase in comorbid gout and CKD. However, improved use of urate-lowering interventions could mitigate this growth and reduce the health and economic burdens of gout.

导言:痛风是慢性肾脏病(CKD)的常见并发症,发病率和医疗费用都很高。然而,很大一部分痛风患者仍未得到充分管理或治疗,这可能会导致患者病情恶化和医疗费用增加。本研究估算了在一个虚拟的美国慢性肾脏病人群中,已控制和未控制的痛风所带来的当前和未来的健康与经济负担:方法:使用一个经过验证的微观模拟模型来预测到 2035 年美国慢性肾脏病患者的痛风负担。利用数据库建立了一个由痛风得到控制或未得到控制的 "个体 "组成的虚拟 CKD 群体。建模假设以文献为基础,而文献在某些情况下是稀缺的。评估了当前治疗方案(基线)的健康和经济效益,以及降尿酸干预方案的潜在效益:结果:在基线方案中,预计美国痛风和慢性肾脏病合并症的发病率将增加 29%,从 2023 年的 790 万增加到 2035 年的 960 万。预计到 2035 年,痛风发作、丘疹和合并症的发展也将显著增加,CKD 患者痛风造成的经济负担将从 2023 年的 389 亿美元增加到 2035 年的 473 亿美元。预计到 2035 年,在病情未得到充分控制的患者中增加口服降尿酸治疗药物的使用,以及在口服降尿酸治疗药物难治性患者中使用培高替尼酶,也将使未得到控制的痛风病例分别减少 744,000 例和 353,000 例。并发症和成本随之显著降低:这项研究预计痛风和慢性肾脏病的合并症将大幅增加。结论:这项研究预测痛风和慢性肾脏病的合并症将大幅增加,然而,改善降尿酸干预措施的使用可以缓解这一增长,并减少痛风带来的健康和经济负担。
{"title":"Projected Health and Economic Burden of Comorbid Gout and Chronic Kidney Disease in a Virtual US Population: A Microsimulation Study.","authors":"Joshua Card-Gowers, Lise Retat, Ada Kumar, Brad A Marder, Lissa Padnick-Silver, Brian LaMoreaux, Laura Webber","doi":"10.1007/s40744-024-00681-2","DOIUrl":"10.1007/s40744-024-00681-2","url":null,"abstract":"<p><strong>Introduction: </strong>Gout, a common comorbidity of chronic kidney disease (CKD), is associated with high morbidity and healthcare utilization. However, a large proportion of gout remains undermanaged or untreated which may lead to worse patient outcomes and greater healthcare costs. This study estimates the present and future health and economic burden of controlled and uncontrolled gout in a virtual United States (US) CKD population.</p><p><strong>Methods: </strong>A validated microsimulation model was used to project the burden of gout in patients with CKD in the USA through 2035. Databases were utilized to build a virtual CKD population of \"individuals\" with controlled or uncontrolled gout. Modelling assumptions were made on the basis of the literature, which was sparse in some cases. Health and economic outcomes with the current care (baseline) scenario were evaluated, along with potential benefits of urate-lowering intervention scenarios.</p><p><strong>Results: </strong>The prevalence of comorbid gout and CKD in the USA was projected to increase by 29%, from 7.9 million in 2023 to 9.6 million in 2035 in the baseline scenario. Gout flares, tophi, and comorbidity development were also projected to increase markedly through 2035, with the economic burden of gout in the CKD population subsequently increasing from $38.9 billion in 2023 to $47.3 billion in 2035. An increased use of oral urate-lowering therapies in undermanaged patients, and pegloticase use in patients refractory to oral urate-lowering therapies were also project to result in 744,000 and 353,000 fewer uncontrolled gout cases, respectively, by 2035. Marked reductions in complications and costs ensued.</p><p><strong>Conclusions: </strong>This study projected a substantial increase in comorbid gout and CKD. However, improved use of urate-lowering interventions could mitigate this growth and reduce the health and economic burdens of gout.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"913-926"},"PeriodicalIF":2.9,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11264668/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141247763","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
New Insights on the Therapeutic Potential of Runt-Related Transcription Factor 2 for Osteoarthritis: Evidence from Mendelian Randomization. Runt 相关转录因子 2 治疗骨关节炎潜力的新见解:孟德尔随机化的证据。
IF 2.9 3区 医学 Q2 RHEUMATOLOGY Pub Date : 2024-08-01 Epub Date: 2024-06-14 DOI: 10.1007/s40744-024-00682-1
Jiale Xie, Xin Xu, Mingyi Yang, Hui Yu, Jinrong Hao, Dinglong Yang, Peng Xu

Introduction: Research has highlighted the role of runt-related transcription factor 2 (Runx2) in the development of osteoarthritis (OA); however, its causal association remains unclear. This study aimed to explore whether Runx2 expression is causally associated with OA and assess its therapeutic potential for OA.

Methods: Genetic proxy instruments for Runx2 expression were obtained from gene expression quantitative trait locus (eQTLs) study of eQTLGen Consortium (n = 31,684). Aggregated genome-wide association study (GWAS) data for OA (including all OA [177,517 cases and 649,173 controls], knee OA (KOA) [62,497 cases and 333,557 controls], and hip OA (HOA) [36,445 cases and 316,943 controls]) were extracted from the Genetics of Osteoarthritis Consortium. We integrated eQTLs data with OA GWAS data to estimate their causal association and to estimate the potential of Runx2 as a drug target in the treatment of OA using summary data-based Mendelian randomization (SMR) analysis. Furthermore, different OA GWAS data (including all OA [77,052 cases and 378,169 controls], KOA [24,955 cases and 378,169 controls], and HOA [15,704 cases and 378,169 controls]) derived from the GWAS Catalog database were used for replication study.

Results: SMR analysis showed that high expression levels of Runx2 were associated with an increased risk of all OA [odds ratio (OR) 1.044, 95% confidence interval (CI) 1.023-1.067; P = 5.03 × 10-5], KOA (OR 1.040, 95% CI 1.006-1.075; P = 0.021), and HOA (OR 1.067, 95% CI 1.022-1.113; P = 0.003). This suggests that Runx2 inhibitors may have promising potential for the treatment of OA. Notably, the causal effects of Runx2 with all OA (OR 1.053, 95% CI 1.027-1.079; P = 3.95 × 10-5) and KOA (OR 1.043, 95% CI 1.001-1.087; P = 0.045) were repeated in the replication study, but limited evidence supported the association of Runx2 expression levels with HOA (OR 1.045, 95% CI 0.993-1.101; P = 0.094).

Conclusions: Our analyses indicate a positive correlation between Runx2 expression and OA risk across all three phenotypes, suggesting the potential of Runx2 inhibitors in the treatment of OA and providing evidence from a genetic perspective.

导言:研究强调了Runt相关转录因子2(Runx2)在骨关节炎(OA)发病中的作用,但其因果关系仍不清楚。本研究旨在探讨Runx2的表达是否与OA存在因果关系,并评估其治疗OA的潜力:Runx2表达的遗传替代工具来自eQTLGen Consortium的基因表达定量性状位点(eQTLs)研究(n = 31,684)。从骨关节炎遗传学联盟(Genetics of Osteoarthritis Consortium)提取了OA(包括所有OA[177,517例病例和649,173例对照]、膝关节OA(KOA)[62,497例病例和333,557例对照]以及髋关节OA(HOA)[36,445例病例和316,943例对照])的全基因组关联研究(GWAS)汇总数据。我们整合了 eQTLs 数据和 OA GWAS 数据,以估算它们之间的因果关系,并利用基于汇总数据的孟德尔随机分析(SMR)估算 Runx2 作为治疗 OA 的药物靶点的潜力。此外,从GWAS目录数据库中提取的不同OA GWAS数据(包括所有OA[77,052个病例和378,169个对照]、KOA[24,955个病例和378,169个对照]以及HOA[15,704个病例和378,169个对照])也被用于重复研究:SMR分析表明,Runx2的高表达水平与所有OA[几率比(OR)1.044,95%置信区间(CI)1.023-1.067;P = 5.03 × 10-5]、KOA(OR 1.040,95% CI 1.006-1.075;P = 0.021)和HOA(OR 1.067,95% CI 1.022-1.113;P = 0.003)风险的增加有关。这表明,Runx2抑制剂可能具有治疗OA的潜力。值得注意的是,Runx2与所有OA(OR 1.053,95% CI 1.027-1.079;P = 3.95 × 10-5)和KOA(OR 1.043,95% CI 1.001-1.087;P = 0.045)的因果效应在复制研究中重复出现,但支持Runx2表达水平与HOA相关性的证据有限(OR 1.045,95% CI 0.993-1.101;P = 0.094):我们的分析表明,在所有三种表型中,Runx2表达与OA风险呈正相关,这表明Runx2抑制剂在治疗OA方面具有潜力,并从遗传学角度提供了证据。
{"title":"New Insights on the Therapeutic Potential of Runt-Related Transcription Factor 2 for Osteoarthritis: Evidence from Mendelian Randomization.","authors":"Jiale Xie, Xin Xu, Mingyi Yang, Hui Yu, Jinrong Hao, Dinglong Yang, Peng Xu","doi":"10.1007/s40744-024-00682-1","DOIUrl":"10.1007/s40744-024-00682-1","url":null,"abstract":"<p><strong>Introduction: </strong>Research has highlighted the role of runt-related transcription factor 2 (Runx2) in the development of osteoarthritis (OA); however, its causal association remains unclear. This study aimed to explore whether Runx2 expression is causally associated with OA and assess its therapeutic potential for OA.</p><p><strong>Methods: </strong>Genetic proxy instruments for Runx2 expression were obtained from gene expression quantitative trait locus (eQTLs) study of eQTLGen Consortium (n = 31,684). Aggregated genome-wide association study (GWAS) data for OA (including all OA [177,517 cases and 649,173 controls], knee OA (KOA) [62,497 cases and 333,557 controls], and hip OA (HOA) [36,445 cases and 316,943 controls]) were extracted from the Genetics of Osteoarthritis Consortium. We integrated eQTLs data with OA GWAS data to estimate their causal association and to estimate the potential of Runx2 as a drug target in the treatment of OA using summary data-based Mendelian randomization (SMR) analysis. Furthermore, different OA GWAS data (including all OA [77,052 cases and 378,169 controls], KOA [24,955 cases and 378,169 controls], and HOA [15,704 cases and 378,169 controls]) derived from the GWAS Catalog database were used for replication study.</p><p><strong>Results: </strong>SMR analysis showed that high expression levels of Runx2 were associated with an increased risk of all OA [odds ratio (OR) 1.044, 95% confidence interval (CI) 1.023-1.067; P = 5.03 × 10<sup>-5</sup>], KOA (OR 1.040, 95% CI 1.006-1.075; P = 0.021), and HOA (OR 1.067, 95% CI 1.022-1.113; P = 0.003). This suggests that Runx2 inhibitors may have promising potential for the treatment of OA. Notably, the causal effects of Runx2 with all OA (OR 1.053, 95% CI 1.027-1.079; P = 3.95 × 10<sup>-5</sup>) and KOA (OR 1.043, 95% CI 1.001-1.087; P = 0.045) were repeated in the replication study, but limited evidence supported the association of Runx2 expression levels with HOA (OR 1.045, 95% CI 0.993-1.101; P = 0.094).</p><p><strong>Conclusions: </strong>Our analyses indicate a positive correlation between Runx2 expression and OA risk across all three phenotypes, suggesting the potential of Runx2 inhibitors in the treatment of OA and providing evidence from a genetic perspective.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"1001-1009"},"PeriodicalIF":2.9,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11264677/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141318183","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
Cardiovascular Risk Evaluation in Psoriatic Arthritis by Aortic Stiffness and the Systemic Coronary Risk Evaluation (SCORE): Results of the Prospective PSOCARD Cohort Study. 通过主动脉僵硬度和系统性冠状动脉风险评估 (SCORE) 评估银屑病关节炎的心血管风险:前瞻性 PSOCARD 队列研究的结果。
IF 2.9 3区 医学 Q2 RHEUMATOLOGY Pub Date : 2024-08-01 Epub Date: 2024-05-31 DOI: 10.1007/s40744-024-00676-z
Konstantinos Triantafyllias, Stefanie Liverakos, Muthuraman Muthuraman, Lorenzo Cavagna, Ioannis Parodis, Andreas Schwarting

Introduction: Psoriatic arthritis (PsA) is associated with increased cardiovascular (CV) risk and mortality. Aortic stiffness measured by carotid-femoral pulse wave velocity (cfPWV) has been shown to predict CV risk in the general population. The present study aimed to examine cfPWV values of patients with PsA compared to healthy controls and to evaluate associations of cfPWV with patient- and disease-associated characteristics, as well as with an established traditional CV prediction score of the European Society of Cardiology (Systemic Coronary Risk Evaluation; SCORE), for the first time.

Methods: cfPWV and SCORE were evaluated in patients with PsA and healthy controls, along with clinical and laboratory disease parameters. Differences in cfPWV measurements between the two groups and associations of cfPWV with patient- and disease-associated characteristics were statistically evaluated.

Results: A total of 150 patients with PsA (PSOCARD cohort) and 88 control subjects were recruited. cfPWV was significantly higher in the PsA group compared to controls, even after adjustment for confounders (padj = 0.034). Moreover, cfPWV was independently associated with disease duration (r = 0.304, p = 0.001), age (rho = 0.688, p < 0.001), systolic arterial pressure (rho = 0.351, p < 0.001), glomerular filtration rate (inverse: rho = - 0.264, p = 0.001), and red cell distribution width, a marker of major adverse CV events (MACE) (rho = 0.190, p = 0.02). SCORE revealed an elevated CV risk in 8.73% of the patients, whereas cfPWV showed increased aortic stiffness and end-organ disease in 16.00% of the same cohort.

Conclusions: In the largest cfPWV/PsA cohort examined to date, patients with PsA exhibited increased aortic stiffness compared to healthy controls. PsA duration was the most important independent disease-associated predictor of increased aortic stiffness, next to traditional CV risk factors. cfPWV measurements may help identify subclinical end-organ disease and abnormal aortic stiffness and thus assist CV risk classification in PsA.

导言:银屑病关节炎(PsA)与心血管(CV)风险和死亡率增加有关。通过颈动脉-股动脉脉搏波速度(cfPWV)测量的主动脉僵硬度已被证明可预测普通人群的心血管风险。本研究旨在检测 PsA 患者与健康对照组相比的 cfPWV 值,并首次评估 cfPWV 与患者和疾病相关特征以及欧洲心脏病学会已建立的传统 CV 预测评分(系统性冠状动脉风险评估;SCORE)之间的关联。方法:对 PsA 患者和健康对照组的 cfPWV 和 SCORE 以及临床和实验室疾病参数进行了评估。方法:对 PsA 患者和健康对照组的 cfPWV 和 SCORE 以及临床和实验室疾病参数进行评估,并对两组间 cfPWV 测量值的差异以及 cfPWV 与患者和疾病相关特征的关联进行统计评估:共招募了 150 名 PsA 患者(PSOCARD 队列)和 88 名对照组受试者。即使在调整了混杂因素后,PsA 组的 cfPWV 仍显著高于对照组(padj = 0.034)。此外,cfPWV 与病程(r = 0.304,p = 0.001)、年龄(rho = 0.688,p 结论:PsA 组与对照组相比,cfPWV 明显更高:在迄今为止最大的 cfPWV/PsA 队列中,与健康对照组相比,PsA 患者的主动脉僵硬度有所增加。PsA持续时间是主动脉僵化增加的最重要的独立疾病相关预测因素,仅次于传统的CV风险因素。cfPWV测量有助于识别亚临床终末器官疾病和异常的主动脉僵化,从而有助于PsA的CV风险分类。
{"title":"Cardiovascular Risk Evaluation in Psoriatic Arthritis by Aortic Stiffness and the Systemic Coronary Risk Evaluation (SCORE): Results of the Prospective PSOCARD Cohort Study.","authors":"Konstantinos Triantafyllias, Stefanie Liverakos, Muthuraman Muthuraman, Lorenzo Cavagna, Ioannis Parodis, Andreas Schwarting","doi":"10.1007/s40744-024-00676-z","DOIUrl":"10.1007/s40744-024-00676-z","url":null,"abstract":"<p><strong>Introduction: </strong>Psoriatic arthritis (PsA) is associated with increased cardiovascular (CV) risk and mortality. Aortic stiffness measured by carotid-femoral pulse wave velocity (cfPWV) has been shown to predict CV risk in the general population. The present study aimed to examine cfPWV values of patients with PsA compared to healthy controls and to evaluate associations of cfPWV with patient- and disease-associated characteristics, as well as with an established traditional CV prediction score of the European Society of Cardiology (Systemic Coronary Risk Evaluation; SCORE), for the first time.</p><p><strong>Methods: </strong>cfPWV and SCORE were evaluated in patients with PsA and healthy controls, along with clinical and laboratory disease parameters. Differences in cfPWV measurements between the two groups and associations of cfPWV with patient- and disease-associated characteristics were statistically evaluated.</p><p><strong>Results: </strong>A total of 150 patients with PsA (PSOCARD cohort) and 88 control subjects were recruited. cfPWV was significantly higher in the PsA group compared to controls, even after adjustment for confounders (p<sub>adj</sub> = 0.034). Moreover, cfPWV was independently associated with disease duration (r = 0.304, p = 0.001), age (rho = 0.688, p < 0.001), systolic arterial pressure (rho = 0.351, p < 0.001), glomerular filtration rate (inverse: rho = - 0.264, p = 0.001), and red cell distribution width, a marker of major adverse CV events (MACE) (rho = 0.190, p = 0.02). SCORE revealed an elevated CV risk in 8.73% of the patients, whereas cfPWV showed increased aortic stiffness and end-organ disease in 16.00% of the same cohort.</p><p><strong>Conclusions: </strong>In the largest cfPWV/PsA cohort examined to date, patients with PsA exhibited increased aortic stiffness compared to healthy controls. PsA duration was the most important independent disease-associated predictor of increased aortic stiffness, next to traditional CV risk factors. cfPWV measurements may help identify subclinical end-organ disease and abnormal aortic stiffness and thus assist CV risk classification in PsA.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"897-911"},"PeriodicalIF":2.9,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11265042/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141180636","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
Improved Health Outcomes in Patients with Systemic Lupus Erythematosus Following Early Belimumab Initiation Without Prior Immunosuppressant Use: A Real-World Descriptive Study. 系统性红斑狼疮患者在未使用免疫抑制剂的情况下尽早使用贝利木单抗可改善健康状况:一项真实世界描述性研究
IF 2.9 3区 医学 Q2 RHEUMATOLOGY Pub Date : 2024-08-01 Epub Date: 2024-06-07 DOI: 10.1007/s40744-024-00675-0
Bernard Rubin, Yan Chen, Karen Worley, Brendan Rabideau, Benson Wu, Rose Chang, Maral DerSarkissian

Introduction: Patients with systemic lupus erythematosus (SLE) have variable treatment pathways, including antimalarials, glucocorticoids, immunosuppressants, and/or biologics. This study describes differences in clinical outcomes when initiating belimumab (BEL) before and after immunosuppressant use.

Methods: This real-world, retrospective cohort study (GSK Study 217536) used de-identified administrative claims data from January 2015 to December 2022 in the Komodo Health Database. Adults with moderate/severe SLE initiating BEL (index date) were identified from January 2017 to May 2022, allowing a ≥ 24-month baseline period. Patients were stratified into those initiating BEL before immunosuppressant use (no immunosuppressant use within 24 months before index) and those initiating BEL after immunosuppressant use (one immunosuppressant used within 24 months before index). Oral glucocorticoid (OGC) use, SLE flares, new organ damage, and all-cause healthcare resource utilization (HCRU) were analyzed descriptively over a 24-month follow-up.

Results: Baseline SLE severity was similar for patients initiating BEL before (n = 2295) versus after (n = 4114) immunosuppressant use (moderate, 83.1% vs 79.0%; severe, 16.8% vs 21.0%). Patients initiating BEL before versus after immunosuppressant use had lower SLE flare rates and OGC use. Post-index, patients initiating BEL before versus after immunosuppressant use discontinued their OGC sooner (moderate baseline SLE, 4.5 vs 8.9 months; severe baseline SLE, 6.2 vs 11.6 months). Patients initiating BEL before versus after immunosuppressant use had lower SLE flare rates per person-year at all time points (especially severe flare rates in patients with severe baseline SLE, 0.70 vs 1.48 through 24 months post-index). Median time to new organ damage occurrence was longer in patients initiating BEL before versus after immunosuppressant use (moderate baseline SLE, 32.1 vs 26.7 months; severe baseline SLE, 22.7 vs 21.6 months). All-cause HCRU was similar between cohorts.

Conclusions: These results suggest that patients initiating BEL before versus after immunosuppressant use had more favorable outcomes.

导言:系统性红斑狼疮(SLE)患者的治疗途径多种多样,包括抗疟药、糖皮质激素、免疫抑制剂和/或生物制剂。本研究描述了在使用免疫抑制剂之前和之后开始使用贝利木单抗(BEL)时临床结果的差异:这项真实世界的回顾性队列研究(葛兰素史克研究 217536)使用了 Komodo Health 数据库中 2015 年 1 月至 2022 年 12 月期间去标识化的行政报销数据。中度/重度系统性红斑狼疮成人患者于 2017 年 1 月至 2022 年 5 月期间开始使用 BEL(指数日期),基线期≥24 个月。将患者分为在使用免疫抑制剂前(指数前 24 个月内未使用过免疫抑制剂)开始 BEL 的患者和在使用免疫抑制剂后(指数前 24 个月内使用过一种免疫抑制剂)开始 BEL 的患者。对随访24个月期间的口服糖皮质激素(OGC)使用情况、系统性红斑狼疮复发、新的器官损伤和全因医疗资源利用率(HCRU)进行了描述性分析:结果:在使用免疫抑制剂之前(n = 2295)和之后(n = 4114)开始使用BEL的患者的系统性红斑狼疮严重程度基线相似(中度,83.1% vs 79.0%;重度,16.8% vs 21.0%)。在使用免疫抑制剂之前和之后开始使用BEL的患者,其系统性红斑狼疮复发率和OGC使用率均较低。索引后,使用免疫抑制剂之前和之后开始使用 BEL 的患者停用 OGC 的时间更早(中度基线系统性红斑狼疮,4.5 个月对 8.9 个月;重度基线系统性红斑狼疮,6.2 个月对 11.6 个月)。在使用免疫抑制剂之前和之后开始使用BEL的患者,在所有时间点的每人每年系统性红斑狼疮复发率都较低(尤其是重度基线系统性红斑狼疮患者的严重复发率,指数后24个月内分别为0.70和1.48)。与使用免疫抑制剂之前相比,开始使用BEL的患者出现新器官损伤的中位时间更长(中度基线SLE患者为32.1个月,重度基线SLE患者为26.7个月;重度基线SLE患者为22.7个月,重度基线SLE患者为21.6个月)。两组患者的全因HCRU相似:这些结果表明,在使用免疫抑制剂之前和之后开始使用BEL的患者的预后更佳。
{"title":"Improved Health Outcomes in Patients with Systemic Lupus Erythematosus Following Early Belimumab Initiation Without Prior Immunosuppressant Use: A Real-World Descriptive Study.","authors":"Bernard Rubin, Yan Chen, Karen Worley, Brendan Rabideau, Benson Wu, Rose Chang, Maral DerSarkissian","doi":"10.1007/s40744-024-00675-0","DOIUrl":"10.1007/s40744-024-00675-0","url":null,"abstract":"<p><strong>Introduction: </strong>Patients with systemic lupus erythematosus (SLE) have variable treatment pathways, including antimalarials, glucocorticoids, immunosuppressants, and/or biologics. This study describes differences in clinical outcomes when initiating belimumab (BEL) before and after immunosuppressant use.</p><p><strong>Methods: </strong>This real-world, retrospective cohort study (GSK Study 217536) used de-identified administrative claims data from January 2015 to December 2022 in the Komodo Health Database. Adults with moderate/severe SLE initiating BEL (index date) were identified from January 2017 to May 2022, allowing a ≥ 24-month baseline period. Patients were stratified into those initiating BEL before immunosuppressant use (no immunosuppressant use within 24 months before index) and those initiating BEL after immunosuppressant use (one immunosuppressant used within 24 months before index). Oral glucocorticoid (OGC) use, SLE flares, new organ damage, and all-cause healthcare resource utilization (HCRU) were analyzed descriptively over a 24-month follow-up.</p><p><strong>Results: </strong>Baseline SLE severity was similar for patients initiating BEL before (n = 2295) versus after (n = 4114) immunosuppressant use (moderate, 83.1% vs 79.0%; severe, 16.8% vs 21.0%). Patients initiating BEL before versus after immunosuppressant use had lower SLE flare rates and OGC use. Post-index, patients initiating BEL before versus after immunosuppressant use discontinued their OGC sooner (moderate baseline SLE, 4.5 vs 8.9 months; severe baseline SLE, 6.2 vs 11.6 months). Patients initiating BEL before versus after immunosuppressant use had lower SLE flare rates per person-year at all time points (especially severe flare rates in patients with severe baseline SLE, 0.70 vs 1.48 through 24 months post-index). Median time to new organ damage occurrence was longer in patients initiating BEL before versus after immunosuppressant use (moderate baseline SLE, 32.1 vs 26.7 months; severe baseline SLE, 22.7 vs 21.6 months). All-cause HCRU was similar between cohorts.</p><p><strong>Conclusions: </strong>These results suggest that patients initiating BEL before versus after immunosuppressant use had more favorable outcomes.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"947-962"},"PeriodicalIF":2.9,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11264657/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141284643","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
Methotrexate, Tofacitinib, and Biologic Disease-Modifying Antirheumatic Drug Safety and Effectiveness Among Patients with Rheumatoid Arthritis in Japan: CorEvitas Registry Observational Study 日本类风湿关节炎患者服用甲氨蝶呤、托法替尼和生物制剂改变病情抗风湿药物的安全性和有效性:CorEvitas 登记观察研究
IF 3.8 3区 医学 Q2 RHEUMATOLOGY Pub Date : 2024-07-27 DOI: 10.1007/s40744-024-00700-2
Yoshiya Tanaka, Mitsumasa Kishimoto, Koshiro Sonomoto, Koichi Amano, Masayoshi Harigai, Alina Onofrei, Jacqueline O’Brien, Zachary Margolin, Christine Barr, Yasushi Mizuno, Ekta Agarwal, Naonobu Sugiyama, Hisashi Yamanaka

Introduction

The evolution of disease-modifying antirheumatic drugs (DMARDs) for the treatment of rheumatoid arthritis (RA) has improved patient prognosis. However, more real-world safety/effectiveness data comparing methotrexate (MTX), tofacitinib, tumor necrosis factor inhibitors (TNFi), and non-TNFi biologic DMARDs (bDMARDs) are warranted.

Methods

The CorEvitas RA Japan registry was used to identify patients with rheumatologist-diagnosed RA who initiated MTX/tofacitinib/TNFi/non-TNFi bDMARDs. Safety outcomes included incidence of major adverse cardiovascular events (MACE), total cardiovascular disease, total serious infections, total herpes zoster, and total malignancies (excluding non-melanoma skin cancer). Effectiveness outcomes included change from baseline (Δ) in Clinical Disease Activity Index (CDAI) and proportion of patients achieving a minimum clinically important difference (MCID) in CDAI at month 6. Adjusted regression models were fit; marginal means were estimated.

Results

Overall, 1972 patients were included in the safety cohort: MTX (N = 298); tofacitinib (N = 253); TNFi (N = 663); non-TNFi (N = 758). Mean follow-up time was 3.8, 2.9, 3.0, and 2.9 years for MTX, tofacitinib, TNFi, and non-TNFi, respectively. Adjusted incidence rates (IRs, patients with events/100 patient-years [95% confidence intervals]) for MACE and total cardiovascular disease, respectively, were numerically lower for MTX (0.34 [0, 0.83]; 0.42 [0, 0.92]) and TNFi (0.09 [0, 0.27]; 0.61 [0.15, 1.07]) versus tofacitinib (0.48 [0, 1.20]; 2.30 [0.38, 4.22]) and non-TNFi (0.77 [0.35, 1.19]; 1.28 [0.73, 1.82]). Serious infections were numerically higher for non-TNFi (4.47 [3.38, 5.56]); herpes zoster was higher for tofacitinib (7.41 [4.52, 10.29]), versus other groups. IRs for malignancies were comparable between groups. Mean ΔCDAI and rates of achieving MCID in CDAI at month 6 were generally greater with tofacitinib versus other groups.

Conclusion

Some variations in incidence of safety outcomes were observed between treatments, while certain effectiveness outcomes favored tofacitinib. Sample size variation between groups and low number of safety events limited the analysis. Further studies are warranted to investigate observed differences.

ClinicalTrials.gov

NCT05572567.

导言用于治疗类风湿性关节炎(RA)的改变病情抗风湿药(DMARDs)的发展改善了患者的预后。然而,我们需要更多真实世界的安全性/有效性数据,对甲氨蝶呤(MTX)、托法替尼、肿瘤坏死因子抑制剂(TNFi)和非TNFi生物DMARDs(bDMARDs)进行比较。方法:CorEvitas RA日本登记处用于识别经风湿免疫科确诊、开始使用MTX/托法替尼/TNFi/非TNFi bDMARDs的RA患者。安全性结果包括主要心血管不良事件(MACE)发生率、心血管疾病总数、严重感染总数、带状疱疹总数和恶性肿瘤总数(不包括非黑色素瘤皮肤癌)。疗效结果包括临床疾病活动指数(CDAI)与基线相比的变化(Δ)以及第6个月时CDAI达到最小临床意义差异(MCID)的患者比例。 结果总体而言,1972名患者被纳入安全性队列:MTX(N = 298);托法替尼(N = 253);TNFi(N = 663);非TNFi(N = 758)。MTX、托法替尼、TNFi和非TNFi的平均随访时间分别为3.8年、2.9年、3.0年和2.9年。MACE和总心血管疾病的调整后发病率(IRs,事件患者/100患者年[95%置信区间])分别为MTX较低(0.34[0,0.83];0.42[0,0.92])和 TNFi(0.09[0,0.27];0.61[0.15,1.07])在数值上低于托法替尼(0.48[0,1.20];2.30[0.38,4.22])和非 TNFi(0.77[0.35,1.19];1.28[0.73,1.82])。非 TNFi(4.47 [3.38, 5.56])的严重感染率更高;托法替尼(7.41 [4.52, 10.29])的带状疱疹感染率高于其他组别。各组间恶性肿瘤的IR值相当。平均ΔCDAI和第6个月时CDAI的MCID达标率,托法替尼普遍高于其他组。组间样本量的差异和较低的安全事件数量限制了分析。有必要开展进一步研究,以调查观察到的差异。ClinicalTrials.govNCT05572567。
{"title":"Methotrexate, Tofacitinib, and Biologic Disease-Modifying Antirheumatic Drug Safety and Effectiveness Among Patients with Rheumatoid Arthritis in Japan: CorEvitas Registry Observational Study","authors":"Yoshiya Tanaka, Mitsumasa Kishimoto, Koshiro Sonomoto, Koichi Amano, Masayoshi Harigai, Alina Onofrei, Jacqueline O’Brien, Zachary Margolin, Christine Barr, Yasushi Mizuno, Ekta Agarwal, Naonobu Sugiyama, Hisashi Yamanaka","doi":"10.1007/s40744-024-00700-2","DOIUrl":"https://doi.org/10.1007/s40744-024-00700-2","url":null,"abstract":"<h3 data-test=\"abstract-sub-heading\">Introduction</h3><p>The evolution of disease-modifying antirheumatic drugs (DMARDs) for the treatment of rheumatoid arthritis (RA) has improved patient prognosis. However, more real-world safety/effectiveness data comparing methotrexate (MTX), tofacitinib, tumor necrosis factor inhibitors (TNFi), and non-TNFi biologic DMARDs (bDMARDs) are warranted.</p><h3 data-test=\"abstract-sub-heading\">Methods</h3><p>The CorEvitas RA Japan registry was used to identify patients with rheumatologist-diagnosed RA who initiated MTX/tofacitinib/TNFi/non-TNFi bDMARDs. Safety outcomes included incidence of major adverse cardiovascular events (MACE), total cardiovascular disease, total serious infections, total herpes zoster, and total malignancies (excluding non-melanoma skin cancer). Effectiveness outcomes included change from baseline (Δ) in Clinical Disease Activity Index (CDAI) and proportion of patients achieving a minimum clinically important difference (MCID) in CDAI at month 6. Adjusted regression models were fit; marginal means were estimated.</p><h3 data-test=\"abstract-sub-heading\">Results</h3><p>Overall, 1972 patients were included in the safety cohort: MTX (<i>N</i> = 298); tofacitinib (<i>N</i> = 253); TNFi (<i>N</i> = 663); non-TNFi (<i>N</i> = 758). Mean follow-up time was 3.8, 2.9, 3.0, and 2.9 years for MTX, tofacitinib, TNFi, and non-TNFi, respectively. Adjusted incidence rates (IRs, patients with events/100 patient-years [95% confidence intervals]) for MACE and total cardiovascular disease, respectively, were numerically lower for MTX (0.34 [0, 0.83]; 0.42 [0, 0.92]) and TNFi (0.09 [0, 0.27]; 0.61 [0.15, 1.07]) versus tofacitinib (0.48 [0, 1.20]; 2.30 [0.38, 4.22]) and non-TNFi (0.77 [0.35, 1.19]; 1.28 [0.73, 1.82]). Serious infections were numerically higher for non-TNFi (4.47 [3.38, 5.56]); herpes zoster was higher for tofacitinib (7.41 [4.52, 10.29]), versus other groups. IRs for malignancies were comparable between groups. Mean ΔCDAI and rates of achieving MCID in CDAI at month 6 were generally greater with tofacitinib versus other groups.</p><h3 data-test=\"abstract-sub-heading\">Conclusion</h3><p>Some variations in incidence of safety outcomes were observed between treatments, while certain effectiveness outcomes favored tofacitinib. Sample size variation between groups and low number of safety events limited the analysis. Further studies are warranted to investigate observed differences.</p><h3 data-test=\"abstract-sub-heading\">ClinicalTrials.gov</h3><p>NCT05572567.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":"39 1","pages":""},"PeriodicalIF":3.8,"publicationDate":"2024-07-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141779778","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Characteristics and 6-Month Outcomes in Patients with Rheumatoid Arthritis Initiating Infliximab Biosimilar IFX-dyyb in a Real-World Setting. 在真实世界环境中使用英夫利西单抗生物仿制药 IFX-dyb 的类风湿关节炎患者的特征和 6 个月疗效。
IF 3.8 3区 医学 Q2 RHEUMATOLOGY Pub Date : 2024-06-01 Epub Date: 2024-03-20 DOI: 10.1007/s40744-024-00653-6
Joshua F Baker, Catherine Bakewell, Ara Dikranian, Gordon Lam, Jacqueline O'Brien, Page C Moore, Miao Yu, Peter Hur, Karim R Masri

Introduction: Real-world studies describing biosimilar initiation or switching in patients with rheumatoid arthritis (RA) are limited. The aim of this study was to assess treatment patterns and effectiveness of real-world patients with RA initiating infliximab biosimilar IFX-dyyb (CT-P13; Inflectra®) in the USA.

Methods: This observational study evaluated patients with RA from the CorEvitas RA Registry who initiated IFX-dyyb and had Clinical Disease Activity Index (CDAI) recorded at baseline and 6 months. The primary outcome was reaching low disease activity (LDA; CDAI ≤ 10) at 6 months in patients with moderate or high disease activity (CDAI > 10) at baseline. Secondary outcomes were change at 6 months in CDAI and certain patient-reported outcomes (PROs). Patient data were stratified by prior treatment: biologic/targeted synthetic disease-modifying antirheumatic drug (tsDMARD)-naïve, reference infliximab (IFX-REF) or IFX biosimilar, or a non-IFX biologic or tsDMARD.

Results: Of 318 patients initiating IFX-dyyb, 176 had baseline and 6-month CDAI scores; 73 (41%) switched from IFX, 61 (35%) switched from another non-IFX/biologic/tsDMARD, 32 (18%) were naïve to biologics/tsDMARDs, and 10 (6%) switched from an IFX biosimilar. Among patients with moderate or high disease activity at baseline, 32.9% (95% CI 22.9, 42.9) achieved LDA at 6 months. Mean 6-month change from baseline in CDAI was - 1.8 (95% CI - 3.3, - 0.3) overall; - 4.7 (- 7.6, - 1.7) in patients who switched from a non-IFX biologic/tsDMARD, - 4.1 (- 7.8, - 0.3) in biologic/tsDMARD-naïve patients, and 1.1 (- 0.4, 2.6) in patients who switched from IFX-REF/IFX biosimilar. Other clinical outcomes/PROs improved at 6 months. Of the IFX-dyyb initiators, 68% remained on IFX-dyyb at 6 months.

Conclusion: In this real-world population of patients with RA initiating IFX-dyyb, the majority switched from IFX-REF or a non-IFX biologic/tsDMARD. CDAI remained stable in patients switching from IFX-REF/IFX biosimilar and improved in patients switching from a non-IFX biologic/tsDMARD and in biologic/tsDMARD-naïve patients.

导言:描述类风湿性关节炎(RA)患者开始或转换使用生物仿制药的真实世界研究十分有限。本研究旨在评估美国RA患者使用英夫利西单抗生物仿制药IFX-dyb(CT-P13;Inflectra®)的治疗模式和有效性:这项观察性研究评估了CorEvitas RA登记处的RA患者,这些患者开始使用IFX-dyb,并在基线和6个月时记录了临床疾病活动指数(CDAI)。主要结果是基线时有中度或高度疾病活动(CDAI > 10)的患者在6个月时达到低疾病活动(LDA;CDAI ≤ 10)。次要结果是6个月时CDAI和某些患者报告结果(PROs)的变化。患者数据按之前的治疗进行了分层:生物制剂/靶向合成改善病情抗风湿药(tsDMARD)--无效、参考英夫利西单抗(IFX-REF)或IFX生物仿制药、或非IFX生物制剂或tsDMARD:在318名开始使用IFX-dyb的患者中,176人有基线和6个月的CDAI评分;73人(41%)从IFX转用,61人(35%)从另一种非IFX/生物制剂/tsDMARD转用,32人(18%)是生物制剂/tsDMARDs的新患者,10人(6%)从IFX生物仿制药转用。在基线时具有中度或高度疾病活动性的患者中,32.9%(95% CI 22.9,42.9)的患者在 6 个月时达到了 LDA。总体而言,CDAI的6个月平均基线变化为-1.8(95% CI - 3.3, - 0.3);从非IFX生物制剂/tsDMARD转用的患者为-4.7(- 7.6, - 1.7),生物制剂/tsDMARD无效患者为-4.1(- 7.8, - 0.3),从IFX-REF/IFX生物仿制药转用的患者为1.1(- 0.4, 2.6)。其他临床结果/PRO在6个月时有所改善。在开始使用IFX-dyb的患者中,68%在6个月后仍在使用IFX-dyb:结论:在这批开始使用IFX-dyb的真实RA患者中,大多数人是从IFX-REF或非IFX生物制剂/tsDMARD转用IFX-dyb的。从 IFX-REF/IFX 生物仿制药转入的患者 CDAI 保持稳定,而从非 IFX 生物制剂/tsDMARD 转入的患者以及对生物制剂/tsDMARD 不敏感的患者 CDAI 有所改善。
{"title":"Characteristics and 6-Month Outcomes in Patients with Rheumatoid Arthritis Initiating Infliximab Biosimilar IFX-dyyb in a Real-World Setting.","authors":"Joshua F Baker, Catherine Bakewell, Ara Dikranian, Gordon Lam, Jacqueline O'Brien, Page C Moore, Miao Yu, Peter Hur, Karim R Masri","doi":"10.1007/s40744-024-00653-6","DOIUrl":"10.1007/s40744-024-00653-6","url":null,"abstract":"<p><strong>Introduction: </strong>Real-world studies describing biosimilar initiation or switching in patients with rheumatoid arthritis (RA) are limited. The aim of this study was to assess treatment patterns and effectiveness of real-world patients with RA initiating infliximab biosimilar IFX-dyyb (CT-P13; Inflectra<sup>®</sup>) in the USA.</p><p><strong>Methods: </strong>This observational study evaluated patients with RA from the CorEvitas RA Registry who initiated IFX-dyyb and had Clinical Disease Activity Index (CDAI) recorded at baseline and 6 months. The primary outcome was reaching low disease activity (LDA; CDAI ≤ 10) at 6 months in patients with moderate or high disease activity (CDAI > 10) at baseline. Secondary outcomes were change at 6 months in CDAI and certain patient-reported outcomes (PROs). Patient data were stratified by prior treatment: biologic/targeted synthetic disease-modifying antirheumatic drug (tsDMARD)-naïve, reference infliximab (IFX-REF) or IFX biosimilar, or a non-IFX biologic or tsDMARD.</p><p><strong>Results: </strong>Of 318 patients initiating IFX-dyyb, 176 had baseline and 6-month CDAI scores; 73 (41%) switched from IFX, 61 (35%) switched from another non-IFX/biologic/tsDMARD, 32 (18%) were naïve to biologics/tsDMARDs, and 10 (6%) switched from an IFX biosimilar. Among patients with moderate or high disease activity at baseline, 32.9% (95% CI 22.9, 42.9) achieved LDA at 6 months. Mean 6-month change from baseline in CDAI was - 1.8 (95% CI - 3.3, - 0.3) overall; - 4.7 (- 7.6, - 1.7) in patients who switched from a non-IFX biologic/tsDMARD, - 4.1 (- 7.8, - 0.3) in biologic/tsDMARD-naïve patients, and 1.1 (- 0.4, 2.6) in patients who switched from IFX-REF/IFX biosimilar. Other clinical outcomes/PROs improved at 6 months. Of the IFX-dyyb initiators, 68% remained on IFX-dyyb at 6 months.</p><p><strong>Conclusion: </strong>In this real-world population of patients with RA initiating IFX-dyyb, the majority switched from IFX-REF or a non-IFX biologic/tsDMARD. CDAI remained stable in patients switching from IFX-REF/IFX biosimilar and improved in patients switching from a non-IFX biologic/tsDMARD and in biologic/tsDMARD-naïve patients.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"841-853"},"PeriodicalIF":3.8,"publicationDate":"2024-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11111629/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140176235","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
Comparative Effectiveness of Bimekizumab and Guselkumab in Patients with Psoriatic Arthritis at 52 Weeks Assessed Using a Matching-Adjusted Indirect Comparison. 使用匹配调整间接比较法评估银屑病关节炎患者使用 Bimekizumab 和 Guselkumab 52 周后的疗效比较。
IF 3.8 3区 医学 Q2 RHEUMATOLOGY Pub Date : 2024-06-01 Epub Date: 2024-03-15 DOI: 10.1007/s40744-024-00659-0
Richard B Warren, Iain B McInnes, Peter Nash, Jean-Marie Grouin, Nikos Lyris, Damon Willems, Vanessa Taieb, Jason Eells, Philip J Mease

Introduction: Matching-adjusted indirect comparisons (MAIC) were used to assess the relative efficacy of bimekizumab 160 mg every 4 weeks (Q4W) compared to guselkumab 100 mg Q4W or every 8 weeks (Q8W) at 48/52 weeks in patients with psoriatic arthritis (PsA) who were biologic disease-modifying antirheumatic drug-naïve (bDMARD-naïve) or with previous inadequate response or intolerance to tumor necrosis factor inhibitors (TNFi-IR).

Methods: Relevant trials were identified as part of a systematic literature review. For patients who were bDMARD-naïve, individual patient data (IPD) from BE OPTIMAL (N = 431) was matched to summary data from DISCOVER-2 (Q4W, n = 245; Q8W, n = 248). For patients who were TNFi-IR, IPD from BE COMPLETE (n = 267) and summary data from COSMOS (Q8W, N = 189). Trial populations were re-weighted using propensity scores. Unanchored comparisons of recalculated bimekizumab and guselkumab 48- or 52-week non-responder imputation outcomes for 20/50/70% improvement in American College of Rheumatology score (ACR20/50/70) and minimal disease activity (MDA) index were analyzed.

Results: In patients who were bDMARD-naïve, bimekizumab was associated with a greater likelihood of ACR50 (odds ratio [95% confidence interval] 1.62 [1.07, 2.44]; p = 0.021), ACR70 (2.20 [1.43, 3.38]; p < 0.001), and MDA (1.82 [1.20, 2.76]; p = 0.005) compared to guselkumab Q4W at week 52. Bimekizumab also had a greater likelihood of ACR70 response (2.08 [1.34, 3.22]; p = 0.001) and MDA (2.07 [1.35, 3.17]; p < 0.001) compared to guselkumab Q8W at week 52. In patients who were TNFi-IR, bimekizumab had a greater likelihood in achieving all evaluated outcomes compared to guselkumab Q8W at week 48/52 (ACR20, 1.77 [1.15, 2.72]; p = 0.010; ACR50, 1.56 [1.03, 2.36]; p = 0.037; ACR70, 1.66 [1.05, 2.61]; p = 0.028; and MDA, 1.95 [1.27, 3.02]; p = 0.003).

Conclusions: According to MAICs, bimekizumab demonstrated greater or comparable efficacy on ACR50/70 and MDA outcomes than guselkumab in patients with PsA who were bDMARD-naïve and TNFi-IR at week 48/52. Bimekizumab had a more favorable likelihood than guselkumab in achieving more stringent treatment outcomes.

Trial registrations: NCT03895203, NCT03896581, NCT04009499, NCT03158285, NCT03796858.

简介采用匹配调整间接比较法(MAIC)评估了在48/52周的时间内,在未使用生物制剂疾病修饰抗风湿药(bDMARD-naïve)或既往对肿瘤坏死因子抑制剂(TNFi-IR)反应不足或不耐受的银屑病关节炎(PsA)患者中,每4周(Q4W)服用160毫克的bimekizumab与每8周(Q8W)服用100毫克的guselkumab相比的相对疗效。生物制剂抗风湿药(bDMARD)无效或对肿瘤坏死因子抑制剂(TNFi-IR)反应不足或不耐受的银屑病关节炎(PsA)患者。研究方法:作为系统性文献回顾的一部分,确定了相关试验。对于 bDMARD-naïve 患者,将 BE OPTIMAL(N = 431)的单个患者数据(IPD)与 DISCOVER-2 的汇总数据(Q4W,n = 245;Q8W,n = 248)进行匹配。对于 TNFi-IR 患者,BE COMPLETE 的 IPD(n = 267)与 COSMOS 的汇总数据(Q8W,N = 189)相匹配。使用倾向得分对试验人群进行重新加权。对美国风湿病学会评分(ACR20/50/70)和最小疾病活动度(MDA)指数改善20%/50%/70%的重新计算的bimekizumab和guselkumab 48周或52周非应答者归因结果进行了非锚定比较分析:在bDMARD无效的患者中,bimekizumab与ACR50(几率比[95%置信区间] 1.62 [1.07,2.44];p = 0.021)、ACR70(2.20 [1.43,3.38];p根据MAICs,对于48/52周时bDMARD无效且TNFi-IR的PsA患者,bimekizumab在ACR50/70和MDA疗效方面比guselkumab更强或疗效相当。在获得更严格的治疗结果方面,比美单抗比古舍库单抗更有优势:NCT03895203、NCT03896581、NCT04009499、NCT03158285、NCT03796858。
{"title":"Comparative Effectiveness of Bimekizumab and Guselkumab in Patients with Psoriatic Arthritis at 52 Weeks Assessed Using a Matching-Adjusted Indirect Comparison.","authors":"Richard B Warren, Iain B McInnes, Peter Nash, Jean-Marie Grouin, Nikos Lyris, Damon Willems, Vanessa Taieb, Jason Eells, Philip J Mease","doi":"10.1007/s40744-024-00659-0","DOIUrl":"10.1007/s40744-024-00659-0","url":null,"abstract":"<p><strong>Introduction: </strong>Matching-adjusted indirect comparisons (MAIC) were used to assess the relative efficacy of bimekizumab 160 mg every 4 weeks (Q4W) compared to guselkumab 100 mg Q4W or every 8 weeks (Q8W) at 48/52 weeks in patients with psoriatic arthritis (PsA) who were biologic disease-modifying antirheumatic drug-naïve (bDMARD-naïve) or with previous inadequate response or intolerance to tumor necrosis factor inhibitors (TNFi-IR).</p><p><strong>Methods: </strong>Relevant trials were identified as part of a systematic literature review. For patients who were bDMARD-naïve, individual patient data (IPD) from BE OPTIMAL (N = 431) was matched to summary data from DISCOVER-2 (Q4W, n = 245; Q8W, n = 248). For patients who were TNFi-IR, IPD from BE COMPLETE (n = 267) and summary data from COSMOS (Q8W, N = 189). Trial populations were re-weighted using propensity scores. Unanchored comparisons of recalculated bimekizumab and guselkumab 48- or 52-week non-responder imputation outcomes for 20/50/70% improvement in American College of Rheumatology score (ACR20/50/70) and minimal disease activity (MDA) index were analyzed.</p><p><strong>Results: </strong>In patients who were bDMARD-naïve, bimekizumab was associated with a greater likelihood of ACR50 (odds ratio [95% confidence interval] 1.62 [1.07, 2.44]; p = 0.021), ACR70 (2.20 [1.43, 3.38]; p < 0.001), and MDA (1.82 [1.20, 2.76]; p = 0.005) compared to guselkumab Q4W at week 52. Bimekizumab also had a greater likelihood of ACR70 response (2.08 [1.34, 3.22]; p = 0.001) and MDA (2.07 [1.35, 3.17]; p < 0.001) compared to guselkumab Q8W at week 52. In patients who were TNFi-IR, bimekizumab had a greater likelihood in achieving all evaluated outcomes compared to guselkumab Q8W at week 48/52 (ACR20, 1.77 [1.15, 2.72]; p = 0.010; ACR50, 1.56 [1.03, 2.36]; p = 0.037; ACR70, 1.66 [1.05, 2.61]; p = 0.028; and MDA, 1.95 [1.27, 3.02]; p = 0.003).</p><p><strong>Conclusions: </strong>According to MAICs, bimekizumab demonstrated greater or comparable efficacy on ACR50/70 and MDA outcomes than guselkumab in patients with PsA who were bDMARD-naïve and TNFi-IR at week 48/52. Bimekizumab had a more favorable likelihood than guselkumab in achieving more stringent treatment outcomes.</p><p><strong>Trial registrations: </strong>NCT03895203, NCT03896581, NCT04009499, NCT03158285, NCT03796858.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"829-839"},"PeriodicalIF":3.8,"publicationDate":"2024-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11111623/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140137219","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
Treatment Persistence and Switching Patterns of Adalimumab Biosimilar ABP 501 in European Patients with Rheumatologic Diseases. 阿达木单抗生物仿制药 ABP 501 在欧洲风湿病患者中的治疗持续性和转换模式。
IF 3.8 3区 医学 Q2 RHEUMATOLOGY Pub Date : 2024-06-01 Epub Date: 2024-03-04 DOI: 10.1007/s40744-024-00647-4
Ran Jin, Silvia Kruppert, Florian Scholz, Isabelle Bardoulat, Khalil Karzazi, Francois Morand, Greg Kricorian, David Collier, Jonathan Kay

Introduction: ABP 501 was an adalimumab (ADA) biosimilar approved for treating immune-mediated inflammatory diseases (IMIDs) including rheumatoid arthritis (RA), psoriatic arthritis (PsA), and ankylosing spondylitis (AS). In this retrospective study, we aimed to examine the treatment patterns of ABP 501 among patients with these IMIDs using German and French pharmacy claims databases.

Methods: Patients with RA, PsA, or AS who initiated ABP 501 between October 2018 and March 2020 and were observed continuously for ≥ 365 days both before and after ABP 501 initiation were included. Descriptive analyses of persistence and switch after ABP 501 discontinuation were conducted and reported for each disease cohort by prior use of ADA products (patients naïve to ADA or patients experienced with ADA).

Results: Median (95% confidence interval) persistence on ABP 501 was 9.4 (8.6-10.3), 10.2 (9.0-11.7), and 12.1 (11.0-13.1) months in German patients, and 11.7 (9.9-13.3), 7.1 (5.8-8.4), and 10.8 (9.6-11.9) months in French patients for RA, PsA, and AS, respectively. For patients who switched from ABP 501 to another targeted therapy during the first 12 months of follow-up, switching patterns varied between patients naïve to ADA and patients experienced with ADA in both Germany and France, with patients naïve to ADA switching most frequently to other targeted therapies including non-ADA tumor necrosis factor inhibitor (TNFi), non-TNFi biologic, or Janus Kinase inhibitor (JAKi) and patients experienced with ADA switching most frequently back to ADA reference product (RP).

Conclusions: Across three rheumatologic diseases, about half of patients persisted on ABP 501 at the end of 12 months after treatment initiation in both Germany and France. Patients experienced with ADA were more likely to switch back to ADA RP, regardless of indication and country, suggesting a possible nocebo effect. Future studies are warranted to understand reasons of discontinuation and switching.

简介:ABP 501 是一种阿达木单抗 (ADA) 生物仿制药,被批准用于治疗免疫介导的炎症性疾病 (IMID),包括类风湿性关节炎 (RA)、银屑病关节炎 (PsA) 和强直性脊柱炎 (AS)。在这项回顾性研究中,我们旨在利用德国和法国的药房报销数据库,研究这些 IMIDs 患者的 ABP 501 治疗模式:纳入在 2018 年 10 月至 2020 年 3 月期间开始使用 ABP 501,且在开始使用 ABP 501 前后连续观察≥ 365 天的 RA、PsA 或 AS 患者。对ABP 501停药后的持续性和转换进行了描述性分析,并按之前使用过ADA产品(初次使用ADA的患者或使用过ADA的患者)报告了每个疾病队列的结果:在德国患者中,ABP 501 的中位持续时间(95% 置信区间)分别为 9.4(8.6-10.3)、10.2(9.0-11.7)和 12.1(11.0-13.1)个月;在法国患者中,RA、PsA 和 AS 的中位持续时间分别为 11.7(9.9-13.3)、7.1(5.8-8.4)和 10.8(9.6-11.9)个月。对于在随访的前12个月中从ABP 501转为另一种靶向疗法的患者,德国和法国的ADA新患者和ADA老患者的转药模式各不相同,其中ADA新患者最常转为其他靶向疗法,包括非ADA肿瘤坏死因子抑制剂(TNFi)、非TNFi生物制剂或Janus激酶抑制剂(JAKi),而ADA老患者最常转回ADA参比产品(RP):在三种风湿病中,德国和法国约有一半的患者在开始治疗 12 个月后仍在使用 ABP 501。无论适应症和国家如何,使用过 ADA 的患者更有可能转回 ADA RP,这表明可能存在安慰剂效应。今后有必要开展研究,以了解停药和转药的原因。
{"title":"Treatment Persistence and Switching Patterns of Adalimumab Biosimilar ABP 501 in European Patients with Rheumatologic Diseases.","authors":"Ran Jin, Silvia Kruppert, Florian Scholz, Isabelle Bardoulat, Khalil Karzazi, Francois Morand, Greg Kricorian, David Collier, Jonathan Kay","doi":"10.1007/s40744-024-00647-4","DOIUrl":"10.1007/s40744-024-00647-4","url":null,"abstract":"<p><strong>Introduction: </strong>ABP 501 was an adalimumab (ADA) biosimilar approved for treating immune-mediated inflammatory diseases (IMIDs) including rheumatoid arthritis (RA), psoriatic arthritis (PsA), and ankylosing spondylitis (AS). In this retrospective study, we aimed to examine the treatment patterns of ABP 501 among patients with these IMIDs using German and French pharmacy claims databases.</p><p><strong>Methods: </strong>Patients with RA, PsA, or AS who initiated ABP 501 between October 2018 and March 2020 and were observed continuously for ≥ 365 days both before and after ABP 501 initiation were included. Descriptive analyses of persistence and switch after ABP 501 discontinuation were conducted and reported for each disease cohort by prior use of ADA products (patients naïve to ADA or patients experienced with ADA).</p><p><strong>Results: </strong>Median (95% confidence interval) persistence on ABP 501 was 9.4 (8.6-10.3), 10.2 (9.0-11.7), and 12.1 (11.0-13.1) months in German patients, and 11.7 (9.9-13.3), 7.1 (5.8-8.4), and 10.8 (9.6-11.9) months in French patients for RA, PsA, and AS, respectively. For patients who switched from ABP 501 to another targeted therapy during the first 12 months of follow-up, switching patterns varied between patients naïve to ADA and patients experienced with ADA in both Germany and France, with patients naïve to ADA switching most frequently to other targeted therapies including non-ADA tumor necrosis factor inhibitor (TNFi), non-TNFi biologic, or Janus Kinase inhibitor (JAKi) and patients experienced with ADA switching most frequently back to ADA reference product (RP).</p><p><strong>Conclusions: </strong>Across three rheumatologic diseases, about half of patients persisted on ABP 501 at the end of 12 months after treatment initiation in both Germany and France. Patients experienced with ADA were more likely to switch back to ADA RP, regardless of indication and country, suggesting a possible nocebo effect. Future studies are warranted to understand reasons of discontinuation and switching.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"523-537"},"PeriodicalIF":3.8,"publicationDate":"2024-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11111632/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140022552","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
Neutrophilic Activity Biomarkers (Plasma Neutrophil Extracellular Traps and Calprotectin) in Established Patients with Rheumatoid Arthritis Receiving Biological or JAK Inhibitors: A Clinical and Ultrasonographic Study. 接受生物或 JAK 抑制剂治疗的已确诊类风湿性关节炎患者的中性粒细胞活性生物标志物(血浆中性粒细胞胞外捕获物和钙蛋白):临床和超声波研究。
IF 3.8 3区 医学 Q2 RHEUMATOLOGY Pub Date : 2024-06-01 Epub Date: 2024-03-02 DOI: 10.1007/s40744-024-00650-9
Beatriz Frade-Sosa, Andrés Ponce, Estíbaliz Ruiz-Ortiz, Noemí De Moner, María J Gómara, Ana Belén Azuaga, Juan C Sarmiento-Monroy, Rosa Morlà, Virginia Ruiz-Esquide, Laura Macías, Nuria Sapena, Lola Tobalina, Julio Ramirez, Juan D Cañete, Jordi Yague, Josep M Auge, José A Gomez-Puerta, Odette Viñas, Isabel Haro, Raimon Sanmarti

Introduction: This study assesses the accuracy of neutrophil activation markers, including neutrophil extracellular traps (NETs) and calprotectin, as biomarkers of disease activity in patients with established rheumatoid arthritis (RA). We also analyse the relationship between NETs and various types of therapies as well as their association with autoimmunity.

Methods: Observational cross-sectional study of patients with RA receiving treatment with biological disease-modifying antirheumatic drugs or Janus kinase inhibitors (JAK-inhibitors) for at least 3 months. Plasma calprotectin levels were measured using an enzyme-linked immunosorbent assay test kit and NETs by measuring their remnants in plasma (neutrophil elastase-DNA and histone-DNA complexes). We also assessed clinical disease activity, joint ultrasound findings and autoantibody status [reumatoid factor (RF), anti-citrullinated peptide/protein antibodies (ACPAs) and anti-carbamylated protein (anti-CarP)]. Associations between neutrophilic biomarkers and clinical or ultrasound scores were sought using correlation analysis. The discriminatory capacity of both neutrophilic biomarkers to detect ultrasound synovitis was analysed through receiver-operating characteristic (ROC) curves.

Results: One hundred fourteen patients were included. Two control groups were included to compare NET levels. The active control group consisted of 15 patients. The second control group consisted of 30 healthy subjects. Plasma NET levels did not correlate with clinical disease status, regardless of the clinic index analysed or the biological therapy administered. No significant correlation was observed between NET remnants and ultrasound synovitis. There was no correlation between plasma NET and autoantibodies. In contrast, plasma calprotectin positively correlated with clinical parameters (swollen joint count [SJC] rho = 0.49; P < 0.001, Clinical Disease Activity Index [CDAI] rho = 0.30; P < 0.001) and ultrasound parameters (rho > 0.50; P < 0.001). Notably, this correlation was stronger than that observed with acute phase reactants.

Conclusion: While NET formation induced by neutrophils may play a role in RA pathogenesis, our study raises questions about the utility of NET remnants in peripheral circulation as a biomarker for inflammatory activity. In contrast, this study strongly supports the usefulness of calprotectin as a biomarker of inflammatory activity in patients with RA.

简介本研究评估了中性粒细胞活化标志物(包括中性粒细胞胞外捕获物(NETs)和钙蛋白)作为类风湿关节炎(RA)已确诊患者疾病活动性生物标志物的准确性。我们还分析了NETs与各类疗法之间的关系及其与自身免疫的关联:观察性横断面研究:对接受生物改变病情抗风湿药或Janus激酶抑制剂(JAK-抑制剂)治疗至少3个月的RA患者进行观察。使用酶联免疫吸附试验试剂盒测量血浆钙蛋白水平,通过测量血浆中的NET残留物(中性粒细胞弹性蛋白酶-DNA和组蛋白-DNA复合物)测量NET水平。我们还评估了临床疾病活动性、关节超声检查结果和自身抗体状态[类风湿因子(RF)、抗瓜氨酸肽/蛋白抗体(ACPA)和抗氨甲酰蛋白(抗CarP)]。中性粒细胞生物标志物与临床或超声评分之间的相关性是通过相关分析来寻找的。两种中性粒细胞生物标记物检测超声滑膜炎的判别能力通过接收器操作特征曲线(ROC)进行分析:结果:共纳入了 114 名患者。为比较NET水平,纳入了两个对照组。主动对照组由 15 名患者组成。第二个对照组由 30 名健康人组成。无论分析的临床指标或采用的生物疗法如何,血浆NET水平都与临床疾病状况无关。NET残留物与超声滑膜炎之间没有明显的相关性。血浆NET与自身抗体之间也没有相关性。相反,血浆钙蛋白与临床参数呈正相关(关节肿胀计数[SJC] rho = 0.49;P 0.50;P 结论:血浆钙蛋白与临床参数呈正相关(关节肿胀计数[SJC] rho = 0.49;P 0.50;P 结论):虽然中性粒细胞诱导的NET形成可能在RA发病机制中发挥作用,但我们的研究对外周循环中的NET残留物作为炎症活动生物标志物的效用提出了质疑。与此相反,本研究强烈支持将钙蛋白作为 RA 患者炎症活动的生物标志物。
{"title":"Neutrophilic Activity Biomarkers (Plasma Neutrophil Extracellular Traps and Calprotectin) in Established Patients with Rheumatoid Arthritis Receiving Biological or JAK Inhibitors: A Clinical and Ultrasonographic Study.","authors":"Beatriz Frade-Sosa, Andrés Ponce, Estíbaliz Ruiz-Ortiz, Noemí De Moner, María J Gómara, Ana Belén Azuaga, Juan C Sarmiento-Monroy, Rosa Morlà, Virginia Ruiz-Esquide, Laura Macías, Nuria Sapena, Lola Tobalina, Julio Ramirez, Juan D Cañete, Jordi Yague, Josep M Auge, José A Gomez-Puerta, Odette Viñas, Isabel Haro, Raimon Sanmarti","doi":"10.1007/s40744-024-00650-9","DOIUrl":"10.1007/s40744-024-00650-9","url":null,"abstract":"<p><strong>Introduction: </strong>This study assesses the accuracy of neutrophil activation markers, including neutrophil extracellular traps (NETs) and calprotectin, as biomarkers of disease activity in patients with established rheumatoid arthritis (RA). We also analyse the relationship between NETs and various types of therapies as well as their association with autoimmunity.</p><p><strong>Methods: </strong>Observational cross-sectional study of patients with RA receiving treatment with biological disease-modifying antirheumatic drugs or Janus kinase inhibitors (JAK-inhibitors) for at least 3 months. Plasma calprotectin levels were measured using an enzyme-linked immunosorbent assay test kit and NETs by measuring their remnants in plasma (neutrophil elastase-DNA and histone-DNA complexes). We also assessed clinical disease activity, joint ultrasound findings and autoantibody status [reumatoid factor (RF), anti-citrullinated peptide/protein antibodies (ACPAs) and anti-carbamylated protein (anti-CarP)]. Associations between neutrophilic biomarkers and clinical or ultrasound scores were sought using correlation analysis. The discriminatory capacity of both neutrophilic biomarkers to detect ultrasound synovitis was analysed through receiver-operating characteristic (ROC) curves.</p><p><strong>Results: </strong>One hundred fourteen patients were included. Two control groups were included to compare NET levels. The active control group consisted of 15 patients. The second control group consisted of 30 healthy subjects. Plasma NET levels did not correlate with clinical disease status, regardless of the clinic index analysed or the biological therapy administered. No significant correlation was observed between NET remnants and ultrasound synovitis. There was no correlation between plasma NET and autoantibodies. In contrast, plasma calprotectin positively correlated with clinical parameters (swollen joint count [SJC] rho = 0.49; P < 0.001, Clinical Disease Activity Index [CDAI] rho = 0.30; P < 0.001) and ultrasound parameters (rho > 0.50; P < 0.001). Notably, this correlation was stronger than that observed with acute phase reactants.</p><p><strong>Conclusion: </strong>While NET formation induced by neutrophils may play a role in RA pathogenesis, our study raises questions about the utility of NET remnants in peripheral circulation as a biomarker for inflammatory activity. In contrast, this study strongly supports the usefulness of calprotectin as a biomarker of inflammatory activity in patients with RA.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"501-521"},"PeriodicalIF":3.8,"publicationDate":"2024-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11111434/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140013201","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 Evaluation of Effectiveness and Safety of Guselkumab in Patients with Psoriatic Arthritis in a Prospective Multicentre "Real-Life" Cohort Study. 在一项前瞻性多中心 "真实生活 "队列研究中评估古舍库单抗对银屑病关节炎患者的有效性和安全性。
IF 3.8 3区 医学 Q2 RHEUMATOLOGY Pub Date : 2024-06-01 Epub Date: 2024-03-04 DOI: 10.1007/s40744-024-00649-2
Piero Ruscitti, Giulia Cataldi, Martina Gentile, Alice Dionisi, Paola Volpe, Annacarla Finucci, Lucrezia Verardi, Claudia Di Muzio, Noemi Italiano, Eleonora Celletti, Myriam Di Penta, Ilenia Di Cola, Alessandra Marrelli, Alessia Alfonsi, Francesco Delle Monache, Francesco Cipollone, Marco Gabini, Paola Cipriani

Introduction: Guselkumab is an interleukin-23 (IL-23) inhibitor licensed for the treatment of psoriatic arthritis (PsA). This study aimed to evaluate the 6-month effectiveness of guselkumab in patients with PsA in a "real-life" multicentre patient cohort. We also estimated the drug retention rate (DRR) of gusulkumab, also assessing the impact of comorbidities and patient clinical characteristics, in a collective 18-month prospective follow-up.

Methods: Between December 2021 and September 2023, consecutive patients with PsA were evaluated if treated at least for 6 months with guselkumab in a prospective multicentre study to evaluate the effectiveness of the drug by means of disease activity index for psoriatic arthritis (DAPSA) and cumulative DRR.

Results: A total of 111 patients with PsA were evaluated and treated with guselkumab (age 56.8 ± 9.9, male sex 20.7%). These patients were mainly characterised by active and long-standing PsA with median disease duration of 6.0 (7.0) years (55.9% disease duration ≥ 5 years), 55.0% showed comorbidities, 78.4% of patients were previously treated with biologic disease-modifying anti-rheumatic drugs (bDMARDs), and 60.4% concomitantly with conventional synthetic DMARDs (csDMARDs). After 6 months, a significant reduction of DAPSA was observed (β - 15.47, p = 0.001, 95% CI - 23.15 to - 9.79) with 39.6% of patients achieving a DAPSA ≤ 14. At the end of cumulative follow-up, 71.2% of patients were still treated with guselkumab whereas 24.3% discontinued the drug because of inefficacy. An 18-month DRR of guselkumab of 66.7% was estimated with a mean time of administration of 9.8 ± 4.1 months. The results of the DRR were stratified according to patient clinical characteristics. The DRR of guselkumab appeared to be not influenced by long disease duration, comorbidities, obesity, concomitant csDMARDs, and previous bDMARDs.

Conclusion: The "real-life" 6-month effectiveness of guselkumab was shown in patients with PsA, mainly characterised by active long-standing disease, previously treated with bDMARDs, and with comorbidities. Furthermore, a good DRR of guselkumab was estimated in the cumulative 18 months of follow-up and appeared to be not influenced by long disease duration, comorbidities, obesity, and previous bDMARDs.

简介古舍库单抗是一种白细胞介素-23(IL-23)抑制剂,获准用于治疗银屑病关节炎(PsA)。本研究旨在评估古舍库单抗在 "真实 "多中心患者队列中对 PsA 患者的 6 个月疗效。我们还估算了古舍库单抗的药物保留率(DRR),并在18个月的前瞻性集体随访中评估了合并症和患者临床特征的影响:方法:2021年12月至2023年9月期间,在一项前瞻性多中心研究中,对连续接受古谢库单抗治疗至少6个月的PsA患者进行评估,通过银屑病关节炎疾病活动指数(DAPSA)和累积DRR评估药物疗效:共对111名PsA患者(年龄为56.8±9.9岁,男性占20.7%)进行了评估,并用古舍库单抗进行了治疗。这些患者的主要特征是PsA处于活动期且病程较长,中位病程为6.0 (7.0)年(55.9%的患者病程≥5年),55.0%的患者有合并症,78.4%的患者之前接受过生物改善病情抗风湿药(bDMARDs)治疗,60.4%的患者同时接受过传统合成DMARDs(csDMARDs)治疗。6 个月后,观察到 DAPSA 明显降低(β - 15.47,p = 0.001,95% CI - 23.15 至 - 9.79),39.6% 的患者 DAPSA ≤ 14。累计随访结束时,71.2%的患者仍在接受古舍库单抗治疗,24.3%的患者因疗效不佳而停药。据估计,古舍库单抗 18 个月的 DRR 为 66.7%,平均用药时间为 9.8 ± 4.1 个月。DRR结果根据患者临床特征进行了分层。古舍库单抗的DRR似乎不受病程长、合并症、肥胖、同时使用csDMARDs和既往使用过bDMARDs的影响:结论:古舍库单抗在PsA患者中的6个月 "真实 "疗效得到了证实,这些患者的主要特点是病程长、既往接受过bDMARDs治疗且有合并症。此外,在累计18个月的随访中,古舍库单抗的DRR估计良好,似乎不受病程长、合并症、肥胖和既往使用过bDMARDs的影响。
{"title":"The Evaluation of Effectiveness and Safety of Guselkumab in Patients with Psoriatic Arthritis in a Prospective Multicentre \"Real-Life\" Cohort Study.","authors":"Piero Ruscitti, Giulia Cataldi, Martina Gentile, Alice Dionisi, Paola Volpe, Annacarla Finucci, Lucrezia Verardi, Claudia Di Muzio, Noemi Italiano, Eleonora Celletti, Myriam Di Penta, Ilenia Di Cola, Alessandra Marrelli, Alessia Alfonsi, Francesco Delle Monache, Francesco Cipollone, Marco Gabini, Paola Cipriani","doi":"10.1007/s40744-024-00649-2","DOIUrl":"10.1007/s40744-024-00649-2","url":null,"abstract":"<p><strong>Introduction: </strong>Guselkumab is an interleukin-23 (IL-23) inhibitor licensed for the treatment of psoriatic arthritis (PsA). This study aimed to evaluate the 6-month effectiveness of guselkumab in patients with PsA in a \"real-life\" multicentre patient cohort. We also estimated the drug retention rate (DRR) of gusulkumab, also assessing the impact of comorbidities and patient clinical characteristics, in a collective 18-month prospective follow-up.</p><p><strong>Methods: </strong>Between December 2021 and September 2023, consecutive patients with PsA were evaluated if treated at least for 6 months with guselkumab in a prospective multicentre study to evaluate the effectiveness of the drug by means of disease activity index for psoriatic arthritis (DAPSA) and cumulative DRR.</p><p><strong>Results: </strong>A total of 111 patients with PsA were evaluated and treated with guselkumab (age 56.8 ± 9.9, male sex 20.7%). These patients were mainly characterised by active and long-standing PsA with median disease duration of 6.0 (7.0) years (55.9% disease duration ≥ 5 years), 55.0% showed comorbidities, 78.4% of patients were previously treated with biologic disease-modifying anti-rheumatic drugs (bDMARDs), and 60.4% concomitantly with conventional synthetic DMARDs (csDMARDs). After 6 months, a significant reduction of DAPSA was observed (β - 15.47, p = 0.001, 95% CI - 23.15 to - 9.79) with 39.6% of patients achieving a DAPSA ≤ 14. At the end of cumulative follow-up, 71.2% of patients were still treated with guselkumab whereas 24.3% discontinued the drug because of inefficacy. An 18-month DRR of guselkumab of 66.7% was estimated with a mean time of administration of 9.8 ± 4.1 months. The results of the DRR were stratified according to patient clinical characteristics. The DRR of guselkumab appeared to be not influenced by long disease duration, comorbidities, obesity, concomitant csDMARDs, and previous bDMARDs.</p><p><strong>Conclusion: </strong>The \"real-life\" 6-month effectiveness of guselkumab was shown in patients with PsA, mainly characterised by active long-standing disease, previously treated with bDMARDs, and with comorbidities. Furthermore, a good DRR of guselkumab was estimated in the cumulative 18 months of follow-up and appeared to be not influenced by long disease duration, comorbidities, obesity, and previous bDMARDs.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"539-551"},"PeriodicalIF":3.8,"publicationDate":"2024-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11111644/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140022551","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
期刊
Rheumatology and Therapy
全部 Acc. Chem. Res. ACS Applied Bio Materials ACS Appl. Electron. Mater. ACS Appl. Energy Mater. ACS Appl. Mater. Interfaces ACS Appl. Nano Mater. ACS Appl. Polym. Mater. ACS BIOMATER-SCI ENG ACS Catal. ACS Cent. Sci. ACS Chem. Biol. ACS Chemical Health & Safety ACS Chem. Neurosci. ACS Comb. Sci. ACS Earth Space Chem. ACS Energy Lett. ACS Infect. Dis. ACS Macro Lett. ACS Mater. Lett. ACS Med. Chem. Lett. ACS Nano ACS Omega ACS Photonics ACS Sens. ACS Sustainable Chem. Eng. ACS Synth. Biol. Anal. Chem. BIOCHEMISTRY-US Bioconjugate Chem. BIOMACROMOLECULES Chem. Res. Toxicol. Chem. Rev. Chem. Mater. CRYST GROWTH DES ENERG FUEL Environ. Sci. Technol. Environ. Sci. Technol. Lett. Eur. J. Inorg. Chem. IND ENG CHEM RES Inorg. Chem. J. Agric. Food. Chem. J. Chem. Eng. Data J. Chem. Educ. J. Chem. Inf. Model. J. Chem. Theory Comput. J. Med. Chem. J. Nat. Prod. J PROTEOME RES J. Am. Chem. Soc. LANGMUIR MACROMOLECULES Mol. Pharmaceutics Nano Lett. Org. Lett. ORG PROCESS RES DEV ORGANOMETALLICS J. Org. Chem. J. Phys. Chem. J. Phys. Chem. A J. Phys. Chem. B J. Phys. Chem. C J. Phys. Chem. Lett. Analyst Anal. Methods Biomater. Sci. Catal. Sci. Technol. Chem. Commun. Chem. Soc. Rev. CHEM EDUC RES PRACT CRYSTENGCOMM Dalton Trans. Energy Environ. Sci. ENVIRON SCI-NANO ENVIRON SCI-PROC IMP ENVIRON SCI-WAT RES Faraday Discuss. Food Funct. Green Chem. Inorg. Chem. Front. Integr. Biol. J. Anal. At. Spectrom. J. Mater. Chem. A J. Mater. Chem. B J. Mater. Chem. C Lab Chip Mater. Chem. Front. Mater. Horiz. MEDCHEMCOMM Metallomics Mol. Biosyst. Mol. Syst. Des. Eng. Nanoscale Nanoscale Horiz. Nat. Prod. Rep. New J. Chem. Org. Biomol. Chem. Org. Chem. Front. PHOTOCH PHOTOBIO SCI PCCP Polym. Chem.
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
0
微信
客服QQ
Book学术公众号 扫码关注我们
反馈
×
意见反馈
请填写您的意见或建议
请填写您的手机或邮箱
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
现在去查看 取消
×
提示
确定
Book学术官方微信
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术
文献互助 智能选刊 最新文献 互助须知 联系我们:info@booksci.cn
Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。
Copyright © 2023 Book学术 All rights reserved.
ghs 京公网安备 11010802042870号 京ICP备2023020795号-1