北京若生智能科技有限公司
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ibrutinib

✓ Approved

Johnson & Johnson Services, Inc. · 辅助诊断 · 辅助诊断

什么是 ibrutinib？

ibrutinib 是一种辅助诊断，由Johnson & Johnson Services, Inc.研发。该药已获批，用于治疗相关适应症，给药途径：Others。

药物档案

公司Johnson & Johnson Services, Inc.
药物类别辅助诊断
给药途径Others
状态Approved
来源： ClinicalTrials.gov, Johnson & Johnson Services, Inc.

治疗适应症

ibrutinib 针对 1 个适应症，涉及 1 个治疗领域。

治疗领域疾病/病症分期
Neoplasms benign, malignant and unspecified (incl cysts and polyps)Uterine cancer✓ Approved

相关研究文献

PubMedExpert review of pharmacoeconomics & outcomes research2026-09-10

Cost-effectiveness of zanubrutinib versus ibrutinib as first-line treatment for patients with Waldenström macroglobulinemia in China.

Chen Weiqi W, Zhu Qiyun Q, Wu Yongyi Y, Yang Zhao Z et al.

Zanubrutinib has demonstrated superior efficacy and safety over ibrutinib for Waldenström macroglobulinemia (WM) in the phase 3 ASPEN trial, but its cost-effectiveness in China remains unknown. This study evaluated the cost-effectiveness of zanubrutinib versus ibrutinib as first-line treatment for WM from the Chinese healthcare system perspective. A three-state partitioned survival model (progression-free, progressive disease, death) was developed over a 15-year horizon using ASPEN trial data. Survival was extrapolated using parametric models and adjusted by relative survival. Direct medical costs were sourced from Chinese databases. ICERs were calculated using a willingness-to-pay threshold of $37,849/QALY (three times China's 2023 GDP per capita). Deterministic and probabilistic sensitivity analyses were conducted. Zanubrutinib resulted in an incremental gain of 0.084 QALYs at a cost saving of $26,768 per patient compared with ibrutinib, yielding an ICER of -$318,719/QALY. The negative ICER indicates that zanubrutinib is both more effective and cost-saving (i.e. a dominant strategy) relative to ibrutinib. Deterministic and probabilistic sensitivity analyses confirmed the robustness of these findings. Under current Chinese pricing and healthcare system conditions, zanubrutinib is a cost-effective and dominant alternative to ibrutinib for first-line treatment of WM.

PMID 42717721
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PubMedFrontiers in cardiovascular medicine2026-09-10

Longitudinal changes in left atrial function during chronic ibrutinib therapy: a prospective observational study.

Kolacevic Zeljkovic Matea M, Basic-Kinda Sandra S, Čaržavec Dubravka D, Vodanovic Marijo M et al.

Ibrutinib is effective for B-cell malignancies but is associated with cardiovascular adverse events, including atrial fibrillation (AF) and hypertension. Longitudinal data on left atrial (LA) remodeling during treatment are limited. We characterized serial changes in LA size and function during chronic ibrutinib therapy. In this prospective observational cohort, 40 patients starting ibrutinib underwent clinical assessment, 24-72-hour Holter monitoring, and echocardiography with LA strain at baseline and 3, 6, 12, and long-term (nominal 36-month) follow-up. Primary analyses used observed paired data, random-intercept mixed models, standardized response means (SRMs), and Benjamini-Hochberg adjustment across 24 primary contrasts. Median age was 65 years and 53% were female. Paired mean LAVI changes were +1.52 mL/m² at 3 months (n = 38), +1.68 at 6 months (n = 36), +2.62 at 12 months (n = 33), and +2.15 at long-term follow-up (n = 31; all q ≤ 0.020). LA reservoir strain worsened from 6 months onward (all q ≤ 0.031), while LA contractile strain, LA lateral-wall TDI, and LV GLS worsened at every follow-up (all q ≤ 0.009). Results were materially unchanged after adjustment for time-varying hypertension and in complete-case sensitivity analyses. Incident AF occurred in 5/40 patients (12.5%; 95% CI 5.5%-26.1%). During chronic ibrutinib therapy, longitudinal imaging showed modest LA enlargement and consistent deterioration in several LA deformation indices. These treatment-associated observations require confirmation in controlled cohorts. ClinicalTrials.gov, identifier NCT03751410.

PMID 42718685
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PubMedAnnals of translational medicine2026-09-10

Individualized pharmacotherapy: background and development.

Jørgensen Jan Trøst JT, Westergaard Niels N

Most drug prescriptions are still based on empiricism and not on solid biological data, which often results in considerable patient variability and, sometimes, low patient benefits. Although variability in patient response to pharmacotherapy has long been recognized, only in recent decades have new molecule analytical methods provided insight into some of the causes, which are often related to somatic or germline genetic variations. Based on this insight, different predictive biomarker tests have been developed to optimize and individualize pharmacotherapy. These biomarker tests are classified as companion diagnostic (CDx) or pharmacogenetic (PGx) tests. In both the United States and Europe, CDx and PGx information is part of the regulatory drug labeling and is included in the Prescribing Information for the individual drugs and biologics. In the United States, this type of information is found in the labeling of more than 400 regulatory-approved drugs and biological products. Despite these measures and the documented clinical utility of CDx and PGx testing, clinical implementation is lagging, especially with regard to PGx. There are various reasons for the lack of testing, such as insufficient education and awareness among healthcare professionals, inadequate access to biomarker testing, regulatory hurdles, and insufficient reimbursements. Although progress has been made in recent years, further efforts are needed to fully realize the potential of individualized pharmacotherapy by integrating the use of predictive biomarkers into routine clinical practice.

PMID 42718847
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PubMedAnnals of thoracic surgery short reports2026-09-10

Diagnostic Dilemmas and The Benefit of Robotic-Assisted Surgery in the Management of Neurogenic Thoracic Outlet Syndrome in Complex Patients.

Federico Emma M EM, Pohlman Alexander A, Lozanoski Madison M, Abdelsattar Zaid M ZM et al.

A 64-year-old male patient presented with progressive, debilitating bilateral arm pain for 2 years following traumatic cervical spine injuries requiring multiple operations. Despite extensive diagnostic workup by several specialists, he was left without a diagnosis, treatment plan, or ability to perform his job. He was diagnosed with bilateral neurogenic thoracic outlet syndrome, based on clinical diagnostic criteria. A 2-staged bilateral robotic first rib resection resulted in complete resolution of his symptoms.

PMID 42719030
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PubMedEmergency radiology2026-09-10

Diagnostic yield of repeat CT pulmonary angiography after a negative examination in the emergency department.

Gorelik Natalia N, Fung Tiffany T, Sacher Eliana E, de Albuquerque Lorenna Mendonça LM et al.

Although repeat CT pulmonary angiography (CTPA) after a negative index examination in the emergency department (ED) is common, its diagnostic utility remains uncertain. This study aimed to determine the incidence and diagnostic yield of repeat CTPA after a negative index examination in the ED. This retrospective cohort study included adults undergoing CTPA across three EDs at our center from 2016 to 2017. CTPA results were classified as positive, negative, or other (equivocal or negative with reported limitations) based on radiology reports. Patients with a negative index CTPA were followed for two years to identify repeat examinations. Diagnostic yield of repeat CTPA at 1 month, 1 year, and 2 years was compared with that of the index examination using a likelihood ratio test for nested proportions. Among 3,112 patients (median age, 60.1 years; 59.1% women), 331 (10.6%) had a positive index CTPA. Of 2,412 patients with a negative index examination, 297 (12.3%) underwent repeat CTPA within 2 years, including 202 (8.4%) performed in our ED. The diagnostic yield of repeat CTPA performed in our ED was lower than that of the index examination: 3.8% (1/26; p = 0.20) at 1 month, 6.0% (9/150; p = 0.051) at 1 year, and 6.4% (13/202; p = 0.04) at 2 years. Repeat CTPA after a negative examination demonstrated a lower diagnostic yield than initial imaging, highlighting an opportunity for more selective use of repeat CTPA guided by clinical pretest probability.

PMID 42717156
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PubMedMuscle & nerve2026-09-10

Guidelines for Genetic Testing of Peripheral Nerve Disorders.

Saporta Mario A MA

Inherited peripheral neuropathies (IPNs) comprise a clinically and genetically heterogeneous group of disorders affecting approximately 1 in 2500 individuals and represent one of the most common inherited neurologic diseases. The rapidly expanding identification of disease-causing genes and the widespread implementation of next-generation sequencing (NGS) have fundamentally transformed the diagnostic evaluation of these disorders. Contemporary molecular testing has substantially increased diagnostic yield, shortened the diagnostic delay, refined disease classification, and strengthened genotype-phenotype correlations. In the United States, NGS-based multigene panels have become the most cost-effective first-line molecular diagnostic approach for most patients with suspected inherited neuropathies, whereas phenotype-directed single-gene testing remains appropriate in selected clinical circumstances and in healthcare systems in which access to comprehensive sequencing is limited. Despite these advances, challenges continue to affect diagnostic accuracy, including interpretation of variants of uncertain significance, detection of copy number variants and repeat expansions, technical limitations associated with highly homologous genomic regions such as SORD, and variability in gene content and analytic performance among commercially available testing platforms. Accurate diagnosis therefore requires integration of clinical phenotype, electrodiagnostic findings, family history, and molecular data. Establishing a precise genetic diagnosis has become increasingly important because it improves prognostic accuracy, guides genetic counseling and cascade testing, identifies patients with treatable hereditary neuropathies such as transthyretin amyloidosis, and facilitates enrollment in gene-specific clinical trials and emerging precision therapies. An evidence-based, phenotype-driven approach that incorporates contemporary molecular technologies is essential to maximize diagnostic efficiency while recognizing the strengths and limitations of currently available genetic testing strategies.

PMID 42717552
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