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更新于：2026-08-19
Johnson & Johnson
更新于：2026-08-19
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肿瘤
免疫系统疾病
其他疾病
小分子化药
单克隆抗体
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NCT07738887
Epcoritamab Plus Venetoclax Plus Ibrutinib in Patients With Chronic Lymphocytic Leukemia With TP53 Alterations
NCT06355986
Community-Based, Cluster-Randomized Trial of Electronic Alert-Based Computerized Decision Support to Prevent Stroke in High-Risk Ambulatory Patients With Atrial Fibrillation (AF-ALERT3)
NL-OMON61271
A Prospective, first in Human pivotal study to evaluate the Adaptive tip catheter used to treat acute ischemic Stroke patients during mechanical Thrombectomy. - PHAST
100 项与 Johnson & Johnson 相关的临床结果
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2026-12-31JOURNAL OF MEDICAL ECONOMICS
Real-world healthcare resource utilization and clinical outcomes among patients with relapsed/refractory multiple myeloma receiving ciltacabtagene autoleucel after four or more prior lines of therapy in inpatient versus outpatient settings
Article
作者: Maitland, Jessica ; Perciavalle, Matthew ; Janakiram, Murali ; Nagar, Saurabh P. ; Ghosh, Sabyasachi ; Bixby, Todd ; Fan, Lin ; Dima, Danai ; Qureshi, Zaina P. ; Emond, Bruno ; Alegria, Victoria
BACKGROUND:
Ciltacabtagene autoleucel (cilta-cel) has demonstrated remarkable efficacy in relapsed or refractory multiple myeloma (RRMM). Outpatient (OP) administration of cilta-cel is increasingly used to improve access and reduce healthcare resource utilization (HCRU) compared to inpatient (IP) administration. We compared all-cause HCRU and clinical outcomes of IP versus OP administration of cilta-cel in patients with RRMM after ≥4 prior lines of therapy (LOT) in clinical practice.
METHODS:
We identified adults receiving cilta-cel between 02/28/2022 and 06/30/2024 after ≥4 prior LOT using Komodo Research Database claims data and classified patients into cohorts by setting of administration (IP/OP). All-cause HCRU, treatment-free interval (TFI), overall survival (OS), and clinical events (e.g. cytokine release syndrome [CRS], immune effector cell-associated neurotoxicity syndrome [ICANS]) were assessed. Outcomes were compared using multivariate regression and reported as incidence rate ratios (IRR) with 95% confidence intervals (CI).
RESULTS:
Among 242 patients, 148 (61.2%) received cilta-cel in IP and 94 (38.8%) in OP. Baseline characteristics were comparable between cohorts. Of patients in the OP cohort, 31.9% did not require an IP admission within 3 months post-infusion. During this period, the OP cohort had significantly fewer IP days per-patient-per-month (2.4 vs. 6.6; IRR [95% CI]: 0.37 [0.28; 0.48], p < 0.001) and more OP days (8.5 vs 5.4; IRR [95% CI]: 1.43 [1.26; 1.63], p < 0.001) than the IP cohort. From the fourth month post-infusion, no significant differences in HCRU were observed. Rates of CRS and ICANS, and long-term outcomes including 6 and 12 month TFI and OS were similar.
CONCLUSION:
OP administration of cilta-cel yielded similar effectiveness and safety outcomes relative to IP administration, while significantly reducing IP resource use. These findings support the feasibility of OP administration of cilta-cel in treating RRMM patients and its potential to reduce the burden on the healthcare system.
2026-12-31JOURNAL OF DERMATOLOGICAL TREATMENT
Real-world effectiveness and safety of guselkumab in adult patients with facial and/or genital psoriasis: a 52-week analysis from the Italian multicentric GULLIVER study
Article
作者: Stingeni, Luca ; Galluzzo, Marco ; Pallotta, Sabatino ; Megna, Matteo ; Corazza, Monica ; Argenziano, Giuseppe ; Lasagni, Claudia ; Piaserico, Stefano ; Costanzo, Antonio ; Fargnoli, Maria Concetta ; Bardazzi, Federico ; Offidani, Annamaria ; Richetta, Antonio Giovanni ; Bonifati, Claudio ; Potenza, Concetta ; Atzori, Laura ; Saibene, Federico ; Gramiccia, Talia ; Papini, Manuela ; Giofrè, Claudia ; Bongiorno, Maria Rita ; Dapavo, Paolo ; Di Lernia, Vito Giuseppe ; Prignano, Francesca ; Lembo, Serena ; Savoia, Paola ; Satolli, Francesca ; Guarneri, Claudio ; Burlando, Martina ; Zichichi, Leonardo ; Rongioletti, Franco ; Loconsole, Francesco ; Micali, Giuseppe ; Peris, Ketty ; Donini, Massimo ; Romanelli, Marco ; Stinco, Giuseppe ; Carrera, Carlo Giovanni
OBJECTIVES:
Facial and genital plaques are common manifestations of psoriasis, are challenging to treat, and significantly impact patients' quality of life (QoL).
METHODS:
GULLIVER is a prospective, non-interventional study conducted in 2020-2023 in Italy, aimed at examining the effectiveness, safety and QoL impact of guselkumab through 52 weeks of treatment in patients with facial and/or genital psoriasis. The primary endpoint was the percentage of patients achieving a static Physician Global Assessment (sPGA) score of ≤1 and a minimum 2-grade improvement in sPGA score at Week 52.
RESULTS:
Of 351 enrolled patients, 88.6% remained on guselkumab treatment at Week 52. The proportions of patients achieving the sPGA targets in the facial and genital groups, respectively, were 83.3% and 76.5% at week 12, increasing to 93.8% and 97.9% at Week 52. Mean Dermatology Life Quality Index score improved from 12.0 ± 7.5 at baseline to 1.1 ± 2.0 at Week 52 for patients with facial psoriasis (p-value <0.001) and from 12.0 ± 6.9 to 1.6 ± 3.5 for those with genital psoriasis (p-value <0.001). Guselkumab was well-tolerated and no new safety signals were identified.
CONCLUSIONS:
This Italian real-world study demonstrated the high effectiveness and a good safety profile of guselkumab in treating facial and genital psoriasis.
2026-09-01JOURNAL OF CHROMATOGRAPHY A
Impurity profiling of lipid-conjugated oligonucleotides using reversed-phase with and without ion-pair reagents and hydrophilic interaction liquid chromatography
Article
作者: Eeltink, Sebastiaan ; Bui, Quang-Dong ; Kesselaers, Emma ; Deschrijver, Tiny ; Noten, Bart
Lipid-oligonucleotide conjugates (LONs) represent a next-generation class of biopharmaceuticals that couple nucleic-acid specificity with lipid-mediated delivery, enabling superior membrane affinity and cellular uptake, for highly targeted therapeutic action. Lipid type and conjugation position strongly influence hydrophobicity, retention, and interaction strength from the exposure of the lipid moiety, thereby affecting the chromatographic behavior of impurities such as shortmers and diastereomers. In this study, we systematically investigated the performance of different chromatographic modes, reversed-phase LC (with and without ion-pairing agents) and hydrophilic interaction LC (HILIC), and assessed the influence of mobile-phase additives on the retention behavior of both single- and double-stranded LONs. RPLC and IP-RPLC proved superior to HILIC for impurity profiling, offering higher separation resolution and MS compatibility. In contrast to naked ONs, LON retention did not follow an on-off mechanism in (IP-)RPLC mode. Moreover, LONs displayed the opposite retention order. A novel metric was developed to account for the hydrophobic contributions of both the oligonucleotide backbone and lipid conjugation, demonstrating a strong correlation with experimentally observed retention behavior in RPLC. High resolving power was achieved for diastereomeric impurity profiling of internally lipid-modified oligonucleotide (iLON) duplexes using a C4 column in RPLC mode, revealing that the extent of phosphorothioate modification suppression depends strongly on both the lipid type and its conjugation position. The resolving power of RPLC was demonstrated by separating >30 of the theoretical 64 diastereomers present in a siRNA sample.
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