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Rho(D) Immune Globulin

✓ Approved

CSL Limited · 多克隆抗体 · 多克隆抗体

什么是 Rho(D) Immune Globulin？

Rho(D) Immune Globulin 是一种多克隆抗体，由CSL Limited研发。该药已获批，用于治疗相关适应症，给药途径：Injectable (Others)、Intravenous (IV)。

药物档案

公司CSL Limited
药物类别多克隆抗体, 抗体
给药途径Injectable (Others), Intravenous (IV)
状态Approved
来源： ClinicalTrials.gov, CSL Limited

治疗适应症

Rho(D) Immune Globulin 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
Congenital, familial and genetic disordersRhesus haemolytic disease of newborn✓ Approved

相关研究文献

PubMedDrug design, development and therapy2026-10-26

Association Between Serum 25-Hydroxyvitamin D Levels and Immune-Related Adverse Events During PD-1/PD-L1 Inhibitor Therapy: A Retrospective Study.

Zhang Yue Y, Zeng Peng P, Fan Weibin W, Lin Bin B et al.

Vitamin D exerts pleiotropic immunomodulatory effects, yet its relationship with immune-related adverse events (irAEs) during PD-1/PD-L1 inhibitor therapy remains unclear. We examined the association between serum 25-hydroxyvitamin D [25(OH)D] concentrations and documented irAEs in a real-world cohort. In this single-center retrospective study, we analyzed 46 serum 25(OH)D test records from 35 patients treated with PD-1/PD-L1 inhibitors between October 2023 and April 2026; lung cancer was the predominant tumor type. Documented irAEs were adverse events recorded in the dataset, adjudicated as immunotherapy-related by the treating clinicians and graded according to CTCAE version 5.0. Vitamin D status was classified as deficient (<30 nmol/L), insufficient (30 to <50 nmol/L), or sufficient (≥50 nmol/L). Because repeated records from the same patient are not statistically independent, record-level analyses were treated as exploratory, whereas the primary analysis was performed at the patient level using each patient's first available 25(OH)D measurement to ensure independence of observations. Eleven record-level irAEs were documented in 9 patients; after exclusion of one event with unverifiable immune-mediated attribution (isolated hypokalemia), 8 patients had adjudicated irAEs in the primary analysis. At the exploratry record level, irAE proportions decreased stepwise across vitamin D categories: 60.0% (deficient), 20.0% (insufficient), and 6.3% (sufficient) (Cochran-Armitage trend, P=0.003). In the primary patient-level analysis, proportions were 62.5%, 13.3%, and 8.3%, respectively (trend P=0.008); first-test 25(OH)D concentrations were lower in patients with irAEs than in those without (median 26.70 vs 45.50 nmol/L; P=0.007), although the binary comparison (deficient/insufficient vs sufficient) was not statistically significant (P=0.216; OR=4.813, 95% CI: 0.517-44.824). In 10 of the 11 event-positive records, the documented event preceded the linked vitamin D measurement. Lower serum 25(OH)D concentrations were associated with documented irAEs in this small exploratory dataset. Given the temporal ambiguity and residual confounding, the findings are hypothesis-generating and cannot establish causality or prediction; whether vitamin D status can help risk-stratify patients for irAEs-rather than merely reflecting immune activation or nutritional status-requires prospective studies with protocol-defined pretreatment sampling.

PMID 42928853
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PubMedActas espanolas de psiquiatria2026-10-26

Association Among Systemic Immune-Inflammation Index, Vitamin D Status and Clinical Subtypes of ADHD: A Retrospective Investigation.

Lu Tingting T, Chen Yingying Y, Hu Feiping F, Zhu Yingping Y

Attention-deficit/hyperactivity disorder (ADHD) has been linked to immune dysregulation and nutritional imbalance. The systemic immune-inflammation index (SII) is a composite inflammatory marker, while serum 25-hydroxyvitamin D (25(OH)D) reflects vitamin D status. Their joint association with paediatric ADHD remains incompletely characterised. In this retrospective case-control study, 78 treatment-naïve children with ADHD and 40 non-ADHD outpatient comparison children selected using frequency matching by age and sex were included. The most recent laboratory results available in the outpatient record were extracted. Given that some 25(OH)D values were derived from reports obtained outside our hospital, all available 25(OH)D records were manually re-checked against source documents and standardised to ng/mL prior to analysis. Group comparisons, whole-sample Spearman correlation analyses, logistic regression models including an interaction term between standardised SII and standardised 25(OH)D and exploratory receiver operating characteristic (ROC) analyses were performed. Sensitivity analysis and Firth penalised logistic regression were additionally conducted. Compared with the comparison group, children with ADHD had significantly higher SII, C-reactive protein (CRP), neutrophil-to-lymphocyte ratio (NLR) and platelet-to-lymphocyte ratio (PLR) levels, together with lower serum 25(OH)D. The ADHD group was more likely to fall into lower clinically defined 25(OH)D categories, whereas the comparison group was more frequently in the ≥30 ng/mL category; this pattern remained directionally consistent after stratification by season of blood draw. In the whole study sample, SII was positively correlated with attention, impulsivity and oppositional scores, whereas serum 25(OH)D was inversely correlated with these symptom dimensions; SII was also inversely correlated with 25(OH)D. In the parsimonious model, the interaction term between standardised SII and standardised 25(OH)D was statistically significant (odds ratio (OR) = 3.06, 95% confidence interval (CI) 1.59-6.80, p = 0.002), and it remained significant in the broader sensitivity model and Firth penalised regression. In exploratory within-sample analysis, ROC curves yielded area under curves (AUCs) of 0.808 for SII, 0.781 for serum 25(OH)D and 0.836 for the parsimonious multivariable model. Paediatric ADHD was associated with high inflammatory burden and low serum 25(OH)D status in this retrospective outpatient sample. The statistically significant interaction between SII and 25(OH)D suggests a stable pattern of effect modification on the logistic model scale. These findings support a potentially relevant immuno-nutritional pattern in ADHD, but prospective validation is needed before causal interpretation or clinical implementation can be considered.

PMID 42928691
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PubMedJournal of magnetic resonance imaging : JMRI2026-10-26

Perivascular Diffusivity and Periventricular Susceptibility Changes in Relapsing-Remitting Multiple Sclerosis: A Combined DTI-ALPS and QSM Study.

Revanth R B RB, Smitha K A KA, Jithin S S SS, Meena Pandi P et al.

Progressive periventricular damage in multiple sclerosis (MS) has been linked to impaired perivascular clearance and to susceptibility changes attributed to iron deposition and myelin loss. Their relationship is unclear. To compare diffusion tensor image analysis along the perivascular space (DTI-ALPS) and periventricular quantitative susceptibility mapping (QSM) between relapsing-remitting multiple sclerosis (RRMS) patients and healthy controls; and to evaluate their correlation and relationships with clinical disability (Expanded Disability Status Scale, EDSS). Retrospective case-control study. Thirty one patients with RRMS (mean age, 34.6 ± 8.4 years) and 30 age- and sex-matched healthy controls (mean age, 34.2 ± 8.1 years). 1.5 T; Diffusion tensor imaging (DTI) and multi-echo gradient-echo (GRE) sequences. DTI-ALPS index and periventricular QSM values were measured from manually placed bilateral regions of interest (ROIs). Standardized Montreal Neurological Institute (MNI)-space coordinates were used for DTI-ALPS analysis, and QSM ROIs in periventricular normal-appearing white matter were reviewed by a neuroradiologist. Disability was assessed using the EDSS. Groups were compared using independent-samples t-tests and Cohen's d. Correlations were assessed using Pearson's r, with Spearman's rho as a sensitivity analysis (p < 0.05, two-tailed). DTI-ALPS was lower in MS patients than controls (1.27 ± 0.22 vs. 1.45 ± 0.22; d = 0.828), whereas periventricular QSM was higher (-15.35 ± 4.92 vs. -21.70 ± 6.40 ppb; d = 1.116). A strong negative correlation between the two biomarkers was observed across all subjects (r = -0.738). Both measures correlated with EDSS (DTI-ALPS r = -0.509; QSM r = 0.501) and differed between EDSS subgroups (EDSS > 2.0 vs. ≤ 2.0: DTI-ALPS 1.160 vs. 1.364; QSM -12.33 vs. -17.83 ppb). Reduced DTI-ALPS and higher periventricular QSM-derived susceptibility were each moderately associated with disability in RRMS. The negative DTI-ALPS-QSM correlation in both groups indicates an association between perivascular diffusivity, a putative marker of glymphatic function, and periventricular QSM-derived susceptibility; causality cannot be established from this cross-sectional design. 2.

PMID 42929234
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PubMedJournal of virology2026-10-26

Early innate immune signatures correlate with Ad26.COV2.S vaccine immunogenicity and protective efficacy.

Colarusso Alessandro A, Stephenson Kathryn E KE, Collier Ai-Ris Y A-RY, Wegmann Frank F et al.

The innate immune system is rapidly activated following antigen exposure and plays a critical role in shaping the ensuing adaptive immune responses. In this study, we performed bulk RNA sequencing and proteomic profiling in a cohort of 25 rhesus macaques following Ad26.COV2.S immunization to characterize early innate correlates of vaccine immunogenicity and protection. Our results show that innate immune activation occurred as early as day 1 post-vaccination and demonstrated a systemic enrichment of antiviral interferon pathways, cytokine signaling, and activation of innate immune cell signatures. These early transcriptomic signatures correlated positively with humoral and cellular immune responses at 6 weeks following vaccination and correlated inversely with viral loads following SARS-CoV-2 challenge. Similar correlates of immunogenicity were observed in a cohort of 25 adult healthy participants vaccinated with Ad26.COV2.S. Taken together, these findings highlight the importance of early activation of the innate immune responses following Ad26.COV2.S vaccination in shaping the protective adaptive immune response.IMPORTANCEEarly innate immune responses may shape vaccine immunogenicity and protection. We evaluated responses to Ad26.COV2.S vaccination in rhesus macaques and humans and found that day 1 innate immune signatures correlated with subsequent adaptive responses. These findings suggest that early post-vaccination immune programming influences immunogenicity and protective efficacy months later.

PMID 42929544
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PubMedDevelopment (Cambridge, England)2026-10-26

Immune-epithelial interactions orchestrate stem-cell niche formation and morphogenesis requiring TGF-β signaling.

Traugh Nicole N, Trepicchio Colin C, Rauner Gat G, Parrish Meadow M et al.

Epithelial morphogenesis is generally attributed to mesenchymal and extracellular matrix interactions, whereas the role of immune cells in tissue assembly remains poorly defined. Here, we established a patient-derived, single-cell 3D hydrogel organoid system to examine immune-epithelial interactions during human mammary morphogenesis. CD45⁺ immune cells integrate into developing breast epithelial structures and persist throughout organoid formation, recapitulating their spatial organization in vivo. Functionally, immune cells act as instructive regulators in a donor-dependent manner, enhancing organoid number, branching, and proliferation. Reciprocal mixing experiments demonstrate that this phenotype is determined by the immune compartment, identifying distinct "inducer" and "non-inducer" states. Live imaging reveals that inducer immune cells undergo directed migration and establish stable early interactions with nascent epithelial clusters, whereas non-inducer cells fail to engage. Although inducer co-cultures produce a pro-morphogenic cytokine environment, soluble factors alone are insufficient to reproduce the phenotype. Instead, TGF-β signaling is required under these conditions, as pathway inhibition attenuates immune-driven morphogenesis whereas exogenous ligand is insufficient. These findings identify immune cells as essential, context-dependent regulators of enhanced epithelial morphogenesis in this organoid system.

PMID 42929511
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PubMedBiosensors2026-10-26

Immunocompetent Lung-on-a-Chip: Engineering the Pulmonary Immune Microenvironment for Disease Modeling.

Li Xingrui X, Li Yinan Y, Xu Jiashuang J, Sun Rui R et al.

Lung-on-a-chip (LOC) models are increasingly used to study pulmonary disease, yet most platforms are still judged primarily by structural fidelity rather than immune function. Here, we review the emergence of immunocompetent LOCs and propose a functional grading framework to benchmark immune integration, from barrier-only models to innate immune surveillance, adaptive immune responses, and lymphoid structure reconstitution. Using this framework, we assess how engineering parameters, including materials, mechanics, fluidics, extracellular matrix, and immune cell sourcing, define the level of immunocompetence that a platform can achieve. We show that the field has progressed considerably in recapitulating innate immunity but remains stalled at the transition to antigen-specific T- and B-cell responses, because current platforms struggle to reconcile the prolonged cell-cell contacts required for adaptive priming with the continuous perfusion needed for tissue homeostasis. Overcoming this gap will demand longer-term culture stability, improved strategies for autologous multi-lineage cell sourcing, and the integration of LOCs with multi-organ immune circuits, spatial multi-omics, and AI-driven multimodal data analytics. Together, these advances are likely to define the next generation of translational pulmonary immune models.

PMID 42930094
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