Drug Database
RH

Rho(D) Immune Globulin

✓ Approved

CSL Limited · Polyclonal Antibodies · Polyclonal Antibodies

What is Rho(D) Immune Globulin?

Rho(D) Immune Globulin is a polyclonal antibodies developed by CSL Limited. It is approved for therapeutic indications via injectable (others) or intravenous (iv).

Drug Profile

CompanyCSL Limited
Drug ClassPolyclonal Antibodies, Antibody
RouteInjectable (Others), Intravenous (IV)
StatusApproved
Sources: ClinicalTrials.gov, CSL Limited

Therapeutic Indications

Rho(D) Immune Globulin is developed for 1 unique indication across 1 therapeutic area.

Therapeutic AreaConditionPhase
Congenital, familial and genetic disordersRhesus haemolytic disease of newborn✓ Approved

Related Research Articles

PubMedJournal of ultrasound in medicine : official journal of the American Institute of Ultrasound in Medicine2026-09-19

Diagnostic Accuracy of Quantitative Ultrasound Liver Fat Estimation with MRI-PDFF as the Reference Standard.

Roccarina Davide D, Ferraioli Giovanna G, Hidalgo Ronald R, Barr Richard G RG

To assess the performance of 3 ultrasound-based liver fat quantification algorithms-tissue attenuation imaging (TAI), tissue scatter imaging (TSI; Nakagami parameter), and ultrasound-derived fat fraction (USFF)-using magnetic resonance imaging-derived proton density fat fraction (MRI-PDFF) as the reference standard. In this prospective, IRB-approved, HIPAA-compliant study conducted at 2 North American centers, adults with or at risk for hepatic steatosis underwent quantitative ultrasound and same-day MRI-PDFF. The US examinations were performed with the Samsung RS85 system (Samsung Medison, Seoul, South Korea) using a C1-5S transducer. The software version utilized was 2.08.01.3538. Correlations were assessed using Spearman's rho. Diagnostic performance for steatosis grades S > 0, S > 1, and S > 2 was evaluated using AUROC analysis. Overall accuracy across grades was also assessed with the Obuchowski measure. Correlations and AUROCs were compared using Steiger's and DeLong's tests, respectively. Among 181 participants (113 women; median age, 57 years), MRI-PDFF correlated strongly with TAI and USFF (rho, 0.77 and 0.79) and moderately with TSI (rho, 0.57). For S > 0, AUROCs were 0.92 for TAI, 0.78 for TSI, and 0.93 for USFF; for S > 1, 0.88, 0.77, and 0.89; and for S > 2, 0.81, 0.73, and 0.83, respectively. Obuchowski measures were 0.87, 0.76, and 0.88. TAI and USFF were significantly more accurate than TSI (p = .03 and p = .02), with no significant difference between them (p = .79). TAI and USFF showed high, comparable performance for detecting hepatic steatosis and outperformed TSI. USFF was numerically superior to TAI, without significant incremental benefit. Discrimination between moderate and severe steatosis remained limited in the US evaluation.

PMID 42760613
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PubMedThe Journal of dermatology2026-09-19

Association of Oxidative Stress Index With Disease Control During Omalizumab-Based Treatment in Antihistamine-Refractory Chronic Spontaneous Urticaria: A Prospective Observational Study.

Aşık-Cansız Kübra K, Sayaca Nurhan Aliye NA, Yıldırım Eylem E, Özyurt Beyhan Cengiz BC et al.

Chronic spontaneous urticaria (CSU) is monitored mainly with patient-reported outcomes, whereas objective biomarkers that reflect disease status remain limited. This prospective observational cohort study included 55 adults with antihistamine-refractory CSU who initiated omalizumab as part of routine clinical care and 30 healthy controls for baseline oxidative stress comparisons. Total antioxidant status (TAS), total oxidant status (TOS), and oxidative stress index (OSI) were measured at baseline and month 6, and at month 12 in patients requiring treatment escalation. Disease control, disease activity, and quality of life were assessed using validated instruments. Unadjusted baseline TOS and OSI were lower in patients than in controls, but these differences were attenuated and were no longer statistically significant after adjustment for age, sex, and BMI (log-TOS: β = -0.297, p = 0.115; log-OSI: β = -0.310, p = 0.102). Month-6 OSI was higher in uncontrolled than controlled patients [0.274 (0.162-0.382) vs. 0.135 (0.100-0.245) AU, p = 0.010] and remained associated with uncontrolled disease after adjustment for baseline OSI, BMI, CRP, total IgE, and angioedema presence (β = 0.572, p = 0.030). Within-person change in OSI correlated inversely with change in UCT (rho = -0.596, p < 0.001), whereas its association with change in CU-Q2oL did not reach statistical significance (rho = 0.264, p = 0.053). In the 15-patient escalation subgroup, OSI did not change significantly over time (Friedman p = 0.074). These exploratory findings indicate that on-treatment OSI was associated with concurrent disease control and that within-person OSI change paralleled change in UCT. Incremental value beyond validated patient-reported outcomes, predictive performance, and treatment-guiding value was not established.

PMID 42760636
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PubMedMedicine2026-09-19

The causal associations between 25(OH) vitamin D levels and ectopic pregnancy: A 2-sample Mendelian randomization study.

Zhang Pei-Jin PJ, Bo Shao S, Liang Shuang S, Zhang Hong-Yuan HY et al.

Previous research has indicated a potential link between 25-hydroxyvitamin D [25(OH)D] and ectopic pregnancy (EP), but the underlying causal relationship remains unclear. We performed a 2-sample Mendelian randomization (MR) study to investigate the causal association between circulating 25(OH)D and ectopic pregnancy (EP). The primary analysis used summary statistics from a 25(OH)D GWAS of 4,96,946 European-ancestry participants and FinnGen summary statistics for EP (3111 cases and 89,340 controls). To assess whether the finding was robust to the choice of 25(OH)D GWAS, we repeated the MR analysis using a separate 25(OH)D GWAS (n = 4,41,291 European-ancestry participants) as a replication analysis; it was not used solely as a within-analysis sensitivity test. The primary and replication analyses used inverse-variance weighting (IVW) as the main method, complemented by weighted mode, simple mode, weighted median, and MR-Egger analyses. Heterogeneity and pleiotropy assessments, leave-one-out analyses, and other sensitivity analyses were conducted within each MR analysis. IVW estimates showed that increased serum 25(OH)D levels promoted EP (OR = 1.323, 95% CI = 1.024-1.710, P = .032). The replication analysis also revealed similar trends (OR = 1.383, 95% CI = 1.041-1.836, P = .025). The primary and replicated analyses were combined in a meta-analysis, and the result showed a significant causal influence (OR = 1.350, 95% CI = 1.116-1.632, P = .002). Sensitivity analysis confirmed the robustness of the MR estimations. In this MR study of European-ancestry participants, genetically predicted higher circulating 25(OH)D levels were associated with a higher risk of EP. These findings do not establish serum 25(OH)D as a diagnostic marker for EP. Rather, if confirmed in further clinical studies, elevated vitamin D may be considered a potential associated risk factor only in the context of established clinical signs and symptoms of EP.

PMID 42760711
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PubMedFrontiers in medicine2026-09-19

Elevated ALT correlates with severe liver injury, monocyte infiltration, and Pro-inflammatory immune dysregulation in chronic hepatitis B virus infection.

Huang Jian J, Xu Ning N, Liang Xiuyan X, Cai Defeng D

Hepatitis B virus (HBV) infection remains a global health burden. Although alanine aminotransferase (ALT) is a well-established marker of liver injury, its relationship with immune infiltration, monocyte activation, and inflammatory immune skewing in chronic HBV infection remains incompletely understood. This study aimed to investigate the associations of ALT with liver injury, monocyte infiltration, and hepatic immune microenvironment dysregulation. A total of 192 HBV-infected patients and 37 healthy controls were enrolled. Serum ALT, AST, HBV seromarkers, HBV-DNA, alpha-fetoprotein (AFP), and serum fibrosis markers (COLIV, HA, PIIINP, LN) were measured. Univariate and multivariate regression analyses were used to adjust for confounders including age, sex, HBV-DNA, fibrosis markers, and HBeAg status. Transcriptomic data from the GSE84044 liver biopsy cohort (n = 105) were analyzed using the xCell algorithm to evaluate hepatic immune infiltration, macrophage polarization, and immune scores. Gene set enrichment analysis (GSEA) was performed to explore monocyte chemotaxis, activation, and WNT/β-catenin signaling pathway. Chronic hepatitis B (CHB) patients showed significantly elevated ALT and AST. Higher ALT levels were strongly associated with elevated fibrosis markers and AFP, indicating more severe liver injury. Peripheral monocytes count and intrahepatic monocyte infiltration were both significantly increased in high-ALT patients. However, after multivariate adjustment, ALT was no longer independently associated with monocyte infiltration, suggesting that the association was largely attributable to overall disease severity rather than a specific ALT-related association. GSEA showed that ALT was positively correlated with monocyte chemotaxis, activation, macrophage differentiation, and WNT/β-catenin signaling pathway. Immune landscape analysis revealed a pro-inflammatory immune profile in high-ALT patients, characterized by increased M1 macrophages, CD8+ T cells, and elevated immune scores, accompanied by decreased Tregs and Th1 cells. Elevated ALT in chronic HBV infection correlates with severe liver injury and a pro-inflammatory, dysregulated hepatic immune microenvironment characterized by enhanced monocyte infiltration and M1 macrophage polarization. Transcriptomic associations reveal a statistical link between WNT/β-catenin signaling activation and hepatic immune dysregulation in HBV-related liver injury; these correlative findings provide preliminary clues for developing immunomodulatory therapeutic strategies for CHB.

PMID 42761001
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PubMedFrontiers in immunology2026-09-19

Enzyme replacement therapy (ERT) combined with transient low-dose methotrexate (TLD-MTX) results in age- and disease-dependent immune profile changes in Infantile- vs. late-onset Pompe disease patients.

Amirifar Parisa P, Desai Ankit K AK, Jung Seung-Hye SH, Young Sarah P SP et al.

Transient low-dose methotrexate (MTX) induces long-term immune tolerance to enzyme replacement therapy (ERT) in Pompe disease; however, the underlying immunological mechanisms remain unclear. We hypothesized that TLD-MTX would reduce immune activation and induce a regulatory phenotype in patients with Infantile-Onset Pompe Disease (IOPD) and Late-Onset Pompe Disease (LOPD) treated with ERT. We evaluated immune cell profile changes in patients treated with ERT+MTX using multiparameter flow cytometry on peripheral blood mononuclear cells collected at baseline and six months post-treatment. We analyzed 40 immune parameters in (1) thirteen unpaired samples from ERT+MTX-untreated (n=10) and -treated (n=3) IOPD patients and (2) six paired pre- and post-treatment samples from LOPD (n=6) patients. Linear regression analyses were used to assess correlations between immune parameters and disease activity measured by urinary glucose tetrasaccharide (Glc4; a breakdown product of glycogen). In IOPD, ERT+MTX-treated samples (median age: 12.3 months) showed reduced % CD16+ monocytes and increased classical CD14+CD16- monocytes, suggesting a shift toward a less activated immune profile. Untreated samples had higher % mature memory B cells and lower % plasmablasts, central memory CD4+ and CD8+ T cells, and TIGIT+ CD8+ T cells. In contrast, LOPD patients (median age: 51.5 years) exhibited decreased % B cells and increased % TIGIT+ CD4+ T cells after treatment. Baseline Glc4 levels were higher in IOPD than LOPD (42.5 vs. 7) and decreased in both groups following ERT+MTX. In untreated IOPD patients, Glc4 levels positively correlated with CD16+ monocytes, mature memory B cells, and terminally differentiated CD8+ T cells; these associations were not observed after treatment. In LOPD, T follicular regulatory cells correlated with Glc4 prior to treatment but not after, and no additional significant correlations were identified. These findings demonstrate distinct immune profiles before and after ERT+MTX treatment in IOPD and LOPD patients. In IOPD, reduced pro-inflammatory monocytes and memory T cells provide evidence to suggest decreased immune activation. In LOPD, increased TIGIT+ CD4+ T cells may reflect a regulatory mechanism contributing to immune tolerance.

PMID 42760993
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PubMedCancer medicine2026-09-19

Comparative Analysis of the Immune Profiles of Women and Men With Hepatocellular Carcinoma.

Macek Jilkova Zuzana Z, Ghelfi Julien J, Dumolard Lucile L, Sinniger Valerie V et al.

Hepatocellular carcinoma (HCC) is the most common primary liver cancer and a major global health concern, with a higher incidence in men than in women. In the era of immunotherapy, understanding sex-based immunological differences is crucial. This study investigated sex-specific differences in anti-tumor immunity in HCC through immune profiling of liver biopsies and blood samples. A prospective cohort of 101 patients was analyzed by multiparametric flow cytometry to assess lymphocyte populations and immune checkpoint molecule expression on tumoral and nontumoral biopsies and blood samples. Then, a retrospective cohort of 56 patients was analyzed for circulating immune markers and functional assessment. Our findings indicate that while overall intrahepatic immune composition was similar between sexes, female patients exhibited higher intra-tumoral PD-1high+CD8+ T cell frequency compared to men (13.3% ± 2.6% vs. 6.5% ± 0.7%, p = 0.0127), suggesting greater T cell exhaustion. Additionally, NK cells expressing CTLA-4 and ICOS were more frequent in females. Circulating immune profiles also differed, with female patients showing increased CTLA-4+ CD4+ and CD8+ T cells (p = 0.0005 and p = 0.0164) and reduced IFNγ expression, mainly in central memory CD8+ T cells. These findings highlight the importance of considering sex-related differences in the context of immunotherapy for HCC and underline the need for further investigation in larger cohorts.

PMID 42760831
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