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immunoglobulin (Bivigam)

✓ Approved

ADMA Biologics, Inc. · 多克隆抗体 · 多克隆抗体

什么是 immunoglobulin？

immunoglobulin 是一种多克隆抗体，由ADMA Biologics, Inc.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

商品名Bivigam
公司ADMA Biologics, Inc.
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, ADMA Biologics, Inc.

治疗适应症

immunoglobulin 针对 5 个适应症，涉及 2 个治疗领域。

治疗领域疾病/病症分期
Congenital, familial and genetic disordersCombined immunodeficiency✓ Approved
Congenital, familial and genetic disordersWiskott-Aldrich syndrome✓ Approved
Immune system disordersSelective IgG subclass deficiency✓ Approved
Congenital, familial and genetic disordersBruton's agammaglobulinaemia✓ Approved
Immune system disordersImmunodeficiency✓ Approved

相关研究文献

PubMedCureus2026-09-10

Paraplegia Caused by IgG4-Related Hypertrophic Pachymeningitis With an Elevated Cerebrospinal Fluid Immunoglobulin G4 Concentration.

Doyama Hisaki H, Matsumoto Yasuko Y, Kurosaka Akiho A, Kobayashi Motoya M et al.

Immunoglobulin G4-related hypertrophic pachymeningitis (IgG4-RP) is a rare manifestation of immunoglobulin G4 (IgG4)-related disease and an uncommon cause of hypertrophic pachymeningitis (HP). Because serum IgG4 concentration is not necessarily elevated, the diagnosis of IgG4-RP is often challenging. We report a rare case of IgG4-RP in a 78-year-old woman presenting with complete paraplegia, sensory loss in the lower extremities, and bladder and rectal dysfunction. Gadolinium-enhanced magnetic resonance imaging showed enhancing spinal epidural lesions. A histopathological examination revealed dense lymphocyte and plasma-cell infiltration with fibrosis and increased IgG4-positive plasma cells, leading to the diagnosis of IgG4-RP. Although the serum IgG4 concentration was within the reference range, retrospective analysis of cerebrospinal fluid (CSF) showed a markedly elevated IgG4 concentration, with an increased IgG4 index and IgG4Loc. Glucocorticoid therapy resulted in radiological and neurological improvement. This case highlights the importance of considering IgG4-RP in patients with spinal HP even if serum IgG4 concentration is not elevated. Furthermore, CSF IgG4 measurement may contribute to the diagnosis of IgG4-RP, although further studies are required to establish its clinical utility.

PMID 42719365
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PubMedFrontiers in medicine2026-09-10

Case Report: Balancing immunosuppression and infection-intravenous immunoglobulin in anti-HMGCR immune-mediated necrotizing myopathy complicated by severe pneumonia.

Fu Jing J, Zhao Qiong Q, Lou Jing-Bo JB, Tang Gui-Hua GH et al.

A 65-year-old male with a 3-year history of atorvastatin use presented with progressive proximal muscle weakness, dysphagia, and markedly elevated creatine kinase (2,277 U/L). Initially misdiagnosed with polymyositis, he deteriorated with severe pneumonia, septicemia, and type I respiratory failure requiring mechanical ventilation. Interleukin-6 rose from 12.83 to 610.9 pg/mL during sepsis. After confirmation of anti-HMGCR antibody positivity (18 arbitrary units [AU], cutoff >10 AU) via line blot assay, we discontinued methotrexate, maintained methylprednisolone at 40 mg, and initiated intravenous immunoglobulin (IVIG) 0.4 g/kg/day for 5 days with broad-spectrum antibiotics. Within two weeks, proximal muscle strength (MRC scale) improved from 2/5 to 4/5, IL-6 normalized to 8.56 pg/mL, and respiratory failure resolved. This case suggests that IVIG may serve as a safe immunomodulatory bridge in critically ill IMNM patients with severe infections.

PMID 42718719
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PubMedJournal of medical virology2026-09-10

Molecular Evidence of Human T‑Cell Leukemia Virus Type 1 Transmission by Needlestick Injury in Healthcare Workers.

Tokunaga Masahito M, Kuramitsu Madoka M, Saito Masumichi M, Yoshimori Miyuki M et al.

Human T‑cell leukemia virus type 1 (HTLV‑1) is a retrovirus that spreads primarily through cell-to-cell transmission. Occupational transmission of HTLV-1 by needlestick injury is considered exceedingly rare, with no reported molecularly confirmed cases. We report two healthcare workers who experienced accidental needlestick injuries while caring for patients seropositive for HTLV‑1 and subsequently seroconverted. Full‑length HTLV‑1 proviral sequencing revealed complete nucleotide identity between source patients and infected nurses. These strains belonged to the HTLV-1 subtype 1a Japanese subgroup but were distinct from 315 previously registered strains. Proviral integration site analysis demonstrated nonoverlapping integration profiles between source patients and healthcare workers, providing direct evidence of de novo HTLV‑1 infection rather than expansion of transferred infected cells. Longitudinal analysis in one case showed dynamic clonal turnover between 5 and 14 months after transmission; > 90% of infected-cell clones were replaced, although the proviral load remained stable and low. Serological profiling revealed transiently elevated immunoglobulin M responses to Gag p19 peptides during early infection, followed by gradual immunoglobulin G maturation. These findings provide the first molecular confirmation of HTLV‑1 transmission via needlestick injury resulting in de novo infection, revealing an under-recognized occupational exposure route and supporting reconsideration of post-exposure testing strategies, particularly in endemic regions.

PMID 42720182
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PubMedMedComm2026-09-10

Immunoglobulin Kappa Light Chain Produced by Cardiomyocytes and Participates in Maintaining Intercalated Disc Integrity.

Zhu Zhu Z, Sheng Yixuan Y, Chang Yun Y, Chang Yuan Y et al.

In this study, we unexpectedly found that the immunoglobulin kappa light chain (Igκ) was expressed in normal cardiomyocytes of mice and humans, especially in intercalated discs (ICDs). Cardiomyocyte-specific knockout of Igκ in mice results in reduced myocardial contraction, atrioventricular block (AV block), and even sudden death. Histological analysis revealed that Igκ knockout in cardiomyocytes leads to structural disorder of ICDs, dissemination of the cytoskeleton proteins desmin and F-actin, as well as the loss of desmoplakin (DSP), N-cadherin, and connexin 43 (Cx43) on ICDs. Mechanistically, Igκ can bind to and stabilize plectin, a cytoskeleton-cross-linking protein that facilitates the assembly of desmin‒actin networks that maintain normal cytoskeletal architecture. Igκ can also anchor desmin to the DSP through plectin, thereby stabilizing the integrity of the ICDs. This molecular interplay critically reinforces cardiomyocyte cohesion and maintains structural and functional homeostasises. Our findings are the first to identify cardiomyocyte-expressed Igκ as a novel ICD-related molecule that participates in cardiomyocyte contraction and conduction by stabilizing plectins. Importantly, this work extends current arrhythmogenic cardiomyopathy (ACM) pathogenic models by revealing that ablation of the non-desmosomal gene Igκ disrupts ICD integrity, uncovering a new mechanism for non-desmosomal gene-related ACM and highlighting Igκ as a potential target for therapeutic investigations.

PMID 42719716
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PubMedFrontiers in immunology2026-09-10

X-linked hyper-IgM syndrome presenting as severe Pneumocystis pneumonia in a 6-month-old infant: a case report.

Guo Ying Y, He Xiaoli X, Zhang Lijun L, Li Mengting M et al.

X-linked hyper-immunoglobulin M (XHIGM) syndrome is a rare primary immunodeficiency caused by mutations in the CD40 ligand gene (CD40LG), characterized by defective T-cell-dependent B-cell class-switch recombination. Patients typically present with recurrent infections in early childhood, but diagnosis is often delayed due to heterogeneous clinical manifestations and the fact that serum IgM levels may remain within the normal range in a significant proportion of patients. Here we report a case of XHIGM in an infant whose diagnostic journey began with recurrent lymphadenitis and culminated in life-threatening Pneumocystis jirovecii pneumonia (PJP). A 6-month-old male infant was admitted with severe respiratory distress and hypoxemia. He had recurrent axillary lymphadenitis at 1 and 2 months of age and significant failure to thrive. Chest CT showed bilateral consolidative and interstitial opacities. Immunological evaluation revealed markedly decreased IgA, normal IgM and IgG, and profound T-cell lymphopenia. Sputum metagenomic sequencing identified Pneumocystis jirovecii. Whole-genome sequencing identified a hemizygous likely pathogenic CD40LG mutation (NM_000074.3:c.520C>T, p.Q174*); his mother was a carrier. He was treated with mechanical ventilation, trimethoprim-sulfamethoxazole (TMP-SMX), micafungin, corticosteroids, and intravenous immunoglobulin (IVIG), and was discharged after 36 days. In infants with recurrent or opportunistic infections, persistently low IgA and declining T-cell counts-even when initial screening appears normal-should raise suspicion for underlying immunodeficiency and prompt genetic evaluation. Early aggressive management and evaluation for hematopoietic stem cell transplantation are essential to improve outcomes.Serial immunological evaluation is essential in infants with recurrent or opportunistic infections, as persistently low IgA and declining T-cell counts-even when initial screening appears normal-should prompt genetic evaluation for underlying immunodeficiency. Early aggressive management and evaluation for hematopoietic stem cell transplantation are essential to improve outcomes.

PMID 42718418
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PubMedImmunological investigations2026-09-10

IgG4 and Rheumatoid Arthritis: A Comprehensive Review of Its Role in Inflammation, Biomarker Potential, and Therapeutic Implications.

Zhang Li L, Shen Haili H, Li Yuan Y

Immunoglobulin G4 (IgG4) is the least abundant IgG subclass and has distinctive structural and functional properties, including Fab-arm exchange and limited activation of antibody-dependent effector mechanisms. These features contribute to its generally non-inflammatory and tolerogenic profile. However, the role of IgG4 in rheumatoid arthritis (RA) remains incompletely understood. This review aims to summarize and critically evaluate the biological characteristics of IgG4, its clinical significance in RA, and the potential therapeutic implications of IgG4-mediated immune responses. Elevated serum IgG4 levels have been reported in a subset of patients with RA and have been associated with disease activity, inflammatory markers, autoantibody levels, and treatment response in some studies. IgG4 autoantibodies, including antinuclear IgG4 antibodies, have also been detected in autoimmune diseases and may influence complement activation and proinflammatory cytokine production. However, findings remain heterogeneous, and current evidence is insufficient to establish IgG4 as an independent diagnostic or prognostic biomarker in routine RA care. IgG4 may have a complex, context-dependent role in RA, potentially reflecting both immune dysregulation and compensatory anti-inflammatory responses. Further research is needed to clarify its pathogenic mechanisms, clinical utility, and potential as a therapeutic target.

PMID 42720141
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