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IV

IVIG (BT 681 5% / IVIG 5%, Biotest / IVIG 10%, Biotest)

✓ Approved

Grifols, S.A. · 单克隆抗体 · 单克隆抗体

什么是 IVIG？

IVIG 是一种单克隆抗体，由Grifols, S.A.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BT 681 5%, IVIG 5%, Biotest, IVIG 10%, Biotest
公司Grifols, S.A.
药物类别单克隆抗体, 多克隆抗体, 抗体
给药途径Injectable (Others), Intravenous (IV)
状态Approved
来源： ClinicalTrials.gov, Grifols, S.A.

治疗适应症

IVIG 针对 8 个适应症，涉及 5 个治疗领域。

治疗领域疾病/病症分期
Nervous system disordersChronic inflammatory demyelinating polyradiculoneuropathy✓ Approved
Immune system disordersSelective IgG subclass deficiency✓ Approved
Nervous system disordersMultifocal motor neuropathy✓ Approved
Nervous system disordersGuillain-Barre syndrome✓ Approved
Blood and lymphatic system disordersThrombocytopenia✓ Approved

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相关研究文献

PubMedItalian journal of pediatrics2026-06-13

Predictive value of the hemoglobin-albumin-lymphocyte-platelet score for intravenous immunoglobulin resistance in children with Kawasaki disease.

Li Kai K, Li Fei F, Zeng Na N, Sang Haiyan H et al.

Intravenous immunoglobulin (IVIG) resistance is a major clinical challenge in children with Kawasaki disease (KD) and is associated with an increased risk of coronary artery lesions. Early identification of patients at high risk of IVIG resistance remains clinically important. Medical data were collected from KD patients at Anhui Provincial Hospital between January 2018 and December 2023. Multivariable logistic regression was performed to identify independent risk factors for IVIG resistance in KD. The study further performed subgroup analyses and restricted cubic spline (RCS) to visualize the dose-response association between hemoglobin-albumin-lymphocyte-platelet score (HALP) and IVIG resistance. The predictive performance of HALP was evaluated using receiver operating characteristic (ROC) curves and decision curve analysis (DCA), and internal validation was performed using bootstrap resampling. A total of 598 patients were included, of whom 58 (9.7%) were identified as IVIG-resistant. Patients with IVIG-resistant KD had significantly lower HALP scores, and low HALP was identified as an independent risk factor for IVIG resistance. The association was consistent across subgroups defined by age, sex, and incomplete KD (IKD). The area under the curve (AUC) for HALP in predicting IVIG resistance was 0.854, outperforming NLR (AUC = 0.751), PLR (AUC = 0.793), and SII (AUC = 0.759). In addition, DCA showed that HALP provided greater net benefit when the threshold probability ranged from 0.02 to 0.63. Moreover, subgroup ROC indicated that HALP had higher predictive value in patients aged ≤ 6 months (AUC = 0.934) and ≥ 48 months (AUC = 0.947). HALP is independently associated with IVIG resistance in children with KD and demonstrated good performance for early risk stratification, particularly in patients aged ≤ 6 months and ≥ 48 months. As a simple and readily available biomarker, HALP may serve as a useful complementary tool in routine pediatric clinical practice.

PMID 42286758
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PubMedJournal of autoimmunity2026-06-12

Long-term effectiveness, safety, and cost-effectiveness of intravenous immunoglobulin for generalized myasthenia gravis in an era of molecular targeted drugs: Insights from Japanese post-marketing surveillance.

Suzuki Shigeaki S, Iida Minami M, Wakahara Takuya T, Shiko Yuki Y et al.

Intravenous immunoglobulin (IVIg) is widely used for generalized myasthenia gravis (gMG), but long-term, large-scale, real-world evidence remains limited. This study evaluated the 2-year effectiveness, safety, and cost-effectiveness of IVIg in Japanese patients with gMG. This retrospective, observational, post-marketing surveillance study was conducted between 2011 and 2016 at 316 facilities across Japan. All patients with gMG who received the first IVIg dose were eligible for enrolment. Patients who did not receive corticosteroids or immunosuppressants before IVIg initiation were excluded. The primary outcome was the time to retreatment with IVIg, intravenous methylprednisolone, plasmapheresis, or thymectomy due to disease progression or relapse. The cost-effectiveness of IVIg and molecular targeted drugs was evaluated using cost per responder and cost per Myasthenia Gravis Activities of Daily Living (MG-ADL) improvement analyses. In total, 1041 patients were included in this study (mean age, 58.7 years; women, 674 [65%]; mean MG-ADL score, 9.45; mean follow-up period, 331.5 days). The median time to retreatment was 386 days (95% confidence interval [CI]: 302-545) in all patients and 175 days (95% CI: 147-214) in 410 patients who received the second IVIg dose (p < 0.0001, log-rank test). The MG-ADL responder rate (≥2-point improvement) was 65.7% on day 14 and 46.7% on day 180. The cost per MG-ADL improvement was estimated at 7000-17,000 Japanese yen, which was substantially lower than that for molecular targeted drugs. These findings support the long-term effectiveness and cost-effectiveness of IVIg for gMG, without new safety concerns.

PMID 42275909
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PubMedJournal of clinical medicine2026-06-12

Use of Intravenous Immunoglobulins in Pediatric Viral Meningoencephalitis: A Real-World Retrospective Observational Study.

Lazzareschi Ilaria I, Mercuri Mariachiara M, Renzelli Ludovica L, Veredice Chiara C et al.

Background: Viral meningoencephalitis is a frequent cause of acute central nervous system infection in children, particularly in neonates and young infants. Although etiological diagnosis has improved through molecular testing, management remains largely supportive, and intravenous immunoglobulins (IVIGs) are occasionally used in clinical practice despite limited supporting evidence. Methods: We performed a single-center retrospective observational study including pediatric patients aged 0-10 years admitted between 2016 and 2025 with molecularly confirmed viral meningoencephalitis. Demographic, clinical, microbiological, therapeutic, and follow-up data were collected. Neurological outcomes and length of hospital stay were compared between patients treated with IVIG and those who were not. Results: Twenty-nine patients were included. Enterovirus was the most frequently identified pathogen (50.0%), followed by human herpesvirus (35.7%) and human parechovirus (14.3%). IVIG was administered to 28% of patients, all with enterovirus infection. IVIG-treated patients were significantly younger at presentation and more frequently presented with apnea (42.9% vs. 0%, p = 0.014). Most patients had a favorable neurological outcome (85.7%). Unfavorable outcomes, including neurodevelopmental delay and/or epilepsy, occurred in a minority of cases (14.3%) and exclusively in enterovirus-infected patients. No significant association was found between IVIG administration and neurological outcome. Conclusions: In this real-world pediatric cohort, IVIG use was associated with more severe clinical features rather than improved neurological outcomes, underscoring the need for careful consideration and further investigation in this setting, particularly in the subgroup of infants with enterovirus encephalitis.

PMID 42278884
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PubMedFrontiers in immunology2026-06-12

A recombinant IgG1 Fc-domain protein ameliorates inflammatory demyelinating peripheral neuropathy.

Otlu Husniye G HG, Gao Tong T, Coffey Greg P GP, Bright Jessica M JM et al.

Guillain-Barré syndrome (GBS) and chronic inflammatory demyelinating polyneuropathy (CIDP) are immune-mediated inflammatory neuropathies characterized by T cell- and/or autoantibody-driven injury to peripheral nerves. Although intravenous immunoglobulin (IVIg) is effective in both conditions, its use is limited by high dosing requirements, supply constraints, and manufacturing complexity. NVG-2089 is a recombinant IgG1 Fc-domain protein engineered to selectively agonize type II Fc receptors, promoting anti-inflammatory signaling through expansion of regulatory T cells (Tregs) and upregulation of the inhibitory Fcγ receptor FcγRIIB. Its efficacy in immune complex-mediated disease and T cell-driven neuroinflammation prompted evaluation of its therapeutic potential in an animal model of inflammatory demyelinating neuropathy. We conducted a randomized, blinded preclinical study in the spontaneous autoimmune peripheral polyneuropathy model, a well-established murine model of inflammatory demyelinating neuropathy. Animals were treated with NVG-2089, high-dose IVIg, or vehicle. Outcomes included behavioral performance, nerve electrophysiology, peripheral nerve morphometrics, immunohistochemistry, and flow cytometric immunophenotyping. Both NVG-2089 and IVIg stabilized motor and sensory performance, preserved compound muscle action potential (CMAP) amplitudes, and attenuated demyelination-associated prolongation of distal latency and CMAP duration. Morphometric analyses demonstrated preservation of myelinated fiber density and normalization of g-ratio distributions in both treatment groups. Immunophenotyping indicated an expansion of functionally activated CD25+CD39+ Tregs in the spleen, along with increased FcγRIIB expression on B cells, monocytes, and dendritic cells across systemic and nerve-associated compartments, consistent with engagement of shared anti-inflammatory pathways. NVG-2089 demonstrated robust neuroprotective efficacy comparable to IVIg while requiring a substantially lower protein dose. These findings support NVG-2089 as a promising, dose-efficient alternative to IVIg for the treatment of inflammatory demyelinating neuropathies, including GBS and CIDP.

PMID 42282969
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PubMedBMC cancer2026-06-12

Clinical analysis and prognostic factors in children with neuroblastoma-associated opsoclonus-myoclonus syndrome: a multicenter retrospective study.

Zheng Chenjun C, Wan Chengliang C, Wang Jinhu J, Wu Yurui Y et al.

The long-term neurological outcomes for children diagnosed with neuroblastoma associated with Opsoclonus Myoclonus Syndrome (NB-OMS) are not well characterized, primarily due to the infrequency of the condition. This multicenter study sought to evaluate the rate of neurological recovery and the long-term neurodevelopmental sequelae within this patient population. A retrospective study at nine Chinese medical centers (January 2015 - January 2025) involved 39 children with NB-OMS. Researchers gathered data on demographics, clinical presentation, tumor traits, treatment, and outcomes. Non-parametric tests and multivariate logistic regression identified prognostic factors. In this study, a cohort of 39 patients was examined, with a median age at onset of 22 months. The retroperitoneum was identified as the most prevalent tumor location, accounting for 79.5% of cases. The majority of tumors were classified within the low-risk and intermediate risk, as determined by the International Neuroblastoma Risk Group Staging System, comprising 87.2% of the sample. Follow-up was conducted for 37 patients, all of whom exhibited symptom improvement, resulting in a 100% survival rate. Nonetheless, neurological sequelae were detected in 16 children (43.2%). A higher OMS severity score at onset demonstrated a strong trend towards significance (OR = 1.42, 95% CI: 1.00-2.01, P = 0.051). Multivariate analysis revealed that delayed initiation of treatment, defined as greater than 30 days, was a significant independent risk factor for the development of sequelae (Odds Ratio [OR] = 22.98, 95% Confidence Interval [CI]: 2.67-197.63, P = 0.004). Additionally, relapse of opsoclonus-myoclonus syndrome emerged as a significant independent risk factor (OR = 13.74, 95% CI: 1.37-137.34, P = 0.026). Furthermore, the use of combination immunotherapy, consisting of corticosteroids and intravenous immunoglobulin (IVIG), was associated with a significantly reduced median time to symptom resolution compared to non-combination therapy (5 months versus 8.5 months, P = 0.001). OMS is a chronic immune disorder often misdiagnosed, leading to treatment delays. Prompt first-line immunotherapy can quickly alleviate OMS symptoms. Early treatment and reducing relapses are crucial for better long-term outcomes. Future multicenter studies are needed to confirm the effectiveness of new immunotherapies.

PMID 42277674
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PubMedFrontiers in pharmacology2026-06-11

Evaluating the association between intravenous immunoglobulin and thromboembolic events in patients with autoimmune diseases: a retrospective real-world study.

Chen Jie J, Hu Jie J, Zhang Yanfang Y, Wang Suhong S et al.

Intravenous immunoglobulin (IVIG), a cornerstone in the management of autoimmune diseases (ADs), entails a concerning risk of thromboembolic events (TEEs). Current risk-stratification models, however, suffer from a critical omission, as they do not include dynamic biomarkers such as D-dimer. Additionally, the effectiveness of intermittent pneumatic compression (IPC) as a physical thromboprophylactic measure before IVIG infusion constitutes an unmet research need. This study was therefore designed to fill these voids by defining the incidence and independent risk factors for IVIG-associated thrombosis in AD patients and by evaluating the prophylactic potential of IPC, with the ultimate goal of informing risk identification and prevention strategies for high-risk patients. This study enrolled all AD patients receiving IVIG between January 2022 and October 2024. Patients were grouped by TEE occurrence. We analyzed demographic, clinical, and laboratory data to calculate TEE incidence, identify independent risk factors via logistic regression, and assess the cumulative IVIG dose-TEE association using Kaplan-Meier curves. The incidence of thromboembolic events was 9.36% (57/609). Multivariate analysis identified these independent risk factors for TEEs: cumulative IVIG dose (OR = 1.00, 95% CI: 1.00-1.00, P = 0.018), age ≥60 (OR = 2.91, 95% CI: 1.52-5.80, P = 0.002), immobility ≥3 days (OR = 6.28, 95%CI: 2.44-20.54, P = 0.001), diagnosis of myelitis (OR = 3.40, 95% CI: 1.01-10.64, P = 0.040) or acute post-transplant rejection (OR = 2.98, 95% CI: 1.02-8.64, P = 0.044), elevated pre-treatment D-dimer (OR = 4.56, 95% CI: 2.14-10.63, P < 0.001), and glucocorticoid use (OR = 2.04, 95% CI: 1.04-4.13, P = 0.041). Pre-treatment IPC showed no protective effect (P = 0.107). A significant dose-response relationship existed, with TEEs increasing markedly above cumulative doses of 100 g. Independent risk factors for IVIG-associated thrombosis in AD patients included age ≥60, myelitis, transplant rejection, immobility ≥3 days, IVIG dose >100 g, elevated pre-treatment D-dimer, and glucocorticoid use. Prophylactic low-molecular-weight heparin is recommended for these high-risk individuals.

PMID 42272831
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