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Overview

Basic Info

Drug Type

Immunoglobulin

Synonyms

human normal immunoglobulin(Baxter ), Subcuvia

Target-

Mechanism-

Therapeutic Areas-

Active Indication-

Inactive Indication-

Originator Organization

Baxalta Innovations GmbH

Active Organization

Baxalta Innovations GmbH

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

DE (05 Aug 2004)

Regulation-

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1. An experiment was conducted to determine differences in the expression of genes encoding intestinal barrier proteins between fast, medium and slow-growing chickens. Chicken breeds Athens Canadian Random Bred (ACRB), Longenecker's Heritage (LHR), RedBro, Hubbard H1 (HH1), Cobb500 and Ross708 were raised from hatch for 35 d.2. Ileal samples were collected at embryonic day E19 (-2 days post-hatch), hatch and d 7, 14, 21, 28 and 35 post-hatch to assess the expression of genes encoding tight junction proteins (claudins, CLDN; occludin, OCLN; zonula occludens, ZO; and junctional adhesion molecules, JAM), mucin (Muc2), immunoglobulin A (IgA), polymeric immunoglobulin receptor (pIgR) and fatty acid binding protein (FABP2).3. Expression of CLDN-1 was increased (p < 0.0001) in LHR compared to Cobb500 while CLDN-5 was increased (p < 0.0001) in ACRB, HH1, RedBro and Ross708 compared to LHR as well as in ACRB compared to Cob500. Occludin was upregulated (p = 0.01) in ACRB and LHR compared to Ross708 at d 14 post-hatch. Expression of ZO-1 was upregulated (p = 0.001) in LHR compared to Ross708, HH1 and Cobb500. Tight junction genes, except CLDN-4, JAM-2 and JAM-3 were downregulated (p < 0.0001) at hatch and d 7 post-hatch. Expression of Muc2 was increased (p < 0.0001) in LHR compared to RedBro and from -2 d to d 7 post-hatch.4. Immunoglobulin A was increased (p = 0.001) in LHR compared to Ross708 and HH1 at -2 d post-hatch and in LHR compared to ACRB, Cobb500 and Ross708 at hatch. In addition, IgA expression was increased in all breeds at d 14 post-hatch while pIgR was upregulated (p = 0.02) in Cobb500 and Ross708 compared to ACRB, HH1, LHR and RedBro at hatch.5. The gene expression patterns suggest that selection for growth may have not induced changes in junctional complexes and immune defence genes. However, the results confirmed that the expression of these genes is age dependent.

01 Jul 2024·American heart journal

Different dose aspirin plus immunoglobulin (DAPI) for prevention of coronary artery abnormalities in Kawasaki disease: Study protocol for a multi-center, prospective, randomized, open-label, blinded end-point, non-inferiority trial

Article

Author: Li, Wei ; Zhang, Li ; Wang, Yanfei ; Xie, Xiaofei ; Xia, Shuliang ; Hu, Lin ; Zhang, Xu ; Li, Jianbin ; Wang, Zhouping ; Huang, Ping ; Yuan, Jia ; Wu, Yujian ; Li, Ming ; Li, Fengxiang

BACKGROUND:

Kawasaki disease is a pediatric acute systemic vasculitis that specifically involves the coronary arteries. Timely initiation of immunoglobulin plus aspirin is necessary for diminishing the incidence of coronary artery abnormalities (CAAs). The optimal dose of aspirin, however, remains controversial. The trial aims to evaluate if low-dose aspirin is noninferior to moderate-dose in reducing the risk of CAAs during the initial treatment of Kawasaki disease.

METHODS:

This is a multi-center, prospective, randomized, open-label, blinded endpoint, noninferiority trial to be conducted in China. The planned study duration is from 2023 to 2026. Data will be analyzed according to intention-to-treat principles. Participants are children and adolescents under the age of 18 with Kawasaki disease, recruited from the inpatient units. A sample size of 1,346 participants will provide 80% power with a one-sided significance level of 0.025. Qualifying children will be randomized (1:1) to receive either intravenous immunoglobulin (2 g/kg) plus oral moderate-dose aspirin (30-50 mg·kg^-1·d^-1) until the patient is afebrile for at least 48 hours, or immunoglobulin plus low-dose aspirin (3-5 mg·kg^-1·d^-1) as initial treatment. The primary outcome will be the occurrence of CAAs at 8 weeks after immunoglobulin infusion. Independent blinded pediatric cardiologists will assess the primary endpoint using echocardiography.

CONCLUSIONS:

There is a shortage of consensus on the dose of aspirin therapy for Kawasaki disease due to the lack of evidence. The results of our randomized trial will provide more concrete evidence for the efficacy and adverse events of low- or moderate-dose aspirin in the acute phase of Kawasaki disease.

TRIAL REGISTRATION:

www.chictr.org.cn: ChiCTR2300072686.

09 Apr 2024·Blood advances

Immunoglobulin replacement vs prophylactic antibiotics for hypogammaglobulinemia secondary to hematological malignancy

Article

Author: Trotman, Judith ; McQuilten, Zoe K. ; Dendle, Claire ; Pepperell, Dominic ; Morrissey, C. Orla ; Pullon, Humphrey ; Thao, Le Thi Phuong ; Waters, Neil ; Keegan, Anastazia ; Wellard, Cameron ; Gilbertson, Michael ; van Tonder, Tina ; Weinkove, Robert ; Wood, Erica M. ; Weston, Helen ; Johnston, Anna ; Crispin, Philip ; Degelia, Amber ; Reynolds, John

Abstract:

Immunoglobulin replacement and prophylactic antibiotics are commonly used to prevent infections in patients with secondary hypogammaglobulinemia due to hematological malignancies but have never been directly compared. In this randomized controlled feasibility trial conducted in 7 hospitals in Australia and New Zealand, we enrolled patients with secondary hypogammaglobulinemia with either a history of recurrent/severe infection or an immunoglobulin G level <4 g/L. Participants were randomized in a 1:2 ratio to immunoglobulin (0.4 g/kg per 4 weeks IV) or daily antibiotics (trimethoprim-sulfamethoxazole 160 mg/800 mg or, if contraindicated, 100 mg doxycycline) for 12 months. Participants allocated to antibiotics were allowed to crossover after grade ≥3 infections. The primary outcome was proportion of patients alive on the assigned treatment 12 months after randomization. Between August 2017 and April 2019, 63 patients were randomized: 42 to antibiotics and 21 to immunoglobulin. Proportion of participants alive on allocated treatment at 12 months was 76% in the immunoglobulin and 71% in the antibiotic arm (Fisher exact test P=.77; odds ratio, 0.78; 95% CI, 0.22-2.52). The lower quartile for time to first major infection (median, not reached) was 11.1 months for the immunoglobulin and 9.7 months for the antibiotic arm (log-rank test, P=.65). Three participants in the immunoglobulin and 2 in the antibiotic arm had grade ≥3 treatment-related adverse events. A similar proportion of participants remained on antibiotic prophylaxis at 12 months to those on immunoglobulin, with similar rates of major infections. Our findings support the feasibility of progressing to a phase 3 trial. Trial registration #ACTRN12616001723471.

100 Deals associated with Immunoglobulin(Baxalta Innovations GmbH)

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R&D Status

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


EHA2022	Not Applicable	Multiple Myeloma	2,445	IMMUNOGLOBULIN (Patients who received Ig)	jyobfkslrw(plbwwqyrli) = hymndjogpw bajiwdttrj (rhbxbbtbjy )	-	12 May 2022
				IMMUNOGLOBULIN (Patients who did not receive Ig)	jyobfkslrw(plbwwqyrli) = cipkwzmgcr bajiwdttrj (rhbxbbtbjy )
ASN2021	Not Applicable	Kidney Failure, Chronic	42	Moderna vaccine	tnwdbuzqej(sdmvclwiju) = qekimyhgla pyfdisxrgq (bajnjebnop ) View more	Positive	27 Oct 2021
				Pfizer vaccine	tnwdbuzqej(sdmvclwiju) = axevaszkra pyfdisxrgq (bajnjebnop ) View more
ICD-9 code 323.9 (AAN2019)	Not Applicable	Hashimoto's Encephalitis	-	Intravenous Immunoglobulin (IVIG)	yftlfwvhpm(dqfsclhuwy) = geovxyunum qnjwplbqvj (pzuxvmefrx )	-	09 Apr 2019
				Plasma Exchange (PLEX)	yftlfwvhpm(dqfsclhuwy) = khirlfvwxy qnjwplbqvj (pzuxvmefrx )
P5.044 (AAN2016)	Not Applicable	Polyradiculoneuropathy, Chronic Inflammatory Demyelinating \| Multiple Myeloma	-	IVIG	rdzubclqhn(mpztludvzk) = lddzbvqhmo vxvcfmlmre (saevpwenmp ) View more	-	05 Apr 2016
				Immunoglobulin	rdzubclqhn(mpztludvzk) = pogzcldkrk vxvcfmlmre (saevpwenmp ) View more
NNINDS 1R01NS093653 (ANA2015)	Not Applicable	Small Fiber Neuropathy autoimmunity	30	IVIG 2 grams/kg/4 weeks	skhcykkymf(aauprtkjbg) = vtnqatsbas squiysyvuj (lvlfvdyxal, 2.5)	Positive	25 Sep 2015
SP153 (ERA2015)	Not Applicable	Glomerulonephritis, Membranous IgG \| IgM \| IgA	61	IMMUNOGLOBULIN (rich form LMN)	bkwfozxvll(aulszkarcw) = uzelaiaszd kcblxpgott (jroxhblxwe )	Negative	21 May 2015
				IMMUNOGLOBULIN (poor form LMN)	bkwfozxvll(qtjjssnnmk) = zobgsggdrk pxjennsenz (brspzgfgkb ) View more