Use Of Immune Globulin Research Articles

Epidemiology of rabies immune globulin use in paediatric and adult patients in the USA: a cross-sectional prevalence study

ObjectivesTo compare the epidemiology of paediatric and adult patients receiving rabies immune globulin (RIG).DesignCross-sectional prevalence study.SettingEligible participants from the Symphony Integrated Dataverse presenting between 2013 and 2019.ParticipantsAll adult and paediatric...

Use of Immune Globulin Manufactured from a Blended Plasma Pool of High-Titer RSV and Normal Source Plasma in an Adult with Severe ARDS COVID-19: Case Report

Use of Immune Globulin Manufactured from a Blended Plasma Pool of High-Titer RSV and Normal Source Plasma in an Adult with Severe ARDS COVID-19: Case Report

PND27 Cost-of-Illness for Adults with Generalized Myasthenia Gravis in the US

Generalized myasthenia gravis (gMG) is an antibody-mediated disorder that interferes with the function of acetylcholine receptors important to muscle contraction. While crises are high-cost events, there is limited published evidence for associated costs and healthcare resource utilization (HRU) for the US. Evaluate direct costs in adults with gMG (including crisis events) using administrative claims data. Adults with ≥1 diagnostic claim were identified from Symphony Health’s Integrated Dataverse® (January 1, 2014 - December 31, 2019)of pharmaceutical and medical claims. Twelve-month costs were evaluated from an index date (first claim from 2018 to 2019), and included gMG therapies such as acetylcholinesterase inhibitors, corticosteroids, NSISTs, immune-globulins, rituximab and eculizumab. Costs were also assessed three years before, during, and one-year following crisis. A systematic literature review and clinical expert interviews informed and validated the study design. Of the overall population (N=42 114), 12 884 (30.6%) and 240 (0.57%) were identified as newly diagnosed (incident) and crisis subgroups, respectively. Incident patients incurred higher mean costs compared to non-incident patients ($28 414 vs $17 270) and were more likely to receive steroids (61.8% vs 54.1%) and acetylcholinesterase inhibitors (72.6% vs 65.6%). While few incident (11.3%) and non-incident (11.7%) patients received immune globulins, these therapies formed 77.1% and 79.6% of mean gMG drug costs. Costs were higher 12 months prior to a crisis compared to 12 to 36 months prior. The 12-month period following a crisis event was also associated with high costs. Beyond costs associated directly with crisis, use of immune-globulins, newly diagnosed status and the year prior to and following a crisis are a significant contributor to direct costs in adults with gMG in the US.

Hypogammaglobulinemia during Rituximab Maintenance after Transplantation Is a Surrogate Marker for Disease Control in Patients with Mantle-Cell Lymphoma, an Analysis from the LyMa Trial

Hypogammaglobulinemia during Rituximab Maintenance after Transplantation Is a Surrogate Marker for Disease Control in Patients with Mantle-Cell Lymphoma, an Analysis from the LyMa Trial

Congenital Cytomegalovirus-History, Current Practice, and Future Opportunities.

Cytomegalovirus (CMV) was first identified in the 1950s and noted to cause newborn disease in the 1960s. It is now known to be the most common cause of congenital infection in the world, leading to various central nervous system sequelae, the most common being hearing loss. Cytomegalovirus is a ubiquitous pathogen that affects nearly 30,000 infants annually in the United States, leading to 3,000-4,000 cases of hearing loss. Prevention through vaccination has proved unreliable, as has the use of immune globulin. Prevention through education has been shown to be the most effective method of minimizing infection. Antiviral therapy is effective at reducing the impact of infection on newborns. Continued global efforts will hopefully provide more solutions for this opportunistic infection.

Optimization of intravenous immune globulin use at a comprehensive cancer center

Intravenous immune globulin (IVIG) is a high-cost medication used in a diverse range of settings. At many institutions, IVIG is dosed using total body weight (TBW). Recent evidence suggests that alternative dosing weights reduce waste without compromising clinical outcomes. The objective of this study was to quantify the waste reduction potential generated through the use of alternative IVIG dosing weights. We performed a retrospective analysis of all IVIG doses administered from January 2011 through January 2016 to adults (≥18 years). TBW and height at the time of administration were used to calculate prescribed dose (g/kg), ideal body weight (IBW), and adjusted body weight (AdjBW). Three dosing methods were analyzed, as follows: use of AdjBW if TBW is >120% IBW (method 1), AdjBW for all doses (method 2), and IBW for all doses (method 3). Outcomes included potential IVIG use averted, direct drug cost savings, and reductions in outpatient infusion times for each method. A total of 9,918 doses were administered to 2,564 patients over 5 years, representing an average usage of 75,994 g/year. If dosing methods 1, 2, and 3 had been used, the annual use of IVIG would have decreased by 21.9% (16,658 g/year, p < 0.001), 24.2% (18,371 g/year, p < 0.001), and 35.9% (27,252 g/year, p < 0.001), respectively. This translates into average annual cost differences of $2.37 million, $2.62 million, and $3.89 million and average annual outpatient infusion time savings of 841 hours, 920 hours, and 1,366 hours, respectively. IVIG dosing optimization through use of alternative dosing weights represents a significant source of waste reduction and cost reduction.

Annals for Educators - 18 July 2017

Annals for Educators - 18 July 2017

Subcutaneous Use of Immune Globulin in Patients with Primary Immune Deficiency: A Retrospective Claims Database Analysis

Subcutaneous Use of Immune Globulin in Patients with Primary Immune Deficiency: A Retrospective Claims Database Analysis

Immune Globulin for Patients with Primary Immune Deficiency: An Evidence Based Practice Guideline

Background: The original use of immune globulin (IG) was for replacement in patients with primary immune deficiency (PID). The evidence supporting this stems from the 19650s; however there have not been any rigorously developed evidence based clinical practice guidelines (CPGs) for the use of IG for PID. In 2007, Canadian Blood Services and the National Advisory Committee on Blood and Blood Products in Canada convened a panel of Canadian immunologists and a methodologist to develop a CPG for the use of IG in patients with PID. The objectives of this guideline areto examine the evidence for the use of IG in patients who have PID andto provide guidance for practitioners involved in the care of PID patients and transfusion medicine specialists on the use of IG.Methods: The panel identified key clinical questions and a systematic, expert and bibliography literature search up to July 2008 was conducted to ensure all relevant publications were included. The panel generated recommendations based on the evidence. The levels of evidence and grading of recommendations were adapted from the Canadian Task Force on Preventative Health Care. To validate conclusions and recommendations, the practice guideline will be sent to immunologists internationally and to a patient representative in September 2008. The guideline will be disseminated to all immunologists, internists and pediatricians in Canada to aid implementation of the guideline. The National Advisory Committee of Blood and Blood Products in Canada will assess the performance of the guideline and will renew the guideline at timely intervals.Results and Conclusions: The panel identified the following key clinical questions:what is the prevalence of the PIDs that require IG;does treatment with IG improve morbidity and mortality; andwhat criteria should be used to monitor the effectiveness of IVIG.The literature search was conducted in August 2007 and updated to July 2008. 1087 citations were reviewed. 101 reports, 1 systematic review and 3 consensus documents/guidelines were included. Current estimates suggest PID is under-diagnosed. Although more than 75% of patients require IG at some point in their treatment, the actual incidence of requiring IG is unknown. There is ample evidence that IG reduces infections, hospitalization and days lost from work/school. There is some evidence to suggest that IG may ameliorate chronic illnesses in patients with PID however, there is no data of the effect of IG on malignancy and insufficient data on the effect of IG on autoimmune disease in this patient population to make a recommendation. Quality of life (QoL) has not been adequately assessed in the literature; however the reduction in infections and hospitalizations likely translates to an improved QoL. Although, there is no evidence to suggest clinical superiority of one IVIG formulation over another, for patients with autoimmune manifestations and PID, there is insufficient evidence that subcutaneous IG is equivalent to IVIG. The vaccination of these patients is an evolving field. Due to the complex nature of the management of patients with PID, the panel recommended assessment by an immunologist prior to the initiation of IG and monitoring by a comprehensive care clinic. Clinical outcomes such as frequency of infections, hospitalization, days missed from school/work should be used to monitor the effectiveness of IVIG. Specific recommendations for dosing and interval of IG therapy were made within the guideline based on the literature The development of a national registry for patients with primary immune deficiency, and the development of a surveillance system for adverse events from IG particularly infections were considered priorities for future development.

Hepatitis A

Hepatitis A infection is typically transmitted by the fecal-oral route. Symptomatic infection is highly dependent on the age of the patient and usually follows a self-limited course. Once diagnosed, clinical and biochemical follow-up in the outpatient setting is generally appropriate. Treatment aims are to achieve symptomatic relief and to maintain adequate hydration and caloric intake. In patients with more severe disease, hospitalization may be needed to accomplish aggressive symptomatic therapy and close monitoring of liver function tests and mental status. Prompt evaluation for liver transplantation is appropriate in the rare case where fulminant liver failure develops. Given the absence of specific therapy for hepatitis A virus infection, the most important health care intervention is prevention of infection and/or transmission, which can be accomplished with the safe and effective use of immune globulin and commercially available vaccines.

Effectiveness of immune globulins in preventing infectious hepatitis and hepatitis A: a systematic review

Objective. To assess the effectiveness and safety of immune globulins in preventing infectious hepatitis and hepatitis A. Study design. Systematic review with meta-analysis. Data sources. We searched the Cochrane Library, MEDLINE, EMBASE, Biological Abstracts and Science Citation Index to December 2002. Vaccine manufacturers were contacted for additional data. Review methods. We included randomised controlled trials comparing effectiveness of hepatitis A immune globulins with no intervention or placebo, and carried out a meta-analysis. Results. We included six studies (two in Russian). Tested immune globulins show higher effectiveness than placebo or do-nothing against infectious hepatitis both in primary prevention and in prevention after exposure (effectiveness 83%; RR: 0.17; 95% CI: 0.15–0.19; and effectiveness 69%; RR: 0.31; 95% CI: 0.20–0.47, respectively). We found considerable heterogeneity among studies, possibly due to different methodology, background rates of disease and immune globulins dosage and concentrations. No safety data were reported in the studies. Conclusions. Immune globulins are efficacious in preventing infectious hepatitis and hepatitis A, but included studies do not report data about their safety. Average length of passive protection was three months. Given the notable heterogeneity of performance of immune globulins, short protection conferred and absence of trial safety data, the only indications for the use of immune globulins may be in situations in which inadequate supplies of vaccine are available or when the eight-day window of opportunity for vaccine use is past.

Antibody treatment of lower respiratory tract infections.

Antibody treatment of lower respiratory infection has a long history of success and is receiving renewed interest. A variety of polyclonal and monoclonal preparations are clinically available. Although used primarily for infection prophylaxis, these agents have limited applications in the treatment of established infections. Immune serum was the first effective treatment for pneumococcal pneumonia. Although long-supplanted by the advent of antibiotics, passive immunotherapy for pneumococcal and other infections is being revisited in an era of increasing antibiotic resistance and growing numbers of immunocompromised individuals. Limited clinical evidence supports the use of immune globulins in the treatment of pertussis and severe streptococcal infection. Bone marrow transplant recipients with lower respiratory infections caused by cytomegalovirus or respiratory syncytial virus also may benefit by adjunctive treatment with immune globulins. Additional indications for antibody treatment of respiratory infection may develop with further investigation.

Respiratory Syncytial Virus Activity--United States, 1999-2000 Season

Respiratory syncytial virus (RSV) has a worldwide distribution and can cause serious lower respiratory tract illness (LRTI). RSV is most commonly considered a pathogen among infants and young children; however, it can cause serious LRTI throughout life, especially among those with compromised respiratory, cardiac, or immune systems and the elderly. In temperate climates, RSV infections occur primarily during annual outbreaks, which peak during winter months. In the United States, RSV activity is monitored by the National Respiratory and Enteric Virus Surveillance System (NREVSS), a laboratory-based surveillance system. This report summarizes trends in RSV activity reported to NREVSS during July 2000-June 2001 and presents preliminary surveillance data from the weeks ending July 7 through December 8, 2001, indicating the onset of the 2001-02 RSV season. Health-care providers should consider RSV in the differential diagnosis of lower respiratory tract disease in persons of all ages, use isolation procedures to prevent nosocomial transmission, and consider use of immune globulin or monoclonal antibody prophylaxis in premature infants or infants and children with chronic lung disease.

Genetic variations of hepatitis B virus.

The emergence of hepatitis B virus genetic variants occurs under the influence of host immunity, immunization, the use of immune globulin or antiviral chemotherapy. Most of these are probably the result of the 'immune escape' phenomenon. Some variants, in particular those in the precore and core promoter regions, have been associated with disease severity and progression. Surface antigen variants have implications for the accuracy of laboratory diagnosis and may reduce the effectiveness of vaccination. Polymerase variants are selected as a result of the use of antiviral chemotherapeutic agents. It is important to monitor the occurrence of these variants.

Use of immune globulin to prevent symptomatic cytomegalovirus disease in transplant recipients ‐ A meta‐analysis

Use of immune globulin to prevent symptomatic cytomegalovirus disease in transplant recipients ‐ A meta‐analysis

Use of immune globulin to prevent symptomatic cytomegalovirus disease in transplant recipients ‐ A meta‐analysis

Use of immune globulin to prevent symptomatic cytomegalovirus disease in transplant recipients ‐ A meta‐analysis

AAP advises on timing of measles vaccination after immune globulin use

Journal Article AAP advises on timing of measles vaccination after immune globulin use Get access American Journal of Hospital Pharmacy, Volume 51, Issue 13, 1 July 1994, Page 1600, https://doi.org/10.1093/ajhp/51.13.1600 Published: 01 July 1994

Recommended Timing of Routine Measles Immunization for Children Who Have Recently Received Immune Globulin Preparations

Passively acquired antibody can block replication of live viral vaccines and subsequent active immune responses.1-3 The persistence of transplacentally acquired maternal measles antibodies can interfere with the response to measles vaccine in some infants up to 12 months of age.4,5 Simultaneous or prior administration of immune globulin administered through the intramuscular or intravenous route has a similar blunting or blocking effect on the host response to certain live virus vaccines.1,6,7 The American Academy of Pediatrics previously recommended a 3-month interval after administration of immune globulin before parenteral administration of live viral vaccines, including measles, mumps, and rubella vaccines (MMR). This recommendation was based on the half-life of passively administered immune globulin and data from individuals who received low doses of immune globulin.2 However, immune globulin is now used in larger doses for treatment or prevention of several diseases, 8 necessitating a lengthening in the interval between use of immune globulin and the administration of certain live virus vaccines. INTERFERENCE WITH MEASLES IMMUNIZATION In a recent study high doses of immune globulin interfered with the response to measles immunization for more than 3 months.1 Children who received bacterial polysaccharide immune globulin (BPIG), a product under clinical evaluation, in a dose of 0.5 mL/kg (80 mg of IgG per kilogram) intramuscularly had reduced measles antibody response when measles vaccine was given as long as 5 months after administration of BPIG (Figure). The measles antibody concentrations (pen gram of protein) in BPIG were similar to concentrations found in preparations of immune globulin (IG) for intramuscular administration, specific immune globulin preparations (eg, VZIG, HBIG, and TIG), and immune globulin for intravenous administration (IGIV).

Testing for Antibody to Hepatitis A to Decrease the Cost of Hepatitis A Prophylaxis With Immune Globulin or Hepatitis A Vaccines

The introduction of new vaccines to prevent hepatitis A infection raises the question of the cost of these vaccines relative to immune globulin when short-term protection against hepatitis A is required. Since the prevalence of hepatitis A antibodies (anti-HAV) in the US population increases rapidly with age, testing for anti-HAV may decrease the cost of vaccination programs. A cost-analysis model was developed that incorporates the cost of immune globulin or hepatitis A vaccine, the number of doses of vaccine, the cost of testing for anti-HAV in either commercial or public-sector laboratories, and the prevalence of anti-HAV in the general population by age. In comparison with hepatitis A vaccines, with expected costs between $10 and $25 per dose, use of immune globulin for postexposure prophylaxis or preexposure short-term (< or = 6 months) prophylaxis is much less expensive for all age groups. Testing for anti-HAV does not significantly diminish the cost of immune globulin regimens. In contrast, if anti-HAV testing is performed in a public-sector laboratory at $10 per test, and hepatitis A vaccine costs $10 per dose, testing reduces vaccination costs in those 40 years of age or older for a two-dose vaccine regimen and in those 30 years of age or older for a three-dose regimen. At the other end of the spectrum, if vaccine costs $35 per dose, commercial testing for anti-HAV at $25 per person reduces the costs in those 30 years of age or older if either a two- or three-dose regimen is elected. However, vaccine savings are realized in those 10 years and older if public-sector testing is performed and three doses of vaccine at $35 per dose are utilized. In an intermediate scenario of public-sector testing and vaccines costing $25 per dose, the cost would also be reduced in those 30 years old or older. Testing for anti-HAV in frequent travelers, international government, business, and volunteer workers, military personnel, etc, may be an effective means of decreasing costs of hepatitis A prevention.

Immune globulin use at a multihospital medical center

Use of i.v. immune globulin (IVIG) at four hospitals was audited to evaluate the need for therapeutic protocols and identify strategies for reducing drug expenditures. Charts and nursing notes for patients who received IVIG over a six-month period were reviewed retrospectively to obtain the following data: patient demographics, indication for IVIG use, product used, amount administered, and adverse reactions. Indications were categorized as to whether they are included in FDA-approved labeling, recognized in national guidelines, documented in published studies, or not documented. Expenditures were calculated from acquisition costs. At the first hospital (which offers oncology and other specialty services for adult patients), 71 patients received IVIG for 15 indications, with 89.5% of the orders for unlabeled uses. Of all grams reconstituted, 17.8% were wasted. The rate of documented adverse reactions was 11.3%. At the second, a pediatric hospital, 34 patients received IVIG for six indications, with 65% of the orders for unlabeled uses. Of all grams reconstituted, 13% were wasted. At the third hospital (which specializes in emergency trauma and critical care medicine), two patients received IVIG for a labeled indication. At the fourth (a maternity hospital), no patients received IVIG. Three of four hospitals used IVIG during a six-month audit period. In most instances, the drug was used for indications not included in FDA-approved labeling. Audit information may be useful in creating guidelines for appropriate use of IVIG.