Gammaplex (intravenous normal human immunoglobulin) / Bio Products Lab - LARVOL DELTA

Measles neutralising antibody levels in patients receiving intravenous immunoglobulin treatment - a sub-analysis of a randomized, cross-over bioequivalence trial. (PubMed, PLoS One) - P3 | "Levels of measles neutralising antibodies in the 5% and 10% formulations of this intravenous immunoglobulin product provided protective antibodies well above accepted thresholds and were similar in adult and paediatric patients across both 21-day and 28-day dosing regimens. Switching between Gammaplex products did not affect antibody levels."

Clinical • Journal • Immunology • Infectious Disease • Measles • Pediatrics • Primary Immunodeficiency

Impact of plasma collection date on antibodies to SARS-CoV-2 inintravenous immunoglobulin (CIS 2024) - "SARS-CoV-2 antibodies in Gammaplex expressed as IU/mg IgG versus proportion of donations collected post May 2020.The timing of the pandemic and the detection of widespread stableantibody levels in intravenous immunoglobulin products has implicationsfor future pandemics and for the level of protection afforded to immunedeficient patients. Ensuring measures are in place to allow safe plasmacollection and processing from the start of a pandemic allows IVIG batchescontaining protective antibodies to be made available to immune-deficientpatients as soon as possible."

Immunology • Infectious Disease • Novel Coronavirus Disease • Primary Immunodeficiency • Respiratory Diseases

Analysis of trough levels of total IgG, IgG subclasses, measles neutralizing antibodies and IgG antibodies to encapsulated pathogens after infusion of a 5% or 10% intravenous immunoglobulin (CIS 2023) - "Methods GMX07 was a bioequivalence trial comparing Gammaplex 10% IVIG with Gammaplex 5% IVIG in patients with PI...While thresholds for protective levels for H. influenzae or S. pneumoniae are not clearly defined, delivery of these antibodies to PI patients was demonstrated. Conclusion Our results indicate protective trough levels of IgG and antibody titers are delivered with the 5% and 10% formulations of this IVIG product, with similar results for adult and pediatric PI patients."

Immunology • Infectious Disease • Influenza • Measles • Pediatrics • Pneumococcal Infections • Pneumonia • Primary Immunodeficiency • Respiratory Diseases

Low rates of headache and migraine associated with intravenous immunoglobulin infusion using a 15-minute rate escalation protocol in 123 patients with primary immunodeficiency. (PubMed, Front Immunol) - P3, P4 | "We analyzed headache and migraine in pooled data from three pivotal trials of Gammaplex 5% and 10% in PI (NCT00278954 from January 18, 2006; NCT01289847 from January 27, 2011; NCT01963143 from September 13, 2013)...Rates decreased after the first few infusions. Patients receiving this IVIG product on a 15-minute rate escalation protocol had low rates of headache and migraine for both the 5% and 10% formulations."

Journal • CNS Disorders • Immunology • Migraine • Pain • Pediatrics • Primary Immunodeficiency

Reduction of Infusion Time Using a 10% Intravenous Immunoglobulin Formulation With a 15-Minute Rate Escalation Protocol During Staffing Shortages Due to COVID-19. (PubMed, J Infus Nurs) - "The authors conducted a retrospective database analysis that identified 23 patients receiving IVIg before transitioning to a 10% IVIg product with a 15-minute rate escalation protocol (Gammaplex 10% IVIg) and evaluated the total infusion time before and after the transition...Nurse education on IVIg rate escalation may facilitate faster achievement of the maximum safe infusion rate and reduce infusion times. A trial transition to this 10% IVIg product with a 15-minute rate escalation protocol may also reduce infusion times."

Journal • Infectious Disease • Novel Coronavirus Disease

Pooled Analysis of Headache and Migraine Incidence in Gammaplex 5% and 10% in Patients with Primary Immunodeficiency (EAC 2022) - "Adverse events such as headache and migraine have been reported with IVIG and in some cases may be related to infusion rate, a key determinant of overall infusion time for IVIG. Analyses of the occurrence of headache and migraine showed consistently low rates when compared by gender, age ranges, and percent achieving maximum infusion rate. Both the 5% and 10% formulations of this IVIG product were associated with a low rate of headache and migraine across various points of comparison in patients with PI when utilizing a 15- minute ramp-up infusion protocol."

Retrospective data • CNS Disorders • Immunology • Migraine • Pain • Pediatrics • Primary Immunodeficiency

ACUTE KIDNEY INJURY POST IVIG TREATMENT IN A PATIENT WITH HYPOGAMMAGLOBULINEMIA: SOMETIMES LESS IS MORE (ACAAI 2021) - "She was started by her local oncologist on Gammaplex 10%, a non-sucrose formulation, at 400mg/kg, 35 g every 3 weeks...Clinicians must be aware of the potential nephrotoxicity, which maybe irreversible. Especially in those with risk factors, in whom a clear indication is not present."

Clinical • Acute Kidney Injury • Breast Cancer • Diabetes • Diabetic Nephropathy • Immunology • Infectious Disease • Metabolic Disorders • Nephrology • Oncology • Otorhinolaryngology • Pneumococcal Infections • Pneumonia • Pulmonary Disease • Renal Disease • Respiratory Diseases • Sinusitis • Solid Tumor • Tetanus

[VIRTUAL] Reduction of Infusion Time Using a 10% Immunoglobulin Product During Staffing Shortages Due to COVID-19 (CIS 2021) - "Customized reports identified patients receiving Gammaplex 10% after previously receiving other Ig products... The home environment is an important site of care to help reduce the risk of exposure to COVID-19, especially for those with immunodeficiencies and receiving Ig infusions. Using a 10% Ig product with a 15-minute titration protocol with a shorter infusion time is one strategy to help reduce the amount of time a visiting nurse spends with a patient and allows greater flexibility with nursing scheduling."

Fatigue • Immunology • Infectious Disease • Novel Coronavirus Disease • Pain • Respiratory Diseases

SCIG03: Pharmacokinetics (PK) and Safety of Subgam-VF in Primary Immunodeficiency Diseases (clinicaltrials.gov) - P3; N=38; Active, not recruiting; Sponsor: Bio Products Laboratory; Recruiting ➔ Active, not recruiting; N=50 ➔ 38

Enrollment change • Enrollment closed • Biosimilar • Immunology

A Study to Find Out How Safe and Effective Gammaplex® is in Young People With Primary Immunodeficiency (clinicaltrials.gov) - P4; N=25; Completed; Sponsor: Bio Products Laboratory; Active, not recruiting -> Completed

Trial completion • Biosimilar • Immunology • Renal Cell Carcinoma

A Study of Tolerability, Satisfaction, and Cost Reduction Using a 10% Immunoglobulin Product at Higher Administration Rates. (PubMed, J Infus Nurs) - "Infusions were estimated to be 2.4 hours shorter than previously administered intravenous immunoglobulin infusions, saving $151.61 per visit in nursing costs. Rapid infusion of Gammaplex 10% was found to be a safe option to reduce the costs of intravenous immunoglobulin treatment while maintaining patient satisfaction."

Journal

Two comparative assessments of intravenous immunoglobulin therapy switching patterns in the treatment of chronic inflammatory demyelinating polyneuropathy in the US. (PubMed, Patient Prefer Adherence) - "In both studies, switching rates were lowest for IVIG-G (Gamunex®-C) (Study 1: 9.8%, Study 2: 8.9%), followed by IVIG-F (Flebogamma®) (Study 1: 25.0%, Study 2: 18.2%), and highest for IVIG-other (Octagam®/Gammaplex®) (Study 1: 50.0%, Study 2: 33.3%). However, differences existed in switch rates for different IVIG products. The reason for low switching rates could not be assessed in this study; therefore, further studies are required to detect possible relevant differences in effectiveness and tolerability."

Journal

Monitoring of 5% Treatment Naïve Intravenous Immunoglobulin (IVIg) Primary Immunodeficiency Disease (PIDD) Patients Using the CareExchange® System: A Pilot Study Using 5% Gammaplex® IVIg in the Home Setting (clinicaltrials.gov) - P=N/A; N=20; Active, not recruiting; Sponsor: AxelaCare Health Solutions, LLC; Trial completion date: Jun 2018 ➔ Jun 2020; Trial primary completion date: Jun 2018 ➔ Jun 2020

Clinical • Trial completion date • Trial primary completion date