Intratect (intravenous normal human immunoglobulin) / ADMA Biologics - LARVOL DELTA

IVIG and Rituximab in Antibody-associated Psychosis - SINAPPS2 (clinicaltrials.gov) - P2 | N=70 | Recruiting | Sponsor: University of Cambridge | Trial completion date: Mar 2026 ➔ Mar 2027 | Trial primary completion date: Mar 2026 ➔ Mar 2027

Trial completion date • Trial primary completion date • CNS Disorders • Immunology • Psychiatry

Adequate IVIG dosing is associated with an improved long-term outcome in secondary immunodeficiency: A prospective, non-interventional study. (PubMed, Int J Clin Pharmacol Ther) - "Effectiveness, safety, and quality of life confirmed the positive benefit-risk profile of IgRT. Higher IVIG dosages per body weight led to higher IgG plasma trough levels, in turn leading to reduced infection rates. Obese patients may need body-weight-adjusted treatment to reduce the risk of infection."

Journal • Observational data • Hematological Disorders • Immunology • Infectious Disease • Obesity • Primary Immunodeficiency • Thrombocytopenia • Thrombocytopenic Purpura

IVIG and Rituximab in Antibody-associated Psychosis - SINAPPS2 (clinicaltrials.gov) - P2 | N=70 | Recruiting | Sponsor: University of Cambridge | Trial completion date: Mar 2024 ➔ Mar 2026 | Trial primary completion date: Oct 2023 ➔ Mar 2026

Trial completion date • Trial primary completion date • CNS Disorders • Immunology • Psychiatry

Benefits of immunoglobulin substitution in primary and secondary immunodeficiencies: Interim analysis of a prospective, long-term non-interventional study. (PubMed, Int J Clin Pharmacol Ther) - "Effectiveness, safety, patient satisfaction, and QoL were good, confirming the positive benefit-risk profile of the IVIG."

Clinical • Journal • Observational data • Hematological Disorders • Immunology • Thrombocytopenia • Thrombocytopenic Purpura

Anti-SARS-CoV-2 Antibodies Within IVIg Preparations: Cross-Reactivities With Seasonal Coronaviruses, Natural Autoimmunity, and Therapeutic Implications. (PubMed, Front Immunol) - " 13 samples from 5 commercial IVIg preparations from pre-pandemic donors (HyQvia (Baxalta Innovations GmbH); Privigen (CSL Behring); Intratect (Biotest AG); IgVena (Kedrion S.p.A); and Flebogamma (Grifols S.A.) were blindly screened using a semi-quantitative FDA-approved and validated enzyme-linked immunosorbent assay (ELISA) (Euroimmun, Lubeck, Germany)... Pre-pandemic IVIg donors have either natural autoantibodies or pre-pandemic cross-reactive antibodies against antigenic protein fragments conserved among the "common cold" - related coronaviruses. The findings are important in: (a) assessing true anti-SARS-CoV-2-IgG seroprevalence avoiding false positivity in IVIg-receiving patients; (b) exploring potential protective benefits in patients with immune-mediated conditions and immunodeficiencies receiving acute or chronic maintenance IVIg therapy, and (c) validating data from a recent controlled study that showed significantly lower in-hospital mortality in the..."

Journal • Immunology • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

IVIG and Rituximab in Antibody-associated Psychosis - SINAPPS2 (clinicaltrials.gov) - P2; N=80; Recruiting; Sponsor: University of Cambridge; Trial completion date: Dec 2021 ➔ Mar 2024; Trial primary completion date: Dec 2020 ➔ Oct 2023

Clinical • Trial completion date • Trial primary completion date • CNS Disorders • Immunology • Psychiatry

[VIRTUAL] SUCCESSFUL COMBINED IMMUNE-MODULATING THERAPY OF IN UTERO MYOCARDITIS AS THE MANIFESTATION OF NEONATAL LUPUS IN A RO/SS-A ANTIBODY EXPOSED NEWBORN (EULAR 2020) - "Mother received azathioprine and chloroquine from the beginning of pregnancy and dexamethasone from the 16th weeks of gestation...Intratect was given every 2nd week... Neonatal lupus with various cardiac manifestations may develop in anti-SS-A antibody exposed babies. Therefore, these pregnancies require stringent gynaecologic and cardiologic controls. Although congenital heart block is the most frequent complication developing between the 18-28 th gestational weeks, other manifestations also may occur."

Cardiovascular • Complement-mediated Rare Disorders • Fibrosis • Immune Modulation • Immunology • Inflammation • Lupus • Sjogren's Syndrome