Privigen (human immune globulin intravenous 10%) / CSL Behring - LARVOL DELTA

IVIORDEX: IgIV Plus Prednisone vs High-dose Dexamethasone for ITP (clinicaltrials.gov) - P3 | N=272 | Active, not recruiting | Sponsor: Assistance Publique - Hôpitaux de Paris | Recruiting ➔ Active, not recruiting

Enrollment closed • Congestive Heart Failure • Hematological Disorders • Immune Thrombocytopenic Purpura • Thrombocytopenia • Thrombocytopenic Purpura

EMPIRICAL TIME-SERIES ANALYSES IN THE PAST THREE DECADES 1991-2023 FOR IMMUNE THROMBOCYTOPENIA MEDICATIONS IN THE US MEDICAID PROGRAMS (ISPOR 2026) - "Study medications target platelet count restoration and immune system modulation, including thrombopoietin receptor agonists (TPO-RA), such as Nplate (Romiplostim) and Promacta (Eltrombopag), and IV immunoglobulin (e.g., Gammagard) or anti-D immunoglobulin, Rituximab (an anti-CD20 monoclonal antibody), and newer Tyrosine kinase inhibitors...Comparative market-share analyses were also conducted within and across therapeutic classes Utilization trends revealed Rituxan dominated until 2020, after which biosimilars (Ruxience, Truxima) gained traction, with Ruxience leading. In the IVIG category, Gammagard consistently held the highest utilization, peaking in 2022, followed by Rhophylac and Privigen...Pricing data highlighted Promacta as the most expensive TPO-RA, while Panzyga led IVIG pricing by 2019... Analysis highlights evolving patterns in the utilization, reimbursement, and pricing of ITP therapies within Medicaid programs, shaped by factors such as the introduction of..."

Medicaid • Reimbursement • US reimbursement • Hematological Disorders • Immune Thrombocytopenic Purpura • Thrombocytopenia • Thrombocytopenic Purpura

Effects of Various Immunoglobulin Products on Serum (1-3)-β-D-glucan Levels. (PubMed, Transpl Infect Dis) - "Different immunoglobulin products have different effects on serum β-D-glucan levels after IgRT."

Journal • Infectious Disease • Transplantation

Open-label Trial of IVIG in Children With PANS (clinicaltrials.gov) - P2 | N=17 | Completed | Sponsor: Göteborg University | Recruiting ➔ Completed | N=10 ➔ 17 | Trial completion date: Dec 2026 ➔ Oct 2025 | Trial primary completion date: Dec 2026 ➔ Oct 2025

Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Pediatrics • Psychiatry

The CoVIg study: Randomized Open Label Trial Evaluating Efficacy and Safety of Intravenous Immunoglobulin (IVIg, Privigen) as Add-on to SoC Versus SoC Alone for Coronavirus Disease 2019 (COVID-19) in Patients with Severely Impaired B-cell Function (clinicaltrialsregister.eu) - P1/2 | N=92 | Not yet recruiting | Sponsor: Region Vaesterbotten, Umea University

New P1/2 trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

TINISS: Intravenous Immunoglobulins for the Treatment of Primary Sjögren's Syndrome Associated Painful Sensory Neuropathies (clinicaltrials.gov) - P3 | N=24 | Not yet recruiting | Sponsor: University Hospital, Strasbourg, France

New P3 trial • Pain • Sjogren's Syndrome

TINISS: Intravenous Immunoglobulins for the Treatment of Primary Sjögren's Syndrome Associated Painful Sensory Neuropathies (clinicaltrials.gov) - P3 | N=24 | Completed | Sponsor: University Hospital, Strasbourg, France | Recruiting ➔ Completed | Trial completion date: Jul 2026 ➔ Apr 2025 | Trial primary completion date: Dec 2025 ➔ Apr 2025

Trial completion • Trial completion date • Trial primary completion date • Immunology • Pain • Sjogren's Syndrome

TINISS: Intravenous Immunoglobulins for the Treatment of Primary Sjögren's Syndrome Associated Painful Sensory Neuropathies (clinicaltrials.gov) - P3 | N=24 | Recruiting | Sponsor: University Hospital, Strasbourg, France | Trial completion date: Dec 2022 ➔ Jul 2026 | Trial primary completion date: Dec 2022 ➔ Dec 2025

Trial completion date • Trial primary completion date • Pain • Sjogren's Syndrome

TINISS: Intravenous Immunoglobulins for the Treatment of Primary Sjögren's Syndrome Associated Painful Sensory Neuropathies (clinicaltrials.gov) - P3 | N=24 | Recruiting | Sponsor: University Hospital, Strasbourg, France | Trial completion date: Jul 2021 ➔ Dec 2022 | Trial primary completion date: Jun 2021 ➔ Dec 2022

Trial completion date • Trial primary completion date • Pain • Sjogren's Syndrome

TINISS: Intravenous Immunoglobulins for the Treatment of Primary Sjögren's Syndrome Associated Painful Sensory Neuropathies (clinicaltrials.gov) - P3 | N=24 | Recruiting | Sponsor: University Hospital, Strasbourg, France | Trial completion date: Dec 2020 ➔ Jul 2021 | Trial primary completion date: Dec 2020 ➔ Jun 2021

Trial completion date • Trial primary completion date • Pain • Sjogren's Syndrome

TINISS: Intravenous Immunoglobulins for the Treatment of Primary Sjögren's Syndrome Associated Painful Sensory Neuropathies (clinicaltrials.gov) - P3 | N=24 | Recruiting | Sponsor: University Hospital, Strasbourg, France | Not yet recruiting ➔ Recruiting | Initiation date: Jan 2019 ➔ Jun 2019

Enrollment open • Trial initiation date • Pain • Sjogren's Syndrome

A case series on cutaneous reactions to ivig (ASH 2025) - "The rash lacked mucosal involvement and was disseminatedbeyond sun-exposed areas, first appeared two months after commencing IVIg in November 2022.Despite ongoing systemic corticosteroids and withdrawal of other, potential culprit drugs includingvoriconazole and benralizumab, the rash persisted with cyclical flares over 15 months with somecorticosteroid responsiveness...Rechallenge with IVIg (Octogam) later in 2025 resulted in rapidrecurrence of the exanthema, suggesting a likely causative role.Case 2 depicts an 88-year-old male with chronic lymphocytic leukaemia (CLL), receiving zanubrutinibsince October 2023, with significant hypogammaglobulinaemia for which he was initiated on IVIg. Afterthree uneventful infusions of IVIg (Privigen AU) in 2023, he developed a severe, desquamatingerythrodermic rash following the fourth dose...Over a year later, the patient was re-challenged with analternative IVIg product (Octagam)...Nonetheless, further research is crucial touncover..."

Clinical • Asthma • Atopic Dermatitis • Chronic Lymphocytic Leukemia • Dermatology • Dermatopathology • Hematological Malignancies • Immunology • Leukemia • Respiratory Diseases • Steven-Johnson Syndrome

IVIG vs SCIG in CIDP (clinicaltrials.gov) - P1 | N=20 | Recruiting | Sponsor: Rutgers, The State University of New Jersey | Active, not recruiting ➔ Recruiting | Trial completion date: Dec 2025 ➔ Dec 2026 | Trial primary completion date: Dec 2025 ➔ Dec 2026

Enrollment open • Trial completion date • Trial primary completion date • Pain

Intravenous Immunoglobulin and Prednisolone for RPL After ART. (clinicaltrials.gov) - P2 | N=80 | Completed | Sponsor: Aalborg University Hospital | Recruiting ➔ Completed

Trial completion

Unmasking the ABO Antibody Ingredient List in IVIg Preparations (WTC 2025) - "We used a LuminexTM single-antigen bead assay to measure ABO-Ab to A and B subtypes glycans to detect the ABO-Ab in commercially available IVIg products.* Thirteen IVIg lot numbers from six IVIg preparations (Privigen, Cuvirtru, Cutaquig, Hizentra, Octagram, and Gammagard Liquid) were evaluated using LuminexTM beads coupled to individual subtype ABO-A and -B glycans (subtypes I through VI)... It is valuable to know the level of ABO-Ab in IVIg for many reasons. In many clinical scenarios beyond transplantation, these ABO-Ab may cause IVIg-related red cell hemolysis. In the setting of ABO-incompatible transplantation, the presence of passively acquired ABO-Ab may interfere with the measurement of patient ABO-Ab levels pre- and post-transplant."

Hematological Disorders

IVIG With Rituximab vs Rituximab as First Line Treatment of Pemphigus (clinicaltrials.gov) - P2 | N=20 | Active, not recruiting | Sponsor: The University of Hong Kong | Trial completion date: Dec 2025 ➔ Jun 2026 | Trial primary completion date: Dec 2024 ➔ Dec 2025

Trial completion date • Trial primary completion date

Investigation Into the Viscosity of Commercial IVIG Preparations (ISTH 2025) - "Methods Experiments were performed using: ALYGLO™ (immune globulin intravenous, human-stwk 10% liquid), GC Biopharma; OCTAGAM® 10% [immune globulin intravenous (human) 10% liquid], Octapharma; GAMUNEX®-C [immune globulin injection (human), 10% caprylate/chromatography purified], Grifols Therapeutics LLC; PRIVIGEN® [immune globulin intravenous (human), 10% liquid], CSL Behring LLC, and GAMMAGARD LIQUID® [immune globulin infusion (human) 10%], Takeda Pharmaceuticals...Results The results at 25°C were as follows: ALYGLO: 2.506 cP; OCTAGAM: 3.484 cP; GAMUNEX-C: 2.535 cP; PRIVIGEN: 2.698 cP; GAMMAGARD LIQUID: 2.575 cP. For reference, viscosity of human plasma at 25°C generally ranges from 1.5-1.72 cP. Table or Figure Upload"

Cardiovascular • Nephrology • Renal Disease

IVIG Administration: Lessons from Cross-Institutional Protocol Review. (PubMed, Hosp Pharm) - "The most common formulation of IVIG used was Privigen®, followed by Gammagard®...Significant variation in medication selection and standardization was identified in pre-medication practices and management of adverse reactions. This study highlights the variability in IVIG administration protocols and underscores the need for standardized practices to enhance patient safety and treatment efficacy."

Journal • Immunology • Renal Disease

Empirical Time-Series Analysis (1991–2023) of Immune Thrombocytopenia Medications in U.S. Medicaid Programs (ISPOR 2025) - "Comparative market-share analyses were conducted across therapeutic classes to identify key drivers of market changes, including policy shifts, competition, and new drug entries The utilization trends revealed Rituxan dominated until 2020, after biosimilars (Ruxience, Truxima) gained traction, with Ruxience leading. In the IVIG category, Gammagard consistently held the highest utilization, peaking in 2022, followed by Rhophylac and Privigen. Among TPO-RAs, Promacta surpassed Nplate in 2018, reflecting a shift in prescribing patterns. Pricing data highlighted Promacta as the most expensive TPO-RA, Panzyga led IVIG pricing by 2019... This analysis highlights evolving patterns in the utilization, reimbursement, and pricing of ITP therapies within Medicaid programs, shaped by factors like the introduction of biosimilars, competitive market dynamics, and clinical advancements. These findings provide valuable insights for healthcare policymakers, payers, and clinicians to..."

Medicaid • Reimbursement • US reimbursement • Hematological Disorders • Immune Thrombocytopenic Purpura • Thrombocytopenia • Thrombocytopenic Purpura

Investigation into the Viscosity of Commercial IVIG Preparations (CIS 2025) - "Experiments were performed using ALYGLO® [immune globulin intravenous, human-stwk 10% liquid], GC Biopharma; OCTAGAM® 10% [immune globulin intravenous (human) 10% liquid], Octapharma; GAMUNEX®-C [immune globulin injection (human), 10% caprylate/ chromatography purified], Grifols Therapeutics LLC; PRIVIGEN® [immune globulin intravenous (human), 10% liquid], CSL Behring LLC; and GAMMAGARD LIQUID® [immune globulin infusion (human) 10%], Takeda Pharmaceuticals...The results at 25° C were as follows: ALYGLO: 2.506 cP; OCTAGAM: 3.484 cP; GAMUNEX-C: 2.535 cP; PRIVIGEN: 2.698 cP; and GAMMAGARD LIQUID: 2.575 cP...All products showed consistent, sequential decreases in viscosity as temperatures increased, suggesting that IVIG infusions at room temperature (25°C) may be a safety consideration for the prevention of TEEs. These preliminary results warrant further investigation to identify potential differences in the viscosities of commercially..."

Cardiovascular • Nephrology • Renal Disease

A Phase 2 randomised trial of safety and pharmacokinetics of IgPro20 and IgPro10 in patients with diffuse cutaneous systemic sclerosis. (PubMed, Rheumatology (Oxford)) - P2 | "This study shows that in patients with dcSSc, safety, pharmacokinetic and bioavailability profiles of IgPro20, and safety and pharmacokinetics of IgPro10, are similar to those observed in other approved indications."

Journal • P2 data • PK/PD data • Immunology • Scleroderma • Systemic Sclerosis

IVIG Vs SCIG in CIDP (clinicaltrials.gov) - P1 | N=20 | Active, not recruiting | Sponsor: Rutgers, The State University of New Jersey | Recruiting ➔ Active, not recruiting | Trial completion date: Oct 2024 ➔ Dec 2025 | Trial primary completion date: Oct 2024 ➔ Dec 2025

Enrollment closed • Trial completion date • Trial primary completion date • Pain

Open-label Trial of IVIG in Children With PANS (clinicaltrials.gov) - P2 | N=10 | Recruiting | Sponsor: Göteborg University | Trial completion date: Dec 2023 ➔ Dec 2026 | Trial primary completion date: Dec 2023 ➔ Dec 2026

Trial completion date • Trial primary completion date • Pediatrics • Psychiatry

Indirect Treatment Comparison of Efgartigimod vs Immunoglobulins in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) (ISPOR-EU 2024) - "Among the studies that met the predefined criteria, an ITC was considered feasible against Privigen, Hizentra, and HyQvia. Despite the limitations of the analysis and the limited comparability of the studies, the ITC results indicate that efgartigimod has a comparable or better efficacy profile than EMA-approved immunoglobulins. Further prospective comparative studies are needed to confirm these results."

Pain

AN UNUSUAL REACTION TO HIZENTRA (SUBCUTANEOUS IMMUNE GLOBULIN (HUMAN) 20% LIQUID) (ACAAI 2024) - "Case Description: A 71-year-old female with Myasthenia Gravis on weekly 60 mg infusions of Immune Globulin Subcutaneous (Human) 20% Liquid started 2 years prior, Parkinson's Disease on Carbidopa/ Levodopa, and history of remote stress-induced urticaria, presented with 6 months of recurring, pruritic, erythematous urticarial rash on her arms and torso appearing within hours of infusions. Hizentra is a 20% solution that contains L-proline and polysorbate 80 whereas Privigen is a 10% solution with L-proline, and both have very low IgA content, <50 mcg/mL and <25 mcg/mL respectively. Urticarial Reaction to Subcutaneous Immune Globulin These recurring, pruritic, erythematous urticarial lesions were present on the arms and torso within hours of subcutaneous immune globulin infusion."

CNS Disorders • Dermatology • Immunology • Infectious Disease • Movement Disorders • Myasthenia Gravis • Novel Coronavirus Disease • Parkinson's Disease • Respiratory Diseases • Urticaria