Gammagard Liquid (human normal immunoglobulin 10%) / Takeda - LARVOL DELTA

The Results of ADVANCE-CIDP IVIG Trial: Intravenous Immunoglobulin 10% Therapy With GAMMAGARD LIQUID/Kiovig for Treatment of Relapse in Chronic Inflammatory Demyelinating Polyradiculoneuropathy. (PubMed, Eur J Neurol) - "IVIG 10% effectively treated CIDP relapse and improved functional abilities."

Clinical • Journal • Pain

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

A Comparative Real-World Study Evaluating the Safety of Immune Globulin Infusion (Human) 10% Solution and Other Intravenous Immunoglobulin Therapies for the Treatment of Chronic Inflammatory Demyelinating Polyradiculoneuropathy. (PubMed, Pharmacoepidemiol Drug Saf) - "Thrombotic events, AKI, and hemolytic events were rare among patients with CIDP receiving IVIG. There were no consistently different outcome risks between patients receiving GGL versus other IVIGs with US approval for CIDP."

Clinical • Journal • Real-world evidence • Acute Kidney Injury • Nephrology • Pain • Renal Disease

WHEN A FRIEND BECOMES A FOE − CIRCUMVENTING IVIG REACTIONS (ACAAI 2024) - "Case Description: A 72-year-old Caucasian male with neuromyelitis optica presented with suspected IVIG reaction used for secondary hypogammaglobulinemia due to rituximab...He was treated with steroid taper and cetirizine. Cefdinir and home allopurinol were discontinued...Ig replacement therapy was discontinued and he was diagnosed with drug-induced psoriasis requiring 6-month treatment of apremilast and phototherapy with subsequent resolution...Our case emphasizes potential severe cutaneous adverse effects from IVIG where alternative options are clinically warranted. Generalized peeling and scaling of the skin"

Asthma • Atopic Dermatitis • CNS Disorders • Dermatitis • Dermatology • Immunology • Infectious Disease • Neuromyelitis Optica Spectrum Disorder • Psoriasis • Rare Diseases • Respiratory Diseases • Urticaria

GOING BEYOND ANCHOR BIAS: MIXED FUNGAL INFECTIONS AS A CAUSE OF NONRESOLVING PNEUMONIA (CHEST 2024) - "CASE PRESENTATION: We present a case of 62 a year-old male with a history of HTN, DM, Gout, and Chronic lymphocytic leukemia onvenclexta, obinutuzumab, and prednisone 50 mg who presented to the clinic with worsening of productive coughassociated with fatigue, night sweats and ten pound weight loss over two months...Oral fluconazole was started, and his chemotherapy drugs were changed to just Gammagard...Treatment with sulfamethoxazole-trimethoprim was initiated, and the patientreported marked improvement in the symptoms... It is of the utmost need to prevent diagnostic delays and inaccuracies in immunocompromisedpatients suffering from fungal infections because of easily available treatment. Accumulating therelevant information with thorough history, examination and maintaining a broad differential diagnosisis the key to counter anchor bias. Further research is warranted to assess the influence of anchor biason physician's decision making and patient's clinical..."

Chronic Lymphocytic Leukemia • CNS Disorders • Cough • Fatigue • Gout • Hematological Disorders • Hematological Malignancies • Infectious Disease • Inflammatory Arthritis • Leukemia • Oncology • Pain • Pneumonia • Rheumatology

rATG Versus rATG Combined With Intravenous Immunoglobulin (IVIG) Induction Immunosuppression in HLA Incompatible Transplantation (INHIBIT) (clinicaltrials.gov) - P3 | N=17 | Completed | Sponsor: Institute for Clinical and Experimental Medicine | Recruiting ➔ Completed | N=138 ➔ 17

Enrollment change • Trial completion • Transplantation

Capillary Leak Syndrome Following Immune Checkpoint Inhibition: A Unique Cause of Acute Kidney Injury (NKF-SCM 2024) - "We report a case of CLS following pembrolizumab therapy resulting in severe prerenal AKI that reversed with IV immunoglobulin (IVIG) treatment...14 days after administering IVIG, creatinine was 0.9 mg/dL and UO on torsemide was 1.7 – 2.0 L/day... CLS and AKI reversed with IVIG therapy through decreased T cell activation."

Checkpoint inhibition • Acute Kidney Injury • Glomerulonephritis • Hypotension • Nephrology • Oncology • Renal Disease • Thyroid Gland Hurthle Cell Carcinoma

rATG Versus rATG Combined With Intravenous Immunoglobulin (IVIG) Induction Immunosuppression in HLA Incompatible Transplantation (INHIBIT) (clinicaltrials.gov) - P3 | N=138 | Recruiting | Sponsor: Institute for Clinical and Experimental Medicine | Trial primary completion date: Apr 2022 ➔ Apr 2024

Trial primary completion date • Transplantation

IVIG for Infection Prevention After CAR-T-Cell Therapy (clinicaltrials.gov) - P2 | N=150 | Recruiting | Sponsor: Fred Hutchinson Cancer Center | Not yet recruiting ➔ Recruiting

Enrollment open • Hematological Malignancies • Infectious Disease • Lymphoma • Oncology

IVIG for Infection Prevention After CAR-T-Cell Therapy (clinicaltrials.gov) - P2 | N=150 | Not yet recruiting | Sponsor: Fred Hutchinson Cancer Center | Initiation date: Dec 2023 ➔ Mar 2024

CAR T-Cell Therapy • Trial initiation date • Hematological Malignancies • Infectious Disease • Lymphoma • Oncology

Infection Outcomes and Hypogammaglobulinemia in Patients with Non-Hodgkin Lymphoma Treated with Immunoglobulin Replacement Therapy (ASH 2023) - "In this real-world study of patients with NHL, treatment with IG10% was shown to be associated with significantly lower rates of HGG as well as lower odds of infection, severe infection, and antimicrobial use 3 months after IG10% initiation. Guidelines and consensus-based recommendations are needed to optimize the use of IgG testing, initiation of IgRT, and SID management in patients with NHL."

Clinical • Hematological Malignancies • Infectious Disease • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Stability assessment of anti-bacterial antibodies in immunoglobulin G-depleted serum with validated immunoassays. (PubMed, Immunotherapy) - "Human IgG-depleted serum was spiked with GAMMAGARD Liquid to obtain those samples...Anti-PCP IgG and anti-Hib IgG were shown to be stable for at least 15 months at -20°C. These data confirm the stability of anti-bacterial IgG in human IgG-depleted serum and support the common practice of testing frozen samples."

Journal • Immunology • Infectious Disease • Influenza • Pneumococcal Infections • Primary Immunodeficiency • Respiratory Diseases

IVIG for Infection Prevention After CAR-T-Cell Therapy (clinicaltrials.gov) - P2 | N=150 | Not yet recruiting | Sponsor: Fred Hutchinson Cancer Center

New P2 trial • Hematological Malignancies • Infectious Disease • Lymphoma • Oncology

Therapies for Down Syndrome Regression Disorder (clinicaltrials.gov) - P2 | N=66 | Recruiting | Sponsor: University of Colorado, Denver | Not yet recruiting ➔ Recruiting

Enrollment open • Developmental Disorders • Genetic Disorders

Retrospective Study on Vaccine Responses and Natural Course of COVID-19 Infections in Primary Immunodeficiency (CIS 2023) - "Two of them tested positive for nucleocapsid and spike antibodies in high titers and they were receiving Gammagard or Gamunex infusions, suggesting that these immunoglobulin preparations contain COVID-19 antibodies. We are still in the process of analyzing our data to see if diagnosis, IgG preparations, date of testing, B cell numbers, and drugs play a role in producing nucleocapsid antibodies and high spike antibody titers."

Retrospective data • Developmental Disorders • Genetic Disorders • Immunology • Infectious Disease • Novel Coronavirus Disease • Primary Immunodeficiency • Respiratory Diseases • Solid Tumor • Thymoma • Thymus Cancer

A Safety Study of GAMMAGARD LIQUID (GGL) in Participants With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) (clinicaltrials.gov) - P=N/A | N=6086 | Completed | Sponsor: Takeda | Active, not recruiting ➔ Completed | Trial completion date: Mar 2023 ➔ Dec 2022 | Trial primary completion date: Mar 2023 ➔ Dec 2022

Trial completion • Trial completion date • Trial primary completion date • Pain

IVIORDEX: IgIV Plus Prednisone vs High-dose Dexamethasone for ITP (clinicaltrials.gov) - P3 | N=272 | Recruiting | Sponsor: Assistance Publique - Hôpitaux de Paris | Not yet recruiting ➔ Recruiting | Trial completion date: Jul 2026 ➔ Oct 2026 | Trial primary completion date: Jan 2025 ➔ Apr 2025

Enrollment open • Trial completion date • Trial primary completion date • Congestive Heart Failure • Hematological Disorders • Thrombocytopenia • Thrombocytopenic Purpura

Therapies for Down Syndrome Regression Disorder (clinicaltrials.gov) - P2 | N=66 | Not yet recruiting | Sponsor: University of Colorado, Denver | Trial completion date: Dec 2027 ➔ Dec 2026 | Initiation date: May 2023 ➔ Sep 2023 | Trial primary completion date: Jul 2027 ➔ Dec 2026

Trial completion date • Trial initiation date • Trial primary completion date • Developmental Disorders • Genetic Disorders

ATIVPANDAS: Antibiotic Treatment and Intravenous Immunoglobulin Trial for PANDAS (clinicaltrials.gov) - P2 | N=0 | Withdrawn | Sponsor: CNS Onlus | N=30 ➔ 0 | Unknown status ➔ Withdrawn

Enrollment change • Trial withdrawal

Therapies for Down Syndrome Regression Disorder (clinicaltrials.gov) - P2 | N=66 | Not yet recruiting | Sponsor: University of Colorado, Denver

New P2 trial • Developmental Disorders • Genetic Disorders

Efficacy, Safety, Tolerability, Immunogenicity and Pharmacokinetic Evaluation of HYQVIA in Pediatric PIDD Subjects (clinicaltrials.gov) - P3 | N=44 | Completed | Sponsor: Baxalta now part of Shire | Active, not recruiting ➔ Completed | Trial completion date: May 2023 ➔ Jul 2022 | Trial primary completion date: May 2023 ➔ Jul 2022

Trial completion • Trial completion date • Trial primary completion date • Immunology • Pediatrics • Primary Immunodeficiency

A Safety Study of GAMMAGARD LIQUID (GGL) in Participants With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) (clinicaltrials.gov) - P=N/A | N=7000 | Active, not recruiting | Sponsor: Takeda | Not yet recruiting ➔ Active, not recruiting

Enrollment closed • Pain

A Safety Study of GAMMAGARD LIQUID (GGL) in Participants With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) (clinicaltrials.gov) - P=N/A | N=7000 | Not yet recruiting | Sponsor: Takeda

New trial • Pain

IVIG in the Treatment of Autoimmune Small Fiber Neuropathy With TS-HDS or FGFR-3 Antibodies (clinicaltrials.gov) - P2 | N=20 | Suspended | Sponsor: Loyola University | Trial completion date: Sep 2024 ➔ Dec 2025 | Trial primary completion date: Sep 2023 ➔ Jun 2025

Trial completion date • Trial primary completion date • Immunology • Pain

ADVANCE-CIDP 1: A Study of HyQvia and Gammagard Liquid (Kiovig) in Adults With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) (clinicaltrials.gov) - P3 | N=138 | Completed | Sponsor: Baxalta now part of Shire | Active, not recruiting ➔ Completed

Trial completion • Pain