Octagam (intravenous normal human immunoglobulin) / Octapharma, Pfizer - LARVOL DELTA

From Hematologic Malignancies to Rheumatic Disease: Expanding the Role of Intravenous Immunoglobulin in Secondary Immunodeficiency (ACR Convergence 2026) - "In GAM-33, IVIG was effective in reducing infection frequency and was well tolerated in patients with SID related to hematological malignancies and/or rituximab treatment. Results from NGAM-16 will further our understanding of the efficacy and safety of IVIG in patients with rheumatic or autoimmune conditions on BCDT."

Chronic Lymphocytic Leukemia • Hematological Malignancies • Infectious Disease • Leukemia • Lymphoma • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Oncology • Rheumatology

Extended Investigation Into the Viscosity of Commercial IG Preparations (ISTH 2026) - "Our extended datanow includes product viscosity at normal body temperature (37° C.) 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], CSLBehring LLC; and GAMMAGARD LIQUID® [immune globulin infusion (human) 10%], Takeda Pharmaceuticals...Results The results at 25 °C were as follows: ALYGLO: 2.587 cP; OCTAGAM: 2.646 cP; GAMUNEX-C: 2.598 cP; PRIVIGEN: 2.598 cP; GAMMAPLEX: 2.598 cP...The consistency between the first and second analyses supports the robustness of these observations and warrants further investigation to identify potential differences in the viscosities of commercially available IVIG products, which may have..."

Cardiovascular • Nephrology • Renal Disease

ASSESSMENT OF CLINICALLY RELEVANT AUTOANTIBODIES IN IVIG PRODUCTS BEFORE AND AFTER COVID-19 PANDEMIC (AUTO 2026) - "Despite the eightfold increase in the total concentration of autoantibodies (ANA Hep-2 titer) in IVIG products, most specific, potentially pathogenic autoantibodies remain below the reference limits, which requires further investigation and monitoring of the clinical significance of the total increase."

Clinical • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Investigation Into the Viscosity of Commercial IG Preparations (CIS 2026) - "Experiments were performed using: ALYGLO (immune globulin intravenous, human-stwk 10% liquid), GC Biopharma; OCTAGAM10% (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: 2.587 cP; OCTAGAM: 2.646 cP; GAMUNEX-C: 2.598 cP; PRIVIGEN: 2.598 cP; GAMMAPLEX: 2.598 cP...The consistency between the first and second analyses supports the robustness of these observations and warrants further investigation to identify potential differences in the viscosities of commercially available IVIG products, which may have implications for product selection in at-risk patients. Tabular data are included as downloadable supplement files."

Cardiovascular • Nephrology • Renal Disease

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

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

Evaluating the Safety and Efficacy of Different Intravenous Immunoglobulin 10 Percent Dose Regimens in Pediatric Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) Patients (AAN 2026) - "Design/Methods This is a multicenter, prospective, double-blinded, parallel-group, randomized phase III study to evaluate safety and efficacy of different IVIg 10% (PANZYGA®) dose regimens in pediatric CIDP patients...Secondary outcomes include the percentage of patients with CIDP relapse (increase in mRS score by ≥1 point from the baseline score related to CIDP), time to CIDP relapse, and the percentage of patients with good or excellent response (mRS score of 0 or 1 in each arm at Week 24). Conclusions Finding safe and effective doses of intravenous immunoglobulin 10% for CIDP in the pediatric population can improve their quality of life."

Clinical • Pain • Pediatrics

042011: LCH-IV International Collaborative Treatment Protocol for Children and Adolescents with Langerhans Cell Histiocytosis (clinicaltrialsregister.eu) - P2/3 | N=1124 | Active, not recruiting | Sponsor: St. Anna Childrens Cancer Research Institute GmbH | Not yet recruiting ➔ Active, not recruiting

Enrollment closed • Langerhans Cell Histiocytosis

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

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

Efficacy of Intravenous Immunoglobulin for Systemic Manifestations of Dermatomyositis Beyond Muscular and Cutaneous: Sub-analysis of the ProDERM Study. (PubMed, Rheumatol Ther) - P3 | "IVIg was effective in treating pulmonary, skeletal, constitutional, and gastrointestinal manifestations of dermatomyositis. We advocate exploring IVIg as treatment for dermatomyositis, beyond muscle and skin manifestations."

Journal • Cardiovascular • Dermatomyositis • Dysphonia • Fatigue • Gastrointestinal Disorder • Immunology • Musculoskeletal Pain • Myositis • Rheumatology

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

Efficacy of Intravenous Immunoglobulin on Pulmonary Manifestations in Patients with Dermatomyositis: Post-hoc Analysis of the ProDERM data (EULAR 2025) - "IVIg may have favorable treatment effects on active pulmonary manifestations of DM. Future studies should consider including pulmonary outcomes to assess the effect of treatment on these symptoms."

Clinical • Retrospective data • Cough • Dermatomyositis • Dysphonia • Immunology • Interstitial Lung Disease • Myositis • Pulmonary Disease • Respiratory Diseases • Rheumatology

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

Pulmonary Manifestations in Patients with Dermatomyositis - Effect of IVIG Treatment: Data from the ProDERM Study (AAN 2025) - "IVIg may have favorable treatment effects on active pulmonary manifestations of DM. Further studies are warranted."

Clinical • Dermatomyositis • Dysphonia • Immunology • Interstitial Lung Disease • Myositis • Pulmonary Disease • Respiratory Diseases

Predictors of response to intravenous immunoglobulin in patients with dermatomyositis: the ProDERM study. (PubMed, Rheumatology (Oxford)) - P3 | "IVIg was effective in treating DM patients regardless of demographic features and autoantibody status (for most autoantibodies). Patients with higher cutaneous disease activity and/or anti-TIF1-γ responded best to IVIg, while pulmonary disease activity predicted a lower, but still effective, IVIg response, warranting further investigation."

Journal • Dermatomyositis • Gastrointestinal Disorder • Immunology • Myositis • Pulmonary Disease • Respiratory Diseases

Efficacy of Intravenous Immunoglobulin (Octagam 10%) on Pulmonary Manifestations in Patients with Dermatomyositis: Results from the ProDERM Study (ACR Convergence 2024) - "IVIg may have favorable treatment effects on active pulmonary manifestations of DM. Further studies are warranted."

Clinical • Cough • Dermatomyositis • Dysphonia • Immunology • Interstitial Lung Disease • Myositis • Pulmonary Disease • Respiratory Diseases • Rheumatology

IVIG response in pediatric acute-onset neuropsychiatric syndrome correlates with reduction in pro-inflammatory monocytes and neuropsychiatric measures. (PubMed, Front Immunol) - "Children with moderate-to-severe PANS received six infusions of IVIG (Octagam 5%, Octapharma) every 3 weeks with post treatment follow-up...This pro-inflammatory profile and psychometric scores improved following IVIG treatment. Future work will aim to further elucidate the roles of innate and adaptive immune responses in PANS and the regulatory mechanism(s) of IVIG in PANS treatment."

Journal • CNS Disorders • Immunology • Infectious Disease • Inflammation • Mental Retardation • Mood Disorders • Movement Disorders • Obsessive-Compulsive Disorder • Pediatrics • Psychiatry • CD14

EFFICACY IN INFECTION PROPHYLAXIS AND SAFETY OF INTRAVENOUS IMMUNOGLOBULINS IN PATIENTS WITH HYPOGAMMAGLOBULINEMIA DUE TO HEMATOLOGICAL MALIGNANCIES: RESULTS FROM A NON-INTERVENTIONAL STUDY (EHA 2024) - "Both 5% and 10% IVIG-preparations were effective in reducing the frequency of infections and well tolerated inpatients with SID resulting from hematological malignancies and those treated with rituximab, with a favorablesafety profile."

Clinical • Observational data • Chronic Lymphocytic Leukemia • Hematological Disorders • Hematological Malignancies • Infectious Disease • Leukemia • Lymphoma • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Oncology

Unveiling the Connection Between α-Gal Allergy and Cardiovascular Disease (EAACI 2024) - "Method For this, anti-α-Gal IgG antibodies were purified from a commercial intravenous human IgG concentrate (Octagam®) and added to fluorescently labelled LDL molecules enriched with the α-Gal containing lipid iGB3...Conclusion The IgG-mediated phagocytosis of LDL molecules carrying α-Gal represents an additional mechanism for foam cell formation and thus atherogenesis. Our research, therefore, provides a better understanding of why patients allergic to α-Gal present enlarged atheromatous plaques and also provides a possible explanation for the known association between red meat consumption and an increased risk of ischemic heart disease."

Allergy • Immunology

The many faces of primary immune deficiency in childhood (EAACI 2024) - "Replacement therapy with human immunoglobulin (Octagam 10%) and isoprinosine was started at the age of 5 years and 4 months...The identification of defects in specific molecules or molecular signaling pathways has led to opportunities to apply targeted treatments that have proven particularly effective in controlling disease and improving health. Кey words: immune deficiency, immune dysregulation, lymphoma, replacement therapy"

Clinical • Allergy • Immunology • Inflammatory Arthritis • Lupus • Primary Immunodeficiency • Rheumatology • Sjogren's Syndrome • Systemic Lupus Erythematosus

Evaluation of Autoantibody Status Effect on Dermatomyositis Patients' Response to IVIG Treatment: Post-hoc Analysis of the ProDERM Trial (AAN 2024) - "IVIg appears to be an effective agent for treatment of dermatomyositis, regardless of autoantibody status of the patient."

Clinical • Retrospective data • Dermatomyositis • Immunology • Myositis

Safety and tolerability of intravenous immunoglobulin in patients with active dermatomyositis: results from the randomised, placebo-controlled ProDERM study. (PubMed, Arthritis Res Ther) - P3 | "Results from this study demonstrate that IVIg has a favourable safety profile for treatment of adult dermatomyositis patients and provides evidence that will help to inform treatment choice for these patients. Dermatomyositis patients receiving high-dose IVIg should be monitored for TEEs, and a low rate of infusion should be used to minimise TEE risk, particularly in those with pre-existing risk factors."

Journal • Cardiovascular • Dermatomyositis • Immunology • Myositis

How might IVIG therapy be used to treat infection after BCMA-targeted therapies in MM? (YouTube) - "In this interview Krina Patel opens by explaining how BCMA-targeted therapies, used to treat MM, can result in a higher rate of infection. Patel then goes on to explain the applications of IVIG to treat these infections, outlining which patients the treatment is most appropriate for, as well as the recommended dosing regimens."

Interview • Video

Efficacy of intravenous immunoglobulins (IVIg) in improving skin symptoms in patients with dermatomyositis: a post-hoc analysis of the ProDERM study. (PubMed, EClinicalMedicine) - P3 | "In the First Period (Weeks 0-16), adults with active DM received 2.0 g/kg IVIg (Octagam 10%; Octapharma AG) or placebo every 4 weeks...IVIg treatment significantly improved dermatological symptoms in patients with DM, regardless of disease severity before treatment, suggesting that IVIg is effective for even the most severe cutaneous DM. This study was sponsored by Octapharma Pharmazeutika Produktionsges m.b.H."

Journal • Retrospective data • Dermatology • Dermatomyositis • Immunology • Myositis

TOLERABILITY AND SAFETY OF INTRAVENOUS IMMUNOGLOBULINS (5% AND 10%) FOR THE TREATMENT OF PATIENTS WITH SECONDARY IMMUNODEFICIENCIES – FINAL SUBGROUP RESULTS OF A NON-INTERVENTIONAL SAFETY STUDY (EHA 2023) - "This subgroup analysis shows that both IVIG-products (5% and 10%) are well tolerated and effective in patients with hematological malignancies associated with SID. Immunoglobulin, Safety, Immunodeficiency, IVIg"

Clinical • Back Pain • Bone Marrow Transplantation • Chronic Lymphocytic Leukemia • Dermatology • Hematological Disorders • Hematological Malignancies • Infectious Disease • Leukemia • Lymphoma • Multiple Myeloma • Musculoskeletal Pain • Non-Hodgkin’s Lymphoma • Oncology • Pain • Pruritus • Respiratory Diseases • Transplantation