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

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

Do Myositis Autoantibodies Predict Response to IVIg in Dermatomyositis? A Post-hoc Analysis of the ProDERM Trial (EULAR 2023) - "Conclusion Myositis-specific antibodies were commonly identified in patients with dermatomyositis in the ProDERM study. Further analyses will determine if specific MSA, such as anti-TIF-1 and others, play a role in treatment response to IVIg."

Retrospective data • Dermatomyositis • Immunology • Myositis • IFIH1

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

[VIRTUAL] Safety and Tolerability of IVIg (Octagam 10%) in Patients with Active Dermatomyositis. Results of a Randomized, Double-Blind, Placebo-Controlled Phase III Trial (ACR-CONVERGENCE 2021) - "The safety and tolerability profile for high dose IVIg administration in patients with active DM was as expected with headache, pyrexia and nausea being most commonly reported during or after the infusions. Patients should be monitored for TEE (especially those with additional risk factors) with risk mitigation by using a low maximum infusion rate. This is the first large international, randomized, placebo-controlled phase III trial demonstrating the safety and tolerability of IVIg as a treatment for patients with DM."

Clinical • P3 data • Cardiovascular • Dermatology • Dermatomyositis • Immunology • Myositis • Pain

The ProDERM study: Safety and Tolerability Results from randomized, double-blind, placebo-controlled Phase-III-Trial in Patients with Dermatomyositis. (AAN 2022) - "The safety profile of IVIG administration even at high doses of 2 g/kg was consistent with commonly reported AEs for IVIG administration. Patients should be monitored for TEE (especially those with additional risk factors), if necessary, reduction of infusion rate be considered. This first large, double-blind, placebo-controlled phase III trial demonstrated safety and tolerability of IVIG as a treatment for DM patients."

Clinical • P3 data • Cardiovascular • Dermatology • Dermatomyositis • Immunology • Myositis • Pain

Effect of Treatment with IVIG (octagam10%) on Skin Symptoms and Quality of Life in Subjects with Dermatomyositis. Results of a Large, Randomized, Placebo-controlled International Phase III Trial (ACR Convergence 2022) - "This large international, randomized, placebo-controlled phase III trial demonstrated the efficacy of IVIG treatment to improve skin symptoms in dermatomyositis patients. It also showed a significant difference in the improvement of physical functioning between patients treated with IVIG versus placebo"

Clinical • HEOR • P3 data • Dermatology • Dermatomyositis • Immunology • Myositis

Myositis (PubMed, Z Rheumatol) - "Following the positive ProDERM study, the use of intravenous immunoglobulins (Octagam®) is available for treatment as an approved substance. Based on the INBUILD study, antifibrotic treatment with nintedanib is available for progressive fibrosing pulmonary involvement. For rheumatologists, the updated guidelines represent a document relevant for daily practice with many recommendations for the treatment of patients with myositis."

Journal • Fibrosis • Gastrointestinal Disorder • Immunology • Interstitial Lung Disease • Myositis • Oncology • Pulmonary Disease • Rare Diseases • Respiratory Diseases • Rheumatology

Current and new targets for treating myositis. (PubMed, Curr Opin Pharmacol) - "In the largest clinical trial to date, rituximab was studied in adult and juvenile myositis, but the primary outcome was not met despite 83 percent of subjects with refractory myositis meeting the definition of improvement. The U.S. Food and Drug Administration (FDA) has recently granted approval to Octagam 10% immune globulin intravenous (IVIg), for the treatment of adult dermatomyositis based on impressive results from a double-blind placebo-controlled trial...Further, anti-IL6 therapy cannot be recommended as a recent trial of tocilizumab failed to reach its primary endpoint. Further studies are needed to assess the role of newer therapies such as abatacept (inhibition of T cell co-stimulation), sifalimumab (anti-IFNα), Janus kinase [JAK] inhibitors, apremilast (phosphodiesterase 4 inhibitor), and KZR-616 (selective inhibitor of the immunoproteasome) given their biological plausibility and encouraging recent small-case series results. The future of IIM therapy will..."

Clinical • Journal • Review • Dermatomyositis • Immune Modulation • Immunology • Inflammation • Myositis • Oncology • IFNA1

Use of Janus kinase inhibitors in dermatomyositis: a systematic literature review. (PubMed, Clin Exp Rheumatol) - "Systemic corticosteroids are a cornerstone of therapy, and more recently intravenous immunoglobulin (IVIG; OCTAGAM®) has been approved by the US Food and Drug Administration for the treatment of adults with DM...Although the conclusions that can be drawn from this analysis are limited because of the differences in assessments used across publications, overall treatment of patients with DM or JDM with a JAK inhibitor was associated with significant improvement of a wide range of DM manifestations, including skin lesions, muscle weakness, and ILD. Our systematic literature review suggests that JAK inhibitors may be a viable treatment option for DM/JDM, and randomised controlled trials are necessary to confirm these findings."

Journal • Review • Dermatology • Dermatomyositis • Gastrointestinal Disorder • Immunology • Interstitial Lung Disease • Myositis • Pulmonary Disease • Respiratory Diseases

IVIORDEX: IgIV Plus Prednisone vs High-dose Dexamethasone for ITP (clinicaltrials.gov) - P3; N=272; Not yet recruiting; Sponsor: Assistance Publique - Hôpitaux de Paris; Trial completion date: Apr 2025 ➔ Jul 2026; Initiation date: Oct 2021 ➔ Jan 2022; Trial primary completion date: Oct 2024 ➔ Jan 2025

Clinical • Trial completion date • Trial initiation date • Trial primary completion date • Congestive Heart Failure • Hematological Disorders • Thrombocytopenia • Thrombocytopenic Purpura

Octagam 10% Therapy in COVID-19 Patients With Severe Disease Progression (clinicaltrials.gov) - P3; N=208; Active, not recruiting; Sponsor: Octapharma; Completed ➔ Active, not recruiting; Trial completion date: Jan 2021 ➔ Jan 2022; Trial primary completion date: Jan 2021 ➔ Jan 2022

Clinical • Enrollment closed • Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • CRP

In vitro comparison between different 10% intravenous immunoglobulin preparations (DGHO 2021) - "Material and Purity profile and biological characteristics of IqY mune® were compared to other marketed 10% IVIg (Privigen®, Octagam®, Gamunex®, and Kiovig®). Although different IVIg preparations essentially consist of polyclonal IgG, the different purification processes lead to variations in other characteristics. The IqYmune manufacturing process developed with a QbD approach has generated a 10% IVIg having a higher level of quality and enhanced safety profile while maintaining a high level of efficacy."

Preclinical • Hypotension

FDA Approves IVIG in Dermatomyositis (RheumNow) - P=NA, N=95; "The U.S. Food and Drug Administration (FDA) has approved Octagam 10% [Immune Globulin Intravenous (Human)], as the first and only intravenous immunoglobulin (IVIg) formulation to be approved for adult dermatomyositis (DM)....Other reported adverse effects in DM patients includes headache, fever, nausea, vomiting, increased blood pressure, chills, musculoskeletal pain, increased heart rate, dyspnea, and infusions site reactions."

Clinical data • Regulatory

IVIORDEX: IgIV Plus Prednisone vs High-dose Dexamethasone for ITP (clinicaltrials.gov) - P3; N=272; Not yet recruiting; Sponsor: Assistance Publique - Hôpitaux de Paris

Clinical • New P3 trial • Congestive Heart Failure • Hematological Disorders • Thrombocytopenia • Thrombocytopenic Purpura