Keywords
Immunology
Octapharma presents new clinical data investigating frontiers of treatment for autoimmune disorders at American Academy of Neurology conference
Lachen, Switzerland
08/04/2025
Press release
Octapharma press releases are specifically for health specialist/medical media and are not for consumer press.
Octapharma presented new insights into the use of immunoglobulin therapy for the treatment of autoimmune diseases showcased during an Industry Therapeutic Update (ITU) at the AAN 2025 Meeting, with a focus on dermatomyositis (DM) and chronic inflammatory demyelinating polyneuropathy (CIDP).
Insights included new data from a matching-adjusted indirect comparison (MAIC) of the efficacy and tolerability of intravenous immunoglobin (IVIg) versus subcutaneous efgartigimod alfa.
New clinical findings on the safety of immunoglobulin therapy versus efgartigimod alfa with a focus on infections in patients with myasthenia gravis will also be presented during an oral presentation later this week.
Octapharma shared new clinical data on the use of immunoglobulins for the management of autoimmune neurological disorders as part of an Industry Therapeutic Update (ITU) on April 7, at the 77th American Academy of Neurology (AAN) 2025 Annual Meeting.
Industry Therapeutic Update (ITU)
On Monday, April 7, 2025, data was presented on the following by leading experts:
A Roadmap for CIDP Care: Reviewing Treatment Strategies
Dr. David R. Cornblath reviewed treatment strategies for CIDP, including new data from a matching-adjusted indirect comparison (MAIC) comparing the efficacy and tolerability of Octapharma’s intravenous immunoglobulin (IVIg) therapy panzyga® versus subcutaneous efgartigimod alfa. In these analyses, panzyga® demonstrated a significant higher proportion of patients with confirmed evidence of clinical improvement (ECI) of 85% for panzyga® 1.0g/kg and 92% for panzyga® 2.0g/kg maintenance dose versus 67% for subcutaneous efgartigimod alfa. Additionally, the median time to initial confirmed ECI was significantly shorter with only 3.7 weeks for panzyga® 1.0 g/kg and 3.1 weeks for 2.0 g/kg maintenance dose versus 6.1 weeks for subcutaneous efgartigimod alfa.Furthermore, with panyzga® no relapses were observed over 20 weeks of treatment whereas approximately 25% of patients treated with subcutaneous efgartigimod alfa relapsed by week 20. These data add valuable comparative evidence for assessing the expanding treatment options for CIDP.
Decoding IVIg: How Multi-Pathway Mechanisms Drive Extensive Immune Modulation
Dr. Suraj A. Muley discussed IVIg’s mechanisms of action (MOA) and how targeting multiple MOA for complex multifactorial pathologies like CIDP can fight autoimmune responses and reduce the severity of neurological symptoms.Exploring Frontiers in Dermatomyositis (DM)
Dr. Namita A. Goyal presented the efficacy of Octapharma’s IVIg therapy octagam® 10%, which in 2021 became the first treatment to be approved for DM in the EU, the USA and Canada.
“Octapharma is excited to discuss new data from our immunology portfolio at AAN 2025.” said Olaf Walter, Board Member at Octapharma. “Patients with autoimmune disorders continue to face many challenges in their day-to-day care and symptom management. Octapharma's extensive experience with IVIg therapy, backed by substantial efficacy data, underscores the significant benefits this treatment can bring to patients. We invite healthcare professionals to explore the latest clinical findings at AAN 2025 and join us in advancing patient care through innovative immunotherapy solutions.”
In addition to the results presented on April 7, Octapharma is due to share further data at the AAN’s Scientific Sessions on Wednesday, April 9. The oral presentation will focus on the relative safety of efgartigimod alfa as a treatment for myasthenia gravis.
Oral Presentation
Myasthenia gravis is a chronic autoimmune, neurological disease that causes muscle weakness and fatigue. Immunoglobulin therapy (administered intravenously or subcutaneously) has been widely used for many years to treat this condition. Efgartigimod alfa was recently introduced as an alternative to immunoglobulins for the treatment of myasthenia gravis. To assess the relative safety of efgartigimod alfa and immunoglobulins, investigators from the University of Bologna performed an analysis of data from the U.S. Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS).
Researchers will discuss how this study found that, in the years 2022 and 2023, infections for patients treated with efgartigimod alfa were more frequently reported for Efgartigimod (37%) than for immunoglobulins (24%). Overall, the infection related events for efgartigimod alfa were more likely to be serious (92% vs. 78%) and to result in hospitalisation (52% vs. 27%) than for immunoglobulins. A disproportionality analysis for the period 2022-23 identified only one signal for immunoglobulins, while 13 signals were identified for efgartigimod alfa related to various types of infections including respiratory and viral infections, highlighting the need for careful monitoring to ensure patient safety.
“After approval of a new therapy, it is crucial that its safety be continually monitored in real-world practice via pharmacovigilance databases,” said Dr. Suraj A. Muley, University of Arizona. “The results of our analysis help to provide a more complete picture of the relative safety of different products, which is essential to ensure the well-being of our patients.”
Notes to editors
The full oral presentation on Wednesday, April 9, 2025, Infections-related safety profile of efgartigimod alfa and immunoglobulins in myasthenia gravis, will be held at 13:24 PST in Session S34 – Updates on Myasthenia Gravis. The presentation relates to research by Dr Suraj A. Muley and his team: Drs. Valentina Giunchi, Michele Fusaroli, Mathurin Baquie, Christoph Wissmann and Elisabetta Poluzzi.
Octapharma’s commitment to patients requiring immunotherapy is demonstrated by our unique immunoglobulin product portfolio which offers different formulations, concentrations and routes of administration in liquid, ready-to-use solutions for healthcare professionals and their patients.
About octagam® 10%
Octagam® 10% [Immune Globulin Intravenous (Human)] is an immune globulin intravenous (human) liquid preparation indicated for the treatment of:
Chronic immune thrombocytopenic purpura (ITP) in adults
Dermatomyositis (DM) in adults
WARNINGS: THROMBOSIS, RENAL DYSFUNCTION AND ACUTE RENAL FAILURE
Thrombosis may occur with immune globulin intravenous (IGIV) products, including octagam® 10%. Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of oestrogens, indwelling vascular catheters, hyperviscosity, and cardiovascular risk factors. Renal dysfunction, acute renal failure, osmotic nephropathy, and death may occur with the administration of immune globulin intravenous (Human) (IGIV) products in predisposed patients. Renal dysfunction and acute renal failure occur more commonly in patients receiving IGIV products containing sucrose. octagam® 10% does not contain sucrose.
For patients at risk of thrombosis, renal dysfunction or renal failure, administer octagam® 10% at the minimum infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity.
About panzyga®
Panzyga® is a 10% human normal immunoglobulin solution ready for intravenous administration. The manufacturing process achieves a significant viral reduction through a combination of three dedicated manufacturing process steps: solvent/detergent treatment, ion-exchange chromatography and nanofiltration (20 nm) and thus complies with the latest international consensus on best practices for viral safety. panzyga® is approved for use in treatment of primary immunodeficiency and idiopathic thrombocytopenic purpura in several countries.
About Octapharma
Headquartered in Lachen, Switzerland, Octapharma is one of the largest human protein manufacturers in the world, developing and producing human proteins from human plasma and human cell lines.
Octapharma employs more than 11,000 people worldwide to support the treatment of patients in 120 countries with products across three therapeutic areas: Immunotherapy, Haematology, and Critical Care.
Octapharma has seven R&D sites and five state-of-the-art manufacturing facilities in Austria, France, Germany, Mexico and Sweden, and operates more than 200 plasma donation centres across Europe and the USA. Octapharma has over 40 years of experience in patient care. The company’s American subsidiary, Octapharma USA, is located in Paramus, N.J. For more information, please visit octapharmausa.com.
Octapharma press releases are specifically for health specialist/medical media and are not for consumer press.