PARAMUS, NJ–(BUSINESS WIRE)–United States will be a presenting sponsor of The Myositis Association (TMA) Annual International Patient Conference 2022 which will be held September 8-11 in Orlando, Florida, offering clinical insight into dermatomyositis (DM) and the latest information on treatment options for the rare immune-mediated inflammatory disease.
“We are thrilled to have Octapharma participate in the 2022 Annual International Patient Conference,” said Chrissy Thornton, Executive Director of TMA. “Octapharma’s pivotal clinical research in DM has been an important resource for the myositis community. The company’s leadership in advancing treatment options for patient therapies has been invaluable and we appreciate their continued support.
The United States Food and Drug Administration (FDA) approved last year Octagame® ten% [Immune Globulin Intravenous (Human)] for the treatment of dermatomyositis in adults – the first and only immunoglobulin (IVIg) to be indicated for this rare disease. The approval was based on the program sponsored by Octapharma ProDERM trial, the first study to assess the long-term efficacy and safety of IVIG in adults with diabetes. The prospective, randomized, double-blind, placebo-controlled Phase III clinical trial enrolled 95 patients at 36 sites worldwide, including 17 sites in the United States, and is the largest study evaluating intravenous immunoglobulin as an option treatment of dermatomyositis.
“Octapharma is committed to developing therapies that save and improve the lives of patients with rare diseases, including dermatomyositis,” said United States President Flemming Nielsen. “Adult patients with diabetes no longer have to rely on unapproved treatments for the disorder. We look forward to meeting patients and their families at important educational programs such as the TMA conference to provide the latest information on dermatomyositis.
Laurel Cherwin, RN, BSN, Octapharma USA Clinical Nurse Educator, will present a 90-minute clinical overview of dermatomyositis at the conference. The breakout session is scheduled for Friday, September 9 at 9:30 a.m. Octapharma encourages conference attendees to also visit its conference booth for more information on DM.
Myositis is a general inflammation or swelling of the muscle. The disease is highly variable and has been classified into several forms including dermatomyositis, polymyositis (PM), necrotizing myopathy (NM), sporadic inclusion body myositis (sIBM) and juvenile forms of myositis (JM) .
Dermatomyositis is a rare systemic autoimmune disease of unknown cause affecting approximately 10 in one million US residents. Patients typically suffer from severe skin rashes, chronic muscle inflammation, and progressive muscle weakness, typically affecting adults in their late 40s to early 60s and children between the ages of 5 and 15. Complications include difficulty swallowing, breathing problems due to lung scarring, joint pain, and calcium deposits on muscles, skin, and connective tissues. 1, 2, 3
About Octagam® ten%
Octagame® ten% [Immune Globulin Intravenous (Human)] is a liquid preparation of intravenous immunoglobulin (human) indicated for the treatment of:
Chronic immune thrombocytopenic purpura (ITP) in adults
Dermatomyositis (DM) in adults
THROMBOSIS, RENAL DYSFUNCTION AND ACUTE KIDNEY FAILURE
Thrombosis may occur with intravenous immunoglobulin (IGIV) products, including Octagam® ten%. Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling vascular catheters, hyperviscosity, and cardiovascular risk factors . Renal dysfunction, acute renal failure, osmotic nephropathy and death may occur when immunoglobulin intravenous (human) (IGIV) products are administered to susceptible patients. Renal dysfunction and acute renal failure occur more frequently in patients receiving IVIG products containing sucrose. Octagame® 10% does not contain sucrose. For patients at risk of thrombosis, renal dysfunction or renal failure, administer Octagam® 10% at minimum practicable infusion rate. Ensure adequate hydration in patients prior to administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity.
About Octapharma Group
Based in Lachen, Switzerland, Octapharma is one of the world’s largest manufacturers of human protein products and has been committed to patient care and medical innovation since 1983. Its core business is the development and the production of human proteins from human plasma and human cell lines. . Octapharma employs more than 10,000 people worldwide to support the treatment of patients in more than 115 countries with products in the following therapeutic areas: hematology (bleeding disorders), immunotherapy (immune disorders) and critical care. The Company’s US subsidiary, Octapharma USA, is located in Paramus, NJ Octapharma operates three state-of-the-art manufacturing facilities approved by the United States Food and Drug Administration (FDA), offering a high level of flexibility from production. For more information, please visit octapharmausa.com.
1 – Dermatomyositis; US Department of Health & Human Services, National Institutes of Health, National Center for Translational Sciences, website: https://rarediseases.info.nih.gov/diseases/6263/dermatomyositis.
2 – Dermatomyositis; Mayo Clinic, website: https://www.mayoclinic.org/diseases-conditions/dermatomyositis/symptoms-causes/syc-20353188.
3 – Cordeiro AC, Isenberg DA. Treatment of inflammatory myopathies. Postgrad Med J 2006; 82:417–24.
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