Business Wire India
Octapharma has announced that the final results of the III III podium study will be presented at the American College of Rheumatology (ACR) Convergence 2020 Virtual Meeting. Podium study assessed long-term efficacy, tolerability, and safety of octagum® 10% in patients with dermatitis, an intravenous immunoglobulin (IVIg).
- The primary endpoint of the study was met, the Octagum had a significantly higher proportion of respondents® 10% group (78.7% vs 43.8%; p = 0.0008) compared to placebo group
- Eight response® In the first period of the study, 10% of the cohort was maintained for all efficacy endpoints through the open-label extension period
- The majority of adverse events were mild in intensity and octagon® In this population of patients with dermatitis, 10% was generally well tolerated.
Dermatomyositis is a rare systemic autoimmune disease of unknown cause, targeting muscles and / or skin and other organs. Patients have skin rashes, chronic muscle swelling caused by muscle weakness, and a 10-year survival rate of about 50%.1. While there are no proven and approved treatments for dermatomyositis, some patients receive off-label IVIG therapy2 But data from large randomized placebo-controlled studies of IVIG in these patient populations are scarce. The US Food and Drug Administration (FDA) gave Octpharma an orphan drug designation for Octagam® 10% for the treatment of patients with dermatitis in May 2017.
The ProDERM study was the first conclusive randomized trial evaluating IVIg for dermatomyositis. In the initial 16-week double-blind placebo-controlled period, patients were randomized to receive high-dose octagums® 10% (2g / kg) or placebo every four weeks. This was followed by an open-label extension period during which all patients received the Octagum® 10% every four weeks for another 24 weeks (except for patients who showed clinical worsening while receiving octagum® 10% in the initial 16 weeks). The primary endpoint was the proportion of patients who responded to treatment at week 16, as defined by the 20-point improvement on the Total Improvement Score (TIS) of the 2016 ACR / European League Against Rheumatism (EULAR) myositis response criterion. had gone.3. TIS is based on six myositis core set measures: manual muscle testing, physician global disease activity, patient global disease activity, health assessment questionnaire, muscle enzymes and extra-muscular disease activity.
The study enrolled 95 patients from 36 sites in 10 countries. “The design of the podium study allows patients to discontinue treatment if it worsens, facilitating the recruitment of large numbers of patients for such a rare diseaseSaid Rohit Aggarwal, MD MS, University of Pittsburgh, member of the ProDERM Study Steering Committee. “The large patient population of this study improves outcomes in the clinic, particularly in view of the very heterogeneous nature of the disease, compared to earlier small studies.. “
At week 16, 78.7% (37/47) of patients receiving octagum® 10% were respondents, compared to 43.8% (21/48) of patients receiving placebo. A supportive analysis of the primary endpoint showed a significantly higher mean in the Octagum® 10% group (47.7) than the placebo group on Week 16 (21.3, p <0.0001). At the end of the week at the end of the open-label extension period 40, 69.6% (32/46) of patients who switched from placebo to octagum® There were 10% of respondents, showing that patients initially randomized to placebo improved after switching to Octagum® 10%. The response rate of patients in the IVIG group remained until week 40 (71.1%; 32/45). The safety and tolerability profile suggests that the administration of the octagum® 10% was generally well tolerated in this patient population.
“Until now, patients with dermatomyositis had poor prognosis and a lack of accepted treatment options.Said Olaf Walter, a board member at AllPharma. “We are very excited by the positive results of the study. Improving patients’ lives is central to OctaPharma’s mission, and we are proud to share these data with the aim of providing effective therapy for patients with dermatomyositis. “
The results of the podium study demonstrated the efficacy, safety, and tolerability of the octagum® A large randomized placebo-controlled study of IVIG in 10% of patients with dermatitis and in dermatomocytosis patients is the first to show clinical benefit.
About the study of sodium
SupporterGress in SnakeskinThe atomyositis study (ProDERM, NCT02728752) was an international multi-center double-blind, randomized, placebo-controlled phase III clinical trial that examined the efficacy, safety, and tolerability of the Octagum® 10% in patients with dermatitis. The podium study enrolled 95 patients from 36 sites in 10 countries.
About eighth® 10%
Octagam® 10% is ready to use, a liquid preparation of highly purified human immunoglobulin for intravenous administration. Octagam® 10% is approved for idiopathic thrombocytopenic purpura in the United States, Europe, and Canada. It is approved in Europe and Canada for use in the treatment of primary immunodeficiency, secondary immunodeficiency and Guillain Barre syndrome, and also for CIDP in Europe.
Dermatomyositis is a rare immune-mediated inflammatory myositis secondary to skin rashes on the eyelids, chest, and joints of the hands, as well as proximal muscle weakness ranging from chronic skin and muscle inflammation.4. Despite the significant morbidity and mortality associated with dermatomyositis, there are no clinically proven therapies approved by the US or European regulatory authorities for the treatment of dermatomyositis.
Headquartered in Lachen, Switzerland, Octapharma is one of the world’s largest human protein manufacturers, developing and producing human proteins from human plasma and human cell lines.
Octapharma employs more than 10,000 people worldwide supporting the treatment of patients in 118 countries with products in three therapeutic areas: hematology, immunotherapy and critical care.
Octapharma has seven R&D sites and six state-of-the-art manufacturing facilities in Austria, France, Germany, Mexico and Sweden, with a combined capacity of about 8 million liters of plasma per year.
In addition, Octapharma operates more than 140 plasma donation centers in Europe and the United States.
- Airio A, et al. Detection and mortality of polymyositis and dermatomyositis patients. Clin Rheumatol 2006; 25: 234–239.
- Ho C and Vicintini S for skin conditions. Off-label use of intravenous immunoglobulin: a review of clinical implications. Canadian Agency for Drugs and Technology in Health. 20 April 2018.
- Aggarwal R, et al. 2016 American College of Rheumatology / European League Against Rheumatism Criteria for Minimal, Moderate, and Major Clinical Responses in Adult Dermatomyositis and Polymyositis. Arthritis Rheumatol 2017; 69: 898–910.
- Findley AR, et al. Overview of polymyositis and dermatomyositis. Nervous nerve 2015; 51: 638–656.
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