The Lancet Respiratory Medicine Publishes RAPID Extension Study Data on Effect of Zemaira® [Alpha1-Proteinase Inhibitor (Human)] in Patients with Alpha-1 Antitrypsin Deficiency (AATD)
Results highlight the importance of early intervention
KING OF PRUSSIA, Pa — 05 December 2016
Global biotherapeutics leader CSL Behring announced today that The Lancet Respiratory Medicine, a specialty journal, published findings of the RAPID Open Label Extension study, conducted in patients with alpha-1 antitrypsin deficiency (AATD). Study findings demonstrate that the use of Alpha1-Proteinase Inhibitor (A1-PI) therapy may slow the progressive and irreversible loss of lung tissue, thereby suggesting that early intervention may be beneficial.
The RAPID Open Label Extension study (Randomized, Placebo-controlled Trial of Augmentation Therapy in Alpha-1 Proteinase Inhibitor Deficiency Open Label Extension) consisted of eligible patients who continued for another two years from the original two-year RAPID trial, the largest and longest placebo-controlled AATD trial to ever have been conducted globally. The trial set out to measure the progression of emphysema, assessed by volume-adjusted lung density (measured by CT.)
The RAPID extension study consisted of two groups of patients. The “Early-Start” group received A1-PI therapy during both trials, providing up to four years of continuous treatment, while the “Delayed-Start” group received placebo during the first two years and then switched to Zemaira in the extension trial, providing up to two years of active treatment.
While a similar rate of decline was observed in both groups between months 24 and 48, an advantage was sustained over the four-year period for the “Early-Start” group, which experienced a lower overall rate of lung density decline. During the extension trial, the “Delayed-Start” group failed to catch-up to their “Early-Start” counterparts.
“RAPID is a landmark study on the disease-modifying effect of A1-PI therapy on the progression of emphysema in patients with severe AATD,” said Professor N. Gerard McElvaney, Head of the Department of Medicine Respiratory Research Division, at Beaumont Hospital, Dublin, Royal College of Surgeons in Ireland (RCSI) and lead author of the publication.
"With the publication of the RAPID extension study, we have found that the late introduction of A1-PI therapy is still beneficial – but the lung structure lost by the late introduction is never recovered. RAPID's message is to intervene. The RAPID extension message is to intervene early,” said Kenneth R. Chapman, MD, Director of the Asthma & Airway Centre at the University Health Network in Toronto, Canada.
The RAPID and the RAPID extension trials provide an advancement in understanding the impact of A1-PI therapy. Available A1-PI therapies can differ in terms of product features, which should be considered when choosing the appropriate therapy for patients.
About Alpha-1 Antitrypsin Deficiency (AATD)
AATD is a hereditary condition that can severely affect a patient’s lung function. The condition is marked by a low level or absence of alpha-1-proteinase inhibitor (A1-PI), a natural protein that inhibits neutrophil elastase, thereby preventing destruction of lung tissue. Severe deficiency of A1-PI is associated with a strong tendency for the development of emphysema, a form of chronic obstructive pulmonary disease (COPD), and can significantly impact everyday life and life expectancy.
Zemaira is a highly-purified form of Alpha1 Proteinase Inhibitor (human) currently approved in the US, Canada, Brazil, and New Zealand, where it is indicated for chronic augmentation and maintenance therapy in adults with Alpha1 deficiency and clinical evidence of emphysema. CSL Behring markets Zemaira as Respreeza® in Europe.
Important Safety Information
Alpha1-Proteinase Inhibitor (Human), Zemaira is indicated to raise the plasma level of alpha1-proteinase inhibitor (A1-PI) in patients with A1-PI deficiency and related emphysema. The effect of this raised level on the frequency of pulmonary exacerbations and the progression of emphysema have not been established in clinical trials.
Zemaira may not be suitable for everyone; for example, people with known hypersensitivity to components used to make Zemaira, those with a history of anaphylaxis or severe systemic response to A1-PI products, and those with certain IgA deficiencies. If you think any of these may apply to you, ask your doctor.
Early signs of hypersensitivity reactions to Zemaira include hives, rash, tightness of the chest, unusual breathing difficulty, wheezing, and feeling faint. Immediately discontinue use and consult with physician if such symptoms occur.
In clinical studies, the following adverse reactions were reported in at least 5% of subjects receiving Zemaira: headache, sinusitis, upper respiratory infection, bronchitis, fatigue, increased cough, fever, injection-site bleeding, nasal symptoms, sore throat, and swelled blood vessels.
Because Zemaira is made from human blood, the risk of transmitting infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent, cannot be completely eliminated.
Please see full Prescribing information for Zemaira.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch, or call1-800-FDA-1088.
About CSL BehringCSL Behring is a global biotherapeutics leader which is driven by its promise to save lives. Focused on serving patients’ needs by using the latest technologies, we develop and deliver innovative therapies that are used to treat coagulation disorders, primary immune deficiencies, hereditary angioedema, inherited respiratory disease, and neurological disorders. The company's products are also used in cardiac surgery, organ transplantation, burn treatment and to prevent hemolytic disease of the newborn.
CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. The parent company, CSL Limited (ASX:CSL), headquartered in Melbourne, Australia, employs more than 16,000 people with operations in more than 30 countries. For more information visit www.cslbehring.com and follow us on www.Twitter.com/CSLBehring. For more information about CSL Behring visit www.CSLBehring.com or follow us at www.Twitter.com/CSLBehring.
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