Results of RAPID study of Zemaira (alpha1 antitrypsin) in patients with alpha-1 antitrypsin deficiency published in The Lancet Resp Medicine- CSL Behring
CSL Behring announced that The Lancet Respiratory Medicine published findings of the RAPID Open Label Extension study of Zemaira (alpha1 antitrypsin) 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.
See: "Long-term efficacy and safety of ?1 proteinase inhibitor treatment for emphysema caused by severe ?1 antitrypsin deficiency: an open-label extension trial (RAPID-OLE)" Prof Noel G McElvaney et al. The Lancet Resp Med 1 December 2016 http://dx.doi.org/10.1016/S2213-2600(16)30430-1
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