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https://hdl.handle.net/2440/104779
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dc.contributor.author | McElvaney, N. | - |
dc.contributor.author | Burdon, J. | - |
dc.contributor.author | Holmes, M. | - |
dc.contributor.author | Glanville, A. | - |
dc.contributor.author | Wark, P. | - |
dc.contributor.author | Thompson, P. | - |
dc.contributor.author | Hernandez, P. | - |
dc.contributor.author | Chlumsky, J. | - |
dc.contributor.author | Teschler, H. | - |
dc.contributor.author | Ficker, J. | - |
dc.contributor.author | Seersholm, N. | - |
dc.contributor.author | Altraja, A. | - |
dc.contributor.author | Mäkitaro, R. | - |
dc.contributor.author | Chorostowska-Wynimko, J. | - |
dc.contributor.author | Sanak, M. | - |
dc.contributor.author | Stoicescu, P. | - |
dc.contributor.author | Piitulainen, E. | - |
dc.contributor.author | Vit, O. | - |
dc.contributor.author | Wencker, M. | - |
dc.contributor.author | Tortorici, M. | - |
dc.contributor.author | et al. | - |
dc.date.issued | 2017 | - |
dc.identifier.citation | The Lancet Respiratory Medicine, 2017; 5(1):51-60 | - |
dc.identifier.issn | 2213-2600 | - |
dc.identifier.issn | 2213-2619 | - |
dc.identifier.uri | http://hdl.handle.net/2440/104779 | - |
dc.description.abstract | BACKGROUND: Purified α1 proteinase inhibitor (A1PI) slowed emphysema progression in patients with severe α1 antitrypsin deficiency in a randomised controlled trial (RAPID-RCT), which was followed by an open-label extension trial (RAPID-OLE). The aim was to investigate the prolonged treatment effect of A1PI on the progression of emphysema as assessed by the loss of lung density in relation to RAPID-RCT. METHODS: Patients who had received either A1PI treatment (Zemaira or Respreeza; early-start group) or placebo (delayed-start group) in the RAPID-RCT trial were included in this 2-year open-label extension trial (RAPID-OLE). Patients from 22 hospitals in 11 countries outside of the USA received 60 mg/kg per week A1PI. The primary endpoint was annual rate of adjusted 15th percentile lung density loss measured using CT in the intention-to-treat population with a mixed-effects regression model. This trial is registered with ClinicalTrials.gov, number NCT00670007. FINDINGS: Between March 1, 2006, and Oct 13, 2010, 140 patients from RAPID-RCT entered RAPID-OLE: 76 from the early-start group and 64 from the delayed-start group. Between day 1 and month 24 (RAPID-RCT), the rate of lung density loss in RAPID-OLE patients was lower in the early-start group (-1·51 g/L per year [SE 0·25] at total lung capacity [TLC]; -1·55 g/L per year [0·24] at TLC plus functional residual capacity [FRC]; and -1·60 g/L per year [0·26] at FRC) than in the delayed-start group (-2·26 g/L per year [0·27] at TLC; -2·16 g/L per year [0·26] at TLC plus FRC, and -2·05 g/L per year [0·28] at FRC). Between months 24 and 48, the rate of lung density loss was reduced in delayed-start patients (from -2·26 g/L per year to -1·26 g/L per year), but no significant difference was seen in the rate in early-start patients during this time period (-1·51 g/L per year to -1·63 g/L per year), thus in early-start patients the efficacy was sustained to month 48. INTERPRETATION: RAPID-OLE supports the continued efficacy of A1PI in slowing disease progression during 4 years of treatment. Lost lung density was never recovered, highlighting the importance of early intervention with A1PI treatment. FUNDING: CSL Behring. | - |
dc.description.statementofresponsibility | Noel G McElvaney, Jonathan Burdon, Mark Holmes, Allan Glanville, Peter A B Wark, Philip J Thompson … et al. | - |
dc.language.iso | en | - |
dc.publisher | Elsevier | - |
dc.rights | Copyright ©2017. Elsevier Inc. All rights reserved. | - |
dc.source.uri | http://dx.doi.org/10.1016/s2213-2600(16)30430-1 | - |
dc.subject | RAPID Extension Trial Group | - |
dc.subject | Lung | - |
dc.subject | Humans | - |
dc.subject | Pulmonary Emphysema | - |
dc.subject | alpha 1-Antitrypsin Deficiency | - |
dc.subject | Disease Progression | - |
dc.subject | alpha 1-Antitrypsin | - |
dc.subject | Serine Proteinase Inhibitors | - |
dc.subject | Respiratory Function Tests | - |
dc.subject | Total Lung Capacity | - |
dc.subject | Treatment Outcome | - |
dc.subject | Regression Analysis | - |
dc.subject | Adolescent | - |
dc.subject | Adult | - |
dc.subject | Female | - |
dc.subject | Male | - |
dc.subject | Young Adult | - |
dc.title | Long-term efficacy and safety of α1 proteinase inhibitor treatment for emphysema caused by severe α1 antitrypsin deficiency: an open-label extension trial (RAPID-OLE) | - |
dc.type | Journal article | - |
dc.identifier.doi | 10.1016/S2213-2600(16)30430-1 | - |
pubs.publication-status | Published | - |
Appears in Collections: | Aurora harvest 8 Medicine publications |
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