Effect of Intravenous Interferon β-1a on Death and Days Free from Mechanical Ventilation among Patients with Moderate to Severe Acute Respiratory Distress Syndrome: A Randomized Clinical Trial

JAMA - Journal of the American Medical Association

Volumn 323, Issue 8, 2020, Pages 725-733

  Ranieri, V Marco ^a   Pettilä, Ville ^b   Karvonen, Matti K ^c   Jalkanen, Juho ^c   Nightingale, Peter ^d   Brealey, David ^e   Mancebo, Jordi ^f   Ferrer, Ricard ^g   Mercat, Alain ^h   Patroniti, Nicolò ⁱ   Quintel, Michael ^j   Vincent, Jean Louis ^k   Okkonen, Marjatta ^b   Meziani, Ferhat ^l   Bellani, Giacomo ^m   MacCallum, Niall ^e   Creteur, Jacques ^k   Kluge, Stefan ⁿ   Artigas Raventos, Antonio ^o   Maksimow, Mikael ^c   Piippo, Ilse ^c   Elima, Kati ^p   Jalkanen, Sirpa ^p   Jalkanen, Markku ^c   Bellingan, Geoff ^e   more..

^a UNIVERSITY OF BOLOGNA   (Italy)

^b UNIVERSITY OF HELSINKI   (Finland)

^c Faron Pharmaceuticals Ltd   (Finland)

^d WYTHENSHAWE HOSPITAL   (United Kingdom)

^e UNIVERSITY COLLEGE LONDON HOSPITALS   (United Kingdom)

^f HOSPITAL DE LA SANTA CREU I SANT PAU   (Spain)

^g HOSPITAL UNIVERSITARI VALL D HEBRON   (Spain)

^h UNIVERSITÉ D'ANGERS   (France)

ⁱ UNIVERSITY OF GENOA   (Italy)

^j UNIVERSITY MEDICAL CENTER GÖTTINGEN   (Germany)

^k ERASME HOSPITAL   (Belgium)

^l UNIVERSITÉ DE STRASBOURG   (France)

^m SAN GERARDO HOSPITAL   (Italy)

ⁿ UNIVERSITY MEDICAL CENTER HAMBURG EPPENDORF   (Germany)

^o UNIVERSITAT AUTÒNOMA DE BARCELONA   (Spain)

^p UNIVERSITY OF TURKU   (Finland)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ALKALINE PHOSPHATASE; ASPARTATE AMINOTRANSFERASE; BETA1A INTERFERON; CREATINE KINASE; MYOGLOBIN; PLACEBO; CORTICOSTEROID; IMMUNOLOGICAL ADJUVANT;

ADULT; ADULT RESPIRATORY DISTRESS SYNDROME; ALKALINE PHOSPHATASE BLOOD LEVEL; ARTERIAL OXYGEN TENSION; ARTICLE; ARTIFICIAL VENTILATION; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; COHORT ANALYSIS; CONTROLLED STUDY; CREATINE KINASE BLOOD LEVEL; DIARRHEA; DISEASE CLASSIFICATION; DISEASE SEVERITY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; EUROPE; FEMALE; FEVER; HUMAN; HYPERBILIRUBINEMIA; HYPERTENSION; HYPERTRANSAMINASEMIA; INTENSIVE CARE UNIT; LIVER CELL DAMAGE; LIVER FAILURE; LIVER TOXICITY; MAJOR CLINICAL STUDY; MALE; MIDDLE AGED; MORTALITY; MULTICENTER STUDY; OXYGEN TENSION; PLEURA EFFUSION; PRIORITY JOURNAL; RADIOLOGICAL PROCEDURES; RANDOMIZED CONTROLLED TRIAL; RHABDOMYOLYSIS; SCORING SYSTEM; SIDE EFFECT; TREATMENT OUTCOME; CLINICAL TRIAL; COMBINATION DRUG THERAPY; DRUG INTERACTION; INTRAVENOUS DRUG ADMINISTRATION; PHASE 3 CLINICAL TRIAL; RESPIRATORY DISTRESS SYNDROME; SAMPLE SIZE; TREATMENT FAILURE; VENTILATOR WEANING;

ADJUVANTS, IMMUNOLOGIC; ADRENAL CORTEX HORMONES; ADULT; DOUBLE-BLIND METHOD; DRUG INTERACTIONS; DRUG THERAPY, COMBINATION; FEMALE; HUMANS; INJECTIONS, INTRAVENOUS; INTERFERON BETA-1A; MALE; MIDDLE AGED; RESPIRATION, ARTIFICIAL; RESPIRATORY DISTRESS SYNDROME; SAMPLE SIZE; TREATMENT FAILURE; VENTILATOR WEANING;

EID: 85079669051     PISSN: 00987484     EISSN: 15383598     Source Type: Journal    
DOI: 10.1001/jama.2019.22525     Document Type: Article

References (26)

1. Ranieri VM, Rubenfeld GD, Thompson BT,; ARDS Definition Task Force. Acute respiratory distress syndrome: The Berlin Definition. JAMA. 2012; 307 (23): 2526-2533. 22797452
2. Matthay MA, Zemans RL, Zimmerman GA, Acute respiratory distress syndrome. Nat Rev Dis Primers. 2019; 5 (1): 18. doi: 10.1038/s41572-019-0069-0 30872586
3. Bellani G, Laffey JG, Pham T,; LUNG SAFE Investigators; ESICM Trials Group. Epidemiology, patterns of care, and mortality for patients with acute respiratory distress syndrome in intensive care units in 50 countries. JAMA. 2016; 315 (8): 788-800. doi: 10.1001/jama.2016.0291 26903337
4. Ohta A, Sitkovsky M. Role of G-protein-coupled adenosine receptors in downregulation of inflammation and protection from tissue damage. Nature. 2001; 414 (6866): 916-920. doi: 10.1038/414916a 11780065
5. Thompson LF, Eltzschig HK, Ibla JC, Crucial role for ecto-5′-nucleotidase (CD73) in vascular leakage during hypoxia. J Exp Med. 2004; 200 (11): 1395-1405. doi: 10.1084/jem.20040915 15583013
6. Kiss J, Yegutkin GG, Koskinen K, Savunen T, Jalkanen S, Salmi M. IFN-beta protects from vascular leakage via up-regulation of CD73. Eur J Immunol. 2007; 37 (12): 3334-3338. doi: 10.1002/eji.200737793 18034430
7. Aeffner F, Woods PS, Davis IC. Activation of A1-adenosine receptors promotes leukocyte recruitment to the lung and attenuates acute lung injury in mice infected with influenza A/WSN/33 (H1N1) virus. J Virol. 2014; 88 (17): 10214-10227. doi: 10.1128/JVI.01068-14 24965449
8. Bellingan G, Maksimow M, Howell DC, The effect of intravenous interferon-beta-1a (FP-1201) on lung CD73 expression and on acute respiratory distress syndrome mortality: An open-label study. Lancet Respir Med. 2014; 2 (2): 98-107. doi: 10.1016/S2213-2600(13)70259-5 24503265
9. Bellingan G, Brealey D, Mancebo J, Comparison of the efficacy and safety of FP-1201-lyo (intravenously administered recombinant human interferon beta-1a) and placebo in the treatment of patients with moderate or severe acute respiratory distress syndrome: Study protocol for a randomized controlled trial. Trials. 2017; 18 (1): 536. doi: 10.1186/s13063-017-2234-7 29132404
10. Ferguson ND, Fan E, Camporota L, The Berlin definition of ARDS: An expanded rationale, justification, and supplementary material. Intensive Care Med. 2012; 38 (10): 1573-1582. doi: 10.1007/s00134-012-2682-1 22926653
11. Knaus WA, Draper EA, Wagner DP, Zimmerman JE. APACHE II: A severity of disease classification system. Crit Care Med. 1985; 13 (10): 818-829. doi: 10.1097/00003246-198510000-00009 3928249
12. Brower RG, Matthay MA, Morris A, Schoenfeld D, Thompson BT, Wheeler A; Acute Respiratory Distress Syndrome Network. Ventilation with lower tidal volumes as compared with traditional tidal volumes for acute lung injury and the acute respiratory distress syndrome. N Engl J Med. 2000; 342 (18): 1301-1308. doi: 10.1056/NEJM200005043421801 10793162
13. Guérin C, Reignier J, Richard JC,; PROSEVA Study Group. Prone positioning in severe acute respiratory distress syndrome. N Engl J Med. 2013; 368 (23): 2159-2168. doi: 10.1056/NEJMoa1214103 23688302
14. Wiedemann HP, Wheeler AP, Bernard GR,; National Heart, Lung, and Blood Institute Acute Respiratory Distress Syndrome (ARDS) Clinical Trials Network. Comparison of two fluid-management strategies in acute lung injury. N Engl J Med. 2006; 354 (24): 2564-2575. doi: 10.1056/NEJMoa062200 16714767
15. Thompson BT, Ranieri VM. Steroids are part of rescue therapy in ARDS patients with refractory hypoxemia: No. Intensive Care Med. 2016; 42 (5): 921-923. doi: 10.1007/s00134-016-4255-1 26883256
16. Finkelstein DM, Schoenfeld DA. Combining mortality and longitudinal measures in clinical trials. Stat Med. 1999; 18 (11): 1341-1354. doi: 10.1002/(SICI)1097-0258(19990615)18:11<1341::AID-SIM129>3.0.CO;2-7 10399200
17. Vallittu AM, Erälinna JP, Ilonen J, Salmi AA, Waris M. MxA protein assay for optimal monitoring of IFN-beta bioactivity in the treatment of MS patients. Acta Neurol Scand. 2008; 118 (1): 12-17. doi: 10.1111/j.1600-0404.2007.00968.x 18081914
18. Vincent JL, Moreno R, Takala J, The SOFA (Sepsis-related Organ Failure Assessment) score to describe organ dysfunction/failure: On behalf of the Working Group on Sepsis-Related Problems of the European Society of Intensive Care Medicine. Intensive Care Med. 1996; 22 (7): 707-710. doi: 10.1007/BF01709751 8844239
19. Maksimow M, Kyhälä L, Nieminen A, Early prediction of persistent organ failure by soluble CD73 in patients with acute pancreatitis. Crit Care Med. 2014; 42 (12): 2556-2564. doi: 10.1097/CCM.0000000000000550 25126879
20. Flammer JR, Dobrovolna J, Kennedy MA, The type I interferon signaling pathway is a target for glucocorticoid inhibition. Mol Cell Biol. 2010; 30 (19): 4564-4574. doi: 10.1128/MCB.00146-10 20679482
21. Diez D, Goto S, Fahy JV, Network analysis identifies a putative role for the PPAR and type 1 interferon pathways in glucocorticoid actions in asthmatics. BMC Med Genomics. 2012; 5: 27. doi: 10.1186/1755-8794-5-27 22713245
22. Rubenfeld GD, Caldwell E, Granton J, Hudson LD, Matthay MA. Interobserver variability in applying a radiographic definition for ARDS. Chest. 1999; 116 (5): 1347-1353. doi: 10.1378/chest.116.5.1347 10559098
23. Meade MO, Cook RJ, Guyatt GH, Interobserver variation in interpreting chest radiographs for the diagnosis of acute respiratory distress syndrome. Am J Respir Crit Care Med. 2000; 161 (1): 85-90. doi: 10.1164/ajrccm.161.1.9809003 10619802
24. Beitler JR, Sarge T, Banner-Goodspeed VM,; EPVent-2 Study Group. Effect of titrating positive end-expiratory pressure (PEEP) with an esophageal pressure-guided strategy vs an empirical high PEEP-Fio2 strategy on death and days free from mechanical ventilation among patients with acute respiratory distress syndrome: A randomized clinical trial. JAMA. 2019; 321 (9): 846-857. doi: 10.1001/jama.2019.0555 30776290
25. McCoy CE, Carpenter S, Pålsson-McDermott EM, Gearing LJ, O'Neill LA. Glucocorticoids inhibit IRF3 phosphorylation in response to Toll-like receptor-3 and-4 by targeting TBK1 activation. J Biol Chem. 2008; 283 (21): 14277-14285. doi: 10.1074/jbc.M709731200 18356163
26. Englert JA, Cho MH, Lamb AE, Whole blood RNA sequencing reveals a unique transcriptomic profile in patients with ARDS following hematopoietic stem cell transplantation. Respir Res. 2019; 20 (1): 15. doi: 10.1186/s12931-019-0981-6 30665420