Elevated D-dimers in attacks of hereditary angioedema are not associated with increased thrombotic risk

Allergy: European Journal of Allergy and Clinical Immunology

Volumn 70, Issue 5, 2015, Pages 506-513

  Reshef, Avner ^a   Zanichelli, A ^b   Longhurst, H ^c   Relan, A ^d   Hack, C E ^e  

^a SHEBA MEDICAL CENTER   (Israel)

^b UNIVERSITY OF MILAN   (Italy)

^c BARTS HEALTH NHS TRUST   (United Kingdom)

^d Pharming Group NV   (Netherlands)

^e UNIVERSITY MEDICAL CENTER UTRECHT   (Netherlands)

Author keywords

C1 esterase inhibitor; D dimer; fibrinolysis; hereditary angioedema; thromboembolism

Indexed keywords

COMPLEMENT COMPONENT C1S INHIBITOR; D DIMER; PLACEBO; FIBRIN DEGRADATION PRODUCT; FIBRIN FRAGMENT D; RECOMBINANT PROTEIN; SERPING1 PROTEIN, HUMAN;

ADULT; ANGIONEUROTIC EDEMA; ARTICLE; CARDIOVASCULAR RISK; CONTROLLED STUDY; DEEP VEIN THROMBOSIS; DISEASE ACTIVITY; DRUG EFFICACY; DRUG SAFETY; FEMALE; FIBRINOLYSIS; HUMAN; MAJOR CLINICAL STUDY; MALE; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; PROTEIN BLOOD LEVEL; RANDOMIZED CONTROLLED TRIAL; RISK ASSESSMENT; THROMBOEMBOLISM; TREATMENT OUTCOME; ADOLESCENT; AGED; BLOOD; CLINICAL TRIAL; COMPLICATION; DEFICIENCY; DOUBLE BLIND PROCEDURE; MIDDLE AGED; MULTICENTER STUDY; VENOUS THROMBOSIS; YOUNG ADULT;

ADOLESCENT; ADULT; AGED; COMPLEMENT C1 INACTIVATOR PROTEINS; DOUBLE-BLIND METHOD; FEMALE; FIBRIN FIBRINOGEN DEGRADATION PRODUCTS; HEREDITARY ANGIOEDEMA TYPES I AND II; HUMANS; MALE; MIDDLE AGED; RECOMBINANT PROTEINS; THROMBOEMBOLISM; VENOUS THROMBOSIS; YOUNG ADULT;

EID: 84926418086     PISSN: 01054538     EISSN: 13989995     Source Type: Journal    
DOI: 10.1111/all.12587     Document Type: Article

References (35)

1. Kaplan AP,. Enzymatic pathways in the pathogenesis of hereditary angioedema: the role of C1 inhibitor therapy. J Allergy Clin Immunol 2010; 126: 918-925.
2. Kluft C, Trumpi-Kalshoven MM, Jie AFH, Veldhuyzen-Stolk EC,. Factor XII-dependent fibrinolysis: a double function of plasma kallikrein and the occurrence of a previously undescribed factor XII- and kallikrein-dependent plasminogen proactivator. Thromb Haemost 1979; 41: 756-773.
3. Kleniewski J, Blankenship DT, Cardin AD, Donaldson V,. Mechanism of enhanced kinin release from high molecular weight kininogen by plasma kallikrein after its exposure to plasmin. J Lab Clin Med 1992; 120: 129-139.
4. Stavrou E, Schmaier AH,. Factor XII: what does it contribute to our understanding of the physiology and pathophysiology of hemostasis & thrombosis. Thromb Res 2010; 125: 210-215.
5. Nielsen VG,. Corn trypsin inhibitor decreases tissue-type plasminogen activator-mediated fibrinolysis of human plasma. Blood Coagul Fibrinolysis 2009; 20: 191-196.
6. Levi M, Hack CE, de Boer JP, Brandjes DP, Büller HR, ten Cate JW,. Reduction of contact activation related fibrinolytic activity in factor XII deficient patients. Further evidence for the role of the contact system in fibrinolysis in vivo. J Clin Invest 1991; 88: 1155-1160.
7. Brown NJ, Gainer JV, Stein CM, Vaughan DE,. Bradykinin stimulates tissue plasminogen activator release in human vasculature. Hypertension 1999; 33: 1431-1435.
8. Waage Nielsen E, Thidemann Johansen H, Høgåsen K, Wuillemin W, Hack CE, Mollnes TE,. Activation of the complement, coagulation, fibrinolytic and kallikrein-kinin systems during attacks of hereditary angioedema. Scand J Immunol 1996; 44: 185-192.
9. Cugno M, Hack CE, de Boer JP, Eerenberg AJ, Agostoni A, Cicardi M,. Generation of plasmin during acute attacks of hereditary angioedema. J Lab Clin Med 1993; 121: 38-43.
10. Cugno M, Cicardi M, Bottasso B, Coppola R, Paonessa R, Mannucci PM, et al. Activation of the coagulation cascade in C1-inhibitor deficiencies. Blood 1997; 89: 3213-3218.
11. Konings J, Cugno M, Suffritti C, ten Cate H, Cicardi M, Govers-Riemslag JWP,. Ongoing contact activation in patients with hereditary angioedema. PLoS One 2013; 8: e74043.
12. Bates SM,. D-dimer assays in diagnosis and management of thrombotic and bleeding disorders. Semin Thromb Hemost 2012; 38: 673-682.
13. Gandhi PK, Gentry WM, Bottorff MB,. Thrombotic events associated with C1 esterase inhibitor products in patients with hereditary angioedema: investigation from the United States Food and Drug Administration adverse event reporting system database. Pharmacotherapy 2012; 32: 902-909.
14. German Medical Profession's Drugs Committee. Severe thrombus formation of Berinert® HS. Dtsch Arztebl 2000; 97: A-1016. Available at: http://www.aerzteblatt.de/archiv/22549/Arzneimittelkommission-der-deutschen-Aerzteschaft-Schwerwiegende-Thrombenbildung-nach-Berinert-HS. Accessed January 12, 2015.
15. Horstick G, Berg O, Heimann A, Götze O, Loos M, Hafner G, et al. Application of C1-esterase inhibitor during reperfusion of ischemic myocardium: dose-related beneficial versus detrimental effects. Circulation 2001; 104: 3125-3131.
16. van Veen HA, Koiter J, Vogelezang CJM, van Wessel N, van Dam T, Velterop I, et al. Characterization of recombinant human C1 inhibitor secreted in milk of transgenic rabbits. J Biotechnol 2012; 162: 319-326.
17. Zuraw B, Cicardi M, Levy RJ, Nuijens JH, Relan A, Visscher S, et al. Recombinant human C1-inhibitor for the treatment of acute angioedema attacks in patients with hereditary angioedema. J Allergy Clin Immunol 2010; 126: 821-827.
18. Reshef A, Moldovan D, Obtulowicz K, Liebovich I, Mihaly E, Visscher S, et al. Recombinant human C1 inhibitor for the prophylaxis of hereditary angioedema attacks: a pilot study. Allergy 2013; 68: 118-124.
19. Riedl MA, Bernstein JA, Li H, Reshef A, Lumry W, Moldovan D, et al. Recombinant human C1-esterase inhibitor relieves symptoms of hereditary angioedema attacks: phase 3, randomized, placebo-controlled trial. Ann Allergy Asthma Immunol 2014; 112: 163-169.
20. Farrell C, Hayes S, Relan A, van Amersfoort ES, Pijpstra R, Hack CE,. Population pharmacokinetics of recombinant human C1 inhibitor in patients with hereditary angioedema. Br J Clin Pharmacol 2013; 76: 897-907.
21. Riedl MA, Levy RJ, Suez D, Lockey RF, Baker JW, Relan A, et al. Efficacy and safety of recombinant C1 inhibitor for the treatment of hereditary angioedema attacks: a North American open-label study. Ann Allergy Asthma Immunol 2013; 110: 295-299.
22. European Medicines Agency. Ruconest EPAR. (EMEA summary for the public). Available at: http://www.ema.europa.eu/docs/en-GB/document-library/EPAR-Public-assessment-report/human/001223/WC500098546.pdf. Accessed February 2015.
23. Wells PS, Anderson DR, Rodger M, Ginsberg JS, Kearon C, Gent M, et al. Derivation of a simple clinical model to categorize patients probability of pulmonary embolism: increasing the models utility with the SimpliRED D-dimer. Thromb Haemost 2000; 83: 416-420.
24. Cugno M, Zanichelli A, Bellatorre AG, Griffini S, Cicardi M,. Plasma biomarkers of acute attacks in patients with angioedema due to C1-inhibitor deficiency. Allergy 2009; 64: 254-257.
25. van Geffen M, Cugno M, Lap P, Loof A, Cicardi M, van Heerde W,. Alterations of coagulation and fibrinolysis in patients with angioedema due to C1-inhibitor deficiency. Clin Exp Immunol 2012; 167: 472-478.
26. Etscheid M, Breitner-Ruddock S, Gross S, Hunfeld A, Seitz R, Dodt J,. Identification of kallikrein and FXIa as impurities in therapeutic immunoglobulins: implications for the safety and control of intravenous blood products. Vox Sang 2012; 102: 40-46.
27. Relan A, Bakhtiari K, van Amersfoort ES, Meijers JCM, Hack CE,. Recombinant C1-inhibitor: effects on coagulation and fibrinolysis in patients with hereditary angioedema. BioDrugs 2012; 26: 43-52.
28. Adam SS, Key NS, Greenberg CS,. D-dimer antigen: current concepts and future prospects. Blood 2009; 113: 2878-2887.
29. von Känel R, Bellingrath S, Kudielka BM,. Association of vital exhaustion and depressive symptoms with changes in fibrin D-dimer to acute psychosocial stress. J Psychosom Res 2009; 67: 93-101.
30. Tita-Nwa F, Bos A, Adjei A, Ershler WB, Longo DL, Ferrucci L,. Correlates of D-dimer in older persons. Aging Clin Exp Res 2010; 22: 20-23.
31. Dindo D, Breitenstein S, Hahnloser D, Seifert B, Yakarisik S, Asmis LM, et al. Kinetics of D-dimer after general surgery. Blood Coagul Fibrinolysis 2009; 20: 347-352.
32. Maas C, Govers-Riemslag JWP, Bouma B, Schiks B, Hazenberg BPC, Lokhorst HM, et al. Misfolded proteins activate factor XII in humans, leading to kallikrein formation without initiating coagulation. J Clin Invest 2008; 118: 3208-3218.
33. Shariat-Madar Z, Mahdi F, Warnock M, Homeister JW, Srikanth S, Krijanovski Y, et al. Bradykinin B2 receptor knockout mice are protected from thrombosis by increased nitric oxide and prostacyclin. Blood 2006; 108: 192-199.
34. de Maat S, de Groot PG, Maas C,. Contact system activation on endothelial cells. Semin Thromb Hemost 2014; 40: 887-894.
35. Kajdácsi E, Jani PK, Csuka D, Varga LÁ, Prohászka Z, Farkas H, et al. Endothelial cell activation during edematous attacks of hereditary angioedema types I and II. J Allergy Clin Immunol 2014; 133: 1686-1691.