Managing a pregnant patient with paroxysmal nocturnal hemoglobinuria in the era of eculizumab

Leukemia Research

Volumn 34, Issue 5, 2010, Pages 566-571

  Danilov, Alexey V ^a   Brodsky, Robert A ^b   Craigo, Sabrina ^a   Smith, Hedy ^a   Miller, Kenneth B ^a  

^a TUFTS MEDICAL CENTER   (United States)

^b JOHNS HOPKINS UNIVERSITY   (United States)

Author keywords

Eculizumab; PNH; Pregnancy

Indexed keywords

ACETYLSALICYLIC ACID; BILIRUBIN; ECULIZUMAB; ENOXAPARIN; FOLIC ACID; HAPTOGLOBIN; IRON; LACTATE DEHYDROGENASE; LIVER ENZYME; LOW MOLECULAR WEIGHT HEPARIN; MENINGOCOCCUS VACCINE; PLACEBO; WARFARIN;

ACUTE KIDNEY FAILURE; ANEMIA; ANTICOAGULATION; ARTICLE; BACKACHE; CLINICAL TRIAL; DISEASE ASSOCIATION; DRUG CONTRAINDICATION; DRUG COST; DRUG EFFICACY; DRUG INDUCED HEADACHE; DRUG SAFETY; DRUG TOLERABILITY; ERYTHROCYTE TRANSFUSION; ERYTHROPOIESIS; FETUS MORTALITY; FETUS WASTAGE; HEADACHE; HEMATOLOGIC DISEASE; HUMAN; INCIDENCE; LOW DRUG DOSE; LUNG EMBOLISM; MAINTENANCE THERAPY; MATERNAL HYPERTENSION; MATERNAL MORBIDITY; MATERNAL MORTALITY; MENINGOCOCCOSIS; NAUSEA; NEURAL TUBE DEFECT; NONHUMAN; PAROXYSMAL NOCTURNAL HEMOGLOBINURIA; PATHOGENESIS; PERINATAL MORBIDITY; PREGNANCY; PREGNANCY OUTCOME; PREGNANT WOMAN; PREMATURE LABOR; PRIORITY JOURNAL; PROTEINURIA; RECOMMENDED DRUG DOSE; RHINOPHARYNGITIS; THROMBOCYTE ACTIVATION; THROMBOCYTE TRANSFUSION; THROMBOCYTOPENIA; THROMBOEMBOLISM; THROMBOPHILIA; THROMBOTIC THROMBOCYTOPENIC PURPURA; UNSPECIFIED SIDE EFFECT; VENOUS THROMBOEMBOLISM; VISUAL DISORDER;

EID: 77950072511     PISSN: 01452126     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.leukres.2009.10.025     Document Type: Review

References (50)

1. Brodsky R.A. Narrative review: paroxysmal nocturnal hemoglobinuria: the physiology of complement-related hemolytic anemia. Ann Intern Med 2008, 148:587-595.
2. Socie G., Mary J.Y., de Gramont A., Rio B., Leporrier M., Rose C., et al. Paroxysmal nocturnal haemoglobinuria: long-term follow-up and prognostic factors. French Society of Haematology. Lancet 1996, 348:573-577.
3. de Latour R.P., Mary J.Y., Salanoubat C., Terriou L., Etienne G., Mohty M., et al. Paroxysmal nocturnal hemoglobinuria: natural history of disease subcategories. Blood 2008, 112:3099-3106.
4. Hillmen P., Lewis S.M., Bessler M., Luzzatto L., Dacie J.V. Natural history of paroxysmal nocturnal hemoglobinuria. N Engl J Med 1995, 333:1253-1258.
5. Gralnick H.R., Vail M., McKeown L.P., Merryman P., Wilson O., Chu I., et al. Activated platelets in paroxysmal nocturnal haemoglobinuria. Br J Haematol 1995, 91:697-702.
6. Hugel B., Socie G., Vu T., Toti F., Gluckman E., Freyssinet J.M., et al. Elevated levels of circulating procoagulant microparticles in patients with paroxysmal nocturnal hemoglobinuria and aplastic anemia. Blood 1999, 93:3451-3456.
7. Liebman H.A., Feinstein D.I. Thrombosis in patients with paroxysmal noctural hemoglobinuria is associated with markedly elevated plasma levels of leukocyte-derived tissue factor. Thromb Res 2003, 111:235-238.
8. Grunewald M., Siegemund A., Grunewald A., Schmid A., Koksch M., Schopflin C., et al. Plasmatic coagulation and fibrinolytic system alterations in PNH: relation to clone size. Blood Coagul Fibrinol 2003, 14:685-695.
9. Moyo V.M., Mukhina G.L., Garrett E.S., Brodsky R.A. Natural history of paroxysmal nocturnal haemoglobinuria using modern diagnostic assays. Br J Haematol 2004, 126:133-138.
10. Hall C., Richards S., Hillmen P. Primary prophylaxis with warfarin prevents thrombosis in paroxysmal nocturnal hemoglobinuria (PNH). Blood 2003, 102:3587-3591.
11. Franchini M. Haemostasis and pregnancy. Thromb Haemost 2006, 95:401-413.
12. Sattar N., Greer I.A., Rumley A., Stewart G., Shepherd J., Packard C.J., et al. A longitudinal study of the relationships between haemostatic, lipid, and oestradiol changes during normal human pregnancy. Thromb Haemost 1999, 81:71-75.
13. Cerneca F., Ricci G., Simeone R., Malisano M., Alberico S., Guaschino S Coagulation and fibrinolysis changes in normal pregnancy. Increased levels of procoagulants and reduced levels of inhibitors during pregnancy induce a hypercoagulable state, combined with a reactive fibrinolysis. Eur J Obstet Gynecol Reprod Biol 1997, 73:31-36.
14. Ageno W., Squizzato A., Garcia D., Imberti D. Epidemiology and risk factors of venous thromboembolism. Semin Thromb Hemost 2006, 32:651-658.
15. Chang J., Elam-Evans L.D., Berg C.J., Herndon J., Flowers L., Seed K.A., et al. Pregnancy-related mortality surveillance-United States, 1991-1999. MMWR Surveill Summ 2003, 52:1-8.
16. Heit J.A., Kobbervig C.E., James A.H., Petterson T.M., Bailey K.R., Melton L.J. Trends in the incidence of venous thromboembolism during pregnancy or postpartum: a 30-year population-based study. Ann Intern Med 2005, 143:697-706.
17. Bjorge L., Ernst P., Haram K.O. Paroxysmal nocturnal hemoglobinuria in pregnancy. Acta Obstet Gynecol Scand 2003, 82:1067-1071.
18. Parker C., Omine M., Richards S., Nishimura J., Bessler M., Ware R., et al. Diagnosis and management of paroxysmal nocturnal hemoglobinuria. Blood 2005, 106:3699-3709.
19. Ray J.G., Burows R.F., Ginsberg J.S., Burrows E.A. Paroxysmal nocturnal hemoglobinuria and the risk of venous thrombosis: review and recommendations for management of the pregnant and nonpregnant patient. Haemostasis 2000, 30:103-117.
20. Bais J., Pel M., von dem Borne A., van der Lelie H. Pregnancy and paroxysmal nocturnal hemoglobinuria. Eur J Obstet Gynecol Reprod Biol 1994, 53:211-214.
21. Fieni S., Bonfanti L., Gramellini D., Benassi L., Delsignore R. Clinical management of paroxysmal nocturnal hemoglobinuria in pregnancy: a case report and updated review. Obstet Gynecol Surv 2006, 61:593-601.
22. Hill A., Rother R.P., Hillmen P. Improvement in the symptoms of smooth muscle dystonia during eculizumab therapy in paroxysmal nocturnal hemoglobinuria. Haematologica 2005, 90:ECR40.
23. Tichelli A., Socie G., Marsh J., Barge R., Frickhofen N., McCann S., et al. Outcome of pregnancy and disease course among women with aplastic anemia treated with immunosuppression. Ann Intern Med 2002, 137:164-172.
24. James A.H., Tapson V.F., Goldhaber S.Z. Thrombosis during pregnancy and the postpartum period. Am J Obstet Gynecol 2005, 193:216-219.
25. Hillmen P., Muus P., Duhrsen U., Risitano A.M., Schubert J., Luzzatto L., et al. Effect of the complement inhibitor eculizumab on thromboembolism in patients with paroxysmal nocturnal hemoglobinuria. Blood 2007, 110:4123-4128.
26. Bates S.M., Greer I.A., Hirsh J., Ginsberg J.S. Use of antithrombotic agents during pregnancy: the Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy. Chest 2004, 126:627S-644S.
27. Wesseling J., Van Driel D., Heymans H.S., Rosendaal F.R., Geven-Boere L.M., Smrkovsky M., et al. Coumarins during pregnancy: long-term effects on growth and development of school-age children. Thromb Haemost 2001, 85:609-613.
28. McKenna R., Cole E.R., Vasan U. Is warfarin sodium contraindicated in the lactating mother?. J Pediatr 1983, 103:325-327.
29. Meyers G., Parker C.J. Management issues in paroxysmal nocturnal hemoglobinuria. Int J Hematol 2003, 77:125-132.
30. Greer I.A., Nelson-Piercy C. Low-molecular-weight heparins for thromboprophylaxis and treatment of venous thromboembolism in pregnancy: a systematic review of safety and efficacy. Blood 2005, 106:401-407.
31. Furlan A., Vianello F., Clementi M., Prandoni P. Heparin-induced thrombocytopenia occurring in the first trimester of pregnancy: successful treatment with lepirudin. A case report. Haematologica 2006, 91:ECR40.
32. Mazzolai L., Hohlfeld P., Spertini F., Hayoz D., Schapira M., Duchosal M.A. Fondaparinux is a safe alternative in case of heparin intolerance during pregnancy. Blood 2006, 108:1569-1570.
33. Mehta R., Golichowski A. Treatment of heparin induced thrombocytopenia and thrombosis during the first trimester of pregnancy. J Thromb Haemost 2004, 2:1665-1666.
34. Lindhoff-Last E., Kreutzenbeck H.J., Magnani H.N. Treatment of 51 pregnancies with danaparoid because of heparin intolerance. Thromb Haemost 2005, 93:63-69.
35. Bates S.M., Greer I.A., Pabinger I., Sofaer S., Hirsh J. Venous thromboembolism, thrombophilia, antithrombotic therapy, and pregnancy: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th edition). Chest 2008, 133:844S-886S.
36. Fox N.S., Laughon S.K., Bender S.D., Saltzman D.H., Rebarber A. Anti-factor Xa plasma levels in pregnant women receiving low molecular weight heparin thromboprophylaxis. Obstet Gynecol 2008, 112:884-889.
37. Ray J.G., Chan W.S. Deep vein thrombosis during pregnancy and the puerperium: a meta-analysis of the period of risk and the leg of presentation. Obstet Gynecol Surv 1999, 54:265-271.
38. Thomas T.C., Rollins S.A., Rother R.P., Giannoni M.A., Hartman S.L., Elliott E.A., et al. Inhibition of complement activity by humanized anti-C5 antibody and single-chain Fv. Mol Immunol 1996, 33:1389-1401.
39. Rother R.P., Rollins S.A., Mojcik C.F., Brodsky R.A., Bell L. Discovery and development of the complement inhibitor eculizumab for the treatment of paroxysmal nocturnal hemoglobinuria. Nat Biotechnol 2007, 25:1256-1264.
40. Hillmen P., Young N.S., Schubert J., Brodsky R.A., Socie G., Muus P., et al. The complement inhibitor eculizumab in paroxysmal nocturnal hemoglobinuria. N Engl J Med 2006, 355:1233-1243.
41. Brodsky R.A., Young N.S., Antonioli E., Risitano A.M., Schrezenmeier H., Schubert J., et al. Multicenter phase 3 study of the complement inhibitor eculizumab for the treatment of patients with paroxysmal nocturnal hemoglobinuria. Blood 2008, 111:1840-1847.
42. Brodsky R.A. Advances in the diagnosis and therapy of paroxysmal nocturnal hemoglobinuria. Blood Rev 2008, 22:65-74.
43. Hill A., Hillmen P., Richards S.J., Elebute D., Marsh J.C., Chan J., et al. Sustained response and long-term safety of eculizumab in paroxysmal nocturnal hemoglobinuria. Blood 2005, 106:2559-2565.
44. Hillmen P. The role of complement inhibition in PNH. Hematology: American Society of Hematology Education Program Book 2008, American Society of Hematology, San Francisco, p. 116-123.
45. Davis J. Eculizumab. Am J Health Syst Pharm 2008, 65:1609-1615.
46. Garty B.Z., Ludomirsky A., Danon Y.L., Peter J.B., Douglas S.D. Placental transfer of immunoglobulin G subclasses. Clin Diagn Lab Immunol 1994, 1:667-669.
47. Hillmen P. Eculizumab in paroxysmal nocturnal hemoglobinuria. N Engl J Med 2006, 355:2786-2788.
48. Kelly R., Arnold L.M., Richards S.J., Hill A., Bomken C., Hanley J., et al. Successful pregnancy outcome in paroxysmal nocturnal haemoglobinuria on long term eculizumab. 14th Congress of the European Hematology Association. Haematologica 2009, 452.
49. Danilov A.V., Smith H., Craigo S., Feeney D.M., Relias V., Miller K.B. Paroxysmal nocturnal hemoglobinuria (PNH) and pregnancy in the era of eculizumab. Leuk Res 2009, 33:e4-e5.
50. Nava-Ocampo A.A., Koren G. Human teratogens and evidence-based teratogen risk counseling: the Motherisk approach. Clin Obstet Gynecol 2007, 50:123-131.