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3. 93rd annual convention podium and poster abstracts

Author

Davis, C. M., Strong, S. A., Hellinger, M. D., Williamson, P. R., Larach, S. W., Ferrara, A., Blake, T. B., Medich, D. S., Ziv, Y., Oakley, J. R., Reissman, P., Piccirillo, M., Ulrich, A., Nogueras, J. J., Wexner, S. D., Rubin, M. S., Bodenstein, L. E., Kent, K. C., Williamson, M. E. R., Lewis, W. G., Sagar, P. M., Holdsworth, P. J., Johnston, D., Fazio, V. W., Goldblum, J. R., Sirimarco, M. T., Lavery, I. C., Petras, R. E., Treem, W. R., Cohen, J., Davis, P. M., Hyams, J. S., Eu, K. W., Bartolo, D. C. C., Green, J. D., Riether, R. D., Rosen, L., Stasik, J. J., Sheets, J. A., Reed, J., Khubchandani, I. T., Armitage, N. C., Chapman, M., Hardcastle, J. D., Viamonte, M., Plasencia, G., Wiltz, O., Jacobs, M., Finan, P. J., Passaro, M., Church, J. M., McGannon, E., Wilson, M., Hull-Boiner, S., Kollmorgen, C. F., Meagher, A. P., Wolff, B. G., Pemberton, J. H., Martenson, J. A., Ilstrup, D. M., Moran, M. R., Ramos, A., Rothenberger, D. A., Goldberg, S. M., Johnson, D., Madoff, R. D., Wong, W. D., Finne, III, C. O., Konishi, F., Furuta, K., Kanazawa, K., Lockhart, D., Schmitt, S., Caushaj, P. P., Garcia-Aguilar, J., Belmonte, C., Schiesel, E. C., Mazier, W. P., Senagore, A. J., Piccirillo, M. F., Teoh, T. -A., Yoon, K. -S., Paul, R. A. Patino, Lucas, J., Nelson, R., Norton, N., Cautley, E., Schouten, W. R., Briel, J. W., Auwerda, J. J. A., de Graaf, E. J. R., Lowry, A. C., Sentovich, S. M., Blatchford, G. J., Rivela, L. J., Thorson, A. G., Christensen, M. A., Jorge, J. M. N., Yang, Y. K., Shafik, A., Allendorf, J. D. F., Kayton, M. L., Libutti, S. K., Trokel, M. J., Whelan, R. L., Treat, M. R., Nowygrod, R., Bessler, M., Frank, R. E., Saclarides, T. J., Leurgans, S., Speziale, N. J., Drab, E., Rubin, D., Hull, T. L., Schroeder, T. K., Scholefield, J. H., Ogunbiyi, O. A., Smith, J. H. F., Rogers, K., Sharp, F., Longo, W. E., Vernava, III, A. M., Wade, T. P., Coplin, M. A., Virgo, K. S., Johnson, F. E., Brady, M., Kavolius, J., Quan, S. H. Q., Goldstein, E. T., Feldman, S., Shub, H. A., Bennett, D. R., Kumar, R., McMillen, M. A., Thornton, S., Khoury, D. A., Opelka, F. G., Teoh, T -A., Cohen, S. M., Weiss, E. G., Ortiz, H., De Miguel, M., Armendáriz, P., Rodriguez, J., Chocarro, C., Farouk, R., Dorrance, H. R., Duthie, G. S., Rainey, J. B., Morgado, Jr., P. J., Corman, M. L., Kawamura, Y. J., Sawada, T., Muto, T., Nagai, H., Hill, J., MacLennan, I., Binderow, S. R., Daniel, N., Ehrenpreis, E. D., Jensen, J. E., Bonner, G. F., Ruderman, W. B., Milsom, J. W., Gibbs, D. H., Beck, D. E., Hicks, T. C., Timmcke, A. E., Gathright, Jr, J. B., Cheong, D., Lucas, F. V., McGinity, M., Taylor, B. A., Godwin, P., Holdsworth, P., Lewis, W., Quirke, P., Williamson, M., Kokoszka, J., Pavel, D., Abcarian, H., Stephenson, B. M., Morgan, A. R., Salaman, J. R., Wheeler, M. H., Tran, T. C. K., Willemsen, W., Kuijpers, H. C., Lehman, J. F., Wiseman, J. S., MacFie, J., Sedman, P., May, J., Mancey-Jones, B., Johnstone, D., Nwariaku, F. E., Rochon, R. B., Huber, P. J., Carrico, C. J., Ortega, A., Beart, R., Winchester, D., Steele, G., Green, R., Caushaj, P. F., Devereaux, D., Griffey, S., Reiver, D., Kmiot, W. A., Baker, R., Luchtefeld, M. A., Anthone, G., Schlinkert, R., Roig, J. V., Villoslada, C., Solana, A., Alos, R., Hinojosa, J., Lledo, S., Johnson, D. R. E., Buie, W. D., Jensen, L. L., Heine, J., Hoffmann, B., Timmcke, A., Hicks, T., Opelka, F., Beck, D., Sousa, Jr., A., AraÚjo, S. A., Damico, F. M., Cordeiro, A. C., Pinotti, H. W., Gama, A. H., Fengler, S., Pearl, R., Orsay, C., Seow-Choen, F., Ho, J. M. S., Wiltz, O. H., Torregrosa, M., Brasch, R. C., Bufo, A. J., Krienberg, P., Johnson, G. P., Gowen, G. F., Mullen, P. D., Behrens, D., Hughes, T. G., Wynn, M., Pollack, J. S., Rajagopal, A. S., Huynh, T., Schanbacher, C., Hickson, W. G. E., Yang, Y. -K., Heymen, S., Choi, S. -K., Teoh, T. -A., Wexner, S. D., Vaccaro, C. A., Teoh, T. A., Nogueras, J. J., Choi, S. K., Cheong, D. M. O., Salanga, V. D., MacDonald, A., Baxter, J. N., Finlay, I. G., Mellgren, A., Bremmer, S., Dolk, A., Gillgren, P., Johansson, C., Ahlbäck, S. O., Udén, R., Holmström, B., Ferrara, A., O'Donovan, S., Larach, S. W., Williamson, P. R., Neto, J. A. Reis, Ciquini, S., Quilici, F. A., Reis, Jr., J. A., Torrabadella, L., Salgado, G., Whelan, R. L., Horvath, K. D., Golub, R., Ahsan, H., Cirocco, W., Ziv, Y., Fazio, V. W., Oakley, J. R., Church, J. M., Milsom, J. W., Lavery, L. C., Cohen, S. M., Kmiot, W. A., Reiver, D., Reissman, P., Weiss, E. G., Alós, R., García-Granero, E., Roig, J. V., Uribe, N., Sala, C., Lledo, S., Ozuner, G., Strong, S. A., Bufo, A. J., Daniels, G., Lieberman, R. C., Feldman, S., Lucas, F. V., Longo, W. E., Polites, G., Deshpande, Y., Vernava, A. M., Niehoff, M., Chandel, B., Berglund, D. D., Madoff, R. D., Gemlo, B. T., Spencer, M. P., Goldberg, S. M., Lowry, A. C., Marcello, P. W., Roberts, P. L., Schoetz, D. J., Murray, J. J., Coller, J. A., Veidenheimer, M. C., Koltun, W. A., Bloomer, M. M., Colony, P., Ruggeiro, F., Fleshner, P. R., Michelassi, F., Lewis, W., Williamson, M., Holdsworth, P., Finan, P., Ash, D., Johnston, D., Moran, M. R., Ramos, A., Rothenberger, D. A., Antonenko, D. R., Khanduja, K. S., Fitzgerald, S. D., Meagher, A. P., Moniz-Pereira, P., Wolff, B. G., Outwater, E. K., Marks, G. J., Mohiuddin, M., Sagar, P. M., Hartley, M. N., Mancey-Jones, B., Sedman, P., May, J., MacFie, J., Holbrook, R. F., Rodriguez-Bigas, M. A., Ramakrishnan, K., Palmer, M. L., Petrelli, N. J., Takahashi, T., Nivatvongs, S., Batts, K. P., Lucas, S. W., Klein, S. N., Keidan, R. D., Bannon, J. P., Zhou, J., Armitage, N. C., Hunt, L. M., Robinson, M. H., Hugkulstone, C. E., Clarke, B., Vernon, S. A., Gregson, R. H., Hardcastle, J. D., Ryan, M., Dutta, S., Levine, A., Ortega, A., Anthone, G., Beart, R., Dominguez, J. M., Saclarides, T. J., Bolan, P., Bines, S. D., Adachi, M., Watanabe, T., Sawada, T., Okinaga, K., Muto, T., Hase, K., Shatney, C., Mochizuki, H., Johnson, D., Ure, T., Dehghan, K., Andrus, C. A., Daniel, G. L., D'Emilia, J. C., Rodriguez-Bigas, M., Suh, O. K., Brewer, D. A., Fung, C., Chapuis, P., Bokey, E. L., Garcia, J. C., Banerjee, S., Remzi, F. H., Lavery, I. C., Jorge, J. M. N., Ger, G. C., Gonzalez, L., Gee, A. S., Roe, A. M., Durdey, P., Kaye, M. D., Kyzer, S., Gordon, P. H., Hasegawa, M., Bun, P. Tae, Ikeuchi, D., Onodera, H., Imamura, M., Maetani, S., Blake, T., Hellinger, M., Grewal, H., Klimstra, D. S., Cohen, A. M., Guillem, J. G., Rooney, P. S., Gifford, K. -A., Clarke, P. A., Kuhn, J. A., Bryce, K., Frank, N., Dignan, R. D., Lichliter, W. E., Franko, E., Jacobson, R. M., Preskitt, J. T., Lieberman, Z., Tulanon, P., Steinbach, H., McCarty, T., Simons, T., Plasencia, G., Viamonte, M., Wiltz, O., Jacobs, M., Chen, W. S., Leu, S. Y., Hsu, H., Bessler, M., Halverson, A., Kayton, M. L., Treat, M. R., Nowygrod, R., Congilosi, S., Madoff, R., Wong, W. D., Rothenberger, D., Buie, W. D., Paterson, R., Cartmill, J. A., Trokel, M. J., Gingold, B. S., Cooper, M., Gorfine, S. R., Bauer, J. J., Gelernt, I. M., Kreel, I., Harris, M. T., Vallejo, J. F., Kestenberg, A., Miyajima, N., Kano, N., Ishikawa, Y., Sakai, S., Yamakawa, T., Otchy, D. P., Van Heerden, J. A., Ilstrup, D. M., Weaver, A. L., Winter, L. D., Mav, J., Lee, P. Y., Vetto, J. T., Sullivan, E. S., Rabkin, J., Mayoral, J. L., Matas, A. J., Bove, P., Visser, T., Barkel, D., Villalba, M., Bendick, P., Glover, J., Golub, R. W., Cirocco, W. C., Daniel, N., Altringer, W., Domingues, J. M., Brubaker, L. T., Smith, C. S., Kumar, S., and Gilbert, P.

Published
1994
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29. American Society of Colon and Rectal Surgeons 95th Annual Convention Podium and Poster Abstracts June 9–14, 1996 Seattle, Washington

Author

Obrand, D., Gordon, P. H., Rowley, S., Grace, R. H., Rai, S., Moran, M. R., Rai, A. M., Farouk, R., Lee, P. W. R., Edwards, J., Thorne, M., MacDonald, A. W., Duthie, G. S., Monson, J. R. T., Shabahang, M., Brenner, R., Wright, A., Montgomery, E., Trock, B., Buras, R., Schumaker, L., Nolla, J., Buffan, A., Uskokovic, M., Nauta, R., Evans, S., Velázquez, O. C., Zhou, D., Seto, R. W., Choi, J., Jabbar, A., Breen, F., Rombeau, J. L., Casillas, S., Dietz, D. W., Brand, M. I., Vladisavljevic, A., Jones, S. C., Milsom, J. W., Stuntz, M., Wilmoth, G., Ong, J., Stabile, B., Stamos, M. J., Kahn, H., Alexander, A., Rakinic, J., Nagle, D., Fry, R., Simons, A. J., Kerr, R., Toms, C., Groshen, S., Ross, R., Morris, M., Beart, R., Ortega, A., Anthone, G., Lucha, P., Rosen, L., Stasik, J., Olenwine, J., Riether, R., Khubchandani, I., Ogunbivi, O., Birnbaum, E., Fleshman, J., Kodner, I., McLeod, R. S., Geerts, W., Sniderman, K., Greenwood, C., Gregoire, R., Taylor, B., Silverman, R., Atkinson, K., Burnstein, M., Marshall, J., Burul, C., Anderson, D., Ross, T., Wilson, S., Barton, P., Maetani, S., Onodera, H., Morimoto, H., Imamura, M., Hyams, D. M., Mamounas, E., Petrelli, N., Rockette, H., Jones, J., Wolmark, N., Sofo, L., Ratto, C., Valentini, V., Ippoliti, M., Nucera, P., Merico, M., Bellantone, R., Doglietto, G. B., Crucitti, F., Goes, R., Simons, A., Gunderson, L., Grado, G., Streeter, O., Sun, J. H., Decanini-Garza, P., Kim, D. G., Wong, W. D., Rothenberger, D. A., Madoff, R. D., Madlensky, L., Berk, T., Bapat, B., Redston, M., Gallinger, S., Cohen, Z., Winde, G., Schmid, K. W., Brandt, B., Müller, R., Osswald, H., Jang, Y., Steinhagen, R., Heimann, T., Schnitzler, M., Blackstein, M., McLeod, R., Devesa, J. M., Madrid, J. M. Fernandez, Enriquez, J. M., Geerdes, B. P., Heineman, E., Konsten, J., Baeten, C. G. M., Michot, F., Lehur, P. A., Denis, P., Grise, P. H., Leborgne, J., Teniere, P., Buzelin, J. M., Stebbing, J. F., Brading, A. F., Mortensen, N. J. McC, Gunn, J., Gardiner, A., Abdullah, N., Nyam, D. C. N. K., Pemberton, J. H., Ilstrup, D., Lund, J. N., Scholefield, J. H., Stamm, L., Matzel, K. E., Stadelmaier, U., Dünne, A., Hohenberger, W., Sala, C., Garcia-Granero, E., Molina, M. J., Garcia, J. V., Lledo, S., Ternent, C. A., Shashidharan, M., Blatchford, G. J., Christensen, M. A., Thorson, A. G., Sentovich, S. M., Jensen, L. L., Lowry, A. C., Zaheer, S., Reilly, W. T., Tsang, C., Singer, D., Richard, C. S., Stern, H. S., Oliveira, L., Daniel, N., Bernstein, M., DeMarta, D., Weiss, E. G., Nogueras, J. J., Wexner, S. D., Keighley, M. R. B., Korsgen, S., Agachan, F., Kim, D. -S., Goldberg, S. M., Durham, R. M., Pruitt, G., Longo, W. E., Marchesa, P., Oliart, S., Goldblum, J., Fazio, V. W., Rantis, P. C., Daniel, G. L., Vernava, III, A. M., Becker, J. M., Marie, G. St., Ferzoco, S., Franklin, M., Rosenthal, D., Goldstein, E. T., Bass, E. M., DelPino, A., Tan, A., Pearl, R., Orsay, C., Sher, M. E., Sands, L. R., Påhlman, Lars, Hewett, P. J., Thomas, W. M., King, G., Eaton, M., Allendorf, U. D. F., Bessler, M., Whelan, R. L., Trokel, M., Laird, D., Nowygrod, R., Treat, M. R., Vukasin, P., Steele, G., Weston, L., Allendorf, J. D. F., Sellers, G., Joo, J. S., Bruce, C. J., Coller, J. A., Murray, J. J., Schoetz, Jr., D. J., Roberts, P. L., Schoetz, D., Bockler, M., Rosenblatt, M., Malhorta, S., Roberts, P., Murray, J., Coller, J., Rusin, L., Liu, C. D., Newton, T. R., Zinner, M. J., Ashley, S. W., McFadden, D. W., Tusek, D. L., Church, J. M., Strong, S. A., Grass, J., Steinhart, A. H., Greenberg, G. R., Siminovich, K., Blair, J. E., Cruz, C., Prabhakar, L. P., Laramee, C., Nelson, H., Dozois, R. R., Ozuner, G., Hull, T., Fazio, V., Navaro, G., Bauer, J. J., Gorfine, S. R., Gelemt, I. M., Harris, M. T., Kreel, I., Marcello, P. W., Rusin, L. C., Veidenheimer, M. C., Ogunbiyi, O. A., Thibault, C., Sagar, P., Wolff, B. G., Lee, F., Lee, E. C., Pennoyer, W. P., Vignati, P. V., Cohen, J., MacRae, H. M., O'Connor, B., Ton, E., Hain, J. M., Perez-Ramirez, J. J., Spencer, M. P., Gemlo, B. T., Neto, J. A. Reis, Quilici, F. A., Cordeiro, F., Reis, Jr., J. A., Neto, C. I. Reis, Gottesman, L., Tjandra, J., Takano, M., Kuromizu, J., Tsuji, Y., Lee, C. S., Ferrara, A., Levy, J. R., Larach, S. W., Krecker, M., Williamson, P. R., Wong, D. W., Sarmiento, J. M., Burgart, L. J., Frizelle, F. A., Ilstrup, D. M., Salem, R., Smith, L. E., Rooney, P. S., Chapman, M. A. S., Steele, R. J. C., Koren, R., Gal, R., Kyzer, S., Chaimoff, CH., Rodríguez-Bigas, M. A., Mahoney, M. C., Weber, T. K., Petrelli, N. J., Ault, G., Ceron, O., Conti, P., Hadfield, M. B., Turnbull, L. W., Nicholson, A. A., Horsman, A., Shibata, D., Sentovich, S., Hyland, W., Busse, P., Bleday, R., Allendorf, J., Whelan, R., Horvath, K., Treat, M., Wronski, M., Arbit, E., Bilsky, M., Galicich, J. H., Miller, A. S., Lewis, W. G., Williamson, M. E. R., Sagar, P. M., Holdsworth, P. J., Johnston, D., Smith, A. H., Marchetti, F., Thompson-Fawcett, M. W., Warren, B. F., Mortensen, N. J. M., Bouchard, S., Belliveau, P., Trudel, J., Zinsmeister, A. R., Schleck, C. D., McIntyre, P. B., Hanson, R. B., Read, T. E., Dominguez, J. M., Hyman, N. H., Beck, D. E., Dayton, M. T., Stryker, S. J., Wolf, B. G., Young-Fadok, T. M., Meagher, A., Benn, P. L., Takao, Y., Chen, F. C., Wu, J., Milsom, J., Stein, B. L., Vasilevsky, C. A., Hartley, J. E., Cureshi, A., Sellers, G. J., Van, D., Ludwig, K. A., Garcia-Ruiz, A., Espat, N. J., Rao, G. N., Drew, P. J., Pfeifer, J., Park, U. C., Gonzalez, A., Okamoto, T., Konishi, F., Tsukamoto, T., Senba, S., Kashiwagi, H., Kojima, M., Togashi, T., Kanazawa, K., Yoon, W. H., Kang, Y. N., Hong, K. H., Park, H. D., Koo, S. H., Song, K. S., Kim, J. C., Roh, S. A., Park, K. C., Jessup, J. M., Changchien, C. R., Wang, J. Y., Hsu, K. C., Chen, J. S., Tang, R., You, Y. T., Ho, Y. S., Guttman, R., Nelson, R., Sardinha, T. G. S., Gilliland, J., Kroll, M., Lee, E., Wexler, J., Hudzinski, D., Glass, D., Wolff, B. D., King, D. W., Talley, N., Chen, W. S., Lin, W. C., Hsu, H., Wrightson, W. R., Galandiuk, S., LaRocca, R., Myers, S. R., Tada, M., Inoue, H., Tsubaki, M., Endo, M., Sobzcak, S., Welch, J. P., Cohen, J. L., Allen, L. W., Morrow, J. S., Behen, S. L., Smith, K. W., Cali, J. R., Bailey, H. R., Fucini, C., Elbetti, C., Messerini, L., Law, W. L., Butts, D. R., Max, E., Memon, M. A., Devine, J., Feeney, J., Talley, N. J., Stephenson, E. R., Ilahi, O., Koltun, W. A., Spellman, M., Rantis, R. C., Vernava, A. M., Parra, R. O., Breen, E., Hayes, P., Quinn, D., Whitlow, C. B., Opelka, F. G., Gathright, J. B., Golub, R. W., Maccabee, P. J., Combs, A. J., Grose, E. A., Taylor, B. M., Kozell, K., McGannon, E., Krogh, K., Nielsen, J., Djurhuus, J. C., Mosdal, C., Sabroe, S., Laurberg, S., Chen, M. F., Kerner, B. A., Khanduja, K. S., Wise, Jr., W. E., Padmanabhan, A., Meesig, D. M., Yasin, M. T., Aguilar, P. S., Ho, Y. H., Tan, M., Seow-Choen, F., Rustin, R. B., and Harmon, J. M.

Published
1996
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42. Multicenter phase III study of the complement inhibitor eculizumab for the treatment of patients with paroxysmal nocturnal hemoglobinuria

Author

Brodsky RA, Young NS, Antonioli E, Schrezenmeier H, Schubert J, Valls AG, Coyle L, de Castro C, Fu CL, Maciejewski JP, Bessler M, Kroon HA, Rother RP, Hillmen P., RISITANO, ANTONIO MARIA, Brodsky, Ra, Young, N, Antonioli, E, Risitano, ANTONIO MARIA, Schrezenmeier, H, Schubert, J, Valls, Ag, Coyle, L, de Castro, C, Fu, Cl, Maciejewski, Jp, Bessler, M, Kroon, Ha, Rother, Rp, and Hillmen, P.

Published
2008

45. Baseline characteristics and disease burden in patients in the International Paroxysmal Nocturnal Hemoglobinuria Registry

Author

Schrezenmeier, H., Muus, P., Socie, G., Szer, J., Urbano-Ispizua, A., Maciejewski, J.P., Brodsky, R.A., Bessler, M., Kanakura, Y., Rosse, W., Khursigara, G., Bedrosian, C., Hillmen, P., Schrezenmeier, H., Muus, P., Socie, G., Szer, J., Urbano-Ispizua, A., Maciejewski, J.P., Brodsky, R.A., Bessler, M., Kanakura, Y., Rosse, W., Khursigara, G., Bedrosian, C., and Hillmen, P.

Abstract

Contains fulltext : 136926.pdf (publisher's version ) (Open Access), Paroxysmal nocturnal hemoglobinuria is a rare, acquired disease associated with hemolytic anemia, bone marrow failure, thrombosis, and, frequently, poor quality of life. The International PNH Registry is a worldwide, observational, non-interventional study collecting safety, effectiveness, and quality-of-life data from patients with a confirmed paroxysmal nocturnal hemoglobinuria diagnosis or detectable paroxysmal nocturnal hemoglobinuria clone, irrespective of treatment. In addition to evaluating the long-term safety and effectiveness of eculizumab in a global population, the registry aims to improve diagnosis, optimize patient management and outcomes, and enhance the understanding of the natural history of paroxysmal nocturnal hemoglobinuria. Here we report the characteristics of the first 1610 patients enrolled. Median disease duration was 4.6 years. Median granulocyte paroxysmal nocturnal hemoglobinuria clone size was 68.1% (range 0.01-100%). Overall, 16% of patients had a history of thrombotic events and 14% a history of impaired renal function. Therapies included anticoagulation (31%), immunosuppression (19%), and eculizumab (25%). Frequently reported symptoms included fatigue (80%), dyspnea (64%), hemoglobinuria (62%), abdominal pain (44%), and chest pain (33%). Patients suffered from poor quality of life; 23% of patients had been hospitalized due to paroxysmal nocturnal hemoglobinuria-related complications and 17% stated that paroxysmal nocturnal hemoglobinuria was the reason they were not working or were working less. This international registry will provide an ongoing, valuable resource to further the clinical understanding of paroxysmal nocturnal hemoglobinuria.

Published
2014

46. Baseline characteristics and disease burden in patients in the International Paroxysmal Nocturnal Hemoglobinuria Registry

Author

Schrezenmeier, H., primary, Muus, P., additional, Socie, G., additional, Szer, J., additional, Urbano-Ispizua, A., additional, Maciejewski, J. P., additional, Brodsky, R. A., additional, Bessler, M., additional, Kanakura, Y., additional, Rosse, W., additional, Khursigara, G., additional, Bedrosian, C., additional, and Hillmen, P., additional

Published
2014
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48. Effect of the complement inhibitor eculizumab on thromboembolism in patients with paroxysmal nocturnal hemoglobinuria.

Author

Hillmen, P., Muus, P., Duhrsen, U., Risitano, A.M., Schubert, J., Luzzatto, L., Schrezenmeier, H., Szer, J., Brodsky, R.A., Hill, A., Socie, G., Bessler, M., Rollins, S.A., Bell, L., Rother, R.P., Young, N.S., Hillmen, P., Muus, P., Duhrsen, U., Risitano, A.M., Schubert, J., Luzzatto, L., Schrezenmeier, H., Szer, J., Brodsky, R.A., Hill, A., Socie, G., Bessler, M., Rollins, S.A., Bell, L., Rother, R.P., and Young, N.S.

Abstract

Item does not contain fulltext, Hemolysis and hemoglobinemia contribute to serious clinical sequelae in hemolytic disorders. In paroxysmal nocturnal hemoglobinuria (PNH) patients, hemolysis can contribute to thromboembolism (TE), the most feared complication in PNH, and the leading cause of disease-related deaths. We evaluated whether long-term treatment with the complement inhibitor eculizumab reduces the rate of TE in patients with PNH. Clinical trial participants included all patients in the 3 eculizumab PNH clinical studies, which recruited patients between 2002 and 2005 (n = 195); patients from these studies continued treatment in the current multinational open-label extension study. Thromboembolism rate with eculizumab treatment was compared with the pretreatment rate in the same patients. The TE event rate with eculizumab treatment was 1.07 events/100 patient-years compared with 7.37 events/100 patient-years (P < .001) prior to eculizumab treatment (relative reduction, 85%; absolute reduction, 6.3 TE events/100 patient-years). With equalization of the duration of exposure before and during treatment for each patient, TE events were reduced from 39 events before eculizumab to 3 events during eculizumab (P < .001). The TE event rate in antithrombotic-treated patients (n = 103) was reduced from 10.61 to 0.62 events/100 patient-years with eculizumab treatment (P < .001). These results show that eculizumab treatment reduces the risk of clinical thromboembolism in patients with PNH. This study is registered at http://clinicaltrials.gov (study ID no. NCT00122317).

Published
2007

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