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8. Results of NOPHO ALL2008 treatment for patients aged 1–45 years with acute lymphoblastic leukemia

Author

Toft, N, primary, Birgens, H, additional, Abrahamsson, J, additional, Griškevičius, L, additional, Hallböök, H, additional, Heyman, M, additional, Klausen, T W, additional, Jónsson, ÓG, additional, Palk, K, additional, Pruunsild, K, additional, Quist-Paulsen, P, additional, Vaitkeviciene, G, additional, Vettenranta, K, additional, Åsberg, A, additional, Frandsen, T L, additional, Marquart, H V, additional, Madsen, H O, additional, Norén-Nyström, U, additional, and Schmiegelow, K, additional

Published
2017
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10. Paroxystisk Nokturn Hæmoglobinuri i Danmark

Author

Brieghel, C., Kjeldsen, Lene Juel, Christiansen, I., Nielsen, B., Plesner, Torben, Vestergaard, Hanne, Kræsten Raaschou Jensen, Klas, Klausen, T.W., and Birgens, H.

Abstract

Paroxystisk Nokturn Hæmoglobinuri i Danmark.

Published
2012

11. Response of iron overload to deferasirox in rare transfusion-dependent anaemias: equivalent effects on serum ferritin and labile plasma iron for haemolytic or production anaemias

Author

Porter, Jb, Lin, Kh, Beris, P, Forni, Gl, Taher, A, Habr, D, Domokos, G, Roubert, B, Thein, Sl, EPIC study investigators including Agaoglu, L, Alimena, G, Alonso, D, Ame, S, Angelucci, E, Arrizabalaga, B, Athanasiou Metaxa, M, Augustson, B, Aydinok, Y, Baba, A, Baccarani, M, Beck, J, Beyne Rauzy, O, Birgens, H, Bordessoule, D, Borgna Pignatti, C, Bosly, A, Bouabdallah, K, Bowen, D, Bron, D, Cappellini, Md, Capra, M, Cartron, G, Cazzola, M, Chalkias, C, Chan, Ll, Chancharunee, S, Chapman, C, Charoenkwan, P, Chasapopoulou, E, Cheze, S, Chuansumrit, A, Cianciulli, P, Dauriac, C, Delforge, M, Dölken, G, Dombret, H, Duyster, J, Economopoulos, T, Ehninger, G, Elalfy, M, El Beshlawy, A, Enggaard, L, Fenaux, P, Fillet, G, Filosa, A, Galanello, R, Ganser, A, Gastl, G, Gattermann, N, Giraudier, S, Goldfarb, A, Grigg, A, Guerci Bresler, A, Gumruk, F, Ha, Sy, Haase, D, Heinrich, B, Hertzberg, M, Ho, J, Hsu, Hc, Huang, S, Hunault Berger, M, Inusa, B, Jalumes, D, Jensen, J, Kattamis, A, Kilinc, Y, Kim, Kh, Kinsey, S, Kjeldsen, L, Koren, A, Lai, Me, Lai, Y, Lee, Jw, Lee, Kh, Lee, Sh, Legros, L, Li, C, Li, Ck, Li, Q, Linkesch, W, Lübbert, M, Lutz, D, Mohamed Thalha AJ, Mufti, G, Muus, P, Nobile, F, Ozsahin, H, Papadopoulos, N, Perrotta, S, Petrini, M, Pfeilstöcker, M, Piga, Antonio Giulio, Poole, J, Pungolino, E, Quarta, G, Ravoet, C, Remacha, Af, Rose, C, Roy, L, Saglio, Giuseppe, Sanz, G, Schmid, M, Schmugge, M, Schots, H, Secchi, G, Seymour, Jf, Shah, F, Shah, H, Shen, Z, Slama, B, Sutcharitchan, P, Tamary, H, Taylor, K, Tesch, Hj, Troncy, J, Vassilieff, D, Villegas, A, Viprakasit, V, Wainwright, L, Wassmann, B, Wettervald, M, Will, A, Wörmann, B, Wright, J, Yeh, Sp, Yoon, Ss, Zoumbos, Nc, Zweegman, S., Ozsahin, Ayse Hulya, Porter, Jb, Lin, Kh, Beris, P, Forni, Gl, Taher, A, Habr, D, Domokos, G, Roubert, B, Thein, Sl, on behalf of the EPIC study, Investigator, and Perrotta, Silverio

Subjects
safety, Male, Iron Overload, Adolescent, iron chelation therapy, Iron, Iron Chelating Agents/therapeutic use, Iron Chelating Agents, Benzoates, Anemia/drug therapy, Humans, Blood Transfusion, Benzoates/therapeutic use, Child, Iron/blood, ddc:616, ddc:618, iron overload, rare anaemias, serum ferritin, Ferritins/blood, Anemia, Original Articles, Triazoles, Deferasirox, Child, Preschool, Ferritins, rare anaemia, Female, Triazoles/therapeutic use
Abstract

Objectives: It is widely assumed that, at matched transfusional iron-loading rates, responses to chelation therapy are similar, irrespective of the underlying condition. However, data are limited for rare transfusiondependent anaemias, and it remains to be elucidated if response differs, depending on whether the anaemia has a primary haemolytic or production mechanism. Methods: The efficacy and safety of deferasirox (Exjade) in rare transfusion-dependent anaemias were evaluated over 1 yr, with change in serum ferritin as the primary efficacy endpoint. Initial deferasirox doses were 10–30 mg⁄ kg ⁄ d, depending on transfusion requirements; 34 patients had production anaemias, and 23 had haemolytic anaemias. Results: Patients with production anaemias or haemolytic anaemias had comparable transfusional iron-loading rates (0.31 vs. 0.30 mL red blood cells ⁄ kg ⁄ d), mean deferasirox dosing (19.3 vs. 19.0 mg⁄ kg ⁄ d) and baseline median serum ferritin (2926 vs. 2682 ng ⁄ mL). Baseline labile plasma iron (LPI) levels correlated significantly with the transfusional iron-loading rates and with serum ferritin levels in both cohorts. Reductions in median serum ferritin levels were initially faster in the production than the haemolytic anaemias, but at 1 yr, similar significant reductions of 940 and 617 ng ⁄mL were attained, respectively ()26.0% overall). Mean LPI decreased significantly in patients with production (P < 0.0001) and haemolytic (P = 0.037) anaemias after the first dose and was maintained at normal mean levels (

Published
2011

12. Iron chelation therapy with deferasirox in patients with aplastic anemia: a subgroup analysis of 116 patients from the EPIC trial

Author

Lee, Jw, Yoon, Ss, Shen, Zx, Ganser, A, Hsu, Hc, Habr, D, Domokos, G, Roubert, B, Porter, Jb, Agaoglu, L, Alimena, G, Alonso, D, Ame, S, Angelucci, E, Arrizabalaga, B, Athanasiou Metaxa, M, Augustson, B, Aydinok, Y, Baba, A, Baccarani, M, Beck, J, Beris, P, Beyne Rauzy, O, Birgens, H, Bordessoule, D, Borgna, Caterina, Bosly, A, Bouabdallah, K, Bowden, D, Bowen, D, Bron, D, Cappellini, Md, Capra, M, Cartron, G, Cazzola, M, Chalkias, C, Chan, Ll, Chancharunee, S, Chapman, C, Charoenkwan, P, Chasapopoulou, E, Cheze, S, Chuansumrit, A, Cianciulli, P, Dauriac, C, Delforge, M, Dölken, G, Dombret, H, Duyster, J, Economopoulos, T, Ehninger, G, Elalfy, M, El Beshlawy, A, Enggaard, L, Fenaux, P, Fillet, G, Filosa, A, Forni, G, Galanello, R, Gastl, G, Gattermann, N, Giraudier, S, Goldfarb, A, Grigg, A, Guerci Bresler, A, Gumruk, F, Ha, Sy, Haase, D, Heinrich, B, Hertzberg, M, Ho, J, Huang, S, Hunault Berger, M, Inusa, B, Jaulmes, D, Jensen, J, Kattamis, A, Kilinc, Y, Kim, Kh, Kinsey, S, Kjeldsen, L, Koren, A, Lai, Me, Lai, Y, Lee, Kh, Lee, Sh, Legros, L, Li, C, Li, Ck, Li, Q, Lin, Kh, Linkesch, W, Lübbert, M, Lutz, D, Mohamed Thalha AJ, Mufti, G, Muus, P, Nobile, F, Papadopoulos, N, Perrotta, S, Petrini, M, Pfeilstöcker, M, Piga, A, Poole, J, Pungolino, E, Quarta, G, Ravoet, C, Remacha, Af, Rose, C, Roy, L, Saglio, G, Sanz, G, Schmid, M, Schmugge, M, Schots, H, Secchi, G, Seymour, Jf, Shah, F, Shah, H, Shen, Z, Slama, B, Sutcharitchan, P, Taher, A, Tamary, H, Taylor, K, Tesch, Hj, Thein, Sl, Troncy, J, Vassilieff, D, Villegas, A, Viprakasit, V, Wainwright, L, Wassmann, B, Wettervald, M, Will, A, Wörmann, B, Wright, J, Yeh, Sp, Zoumbos, Nc, Zweegman, S., Lee, Jw, Yoon, S, Shen, Zx, Ganser, A, Hsu, Hc, Habr, D, Domokos, G, Roubert, B, Porter, Jb, EPIC study, Investigator, and Perrotta, Silverio

Subjects
Male, Biochemistry, Gastroenterology, Benzoates, beta-thalassemia, chemistry.chemical_compound, overloaded patients, oxidative stress, Prospective Studies, Prospective cohort study, pathophysiology, Beta thalassemia, complications, epidemiology, labile plasma iron, myelodysplastic syndromes, serum ferritin, transfusion-dependent anemias, Anemia, Aplastic, Hematology, Middle Aged, Tolerability, Creatinine, Iron chelation, Female, medicine.drug, Adult, medicine.medical_specialty, aplastic anemia, Adolescent, Anemia, Immunology, Iron Chelating Agents, Young Adult, Internal medicine, medicine, Humans, Aplastic anemia, therapy, business.industry, Myelodysplastic syndromes, Deferasirox, deferasirox, Cell Biology, Triazoles, medicine.disease, Chelation Therapy, Surgery, chemistry, Ferritins, business
Abstract

The prospective 1-year Evaluation of Patients' Iron Chelation with Exjade (EPIC) study enrolled a large cohort of 116 patients with aplastic anemia; the present analyses evaluated the efficacy and safety of deferasirox in this patient population. After 1 year, median serum ferritin decreased significantly from 3254 ng/mL at baseline to 1854 ng/mL (P < .001). Decreases occurred in chelation-naive (3229-1520 ng/mL; P < .001, last-observation-carried-forward analysis), and previously chelated (3263-2585 ng/mL; P = .21, last-observation-carried-forward analysis) patients and were reflective of dose adjustments and ongoing iron intake. Baseline labile plasma iron levels were within normal range despite high serum ferritin levels. The most common drug-related adverse events were nausea (22%) and diarrhea (16%). Serum creatinine increases more than 33% above baseline and the upper limit of normal occurred in 29 patients (25%), but there were no progressive increases; concomitant use of cyclosporine had a significant impact on serum creatinine levels. The decrease in mean alanine aminotransferase levels at 1 year correlated significantly with reduction in serum ferritin (r = 0.40, P < .001). Mean absolute neutrophil and platelet counts remained stable during treatment, and there were no drug-related cytopenias. This prospective dataset confirms the efficacy and well characterizes the tolerability profile of deferasirox in a large population of patients with aplastic anemia. This study was registered at www.clinicaltrials.gov as #NCT00171821.

Published
2010

13. Deferasirox in iron-overloaded patients with transfusion-dependent myelodysplastic syndromes: Results from the large 1-year EPIC study

Author

Gattermann, N. Finelli, C. Della Porta, M. Fenaux, P. Ganser, A. Guerci-Bresler, A. Schmid, M. Taylor, K. Vassilieff, D. Habr, D. Domokos, G. Roubert, B. Rose, C. Agaoglu, L. Alimena, G. Alonso, D. Ame, S. Angelucci, E. Arrizabalaga, B. Athanasiou-Metaxa, M. Augustson, B. Aydinok, Y. Baba, A. Baccarani, M. Beck, J. Beris, P. Beyne-Rauzy, O. Birgens, H. Bordessoule, D. Borgna-Pignatti, C. Bosly, A. Bouabdallah, K. Bowden, D. Bowen, D. Bron, D. Cappellini, M.D. Capra, M. Cartron, G. Cazzola, M. Chalkias, C. Chan, L.L. Chancharunee, S. Chapman, C. Charoenkwan, P. Chasapopoulou, E. Cheze, S. Chuansumrit, A. Cianciulli, P. Dauriac, C. Delforge, M. Dölken, G. Dombret, H. Duyster, J. Economopoulos, T. Ehninger, G. Elalfy, M. El-Beshlawy, A. Enggaard, L. Fillet, G. Filosa, A. Forni, G. Galanello, R. Gastl, G. Giraudier, S. Goldfarb, A. Grigg, A. Gumruk, F. Ha, S.Y. Haase, D. Heinrich, B. Hertzberg, M. Ho, J. Hsu, H.-C. Huang, S. Hunault-Berger, M. Inusa, B. Jaulmes, D. Jensen, J. Kattamis, A. Kilinc, Y. Kim, K.-H. Kinsey, S. Kjeldsen, L. Koren, A. Lai, M.E. Lai, Y. Lee, J.-W. Lee, K.-H. Lee, S.-H. Legros, L. Li, C. Li, C.-K. Li, Q. Lin, K.-H. Linkesch, W. Lübbert, M. Lutz, D. Mohamed Thalha, A.J. Mufti, G. Muus, P. Nobile, F. Papadopoulos, N. Perrotta, S. Petrini, M. Pfeilstöcker, M. Piga, A. Poole, J. Porter, J.B. Pungolino, E. Quarta, G. Ravoet, C. Jolimont Lobbes, H.H. Remacha, A.F. Roy, L. Saglio, G. Sanz, G. Schmugge, M. Schots, H. Secchi, G. Seymour, J.F. Shah, F. Shah, H. Shen, Z. Slama, B. Sutcharitchan, P. Taher, A. Tamary, H. Tesch, H.-J. Thein, S.L. Troncy, J. Villegas, A. Viprakasit, V. Wainwright, L. Wassmann, B. Wettervald, M. Will, A. Wörmann, B. Wright, J. Yeh, S.-P. Yoon, S.-S. Zoumbos, N.C. Zweegman, S.

Abstract

The prospective 1-year EPIC study enrolled 341 patients with myelodysplastic syndromes (MDS); although baseline iron burden was >2500. ng/mL, ∼50% were chelation-naïve. Overall median serum ferritin decreased significantly at 1 year (p=0.002). Decreases occurred irrespective of whether patients were chelation-naïve or previously chelated; changes were dependent on dose adjustments and ongoing iron intake. Sustained reductions in labile plasma iron were observed. Discontinuation rate (48.7%) and adverse event profile were consistent with previously reported deferasirox data in MDS. Alanine aminotransferase levels decreased significantly; change correlated significantly with reduction in serum ferritin (p

Published
2010

15. Deferasirox in iron-overloaded patients with transfusion-dependent myelodysplastic syndromes: Results from the large 1-year EPIC study

Author

Gattermann, N., Finelli, C., Porta, M. D., Fenaux, P., Ganser, A., Guerci Bresler, A., Schmid, M., Taylor, K., Vassilieff, D., Habr, D., Domokos, G., Roubert, B., Rose, C., Agaoglu, L., Alimena, G., Alonso, D., Ame, S., Angelucci, E., Businco, A., Arrizabalaga, B., Athanasiou Metaxa, M., Augustson, B., Aydinok, Y., Baba, A., Baccarani, M., Beck, J., Beris, P., Beyne Rauzy, O., Birgens, H., Bordessoule, D., Borgna, Caterina, Bosly, A., Bouabdallah, K., Bowden, D., Bowen, D., Bron, D., Cappellini, M. D., Capra, M., Cartron, G., Cazzola, M., Chalkias, C., Chan, L. L., Chancharunee, S., Chapman, C., Charoenkwan, P., Chasapopoulou, E., Cheze, S., Chuansumrit, A., Cianciulli, P., Dauriac, C., Delforge, M., Dölken, G., Dombret, H., Duyster, J., Economopoulos, T., Ehninger, G., Elalfy, M., El Beshlawy, A., Enggaard, L., Fillet, G., Filosa, A., Forni, G., Galanello, R., Gastl, G., Giraudier, S., Goldfarb, A., Grigg, A., Gumruk, F., S. Y., Ha, Haase, D., Heinrich, B., Hertzberg, M., Ho, J., Hsu, H. C., Huang, S., Hunault Berger, M., Inusa, B., Jaulmes, D., Jensen, J., Kattamis, A., Kilinc, Y., Kim, K. H., Kinsey, S., Kjeldsen, L., Koren, A., Lai, M. E., Lai, Y., Lee, J. W., Lee, K. H., Lee, S. H., Legros, L., Li, C., C. K., Li, Li, Q., Lin, K. H., Linkesch, W., Lübbert, M., Lutz, D., Mohamed Thalha, A. J., Mufti, G., Muus, P., Nobile, F., Papadopoulos, N., Perrotta, S., Petrini, M., Pfeilstöcker, M., Piga, A., Poole, J., Porter, J. B., Pungolino, E., Quarta, G., Ravoet, C., Jolimont Lobbes, H. H., Remacha, A. F., Roy, L., Saglio, G., Sanz, G., Schmugge, M., Schots, H., Secchi, G., Seymour, J. F., Shah, F., Shah, H., Shen, Z., Slama, B., Sutcharitchan, P., Taher, A., Tamary, H., Tesch, H. J., Thein, S. L., Troncy, J., Villegas, A., Viprakasit, V., Wainwright, L., Wassmann, B., Wettervald, M., Will, A., Wörmann, B., Wright, J., Yeh, S. P., Yoon, S. S., Zoumbos, N. S., Zweegman, S., Gattermann, N, Finelli, C, Porta, Md, Fenaux, P, Ganser, A, GUERCI BRESLER, A, Schmid, M, Taylor, K, Vassilieff, D, Habr, D, Domokos, G, Roubert, B, Rose, C, EPIC study, Investigator, Perrotta, Silverio, Gattermann N, Finelli C, Porta MD, Fenaux P, Ganser A, Guerci-Bresler A, Schmid M, Taylor K, Vassilieff D, Habr D, Domokos G, Roubert B, Rose C, Baccarani M, EPIC study investigators., and Çukurova Üniversitesi

Subjects
Male, Pediatrics, Cancer Research, Blood transfusion, Thalassemia, medicine.medical_treatment, Gastroenterology, Benzoates, Child, Hematology, biology, Benzoic Acids, Alanine Transaminase, Adolescent, Adult, Aged, Blood Transfusion, Preschool, Female, Ferritins, Humans, Iron Chelating Agents, Iron Overload, Middle Aged, Myelodysplastic Syndromes, Triazoles, Young Adult, Oncology, Child, Preschool, medicine.drug, medicine.medical_specialty, Myelodysplastic syndromes, deferasirox, iron chelation therapy, labile plasma iron, myelodysplastic syndromes, serum ferritin, Serum ferritin, Deferasirox, Iron chelation therapy, Labile plasma iron, Internal medicine, medicine, Adverse effect, iron-overloaded patients, transfusion, Labile plasmairon, business.industry, medicine.disease, Discontinuation, Iron chelationtherapy, Alanine transaminase, biology.protein, business, Myelodysplastic syndrome
Abstract

PubMedID: 20451251 The prospective 1-year EPIC study enrolled 341 patients with myelodysplastic syndromes (MDS); although baseline iron burden was >2500. ng/mL, ~50% were chelation-naïve. Overall median serum ferritin decreased significantly at 1 year (p=0.002). Decreases occurred irrespective of whether patients were chelation-naïve or previously chelated; changes were dependent on dose adjustments and ongoing iron intake. Sustained reductions in labile plasma iron were observed. Discontinuation rate (48.7%) and adverse event profile were consistent with previously reported deferasirox data in MDS. Alanine aminotransferase levels decreased significantly; change correlated significantly with reduction in serum ferritin (p

Published
2010

16. Tailoring iron chelation by iron intake and serum ferritin: the prospective EPIC study of deferasirox in 1744 patients with transfusion-dependent anemias

Author

Cappellini, M. D., Porter, J., El Beshlawy, A., C. K., Li, Seymour, J. F., Elalfy, M., Gattermann, N., Giraudier, S., Lee, J. W., Chan, L. L., Lin, K. H., Rose, C., Taher, A., Thein, S. L., Viprakasit, V., Habr, D., Domokos, G., Roubert, B., Kattamis, A., Agaoglu, L., Alimena, G., Alonso, D., Ame, S., Angelucci, E., Businco, A., Arrizabalaga, B., Athanasiou Metaxa, M., Augustson, B., Aydinok, Y., Baba, A., Baccarani, M., Beck, J., Beris, P., Beyne Rauzy, O., Birgens, H., Bordessoule, D., Borgna, Caterina, Bosly, A., Bouabdallah, K., Bowden, D., Bowen, D., Bron, D., Capra, M., Cartron, G., Cazzola, M., Chalkias, C., Chancharunee, S., Chapman, C., Charoenkwan, P., Chasapopoulou, E., Cheze, S., Chuansumrit, A., Cianciulli, P., Dauriac, C., Delforge, M., Dölken, G., Dombret, H., Duyster, J., Economopoulos, T., Ehninger, G., Enggaard, L., Fillet, G., Filosa, A., Forni, G., Galanello, R., Gastl, G., Goldfarb, A., Grigg, A., Gumruk, F., S. Y., Ha, Haase, D., Heinrich, B., Hertzberg, M., Ho, J., Hsu, H. C., Huang, S., Hunault Berger, M., Inusa, B., Jaulmes, D., Jensen, J., Kilinc, Y., Kim, K. H., Kinsey, S., Kjeldsen, L., Koren, A., Lai, M. E., Lai, Y., Lee, K. H., Lee, S. H., Legros, L., Li, C., Li, Q., Linkesch, W., Lübbert, M., Lutz, D., Mohamed Thalha, A. J., Mufti, G., Muus, P., Nobile, F., Papadopoulos, N., Perrotta, S., Petrini, M., Pfeilstöcker, M., Piga, A., Poole, J., Porter, J. B., Pungolino, E., Quarta, G., Ravoet, C., Jolimont Lobbes, H. H., Remacha, A. F., Roy, L., Saglio, G., Sanz, G., Schmugge, M., Schots, H., Secchi, G., Shah, F., Shah, H., Shen, Z., Slama, B., Sutcharitchan, P., Tamary, H., Tesch, H. J., Troncy, J., Villegas, A., Wainwright, L., Wassmann, B., Wettervald, M., Will, A., Wörmann, B., Wright, J., Yeh, S. P., Yoon, S. S., Zoumbos, N. S., and Zweegman, S.

Subjects
Adult, Male, medicine.medical_specialty, Pediatrics, Blood transfusion, Iron Overload, Adolescent, Anemia, Thalassemia, medicine.medical_treatment, Iron chelation therapy, Transfusion medicine, Transfusion-dependent anemias, Hemosiderosis, Iron Chelating Agents, Gastroenterology, Benzoates, Young Adult, IRON CHELATION, Internal medicine, medicine, Humans, Blood Transfusion, Tissue Distribution, SERUM FERRITIN, Chelation therapy, Prospective Studies, Child, Aged, Aged, 80 and over, business.industry, Myelodysplastic syndromes, Deferasirox, Hematology, Middle Aged, Triazoles, medicine.disease, DEFERASOROX, Deferoxamine, Child, Preschool, Ferritins, Female, Original Article, business, TRANSFUSION-DEPENDENT ANEMIAS, Iron, Dietary, medicine.drug
Abstract

Background Following a clinical evaluation of deferasirox (Exjade) it was concluded that, in addition to baseline body iron burden, ongoing transfusional iron intake should be considered when selecting doses. The 1-year EPIC study, the largest ever investigation conducted for an iron chelator, is the first to evaluate whether fixed starting doses of deferasirox, based on transfusional iron intake, with dose titration guided by serum ferritin trends and safety markers, provides clinically acceptable chelation in patients (agedor=2 years) with transfusional hemosiderosis from various types of anemia.The recommended initial dose was 20 mg/kg/day for patients receiving 2-4 packed red blood cell units/month and 10 or 30 mg/kg/day was recommended for patients receiving less or more frequent transfusions, respectively. Dose adjustments were based on 3-month serum ferritin trends and continuous assessment of safety markers. The primary efficacy end-point was change in serum ferritin after 52 weeks compared with baseline.The 1744 patients enrolled had the following conditions; thalassemia (n=1115), myelodysplastic syndromes (n=341), aplastic anemia (n=116), sickle cell disease (n=80), rare anemias (n=43) and other transfused anemias (n=49). Overall, there was a significant reduction in serum ferritin from baseline (-264 ng/mL; P0.0001), reflecting dosage adjustments and ongoing iron intake. The most common (5%) adverse events were gastrointestinal disturbances (28%) and skin rash (10%). Conclusions Analysis of this large, prospectively collected data set confirms the response to chelation therapy across various anemias, supporting initial deferasirox doses based on transfusional iron intake, with subsequent dose titration guided by trends in serum ferritin and safety markers (clinicaltrials.gov identifier: NCT00171821).

Published
2009

20. Results of NOPHO ALL2008 treatment for patients aged 1–45 years with acute lymphoblastic leukemia

Author

Toft, N, Birgens, H, Abrahamsson, J, Griškevicius, L, Hallböök, H, Heyman, M, Klausen, T W, Jónsson, ÓG, Palk, K, Pruunsild, K, Quist-Paulsen, P, Vaitkeviciene, G, Vettenranta, K, Åsberg, A, Frandsen, T L, Marquart, H V, Madsen, H O, Norén-Nyström, U, and Schmiegelow, K

Abstract

Adults with acute lymphoblastic leukemia (ALL) do worse than children. From 7/2008 to 12/2014, Nordic and Baltic centers treated 1509 consecutive patients aged 1–45 years with Philadelphia chromosome-negative ALL according to the NOPHO ALL2008 without cranial irradiation. Overall, 1022 patients were of age 1–9 years (A), 266 were 10–17 years (B) and 221 were 18–45 years (C). Sixteen patients (three adults) died during induction. All others achieved remission after induction or 1–3 intensive blocks. Subsequently, 45 patients (12 adults) died, 122 patients relapsed (32 adults) with a median time to relapse of 1.6 years and 13 (no adult) developed a second malignancy. Median follow-up time was 4.6 years. Among the three age groups, older patients more often had higher risk ALL due to T-ALL (32%/25%/9%, P<0.001), KMT2A rearrangements (6%/5%/3%, P<0.001) and higher day 29 residual leukemia for B-lineage (P<0.001), but not T-ALL (P=0.53). Event-free survival rates (pEFS5y) were 89±1% (A), 80±3% (B) and 74±4% (C) with significant differences only for non-high risk groups. Except for thrombosis, pancreatitis and osteonecrosis, the risk of 19 specified toxicities was not enhanced by age above 10 years. In conclusion, a pediatric-based protocol is tolerable and effective for young adults, despite their increased frequency of higher risk features.

Published
2018
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28. Epidemiology of haemoglobin disorders in Europe: an overview

Author

Modell, B., primary, Darlison, M., additional, Birgens, H., additional, Cario, H., additional, Faustino, P., additional, Giordano, P. C., additional, Gulbis, B., additional, Hopmeier, P., additional, Lena‐Russo, D., additional, Romao, L., additional, and Theodorsson, E., additional

Published
2007
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31. Erratum

Author

Ellervik, C., Mandrup-Poulsen, T., Birgens, H., and Nordestgaard, B.G.

Subjects
Health
Abstract

An editorial error occurred in the article listed above. The sentence 'We thank Conway for his comment (1) on our article in Diabetes Care (2) on the risk of diabetes [...]

Published
2012

32. Effect of Various Doses of Intravenous Polyclonal IgG on in vivo Levels of 12 Pneumococcal Antibodies in Patients with Chronic Lymphocytic Leukaemia and Multiple Myeloma

Author

Sklenar, I., primary, Schiffman, G., additional, Jønsson, V., additional, Verhoef, G., additional, Birgens, H., additional, Boogaerts, M., additional, Ferrant, A., additional, Christensen, B.E., additional, Hasle, H., additional, Drivsholm, A., additional, Pedersen, Rebsdorf, additional, Peterslund, N.A., additional, Christensen, K.D., additional, Hansen, N.E., additional, Nikoskelainen, J., additional, Lahtinen, R., additional, Gardiner, D., additional, Towse, G., additional, Taesch, S., additional, Jørgensen, T., additional, Schädelin, J., additional, and Hansen, M.M., additional

Published
1993
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36. Cryptococcus neoformans var.neoformans resistant to fluconazole in an HIV-negative patient with chronic lymphocytic leukemia.

Author

Assing, K., Birgens, H., and Arendrup, M.

Subjects
*CRYPTOCOCCUS neoformans, *MENINGITIS, *CENTRAL nervous system diseases, *CRYPTOCOCCUS
Abstract

Cases of fluconazole-resistant Cryptococcus neoformans have been reported in AIDS patients previously treated with fluconazole. We report a case of fluconazole-resistant cryptococcal meningitis in an HIV-negative patient not previously exposed to fluconazole. The patient experienced a clinical relapse after discontinuation of therapy with amphotericin B and subsequent initiation of fluconazole therapy. In vitro resistance was initially verified by Etest and tablet diffusion and later confirmed by NCCLS broth microdilution. [ABSTRACT FROM AUTHOR]

Published
2003
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40. Effect of Cyclosporin A on Human Neutrophil and Monocyte Function.

Author

Kharazmi, A., Svenson, M., Nielsen, H., and Birgens, H. S.

Subjects
CYCLOSPORINE, IMMUNOSUPPRESSIVE agents, CYCLIC peptides, NEUTROPHILS, GRANULOCYTES, PHAGOCYTES, MONOCYTES, LEUCOCYTES, RETICULO-endothelial system
Abstract

The effect of various concentrations of cyclosporin A (CyA), ranging from below peak blood levels to 20 times higher than blood levels of human peripheral blood polymorphonuclear and mononuclear leukocytes, was examined. CyA was found to bind to neutrophils with Kd values in the range of 20–50 nm. CyA at clinically obtainable blood level concentrations had no effect on neutrophil and monocyte chemotaxis, neutrophil oxidative burst, monocyte phagocytosis, or neutrophil bactericidal activity. The data on the release of lactoferrin a secondary granule substance, from activated neutrophils showed that the calcium ionophore A 23187-induced lactoferrin release was inhibited by treatment of cells with 4 μM CyA, whereas release of lactoferrin from zymosan- or phorbol myrislate acetate-activated neutropohils was not affected by the same concentration of CyA. This effect could either be due to differences in the degree of cell membrane perturbation by the various activators or to calcium dependence of neutrophil activation. A third possibility may be that CyA acts at some subsequent steps in the release process of neutrophils. It is concluded that CyA does not interfere with important functions of human phagocytes, the cells that play a major role in the defence against invading microorganisms. [ABSTRACT FROM AUTHOR]

Published
1985
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44. Elevated transferrin saturation and risk of diabetes: three population-based studies.

Author

Ellervik C, Mandrup-Poulsen T, Andersen HU, Tybjærg-Hansen A, Frandsen M, Birgens H, Nordestgaard BG, Ellervik, Christina, Mandrup-Poulsen, Thomas, Andersen, Henrik Ullits, Tybjærg-Hansen, Anne, Frandsen, Merete, Birgens, Henrik, and Nordestgaard, Børge G

Abstract

Objective: We tested the hypothesis that elevated transferrin saturation is associated with an increased risk of any form of diabetes, as well as type 1 or type 2 diabetes separately.Research Design and Methods: We used two general population studies, The Copenhagen City Heart Study (CCHS, N = 9,121) and The Copenhagen General Population Study (CGPS, N = 24,195), as well as a 1:1 age- and sex-matched population-based case-control study with 6,129 patients with diabetes from the Steno Diabetes Centre and 6,129 control subjects, totaling 8,535 patients with diabetes and 37,039 control subjects.Results: In the combined studies, odds ratios in those with transferrin saturation ≥50% vs. <50% were 2.1 (95% CI 1.3-3.4; P = 0.003) for any form of diabetes; 2.6 (1.2-5.6; P = 0.01) for type 1 diabetes; and 1.7 (1.4-2.1; P = 0.001) for type 2 diabetes.Conclusions: Elevated transferrin saturation confers a two- to threefold increased risk of developing any form of diabetes, as well as type 1 and type 2 diabetes separately. [ABSTRACT FROM AUTHOR]

Published
2011
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48. The CLL2 study: preliminary results of flow cytometry immunophenotyping in the first 500 patients

Author

Geisler C, Jk, Larsen, Andersen E, Birgens H, Be, Christensen, Drivsholm A, Mm, Hansen, Peter Hokland, Kb, Jensen, and Plesner T

Subjects
Phenotype, Denmark, Humans, Receptors, Antigen, B-Cell, Flow Cytometry, Prognosis, Leukemia, Lymphocytic, Chronic, B-Cell, Neoplasm Staging
Abstract

In the period 1984-1987, 500 consecutive, newly diagnosed patients with chronic lymphocytic leukaemia (CLL) have been registered in the still open Danish CLL2-study. As part of patient work-up, the immunological phenotype was established in all patients by immunofluorescence microscopy, and in 458 patients also by flow cytometry, with a panel of polyclonal and monoclonal antibodies. The majority of cases exhibited a CD5-pos, SmIgMD-pos phenotype with faint SmIg-fluorescence, and there is as yet no significant difference in survival between SmIgD-pos and SmIgD-neg cases. Seventy cases were FMC7-pos, a marker associated with a higher B-cell differentiation, and this was significantly correlated with stronger SmIg fluorescence intensity and splenomegaly (Rai stage II). The survival of the FMC7-pos patients was not significantly different from that of the FMC7-neg. Thus, in this preliminary phenotype analysis of the first 500 patients in the CLL2 study, no important prognostic subgroups were detected, although this might be due to the still short observation time (median observation time 532 days).

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