A phase III randomized trial comparing glucocorticoid monotherapy versus glucocorticoid and rituximab in patients with autoimmune haemolytic anaemia
Summary The impact of first‐line treatment with the anti‐CD 20 chimeric monoclonal antibody rituximab in patients with warm‐antibody reactive autoimmune haemolytic anaemia (WAIHA) is unknown. We report the first randomized study of 64 patients with newly diagnosed WAIHA who received prednisolone and...
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Veröffentlicht in: | British journal of haematology 2013-11, Vol.163 (3), p.393-399 |
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creator | Birgens, Henrik Frederiksen, Henrik Hasselbalch, Hans C. Rasmussen, Inge H. Nielsen, Ove J. Kjeldsen, Lars Larsen, Herdis Mourits‐Andersen, Torben Plesner, Torben Rønnov‐Jessen, Dorthe Vestergaard, Hanne Klausen, Tobias W. Schöllkopf, Claudia |
description | Summary
The impact of first‐line treatment with the anti‐CD 20 chimeric monoclonal antibody rituximab in patients with warm‐antibody reactive autoimmune haemolytic anaemia (WAIHA) is unknown. We report the first randomized study of 64 patients with newly diagnosed WAIHA who received prednisolone and rituximab combined (N = 32) or prednisolone monotherapy (N = 32). After 12 months, a satisfactory response was observed in 75% of the patients treated with rituximab and prednisolone but in a significantly smaller proportion (36%) of those given prednisolone alone (P = 0·003). Furthermore, relapse‐free survival was significantly better after the combined therapy than after prednisolone monotherapy (P = 0·02). After 36 months, about 70% of the patients were still in remission in the rituximab‐prednisolone group, whereas only about 45% were still in complete or partial remission in the prednisolone group. There was no significant difference between the two groups regarding adverse reactions to the studied medications. Likewise, serious adverse events were equally distributed, and no allergic reactions to rituximab were recorded. In conclusion, our data show that using rituximab and prednisolone combined rather than prednisolone alone as first‐line treatment in WAIHA increases both the rate and the duration of the response. |
doi_str_mv | 10.1111/bjh.12541 |
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The impact of first‐line treatment with the anti‐CD 20 chimeric monoclonal antibody rituximab in patients with warm‐antibody reactive autoimmune haemolytic anaemia (WAIHA) is unknown. We report the first randomized study of 64 patients with newly diagnosed WAIHA who received prednisolone and rituximab combined (N = 32) or prednisolone monotherapy (N = 32). After 12 months, a satisfactory response was observed in 75% of the patients treated with rituximab and prednisolone but in a significantly smaller proportion (36%) of those given prednisolone alone (P = 0·003). Furthermore, relapse‐free survival was significantly better after the combined therapy than after prednisolone monotherapy (P = 0·02). After 36 months, about 70% of the patients were still in remission in the rituximab‐prednisolone group, whereas only about 45% were still in complete or partial remission in the prednisolone group. There was no significant difference between the two groups regarding adverse reactions to the studied medications. Likewise, serious adverse events were equally distributed, and no allergic reactions to rituximab were recorded. In conclusion, our data show that using rituximab and prednisolone combined rather than prednisolone alone as first‐line treatment in WAIHA increases both the rate and the duration of the response.</description><identifier>ISSN: 0007-1048</identifier><identifier>EISSN: 1365-2141</identifier><identifier>DOI: 10.1111/bjh.12541</identifier><identifier>PMID: 23981017</identifier><identifier>CODEN: BJHEAL</identifier><language>eng</language><publisher>Oxford: Blackwell</publisher><subject>Adult ; Aged ; Aged, 80 and over ; Anemia, Hemolytic, Autoimmune - blood ; Anemia, Hemolytic, Autoimmune - drug therapy ; Anemias. Hemoglobinopathies ; Antibodies, Monoclonal, Murine-Derived - administration & dosage ; Antibodies, Monoclonal, Murine-Derived - adverse effects ; Antibodies, Monoclonal, Murine-Derived - therapeutic use ; antibody therapy ; Autoimmune hemolytic anemia ; Biological and medical sciences ; clinical trials ; Disease-Free Survival ; Diseases of red blood cells ; Dyspepsia - etiology ; Dyspnea - etiology ; Fatigue - etiology ; Female ; Hematologic and hematopoietic diseases ; Humans ; immune haemolytic anaemia ; Immunosuppressive Agents - administration & dosage ; Immunosuppressive Agents - adverse effects ; Immunosuppressive Agents - therapeutic use ; Male ; Medical sciences ; Middle Aged ; Pain - etiology ; Pneumonia - etiology ; Prednisolone - administration & dosage ; Prednisolone - adverse effects ; Prednisolone - therapeutic use ; Remission Induction ; Rituximab ; Treatment Outcome ; Tumors</subject><ispartof>British journal of haematology, 2013-11, Vol.163 (3), p.393-399</ispartof><rights>2013 John Wiley & Sons Ltd</rights><rights>2014 INIST-CNRS</rights><rights>2013 John Wiley & Sons Ltd.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4231-d5d37f8fe31d84b1181c5aa4eb0577d3d2eae5752fa624039e7c9199e9ce3c553</citedby><cites>FETCH-LOGICAL-c4231-d5d37f8fe31d84b1181c5aa4eb0577d3d2eae5752fa624039e7c9199e9ce3c553</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1111%2Fbjh.12541$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Fbjh.12541$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,776,780,1411,1427,27901,27902,45550,45551,46384,46808</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=27868650$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/23981017$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Birgens, Henrik</creatorcontrib><creatorcontrib>Frederiksen, Henrik</creatorcontrib><creatorcontrib>Hasselbalch, Hans C.</creatorcontrib><creatorcontrib>Rasmussen, Inge H.</creatorcontrib><creatorcontrib>Nielsen, Ove J.</creatorcontrib><creatorcontrib>Kjeldsen, Lars</creatorcontrib><creatorcontrib>Larsen, Herdis</creatorcontrib><creatorcontrib>Mourits‐Andersen, Torben</creatorcontrib><creatorcontrib>Plesner, Torben</creatorcontrib><creatorcontrib>Rønnov‐Jessen, Dorthe</creatorcontrib><creatorcontrib>Vestergaard, Hanne</creatorcontrib><creatorcontrib>Klausen, Tobias W.</creatorcontrib><creatorcontrib>Schöllkopf, Claudia</creatorcontrib><title>A phase III randomized trial comparing glucocorticoid monotherapy versus glucocorticoid and rituximab in patients with autoimmune haemolytic anaemia</title><title>British journal of haematology</title><addtitle>Br J Haematol</addtitle><description>Summary
The impact of first‐line treatment with the anti‐CD 20 chimeric monoclonal antibody rituximab in patients with warm‐antibody reactive autoimmune haemolytic anaemia (WAIHA) is unknown. We report the first randomized study of 64 patients with newly diagnosed WAIHA who received prednisolone and rituximab combined (N = 32) or prednisolone monotherapy (N = 32). After 12 months, a satisfactory response was observed in 75% of the patients treated with rituximab and prednisolone but in a significantly smaller proportion (36%) of those given prednisolone alone (P = 0·003). Furthermore, relapse‐free survival was significantly better after the combined therapy than after prednisolone monotherapy (P = 0·02). After 36 months, about 70% of the patients were still in remission in the rituximab‐prednisolone group, whereas only about 45% were still in complete or partial remission in the prednisolone group. There was no significant difference between the two groups regarding adverse reactions to the studied medications. Likewise, serious adverse events were equally distributed, and no allergic reactions to rituximab were recorded. In conclusion, our data show that using rituximab and prednisolone combined rather than prednisolone alone as first‐line treatment in WAIHA increases both the rate and the duration of the response.</description><subject>Adult</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Anemia, Hemolytic, Autoimmune - blood</subject><subject>Anemia, Hemolytic, Autoimmune - drug therapy</subject><subject>Anemias. Hemoglobinopathies</subject><subject>Antibodies, Monoclonal, Murine-Derived - administration & dosage</subject><subject>Antibodies, Monoclonal, Murine-Derived - adverse effects</subject><subject>Antibodies, Monoclonal, Murine-Derived - therapeutic use</subject><subject>antibody therapy</subject><subject>Autoimmune hemolytic anemia</subject><subject>Biological and medical sciences</subject><subject>clinical trials</subject><subject>Disease-Free Survival</subject><subject>Diseases of red blood cells</subject><subject>Dyspepsia - etiology</subject><subject>Dyspnea - etiology</subject><subject>Fatigue - etiology</subject><subject>Female</subject><subject>Hematologic and hematopoietic diseases</subject><subject>Humans</subject><subject>immune haemolytic anaemia</subject><subject>Immunosuppressive Agents - administration & dosage</subject><subject>Immunosuppressive Agents - adverse effects</subject><subject>Immunosuppressive Agents - therapeutic use</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Pain - etiology</subject><subject>Pneumonia - etiology</subject><subject>Prednisolone - administration & dosage</subject><subject>Prednisolone - adverse effects</subject><subject>Prednisolone - therapeutic use</subject><subject>Remission Induction</subject><subject>Rituximab</subject><subject>Treatment Outcome</subject><subject>Tumors</subject><issn>0007-1048</issn><issn>1365-2141</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2013</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqN0ctu1DAUBmALgehQWPACyBskukjr40suy1JROlUlNrCOHPukcRXHwU4ow3PwwBhmoBISEt7Yi-_8R_JPyEtgp5DPWXc3nAJXEh6RDYhSFRwkPCYbxlhVAJP1EXmW0h1jIJiCp-SIi6YGBtWGfD-n86AT0u12S6OebPDuG1q6RKdHaoKfdXTTLb0dVxNMiIszwVnqwxSWAaOed_QLxrSmv0WOotEt61fndUfdRGe9OJyWRO_dMlC9LsF5v05IB40-jLs8l4fy2-nn5Emvx4QvDvcx-XT57uPFVXHz4f324vymMJILKKyyourrHgXYWnYANRiltcSOqaqywnLUqCrFe11yyUSDlWmgabAxKIxS4pi82efOMXxeMS2td8ngOOoJw5pakKVUDMqm_A8qheQNhzrTkz01MaQUsW_nmD8h7lpg7c--2txX-6uvbF8dYtfOo_0jfxeUwesD0Mnosc8VGZceXFWXdalYdmd7d-9G3P17Y_v2-mq_-gc9nK8c</recordid><startdate>201311</startdate><enddate>201311</enddate><creator>Birgens, Henrik</creator><creator>Frederiksen, Henrik</creator><creator>Hasselbalch, Hans C.</creator><creator>Rasmussen, Inge H.</creator><creator>Nielsen, Ove J.</creator><creator>Kjeldsen, Lars</creator><creator>Larsen, Herdis</creator><creator>Mourits‐Andersen, Torben</creator><creator>Plesner, Torben</creator><creator>Rønnov‐Jessen, Dorthe</creator><creator>Vestergaard, Hanne</creator><creator>Klausen, Tobias W.</creator><creator>Schöllkopf, Claudia</creator><general>Blackwell</general><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><scope>7T5</scope><scope>H94</scope></search><sort><creationdate>201311</creationdate><title>A phase III randomized trial comparing glucocorticoid monotherapy versus glucocorticoid and rituximab in patients with autoimmune haemolytic anaemia</title><author>Birgens, Henrik ; Frederiksen, Henrik ; Hasselbalch, Hans C. ; Rasmussen, Inge H. ; Nielsen, Ove J. ; Kjeldsen, Lars ; Larsen, Herdis ; Mourits‐Andersen, Torben ; Plesner, Torben ; Rønnov‐Jessen, Dorthe ; Vestergaard, Hanne ; Klausen, Tobias W. ; Schöllkopf, Claudia</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4231-d5d37f8fe31d84b1181c5aa4eb0577d3d2eae5752fa624039e7c9199e9ce3c553</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2013</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Anemia, Hemolytic, Autoimmune - blood</topic><topic>Anemia, Hemolytic, Autoimmune - drug therapy</topic><topic>Anemias. Hemoglobinopathies</topic><topic>Antibodies, Monoclonal, Murine-Derived - administration & dosage</topic><topic>Antibodies, Monoclonal, Murine-Derived - adverse effects</topic><topic>Antibodies, Monoclonal, Murine-Derived - therapeutic use</topic><topic>antibody therapy</topic><topic>Autoimmune hemolytic anemia</topic><topic>Biological and medical sciences</topic><topic>clinical trials</topic><topic>Disease-Free Survival</topic><topic>Diseases of red blood cells</topic><topic>Dyspepsia - etiology</topic><topic>Dyspnea - etiology</topic><topic>Fatigue - etiology</topic><topic>Female</topic><topic>Hematologic and hematopoietic diseases</topic><topic>Humans</topic><topic>immune haemolytic anaemia</topic><topic>Immunosuppressive Agents - administration & dosage</topic><topic>Immunosuppressive Agents - adverse effects</topic><topic>Immunosuppressive Agents - therapeutic use</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Pain - etiology</topic><topic>Pneumonia - etiology</topic><topic>Prednisolone - administration & dosage</topic><topic>Prednisolone - adverse effects</topic><topic>Prednisolone - therapeutic use</topic><topic>Remission Induction</topic><topic>Rituximab</topic><topic>Treatment Outcome</topic><topic>Tumors</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Birgens, Henrik</creatorcontrib><creatorcontrib>Frederiksen, Henrik</creatorcontrib><creatorcontrib>Hasselbalch, Hans C.</creatorcontrib><creatorcontrib>Rasmussen, Inge H.</creatorcontrib><creatorcontrib>Nielsen, Ove J.</creatorcontrib><creatorcontrib>Kjeldsen, Lars</creatorcontrib><creatorcontrib>Larsen, Herdis</creatorcontrib><creatorcontrib>Mourits‐Andersen, Torben</creatorcontrib><creatorcontrib>Plesner, Torben</creatorcontrib><creatorcontrib>Rønnov‐Jessen, Dorthe</creatorcontrib><creatorcontrib>Vestergaard, Hanne</creatorcontrib><creatorcontrib>Klausen, Tobias W.</creatorcontrib><creatorcontrib>Schöllkopf, Claudia</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><collection>Immunology Abstracts</collection><collection>AIDS and Cancer Research Abstracts</collection><jtitle>British journal of haematology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Birgens, Henrik</au><au>Frederiksen, Henrik</au><au>Hasselbalch, Hans C.</au><au>Rasmussen, Inge H.</au><au>Nielsen, Ove J.</au><au>Kjeldsen, Lars</au><au>Larsen, Herdis</au><au>Mourits‐Andersen, Torben</au><au>Plesner, Torben</au><au>Rønnov‐Jessen, Dorthe</au><au>Vestergaard, Hanne</au><au>Klausen, Tobias W.</au><au>Schöllkopf, Claudia</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>A phase III randomized trial comparing glucocorticoid monotherapy versus glucocorticoid and rituximab in patients with autoimmune haemolytic anaemia</atitle><jtitle>British journal of haematology</jtitle><addtitle>Br J Haematol</addtitle><date>2013-11</date><risdate>2013</risdate><volume>163</volume><issue>3</issue><spage>393</spage><epage>399</epage><pages>393-399</pages><issn>0007-1048</issn><eissn>1365-2141</eissn><coden>BJHEAL</coden><abstract>Summary
The impact of first‐line treatment with the anti‐CD 20 chimeric monoclonal antibody rituximab in patients with warm‐antibody reactive autoimmune haemolytic anaemia (WAIHA) is unknown. We report the first randomized study of 64 patients with newly diagnosed WAIHA who received prednisolone and rituximab combined (N = 32) or prednisolone monotherapy (N = 32). After 12 months, a satisfactory response was observed in 75% of the patients treated with rituximab and prednisolone but in a significantly smaller proportion (36%) of those given prednisolone alone (P = 0·003). Furthermore, relapse‐free survival was significantly better after the combined therapy than after prednisolone monotherapy (P = 0·02). After 36 months, about 70% of the patients were still in remission in the rituximab‐prednisolone group, whereas only about 45% were still in complete or partial remission in the prednisolone group. There was no significant difference between the two groups regarding adverse reactions to the studied medications. Likewise, serious adverse events were equally distributed, and no allergic reactions to rituximab were recorded. In conclusion, our data show that using rituximab and prednisolone combined rather than prednisolone alone as first‐line treatment in WAIHA increases both the rate and the duration of the response.</abstract><cop>Oxford</cop><pub>Blackwell</pub><pmid>23981017</pmid><doi>10.1111/bjh.12541</doi><tpages>7</tpages><oa>free_for_read</oa></addata></record> |
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subjects | Adult Aged Aged, 80 and over Anemia, Hemolytic, Autoimmune - blood Anemia, Hemolytic, Autoimmune - drug therapy Anemias. Hemoglobinopathies Antibodies, Monoclonal, Murine-Derived - administration & dosage Antibodies, Monoclonal, Murine-Derived - adverse effects Antibodies, Monoclonal, Murine-Derived - therapeutic use antibody therapy Autoimmune hemolytic anemia Biological and medical sciences clinical trials Disease-Free Survival Diseases of red blood cells Dyspepsia - etiology Dyspnea - etiology Fatigue - etiology Female Hematologic and hematopoietic diseases Humans immune haemolytic anaemia Immunosuppressive Agents - administration & dosage Immunosuppressive Agents - adverse effects Immunosuppressive Agents - therapeutic use Male Medical sciences Middle Aged Pain - etiology Pneumonia - etiology Prednisolone - administration & dosage Prednisolone - adverse effects Prednisolone - therapeutic use Remission Induction Rituximab Treatment Outcome Tumors |
title | A phase III randomized trial comparing glucocorticoid monotherapy versus glucocorticoid and rituximab in patients with autoimmune haemolytic anaemia |
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