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
Hauptverfasser: 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
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container_end_page 399
container_issue 3
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container_title British journal of haematology
container_volume 163
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.
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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. 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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. 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Hemoglobinopathies</topic><topic>Antibodies, Monoclonal, Murine-Derived - administration &amp; 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 &amp; 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 &amp; 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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source Wiley Free Content; MEDLINE; Wiley Online Library Journals Frontfile Complete; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals
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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