A prospective, multicenter, randomized trial comparing steroids and pulse cyclophosphamide versus steroids and oral cyclophosphamide in the treatment of generalized wegener's granulomatosis
Objective. To investigate the effectiveness and side effects of oral versus pulse cyclophosphamide (CYC) in combination with corticosteroids (CS) in the treatment of systemic Wegener's granulomatosis (WG). Methods. Patients with newly diagnosed systemic WG were enrolled in a prospective, random...
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| Veröffentlicht in: | Arthritis and rheumatism 1997-12, Vol.40 (12), p.2187-2198 |
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| creator | Guillevin, Loïc Cordier, Jean‐François Lhote, Franïois Cohen, Pascal Jarrousse, Bernard Royer, Isabelle Lesavre, Philippe Jacquot, Christian Bindi, Pascal Bielefeld, Philippe Desson, Jean‐Franïois Détrée, Frédérick Dubois, Alain Hachulla, Eric Hoen, Bruno Jacomy, Dominique Seigneuric, Christian Lauque, Dominique Stern, Marc Longy‐Boursier, Maité |
| description | Objective. To investigate the effectiveness and side effects of oral versus pulse cyclophosphamide (CYC) in combination with corticosteroids (CS) in the treatment of systemic Wegener's granulomatosis (WG).
Methods. Patients with newly diagnosed systemic WG were enrolled in a prospective, randomized trial. At the time of diagnosis, prior to randomization, every patient received a daily injection of methylprednisolone for 3 days, followed by daily oral prednisone (1 mg/kg/day) and a 0.7‐gm/m2 pulse of CYC. Patients were then randomly assigned to receive either prednisone plus intravenous pulse CYC (group A) or prednisone plus oral CYC (group B) as first‐line treatment. CYC was given for at least 1 year and was then progressively tapered and discontinued.
Results. Fifty patients were included in the study: 27 in group A and 23 in group B. At 6 months, 24 group A patients (88.9%) were in remission, versus 18 group B patients (78.3%). At the end of the trial, 18 group A patients (66.7%) and 13 group B patients (56.5%) were in remission. In group A, 66.7% of the patients experienced side effects, versus 69.6% in group B. Infectious side effects were significantly more frequent in group B (69.6%) than in group A (40.7%) (P < 0.05). The incidence of Pneumocystis carinii pneumonia was higher in oral CYC‐treated patients (30.4%) than in pulse CYC‐treated patients (11.1%). Nine group A patients (33.3%) and 10 group B patients (43.5%) died. Actuarial curves showed that relapses were significantly more frequent in group A (59.2%) than in group B (13%) (P = 0.02).
Conclusion. Our results indicate that pulse CYC is as effective as oral CYC in achieving initial remission of WG and is associated with fewer side effects and lower mortality. However, in the long term, treatment with pulse CYC does not maintain remission or prevent relapses as well as oral CYC. |
| doi_str_mv | 10.1002/art.1780401213 |
| format | Article |
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Methods. Patients with newly diagnosed systemic WG were enrolled in a prospective, randomized trial. At the time of diagnosis, prior to randomization, every patient received a daily injection of methylprednisolone for 3 days, followed by daily oral prednisone (1 mg/kg/day) and a 0.7‐gm/m2 pulse of CYC. Patients were then randomly assigned to receive either prednisone plus intravenous pulse CYC (group A) or prednisone plus oral CYC (group B) as first‐line treatment. CYC was given for at least 1 year and was then progressively tapered and discontinued.
Results. Fifty patients were included in the study: 27 in group A and 23 in group B. At 6 months, 24 group A patients (88.9%) were in remission, versus 18 group B patients (78.3%). At the end of the trial, 18 group A patients (66.7%) and 13 group B patients (56.5%) were in remission. In group A, 66.7% of the patients experienced side effects, versus 69.6% in group B. Infectious side effects were significantly more frequent in group B (69.6%) than in group A (40.7%) (P < 0.05). The incidence of Pneumocystis carinii pneumonia was higher in oral CYC‐treated patients (30.4%) than in pulse CYC‐treated patients (11.1%). Nine group A patients (33.3%) and 10 group B patients (43.5%) died. Actuarial curves showed that relapses were significantly more frequent in group A (59.2%) than in group B (13%) (P = 0.02).
Conclusion. Our results indicate that pulse CYC is as effective as oral CYC in achieving initial remission of WG and is associated with fewer side effects and lower mortality. However, in the long term, treatment with pulse CYC does not maintain remission or prevent relapses as well as oral CYC.</description><identifier>ISSN: 0004-3591</identifier><identifier>EISSN: 1529-0131</identifier><identifier>DOI: 10.1002/art.1780401213</identifier><identifier>PMID: 9416856</identifier><identifier>CODEN: ARHEAW</identifier><language>eng</language><publisher>New York: John Wiley & Sons, Inc</publisher><subject>Administration, Oral ; Adolescent ; Adult ; Aged ; Antirheumatic Agents - adverse effects ; Antirheumatic Agents - therapeutic use ; Biological and medical sciences ; Cyclophosphamide - adverse effects ; Cyclophosphamide - therapeutic use ; Drug Therapy, Combination ; Glucocorticoids - adverse effects ; Glucocorticoids - therapeutic use ; Granulomatosis with Polyangiitis - drug therapy ; Granulomatosis with Polyangiitis - mortality ; Granulomatosis with Polyangiitis - pathology ; Humans ; Injections, Intravenous ; Medical sciences ; Middle Aged ; Prednisone - adverse effects ; Prednisone - therapeutic use ; Prospective Studies ; Recurrence ; Remission Induction ; Sarcoidosis. Granulomatous diseases of unproved etiology. Connective tissue diseases. Elastic tissue diseases. Vasculitis ; Survival Rate ; Treatment Outcome</subject><ispartof>Arthritis and rheumatism, 1997-12, Vol.40 (12), p.2187-2198</ispartof><rights>Copyright © 1997 American College of Rheumatology</rights><rights>1998 INIST-CNRS</rights><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4773-df98ad7cc87f653acd745a5baa7384b96928b7dc88d8f35be43c253dd1a405633</citedby><cites>FETCH-LOGICAL-c4773-df98ad7cc87f653acd745a5baa7384b96928b7dc88d8f35be43c253dd1a405633</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1002%2Fart.1780401213$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1002%2Fart.1780401213$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,776,780,1411,27901,27902,45550,45551</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=2089074$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/9416856$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Guillevin, Loïc</creatorcontrib><creatorcontrib>Cordier, Jean‐François</creatorcontrib><creatorcontrib>Lhote, Franïois</creatorcontrib><creatorcontrib>Cohen, Pascal</creatorcontrib><creatorcontrib>Jarrousse, Bernard</creatorcontrib><creatorcontrib>Royer, Isabelle</creatorcontrib><creatorcontrib>Lesavre, Philippe</creatorcontrib><creatorcontrib>Jacquot, Christian</creatorcontrib><creatorcontrib>Bindi, Pascal</creatorcontrib><creatorcontrib>Bielefeld, Philippe</creatorcontrib><creatorcontrib>Desson, Jean‐Franïois</creatorcontrib><creatorcontrib>Détrée, Frédérick</creatorcontrib><creatorcontrib>Dubois, Alain</creatorcontrib><creatorcontrib>Hachulla, Eric</creatorcontrib><creatorcontrib>Hoen, Bruno</creatorcontrib><creatorcontrib>Jacomy, Dominique</creatorcontrib><creatorcontrib>Seigneuric, Christian</creatorcontrib><creatorcontrib>Lauque, Dominique</creatorcontrib><creatorcontrib>Stern, Marc</creatorcontrib><creatorcontrib>Longy‐Boursier, Maité</creatorcontrib><title>A prospective, multicenter, randomized trial comparing steroids and pulse cyclophosphamide versus steroids and oral cyclophosphamide in the treatment of generalized wegener's granulomatosis</title><title>Arthritis and rheumatism</title><addtitle>Arthritis Rheum</addtitle><description>Objective. To investigate the effectiveness and side effects of oral versus pulse cyclophosphamide (CYC) in combination with corticosteroids (CS) in the treatment of systemic Wegener's granulomatosis (WG).
Methods. Patients with newly diagnosed systemic WG were enrolled in a prospective, randomized trial. At the time of diagnosis, prior to randomization, every patient received a daily injection of methylprednisolone for 3 days, followed by daily oral prednisone (1 mg/kg/day) and a 0.7‐gm/m2 pulse of CYC. Patients were then randomly assigned to receive either prednisone plus intravenous pulse CYC (group A) or prednisone plus oral CYC (group B) as first‐line treatment. CYC was given for at least 1 year and was then progressively tapered and discontinued.
Results. Fifty patients were included in the study: 27 in group A and 23 in group B. At 6 months, 24 group A patients (88.9%) were in remission, versus 18 group B patients (78.3%). At the end of the trial, 18 group A patients (66.7%) and 13 group B patients (56.5%) were in remission. In group A, 66.7% of the patients experienced side effects, versus 69.6% in group B. Infectious side effects were significantly more frequent in group B (69.6%) than in group A (40.7%) (P < 0.05). The incidence of Pneumocystis carinii pneumonia was higher in oral CYC‐treated patients (30.4%) than in pulse CYC‐treated patients (11.1%). Nine group A patients (33.3%) and 10 group B patients (43.5%) died. Actuarial curves showed that relapses were significantly more frequent in group A (59.2%) than in group B (13%) (P = 0.02).
Conclusion. Our results indicate that pulse CYC is as effective as oral CYC in achieving initial remission of WG and is associated with fewer side effects and lower mortality. However, in the long term, treatment with pulse CYC does not maintain remission or prevent relapses as well as oral CYC.</description><subject>Administration, Oral</subject><subject>Adolescent</subject><subject>Adult</subject><subject>Aged</subject><subject>Antirheumatic Agents - adverse effects</subject><subject>Antirheumatic Agents - therapeutic use</subject><subject>Biological and medical sciences</subject><subject>Cyclophosphamide - adverse effects</subject><subject>Cyclophosphamide - therapeutic use</subject><subject>Drug Therapy, Combination</subject><subject>Glucocorticoids - adverse effects</subject><subject>Glucocorticoids - therapeutic use</subject><subject>Granulomatosis with Polyangiitis - drug therapy</subject><subject>Granulomatosis with Polyangiitis - mortality</subject><subject>Granulomatosis with Polyangiitis - pathology</subject><subject>Humans</subject><subject>Injections, Intravenous</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Prednisone - adverse effects</subject><subject>Prednisone - therapeutic use</subject><subject>Prospective Studies</subject><subject>Recurrence</subject><subject>Remission Induction</subject><subject>Sarcoidosis. Granulomatous diseases of unproved etiology. Connective tissue diseases. Elastic tissue diseases. Vasculitis</subject><subject>Survival Rate</subject><subject>Treatment Outcome</subject><issn>0004-3591</issn><issn>1529-0131</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>1997</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqFkU1r3DAQhkVpSLdpr70VdCj0Em8kS7Lk4xL6BYFCSM5mLI13VWzLSHbC5r_1v1XJLunHpScxzDPvO5qXkHecrTlj5QXEec21YZLxkosXZMVVWReMC_6SrBhjshCq5q_I65R-5LIUSpyS01ryyqhqRX5u6BRDmtDO_g7P6bD0s7c4zhjPaYTRhcE_oKNz9NBTG4YJoh-3NGUgeJdoRui09Amp3ds-TLsstoPBO6R3GNOS_kZDfJT5l_QjnXeYTRDmIZvT0NEtjpjhJ_d7fKo-JrrNOy19GGAOyac35KSD7P32-J6R28-fbi6_Flffv3y73FwVVmotCtfVBpy21uiuUgKs01KBagG0MLKtq7o0rXbWGGc6oVqUwpZKOMdBMlUJcUbWB12bb5Uids0U_QBx33DWPMbQ5Bia3zHkgfeHgWlpB3TP-PHuuf_h2Idkoe_yr6xPz1jJTM20zFh9wO59j_v_mDab65s_VvgFM8unuA</recordid><startdate>199712</startdate><enddate>199712</enddate><creator>Guillevin, Loïc</creator><creator>Cordier, Jean‐François</creator><creator>Lhote, Franïois</creator><creator>Cohen, Pascal</creator><creator>Jarrousse, Bernard</creator><creator>Royer, Isabelle</creator><creator>Lesavre, Philippe</creator><creator>Jacquot, Christian</creator><creator>Bindi, Pascal</creator><creator>Bielefeld, Philippe</creator><creator>Desson, Jean‐Franïois</creator><creator>Détrée, Frédérick</creator><creator>Dubois, Alain</creator><creator>Hachulla, Eric</creator><creator>Hoen, Bruno</creator><creator>Jacomy, Dominique</creator><creator>Seigneuric, Christian</creator><creator>Lauque, Dominique</creator><creator>Stern, Marc</creator><creator>Longy‐Boursier, Maité</creator><general>John Wiley & Sons, Inc</general><general>Wiley</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></search><sort><creationdate>199712</creationdate><title>A prospective, multicenter, randomized trial comparing steroids and pulse cyclophosphamide versus steroids and oral cyclophosphamide in the treatment of generalized wegener's granulomatosis</title><author>Guillevin, Loïc ; Cordier, Jean‐François ; Lhote, Franïois ; Cohen, Pascal ; Jarrousse, Bernard ; Royer, Isabelle ; Lesavre, Philippe ; Jacquot, Christian ; Bindi, Pascal ; Bielefeld, Philippe ; Desson, Jean‐Franïois ; Détrée, Frédérick ; Dubois, Alain ; Hachulla, Eric ; Hoen, Bruno ; Jacomy, Dominique ; Seigneuric, Christian ; Lauque, Dominique ; Stern, Marc ; Longy‐Boursier, Maité</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4773-df98ad7cc87f653acd745a5baa7384b96928b7dc88d8f35be43c253dd1a405633</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>1997</creationdate><topic>Administration, Oral</topic><topic>Adolescent</topic><topic>Adult</topic><topic>Aged</topic><topic>Antirheumatic Agents - adverse effects</topic><topic>Antirheumatic Agents - therapeutic use</topic><topic>Biological and medical sciences</topic><topic>Cyclophosphamide - adverse effects</topic><topic>Cyclophosphamide - therapeutic use</topic><topic>Drug Therapy, Combination</topic><topic>Glucocorticoids - adverse effects</topic><topic>Glucocorticoids - therapeutic use</topic><topic>Granulomatosis with Polyangiitis - drug therapy</topic><topic>Granulomatosis with Polyangiitis - mortality</topic><topic>Granulomatosis with Polyangiitis - pathology</topic><topic>Humans</topic><topic>Injections, Intravenous</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Prednisone - adverse effects</topic><topic>Prednisone - therapeutic use</topic><topic>Prospective Studies</topic><topic>Recurrence</topic><topic>Remission Induction</topic><topic>Sarcoidosis. Granulomatous diseases of unproved etiology. Connective tissue diseases. Elastic tissue diseases. Vasculitis</topic><topic>Survival Rate</topic><topic>Treatment Outcome</topic><toplevel>online_resources</toplevel><creatorcontrib>Guillevin, Loïc</creatorcontrib><creatorcontrib>Cordier, Jean‐François</creatorcontrib><creatorcontrib>Lhote, Franïois</creatorcontrib><creatorcontrib>Cohen, Pascal</creatorcontrib><creatorcontrib>Jarrousse, Bernard</creatorcontrib><creatorcontrib>Royer, Isabelle</creatorcontrib><creatorcontrib>Lesavre, Philippe</creatorcontrib><creatorcontrib>Jacquot, Christian</creatorcontrib><creatorcontrib>Bindi, Pascal</creatorcontrib><creatorcontrib>Bielefeld, Philippe</creatorcontrib><creatorcontrib>Desson, Jean‐Franïois</creatorcontrib><creatorcontrib>Détrée, Frédérick</creatorcontrib><creatorcontrib>Dubois, Alain</creatorcontrib><creatorcontrib>Hachulla, Eric</creatorcontrib><creatorcontrib>Hoen, Bruno</creatorcontrib><creatorcontrib>Jacomy, Dominique</creatorcontrib><creatorcontrib>Seigneuric, Christian</creatorcontrib><creatorcontrib>Lauque, Dominique</creatorcontrib><creatorcontrib>Stern, Marc</creatorcontrib><creatorcontrib>Longy‐Boursier, Maité</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><jtitle>Arthritis and rheumatism</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Guillevin, Loïc</au><au>Cordier, Jean‐François</au><au>Lhote, Franïois</au><au>Cohen, Pascal</au><au>Jarrousse, Bernard</au><au>Royer, Isabelle</au><au>Lesavre, Philippe</au><au>Jacquot, Christian</au><au>Bindi, Pascal</au><au>Bielefeld, Philippe</au><au>Desson, Jean‐Franïois</au><au>Détrée, Frédérick</au><au>Dubois, Alain</au><au>Hachulla, Eric</au><au>Hoen, Bruno</au><au>Jacomy, Dominique</au><au>Seigneuric, Christian</au><au>Lauque, Dominique</au><au>Stern, Marc</au><au>Longy‐Boursier, Maité</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>A prospective, multicenter, randomized trial comparing steroids and pulse cyclophosphamide versus steroids and oral cyclophosphamide in the treatment of generalized wegener's granulomatosis</atitle><jtitle>Arthritis and rheumatism</jtitle><addtitle>Arthritis Rheum</addtitle><date>1997-12</date><risdate>1997</risdate><volume>40</volume><issue>12</issue><spage>2187</spage><epage>2198</epage><pages>2187-2198</pages><issn>0004-3591</issn><eissn>1529-0131</eissn><coden>ARHEAW</coden><abstract>Objective. To investigate the effectiveness and side effects of oral versus pulse cyclophosphamide (CYC) in combination with corticosteroids (CS) in the treatment of systemic Wegener's granulomatosis (WG).
Methods. Patients with newly diagnosed systemic WG were enrolled in a prospective, randomized trial. At the time of diagnosis, prior to randomization, every patient received a daily injection of methylprednisolone for 3 days, followed by daily oral prednisone (1 mg/kg/day) and a 0.7‐gm/m2 pulse of CYC. Patients were then randomly assigned to receive either prednisone plus intravenous pulse CYC (group A) or prednisone plus oral CYC (group B) as first‐line treatment. CYC was given for at least 1 year and was then progressively tapered and discontinued.
Results. Fifty patients were included in the study: 27 in group A and 23 in group B. At 6 months, 24 group A patients (88.9%) were in remission, versus 18 group B patients (78.3%). At the end of the trial, 18 group A patients (66.7%) and 13 group B patients (56.5%) were in remission. In group A, 66.7% of the patients experienced side effects, versus 69.6% in group B. Infectious side effects were significantly more frequent in group B (69.6%) than in group A (40.7%) (P < 0.05). The incidence of Pneumocystis carinii pneumonia was higher in oral CYC‐treated patients (30.4%) than in pulse CYC‐treated patients (11.1%). Nine group A patients (33.3%) and 10 group B patients (43.5%) died. Actuarial curves showed that relapses were significantly more frequent in group A (59.2%) than in group B (13%) (P = 0.02).
Conclusion. Our results indicate that pulse CYC is as effective as oral CYC in achieving initial remission of WG and is associated with fewer side effects and lower mortality. However, in the long term, treatment with pulse CYC does not maintain remission or prevent relapses as well as oral CYC.</abstract><cop>New York</cop><pub>John Wiley & Sons, Inc</pub><pmid>9416856</pmid><doi>10.1002/art.1780401213</doi><tpages>12</tpages><oa>free_for_read</oa></addata></record> |
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| ispartof | Arthritis and rheumatism, 1997-12, Vol.40 (12), p.2187-2198 |
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| language | eng |
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| source | MEDLINE; Wiley Online Library Journals Frontfile Complete; Alma/SFX Local Collection |
| subjects | Administration, Oral Adolescent Adult Aged Antirheumatic Agents - adverse effects Antirheumatic Agents - therapeutic use Biological and medical sciences Cyclophosphamide - adverse effects Cyclophosphamide - therapeutic use Drug Therapy, Combination Glucocorticoids - adverse effects Glucocorticoids - therapeutic use Granulomatosis with Polyangiitis - drug therapy Granulomatosis with Polyangiitis - mortality Granulomatosis with Polyangiitis - pathology Humans Injections, Intravenous Medical sciences Middle Aged Prednisone - adverse effects Prednisone - therapeutic use Prospective Studies Recurrence Remission Induction Sarcoidosis. Granulomatous diseases of unproved etiology. Connective tissue diseases. Elastic tissue diseases. Vasculitis Survival Rate Treatment Outcome |
| title | A prospective, multicenter, randomized trial comparing steroids and pulse cyclophosphamide versus steroids and oral cyclophosphamide in the treatment of generalized wegener's granulomatosis |
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