Leflunomide versus cyclophosphamide in the induction treatment of proliferative lupus nephritis in Chinese patients: a randomized trial
Objectives A prospective, multi-center, randomized controlled study was conducted to evaluate the efficacy and safety of a 24-week course low-dose leflunomide combined with prednisone in the induction treatment of proliferative lupus nephritis in Chinese patients. Method Patients ( n = 100) with bi...
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| Veröffentlicht in: | Clinical rheumatology 2019-03, Vol.38 (3), p.859-867 |
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| creator | Zhang, Minfang Qi, Chaojun Zha, Yan Chen, Jian Luo, Ping Wang, Li Sun, Zhuxing Wan, Jianxin Xing, Changying Wang, Song Jiang, Gengru Sun, Mindan Chen, Qinkai Chen, Jianghua Li, Detian Guan, Tianjun Ni, Zhaohui |
| description | Objectives
A prospective, multi-center, randomized controlled study was conducted to evaluate the efficacy and safety of a 24-week course low-dose leflunomide combined with prednisone in the induction treatment of proliferative lupus nephritis in Chinese patients.
Method
Patients (
n
= 100) with biopsy–proved proliferative lupus nephritis were enrolled in this study. They were randomized into two groups and received either leflunomide or cyclophosphamide in conjunction with prednisone for 24 weeks. Leflunomide was given orally with a loading dose of 40 mg/day for 3 days followed by 20 mg/day. Intravenous cyclophosphamide was administered monthly at a dosage of 0.8–1.0 g. The primary efficacy outcome was the frequency of complete remission and partial remission at week 24. The secondary outcomes included changes of urinary protein excretion, serum albumin, complement 3, anti-dsDNA antibody level, and systemic lupus erythematosus disease activity index (SLEDAI) after 24-week therapy.
Results
Of 100 patients, 48 received leflunomide combined with prednisone and other 52 received cyclophosphamide with concomitant prednisone. There were no statistically significant differences between groups in complete remission rate and partial remission rate. At week 24, 23% of patients in the leflunomide group and 27% of patients in the cyclophosphamide group achieved complete remission (
P
= 0.64), while 56% of patients in the leflunomide group and 42% of patients in the cyclophosphamide group achieved partial remission at week 24 (
P
= 0.16). SLEDAI, serum albumin, complement 3, anti-dsDNA antibody level, and urinary protein excretion improved significantly in both groups. No significant difference was seen in the changes of clinical parameters after therapy between the two groups. There was no significant difference in side effects in both groups.
Conclusions
Compared with cyclophosphamide, low-dose leflunomide in combination with prednisone showed both effectiveness and safety in the induction therapy of proliferative lupus nephritis in Chinese patients. |
| doi_str_mv | 10.1007/s10067-018-4348-z |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_2133440654</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2133440654</sourcerecordid><originalsourceid>FETCH-LOGICAL-c415t-898793cd638a812849931c8eb2e3549159599833160ed6e0e3371a343431173e3</originalsourceid><addsrcrecordid>eNp1kc1u1TAQhS0EopfCA7BBltiwCdgZJ7HZoavyI12pm3ZtucmEuErsYCeVel-A1-6EW0BCYuPf75wZ-zD2Wor3UojmQ6axbgohdaFA6eL4hO0krQpjlHnKdqJpRAHS6DP2IudbIUSpjXzOzkCosgYpd-znAftxDXHyHfI7THnNvL1vxzgPMc-D-3XuA1-GberWdvGRdgndMmFYeOz5nOLoe0xu8XfIx3Umi4DzkPzi86bdDz5gRj4TQZr8kTueXOio6BE7MvNufMme9W7M-OpxPmfXny-u9l-Lw-WXb_tPh6JVsloKbXRjoO1q0E7LUitjQLYab0qEShlZmcoYDSBrgV2NAgEa6YD-hF7bAMI5e3fypa5_rJgXO_nc4ji6gHHNtpQASom6UoS-_Qe9jWsK1N1GlVVZQSOIkieqTTHnhL2dk59curdS2C0le0rJUkp2S8keSfPm0Xm9mbD7o_gdCwHlCch0Fb5j-lv6_64PQHeeVw</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2132525370</pqid></control><display><type>article</type><title>Leflunomide versus cyclophosphamide in the induction treatment of proliferative lupus nephritis in Chinese patients: a randomized trial</title><source>MEDLINE</source><source>SpringerLink (Online service)</source><creator>Zhang, Minfang ; Qi, Chaojun ; Zha, Yan ; Chen, Jian ; Luo, Ping ; Wang, Li ; Sun, Zhuxing ; Wan, Jianxin ; Xing, Changying ; Wang, Song ; Jiang, Gengru ; Sun, Mindan ; Chen, Qinkai ; Chen, Jianghua ; Li, Detian ; Guan, Tianjun ; Ni, Zhaohui</creator><creatorcontrib>Zhang, Minfang ; Qi, Chaojun ; Zha, Yan ; Chen, Jian ; Luo, Ping ; Wang, Li ; Sun, Zhuxing ; Wan, Jianxin ; Xing, Changying ; Wang, Song ; Jiang, Gengru ; Sun, Mindan ; Chen, Qinkai ; Chen, Jianghua ; Li, Detian ; Guan, Tianjun ; Ni, Zhaohui</creatorcontrib><description>Objectives
A prospective, multi-center, randomized controlled study was conducted to evaluate the efficacy and safety of a 24-week course low-dose leflunomide combined with prednisone in the induction treatment of proliferative lupus nephritis in Chinese patients.
Method
Patients (
n
= 100) with biopsy–proved proliferative lupus nephritis were enrolled in this study. They were randomized into two groups and received either leflunomide or cyclophosphamide in conjunction with prednisone for 24 weeks. Leflunomide was given orally with a loading dose of 40 mg/day for 3 days followed by 20 mg/day. Intravenous cyclophosphamide was administered monthly at a dosage of 0.8–1.0 g. The primary efficacy outcome was the frequency of complete remission and partial remission at week 24. The secondary outcomes included changes of urinary protein excretion, serum albumin, complement 3, anti-dsDNA antibody level, and systemic lupus erythematosus disease activity index (SLEDAI) after 24-week therapy.
Results
Of 100 patients, 48 received leflunomide combined with prednisone and other 52 received cyclophosphamide with concomitant prednisone. There were no statistically significant differences between groups in complete remission rate and partial remission rate. At week 24, 23% of patients in the leflunomide group and 27% of patients in the cyclophosphamide group achieved complete remission (
P
= 0.64), while 56% of patients in the leflunomide group and 42% of patients in the cyclophosphamide group achieved partial remission at week 24 (
P
= 0.16). SLEDAI, serum albumin, complement 3, anti-dsDNA antibody level, and urinary protein excretion improved significantly in both groups. No significant difference was seen in the changes of clinical parameters after therapy between the two groups. There was no significant difference in side effects in both groups.
Conclusions
Compared with cyclophosphamide, low-dose leflunomide in combination with prednisone showed both effectiveness and safety in the induction therapy of proliferative lupus nephritis in Chinese patients.</description><identifier>ISSN: 0770-3198</identifier><identifier>EISSN: 1434-9949</identifier><identifier>DOI: 10.1007/s10067-018-4348-z</identifier><identifier>PMID: 30426311</identifier><language>eng</language><publisher>London: Springer London</publisher><subject>Adult ; Albumin ; Anti-DNA antibodies ; Antibodies, Antinuclear ; Biopsy ; China ; Complement C3 - immunology ; Cyclophosphamide ; Cyclophosphamide - therapeutic use ; DNA - immunology ; Drug therapy ; Drug Therapy, Combination ; Excretion ; Female ; Glucocorticoids - therapeutic use ; Health risk assessment ; Humans ; Immunosuppressive Agents - therapeutic use ; Induction Chemotherapy ; Induction therapy ; Intravenous administration ; Leflunomide ; Leflunomide - therapeutic use ; Lupus ; Lupus nephritis ; Lupus Nephritis - drug therapy ; Lupus Nephritis - immunology ; Lupus Nephritis - metabolism ; Male ; Medicine ; Medicine & Public Health ; Middle Aged ; Nephritis ; Original Article ; Patients ; Prednisone ; Prednisone - therapeutic use ; Proteinuria ; Remission ; Rheumatology ; Serum Albumin - metabolism ; Statistical analysis ; Systemic lupus erythematosus ; Treatment Outcome</subject><ispartof>Clinical rheumatology, 2019-03, Vol.38 (3), p.859-867</ispartof><rights>The Author(s) 2018</rights><rights>Clinical Rheumatology is a copyright of Springer, (2018). All Rights Reserved. © 2018. This work is published under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c415t-898793cd638a812849931c8eb2e3549159599833160ed6e0e3371a343431173e3</citedby><cites>FETCH-LOGICAL-c415t-898793cd638a812849931c8eb2e3549159599833160ed6e0e3371a343431173e3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s10067-018-4348-z$$EPDF$$P50$$Gspringer$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s10067-018-4348-z$$EHTML$$P50$$Gspringer$$Hfree_for_read</linktohtml><link.rule.ids>314,776,780,27901,27902,41464,42533,51294</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/30426311$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Zhang, Minfang</creatorcontrib><creatorcontrib>Qi, Chaojun</creatorcontrib><creatorcontrib>Zha, Yan</creatorcontrib><creatorcontrib>Chen, Jian</creatorcontrib><creatorcontrib>Luo, Ping</creatorcontrib><creatorcontrib>Wang, Li</creatorcontrib><creatorcontrib>Sun, Zhuxing</creatorcontrib><creatorcontrib>Wan, Jianxin</creatorcontrib><creatorcontrib>Xing, Changying</creatorcontrib><creatorcontrib>Wang, Song</creatorcontrib><creatorcontrib>Jiang, Gengru</creatorcontrib><creatorcontrib>Sun, Mindan</creatorcontrib><creatorcontrib>Chen, Qinkai</creatorcontrib><creatorcontrib>Chen, Jianghua</creatorcontrib><creatorcontrib>Li, Detian</creatorcontrib><creatorcontrib>Guan, Tianjun</creatorcontrib><creatorcontrib>Ni, Zhaohui</creatorcontrib><title>Leflunomide versus cyclophosphamide in the induction treatment of proliferative lupus nephritis in Chinese patients: a randomized trial</title><title>Clinical rheumatology</title><addtitle>Clin Rheumatol</addtitle><addtitle>Clin Rheumatol</addtitle><description>Objectives
A prospective, multi-center, randomized controlled study was conducted to evaluate the efficacy and safety of a 24-week course low-dose leflunomide combined with prednisone in the induction treatment of proliferative lupus nephritis in Chinese patients.
Method
Patients (
n
= 100) with biopsy–proved proliferative lupus nephritis were enrolled in this study. They were randomized into two groups and received either leflunomide or cyclophosphamide in conjunction with prednisone for 24 weeks. Leflunomide was given orally with a loading dose of 40 mg/day for 3 days followed by 20 mg/day. Intravenous cyclophosphamide was administered monthly at a dosage of 0.8–1.0 g. The primary efficacy outcome was the frequency of complete remission and partial remission at week 24. The secondary outcomes included changes of urinary protein excretion, serum albumin, complement 3, anti-dsDNA antibody level, and systemic lupus erythematosus disease activity index (SLEDAI) after 24-week therapy.
Results
Of 100 patients, 48 received leflunomide combined with prednisone and other 52 received cyclophosphamide with concomitant prednisone. There were no statistically significant differences between groups in complete remission rate and partial remission rate. At week 24, 23% of patients in the leflunomide group and 27% of patients in the cyclophosphamide group achieved complete remission (
P
= 0.64), while 56% of patients in the leflunomide group and 42% of patients in the cyclophosphamide group achieved partial remission at week 24 (
P
= 0.16). SLEDAI, serum albumin, complement 3, anti-dsDNA antibody level, and urinary protein excretion improved significantly in both groups. No significant difference was seen in the changes of clinical parameters after therapy between the two groups. There was no significant difference in side effects in both groups.
Conclusions
Compared with cyclophosphamide, low-dose leflunomide in combination with prednisone showed both effectiveness and safety in the induction therapy of proliferative lupus nephritis in Chinese patients.</description><subject>Adult</subject><subject>Albumin</subject><subject>Anti-DNA antibodies</subject><subject>Antibodies, Antinuclear</subject><subject>Biopsy</subject><subject>China</subject><subject>Complement C3 - immunology</subject><subject>Cyclophosphamide</subject><subject>Cyclophosphamide - therapeutic use</subject><subject>DNA - immunology</subject><subject>Drug therapy</subject><subject>Drug Therapy, Combination</subject><subject>Excretion</subject><subject>Female</subject><subject>Glucocorticoids - therapeutic use</subject><subject>Health risk assessment</subject><subject>Humans</subject><subject>Immunosuppressive Agents - therapeutic use</subject><subject>Induction Chemotherapy</subject><subject>Induction therapy</subject><subject>Intravenous administration</subject><subject>Leflunomide</subject><subject>Leflunomide - therapeutic use</subject><subject>Lupus</subject><subject>Lupus nephritis</subject><subject>Lupus Nephritis - drug therapy</subject><subject>Lupus Nephritis - immunology</subject><subject>Lupus Nephritis - metabolism</subject><subject>Male</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Middle Aged</subject><subject>Nephritis</subject><subject>Original Article</subject><subject>Patients</subject><subject>Prednisone</subject><subject>Prednisone - therapeutic use</subject><subject>Proteinuria</subject><subject>Remission</subject><subject>Rheumatology</subject><subject>Serum Albumin - metabolism</subject><subject>Statistical analysis</subject><subject>Systemic lupus erythematosus</subject><subject>Treatment Outcome</subject><issn>0770-3198</issn><issn>1434-9949</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2019</creationdate><recordtype>article</recordtype><sourceid>C6C</sourceid><sourceid>EIF</sourceid><sourceid>BENPR</sourceid><recordid>eNp1kc1u1TAQhS0EopfCA7BBltiwCdgZJ7HZoavyI12pm3ZtucmEuErsYCeVel-A1-6EW0BCYuPf75wZ-zD2Wor3UojmQ6axbgohdaFA6eL4hO0krQpjlHnKdqJpRAHS6DP2IudbIUSpjXzOzkCosgYpd-znAftxDXHyHfI7THnNvL1vxzgPMc-D-3XuA1-GberWdvGRdgndMmFYeOz5nOLoe0xu8XfIx3Umi4DzkPzi86bdDz5gRj4TQZr8kTueXOio6BE7MvNufMme9W7M-OpxPmfXny-u9l-Lw-WXb_tPh6JVsloKbXRjoO1q0E7LUitjQLYab0qEShlZmcoYDSBrgV2NAgEa6YD-hF7bAMI5e3fypa5_rJgXO_nc4ji6gHHNtpQASom6UoS-_Qe9jWsK1N1GlVVZQSOIkieqTTHnhL2dk59curdS2C0le0rJUkp2S8keSfPm0Xm9mbD7o_gdCwHlCch0Fb5j-lv6_64PQHeeVw</recordid><startdate>20190301</startdate><enddate>20190301</enddate><creator>Zhang, Minfang</creator><creator>Qi, Chaojun</creator><creator>Zha, Yan</creator><creator>Chen, Jian</creator><creator>Luo, Ping</creator><creator>Wang, Li</creator><creator>Sun, Zhuxing</creator><creator>Wan, Jianxin</creator><creator>Xing, Changying</creator><creator>Wang, Song</creator><creator>Jiang, Gengru</creator><creator>Sun, Mindan</creator><creator>Chen, Qinkai</creator><creator>Chen, Jianghua</creator><creator>Li, Detian</creator><creator>Guan, Tianjun</creator><creator>Ni, Zhaohui</creator><general>Springer London</general><general>Springer Nature B.V</general><scope>C6C</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>3V.</scope><scope>7T5</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8AO</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>H94</scope><scope>K9.</scope><scope>M0S</scope><scope>M1P</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>7X8</scope></search><sort><creationdate>20190301</creationdate><title>Leflunomide versus cyclophosphamide in the induction treatment of proliferative lupus nephritis in Chinese patients: a randomized trial</title><author>Zhang, Minfang ; Qi, Chaojun ; Zha, Yan ; Chen, Jian ; Luo, Ping ; Wang, Li ; Sun, Zhuxing ; Wan, Jianxin ; Xing, Changying ; Wang, Song ; Jiang, Gengru ; Sun, Mindan ; Chen, Qinkai ; Chen, Jianghua ; Li, Detian ; Guan, Tianjun ; Ni, Zhaohui</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c415t-898793cd638a812849931c8eb2e3549159599833160ed6e0e3371a343431173e3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2019</creationdate><topic>Adult</topic><topic>Albumin</topic><topic>Anti-DNA antibodies</topic><topic>Antibodies, Antinuclear</topic><topic>Biopsy</topic><topic>China</topic><topic>Complement C3 - immunology</topic><topic>Cyclophosphamide</topic><topic>Cyclophosphamide - therapeutic use</topic><topic>DNA - immunology</topic><topic>Drug therapy</topic><topic>Drug Therapy, Combination</topic><topic>Excretion</topic><topic>Female</topic><topic>Glucocorticoids - therapeutic use</topic><topic>Health risk assessment</topic><topic>Humans</topic><topic>Immunosuppressive Agents - therapeutic use</topic><topic>Induction Chemotherapy</topic><topic>Induction therapy</topic><topic>Intravenous administration</topic><topic>Leflunomide</topic><topic>Leflunomide - therapeutic use</topic><topic>Lupus</topic><topic>Lupus nephritis</topic><topic>Lupus Nephritis - drug therapy</topic><topic>Lupus Nephritis - immunology</topic><topic>Lupus Nephritis - metabolism</topic><topic>Male</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>Middle Aged</topic><topic>Nephritis</topic><topic>Original Article</topic><topic>Patients</topic><topic>Prednisone</topic><topic>Prednisone - therapeutic use</topic><topic>Proteinuria</topic><topic>Remission</topic><topic>Rheumatology</topic><topic>Serum Albumin - metabolism</topic><topic>Statistical analysis</topic><topic>Systemic lupus erythematosus</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Zhang, Minfang</creatorcontrib><creatorcontrib>Qi, Chaojun</creatorcontrib><creatorcontrib>Zha, Yan</creatorcontrib><creatorcontrib>Chen, Jian</creatorcontrib><creatorcontrib>Luo, Ping</creatorcontrib><creatorcontrib>Wang, Li</creatorcontrib><creatorcontrib>Sun, Zhuxing</creatorcontrib><creatorcontrib>Wan, Jianxin</creatorcontrib><creatorcontrib>Xing, Changying</creatorcontrib><creatorcontrib>Wang, Song</creatorcontrib><creatorcontrib>Jiang, Gengru</creatorcontrib><creatorcontrib>Sun, Mindan</creatorcontrib><creatorcontrib>Chen, Qinkai</creatorcontrib><creatorcontrib>Chen, Jianghua</creatorcontrib><creatorcontrib>Li, Detian</creatorcontrib><creatorcontrib>Guan, Tianjun</creatorcontrib><creatorcontrib>Ni, Zhaohui</creatorcontrib><collection>Springer Nature OA Free Journals</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Immunology Abstracts</collection><collection>ProQuest Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni)</collection><collection>ProQuest Central UK/Ireland</collection><collection>AUTh Library subscriptions: ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>PML(ProQuest Medical Library)</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>MEDLINE - Academic</collection><jtitle>Clinical rheumatology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Zhang, Minfang</au><au>Qi, Chaojun</au><au>Zha, Yan</au><au>Chen, Jian</au><au>Luo, Ping</au><au>Wang, Li</au><au>Sun, Zhuxing</au><au>Wan, Jianxin</au><au>Xing, Changying</au><au>Wang, Song</au><au>Jiang, Gengru</au><au>Sun, Mindan</au><au>Chen, Qinkai</au><au>Chen, Jianghua</au><au>Li, Detian</au><au>Guan, Tianjun</au><au>Ni, Zhaohui</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Leflunomide versus cyclophosphamide in the induction treatment of proliferative lupus nephritis in Chinese patients: a randomized trial</atitle><jtitle>Clinical rheumatology</jtitle><stitle>Clin Rheumatol</stitle><addtitle>Clin Rheumatol</addtitle><date>2019-03-01</date><risdate>2019</risdate><volume>38</volume><issue>3</issue><spage>859</spage><epage>867</epage><pages>859-867</pages><issn>0770-3198</issn><eissn>1434-9949</eissn><abstract>Objectives
A prospective, multi-center, randomized controlled study was conducted to evaluate the efficacy and safety of a 24-week course low-dose leflunomide combined with prednisone in the induction treatment of proliferative lupus nephritis in Chinese patients.
Method
Patients (
n
= 100) with biopsy–proved proliferative lupus nephritis were enrolled in this study. They were randomized into two groups and received either leflunomide or cyclophosphamide in conjunction with prednisone for 24 weeks. Leflunomide was given orally with a loading dose of 40 mg/day for 3 days followed by 20 mg/day. Intravenous cyclophosphamide was administered monthly at a dosage of 0.8–1.0 g. The primary efficacy outcome was the frequency of complete remission and partial remission at week 24. The secondary outcomes included changes of urinary protein excretion, serum albumin, complement 3, anti-dsDNA antibody level, and systemic lupus erythematosus disease activity index (SLEDAI) after 24-week therapy.
Results
Of 100 patients, 48 received leflunomide combined with prednisone and other 52 received cyclophosphamide with concomitant prednisone. There were no statistically significant differences between groups in complete remission rate and partial remission rate. At week 24, 23% of patients in the leflunomide group and 27% of patients in the cyclophosphamide group achieved complete remission (
P
= 0.64), while 56% of patients in the leflunomide group and 42% of patients in the cyclophosphamide group achieved partial remission at week 24 (
P
= 0.16). SLEDAI, serum albumin, complement 3, anti-dsDNA antibody level, and urinary protein excretion improved significantly in both groups. No significant difference was seen in the changes of clinical parameters after therapy between the two groups. There was no significant difference in side effects in both groups.
Conclusions
Compared with cyclophosphamide, low-dose leflunomide in combination with prednisone showed both effectiveness and safety in the induction therapy of proliferative lupus nephritis in Chinese patients.</abstract><cop>London</cop><pub>Springer London</pub><pmid>30426311</pmid><doi>10.1007/s10067-018-4348-z</doi><tpages>9</tpages><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0770-3198 |
| ispartof | Clinical rheumatology, 2019-03, Vol.38 (3), p.859-867 |
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| language | eng |
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| source | MEDLINE; SpringerLink (Online service) |
| subjects | Adult Albumin Anti-DNA antibodies Antibodies, Antinuclear Biopsy China Complement C3 - immunology Cyclophosphamide Cyclophosphamide - therapeutic use DNA - immunology Drug therapy Drug Therapy, Combination Excretion Female Glucocorticoids - therapeutic use Health risk assessment Humans Immunosuppressive Agents - therapeutic use Induction Chemotherapy Induction therapy Intravenous administration Leflunomide Leflunomide - therapeutic use Lupus Lupus nephritis Lupus Nephritis - drug therapy Lupus Nephritis - immunology Lupus Nephritis - metabolism Male Medicine Medicine & Public Health Middle Aged Nephritis Original Article Patients Prednisone Prednisone - therapeutic use Proteinuria Remission Rheumatology Serum Albumin - metabolism Statistical analysis Systemic lupus erythematosus Treatment Outcome |
| title | Leflunomide versus cyclophosphamide in the induction treatment of proliferative lupus nephritis in Chinese patients: a randomized trial |
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