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Clinical and immunological outcomes of high- and low-dose rituximab treatments in patients with pemphigus: a randomized, comparative, observer-blinded study
Summary Background Rituximab is a promising therapy in pemphigus. However, there is no consensus on optimum dose. Objectives To compare the efficacy, in terms of clinical and immunological outcomes in patients with pemphigus, of a high (2 × 1000 mg) vs. a low dose (2 × 500 mg) of rituximab. Methods...
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| Published in: | British journal of dermatology (1951) 2014-06, Vol.170 (6), p.1341-1349 |
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| container_issue | 6 |
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| container_title | British journal of dermatology (1951) |
| container_volume | 170 |
| creator | Kanwar, A.J. Vinay, K. Sawatkar, G.U. Dogra, S. Minz, R.W. Shear, N.H. Koga, H. Ishii, N. Hashimoto, T. |
| description | Summary
Background
Rituximab is a promising therapy in pemphigus. However, there is no consensus on optimum dose.
Objectives
To compare the efficacy, in terms of clinical and immunological outcomes in patients with pemphigus, of a high (2 × 1000 mg) vs. a low dose (2 × 500 mg) of rituximab.
Methods
This was a randomized, observer‐blinded trial wherein 22 patients with pemphigus were randomized into two treatment groups. Patients received either two doses (day 0 and day 15) of 1000 mg rituximab or 500 mg rituximab, and were followed up for 48 weeks. Clinical activity was assessed by a blinded investigator. Indices of enzyme‐linked immunosorbent assays (ELISAs) for desmoglein (Dsg)1 and Dsg3, and CD19 cell count were examined at regular intervals.
Results
There was no statistically significant difference in early and late clinical end points, and total cumulative dose of corticosteroids between the two groups. At week 40, the fall in Ikeda severity score was significantly more in the 2 × 1000 mg group than in 2 × 500 mg group (P = 0·049). Patients in the 2 × 500 mg group received a significantly higher cumulative dose of azathioprine (P = 0·018). The ELISA indices of Dsg1 and Dsg3 showed a statistically significant decline in the 2 × 1000 mg group only. B cell repopulation occurred earlier in the 2 × 500 mg group by 8 weeks.
Conclusions
A few clinical and immunological study parameters have suggested improved outcomes in patients receiving high‐dose (2 × 1000 mg) rituximab.
What's already known about this topic?
There is no agreement on the optimum dose of rituximab to be used in treating patients with pemphigus.
A single study has reported low‐dose rituximab (2 × 500 mg) to be effective in patients with pemphigus.
What does this study add?
A few clinical (relapse rate, adjuvant requirement) and immunological (fall in desmoglein indices, CD19 cell repopulation) outcomes suggest improved outcomes in patients with pemphigus receiving 2 × 1000 mg rituximab compared with a dose of 2 × 500 mg. |
| doi_str_mv | 10.1111/bjd.12972 |
| format | article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_1551623504</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>1551623504</sourcerecordid><originalsourceid>FETCH-LOGICAL-c4262-1dc7ac6f2963927f6f15faa0297dbf2a56d9aaaad86d466bbc145c1f5848561b3</originalsourceid><addsrcrecordid>eNqNkctu1DAUhi0EotPCghdA3iAVqWl9iZ2EHUyhgMplAULqxnJ86bgkcWo7nU6fpQ-LOzMtKyTOxpb1nf8_Pj8ALzA6xLmO2gt9iElTkUdghilnBcGUPgYzhFBVoIbTHbAb4wVCmCKGnoIdUvISNQ2agdt55wanZAfloKHr-2nwnT9fv_gpKd-bCL2FC3e-KNZM55eF9tHA4NJ07XrZwhSMTL0ZUoRugKNMbn1furSAo-nH3DzFN1DCkAV8726MPoBZepQhs1fmAPo2mnBlQtHmcbTRMKZJr56BJ1Z20Tzfnnvg54f3P-Yfi9NvJ5_mb08LVRJOCqxVJRW3JP-0IZXlFjMrJcob0a0lknHdyFy65rrkvG0VLpnCltVlzThu6R7Y3-iOwV9OJibRu6hM18nB-CkKzBjmhDJU_gdKm5LX2SCjrzeoCj7GYKwYQ15XWAmMxF1uIucm1rll9uVWdmp7ox_I-6Ay8GoLyJizsXmTysW_XJ05Xt2ZHm24pevM6t-O4t3n43vrYtPhYjLXDx0y_Ba8ohUTv76eiC9zyun3-kyc0T9vaMCo</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>1539468145</pqid></control><display><type>article</type><title>Clinical and immunological outcomes of high- and low-dose rituximab treatments in patients with pemphigus: a randomized, comparative, observer-blinded study</title><source>Wiley</source><source>Oxford Journals Online</source><creator>Kanwar, A.J. ; Vinay, K. ; Sawatkar, G.U. ; Dogra, S. ; Minz, R.W. ; Shear, N.H. ; Koga, H. ; Ishii, N. ; Hashimoto, T.</creator><creatorcontrib>Kanwar, A.J. ; Vinay, K. ; Sawatkar, G.U. ; Dogra, S. ; Minz, R.W. ; Shear, N.H. ; Koga, H. ; Ishii, N. ; Hashimoto, T.</creatorcontrib><description>Summary
Background
Rituximab is a promising therapy in pemphigus. However, there is no consensus on optimum dose.
Objectives
To compare the efficacy, in terms of clinical and immunological outcomes in patients with pemphigus, of a high (2 × 1000 mg) vs. a low dose (2 × 500 mg) of rituximab.
Methods
This was a randomized, observer‐blinded trial wherein 22 patients with pemphigus were randomized into two treatment groups. Patients received either two doses (day 0 and day 15) of 1000 mg rituximab or 500 mg rituximab, and were followed up for 48 weeks. Clinical activity was assessed by a blinded investigator. Indices of enzyme‐linked immunosorbent assays (ELISAs) for desmoglein (Dsg)1 and Dsg3, and CD19 cell count were examined at regular intervals.
Results
There was no statistically significant difference in early and late clinical end points, and total cumulative dose of corticosteroids between the two groups. At week 40, the fall in Ikeda severity score was significantly more in the 2 × 1000 mg group than in 2 × 500 mg group (P = 0·049). Patients in the 2 × 500 mg group received a significantly higher cumulative dose of azathioprine (P = 0·018). The ELISA indices of Dsg1 and Dsg3 showed a statistically significant decline in the 2 × 1000 mg group only. B cell repopulation occurred earlier in the 2 × 500 mg group by 8 weeks.
Conclusions
A few clinical and immunological study parameters have suggested improved outcomes in patients receiving high‐dose (2 × 1000 mg) rituximab.
What's already known about this topic?
There is no agreement on the optimum dose of rituximab to be used in treating patients with pemphigus.
A single study has reported low‐dose rituximab (2 × 500 mg) to be effective in patients with pemphigus.
What does this study add?
A few clinical (relapse rate, adjuvant requirement) and immunological (fall in desmoglein indices, CD19 cell repopulation) outcomes suggest improved outcomes in patients with pemphigus receiving 2 × 1000 mg rituximab compared with a dose of 2 × 500 mg.</description><identifier>ISSN: 0007-0963</identifier><identifier>EISSN: 1365-2133</identifier><identifier>DOI: 10.1111/bjd.12972</identifier><identifier>PMID: 24640990</identifier><identifier>CODEN: BJDEAZ</identifier><language>eng</language><publisher>Oxford: Blackwell Publishing Ltd</publisher><subject>Adolescent ; Adrenal Cortex Hormones - therapeutic use ; Adult ; Aged ; Antigens, CD19 - metabolism ; B-Lymphocytes - immunology ; Biological and medical sciences ; Bullous diseases of the skin ; Dermatologic Agents - administration & dosage ; Dermatologic Agents - adverse effects ; Dermatology ; Desmoglein 1 - metabolism ; Desmoglein 3 - metabolism ; Drug Administration Schedule ; Enzyme-Linked Immunosorbent Assay ; Female ; Humans ; Lymphopenia - chemically induced ; Lymphopenia - immunology ; Male ; Medical sciences ; Middle Aged ; Pemphigus - drug therapy ; Pemphigus - immunology ; Pilot Projects ; Recurrence ; Rituximab - administration & dosage ; Rituximab - adverse effects ; Treatment Outcome ; Young Adult</subject><ispartof>British journal of dermatology (1951), 2014-06, Vol.170 (6), p.1341-1349</ispartof><rights>2014 British Association of Dermatologists</rights><rights>2015 INIST-CNRS</rights><rights>2014 British Association of Dermatologists.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4262-1dc7ac6f2963927f6f15faa0297dbf2a56d9aaaad86d466bbc145c1f5848561b3</citedby><cites>FETCH-LOGICAL-c4262-1dc7ac6f2963927f6f15faa0297dbf2a56d9aaaad86d466bbc145c1f5848561b3</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%2Fbjd.12972$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Fbjd.12972$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>315,786,790,27957,27958,50923,51032</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=28640675$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/24640990$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Kanwar, A.J.</creatorcontrib><creatorcontrib>Vinay, K.</creatorcontrib><creatorcontrib>Sawatkar, G.U.</creatorcontrib><creatorcontrib>Dogra, S.</creatorcontrib><creatorcontrib>Minz, R.W.</creatorcontrib><creatorcontrib>Shear, N.H.</creatorcontrib><creatorcontrib>Koga, H.</creatorcontrib><creatorcontrib>Ishii, N.</creatorcontrib><creatorcontrib>Hashimoto, T.</creatorcontrib><title>Clinical and immunological outcomes of high- and low-dose rituximab treatments in patients with pemphigus: a randomized, comparative, observer-blinded study</title><title>British journal of dermatology (1951)</title><addtitle>Br J Dermatol</addtitle><description>Summary
Background
Rituximab is a promising therapy in pemphigus. However, there is no consensus on optimum dose.
Objectives
To compare the efficacy, in terms of clinical and immunological outcomes in patients with pemphigus, of a high (2 × 1000 mg) vs. a low dose (2 × 500 mg) of rituximab.
Methods
This was a randomized, observer‐blinded trial wherein 22 patients with pemphigus were randomized into two treatment groups. Patients received either two doses (day 0 and day 15) of 1000 mg rituximab or 500 mg rituximab, and were followed up for 48 weeks. Clinical activity was assessed by a blinded investigator. Indices of enzyme‐linked immunosorbent assays (ELISAs) for desmoglein (Dsg)1 and Dsg3, and CD19 cell count were examined at regular intervals.
Results
There was no statistically significant difference in early and late clinical end points, and total cumulative dose of corticosteroids between the two groups. At week 40, the fall in Ikeda severity score was significantly more in the 2 × 1000 mg group than in 2 × 500 mg group (P = 0·049). Patients in the 2 × 500 mg group received a significantly higher cumulative dose of azathioprine (P = 0·018). The ELISA indices of Dsg1 and Dsg3 showed a statistically significant decline in the 2 × 1000 mg group only. B cell repopulation occurred earlier in the 2 × 500 mg group by 8 weeks.
Conclusions
A few clinical and immunological study parameters have suggested improved outcomes in patients receiving high‐dose (2 × 1000 mg) rituximab.
What's already known about this topic?
There is no agreement on the optimum dose of rituximab to be used in treating patients with pemphigus.
A single study has reported low‐dose rituximab (2 × 500 mg) to be effective in patients with pemphigus.
What does this study add?
A few clinical (relapse rate, adjuvant requirement) and immunological (fall in desmoglein indices, CD19 cell repopulation) outcomes suggest improved outcomes in patients with pemphigus receiving 2 × 1000 mg rituximab compared with a dose of 2 × 500 mg.</description><subject>Adolescent</subject><subject>Adrenal Cortex Hormones - therapeutic use</subject><subject>Adult</subject><subject>Aged</subject><subject>Antigens, CD19 - metabolism</subject><subject>B-Lymphocytes - immunology</subject><subject>Biological and medical sciences</subject><subject>Bullous diseases of the skin</subject><subject>Dermatologic Agents - administration & dosage</subject><subject>Dermatologic Agents - adverse effects</subject><subject>Dermatology</subject><subject>Desmoglein 1 - metabolism</subject><subject>Desmoglein 3 - metabolism</subject><subject>Drug Administration Schedule</subject><subject>Enzyme-Linked Immunosorbent Assay</subject><subject>Female</subject><subject>Humans</subject><subject>Lymphopenia - chemically induced</subject><subject>Lymphopenia - immunology</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Pemphigus - drug therapy</subject><subject>Pemphigus - immunology</subject><subject>Pilot Projects</subject><subject>Recurrence</subject><subject>Rituximab - administration & dosage</subject><subject>Rituximab - adverse effects</subject><subject>Treatment Outcome</subject><subject>Young Adult</subject><issn>0007-0963</issn><issn>1365-2133</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2014</creationdate><recordtype>article</recordtype><recordid>eNqNkctu1DAUhi0EotPCghdA3iAVqWl9iZ2EHUyhgMplAULqxnJ86bgkcWo7nU6fpQ-LOzMtKyTOxpb1nf8_Pj8ALzA6xLmO2gt9iElTkUdghilnBcGUPgYzhFBVoIbTHbAb4wVCmCKGnoIdUvISNQ2agdt55wanZAfloKHr-2nwnT9fv_gpKd-bCL2FC3e-KNZM55eF9tHA4NJ07XrZwhSMTL0ZUoRugKNMbn1furSAo-nH3DzFN1DCkAV8726MPoBZepQhs1fmAPo2mnBlQtHmcbTRMKZJr56BJ1Z20Tzfnnvg54f3P-Yfi9NvJ5_mb08LVRJOCqxVJRW3JP-0IZXlFjMrJcob0a0lknHdyFy65rrkvG0VLpnCltVlzThu6R7Y3-iOwV9OJibRu6hM18nB-CkKzBjmhDJU_gdKm5LX2SCjrzeoCj7GYKwYQ15XWAmMxF1uIucm1rll9uVWdmp7ox_I-6Ay8GoLyJizsXmTysW_XJ05Xt2ZHm24pevM6t-O4t3n43vrYtPhYjLXDx0y_Ba8ohUTv76eiC9zyun3-kyc0T9vaMCo</recordid><startdate>201406</startdate><enddate>201406</enddate><creator>Kanwar, A.J.</creator><creator>Vinay, K.</creator><creator>Sawatkar, G.U.</creator><creator>Dogra, S.</creator><creator>Minz, R.W.</creator><creator>Shear, N.H.</creator><creator>Koga, H.</creator><creator>Ishii, N.</creator><creator>Hashimoto, T.</creator><general>Blackwell Publishing Ltd</general><general>Wiley-Blackwell</general><scope>BSCLL</scope><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>201406</creationdate><title>Clinical and immunological outcomes of high- and low-dose rituximab treatments in patients with pemphigus: a randomized, comparative, observer-blinded study</title><author>Kanwar, A.J. ; Vinay, K. ; Sawatkar, G.U. ; Dogra, S. ; Minz, R.W. ; Shear, N.H. ; Koga, H. ; Ishii, N. ; Hashimoto, T.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4262-1dc7ac6f2963927f6f15faa0297dbf2a56d9aaaad86d466bbc145c1f5848561b3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2014</creationdate><topic>Adolescent</topic><topic>Adrenal Cortex Hormones - therapeutic use</topic><topic>Adult</topic><topic>Aged</topic><topic>Antigens, CD19 - metabolism</topic><topic>B-Lymphocytes - immunology</topic><topic>Biological and medical sciences</topic><topic>Bullous diseases of the skin</topic><topic>Dermatologic Agents - administration & dosage</topic><topic>Dermatologic Agents - adverse effects</topic><topic>Dermatology</topic><topic>Desmoglein 1 - metabolism</topic><topic>Desmoglein 3 - metabolism</topic><topic>Drug Administration Schedule</topic><topic>Enzyme-Linked Immunosorbent Assay</topic><topic>Female</topic><topic>Humans</topic><topic>Lymphopenia - chemically induced</topic><topic>Lymphopenia - immunology</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Pemphigus - drug therapy</topic><topic>Pemphigus - immunology</topic><topic>Pilot Projects</topic><topic>Recurrence</topic><topic>Rituximab - administration & dosage</topic><topic>Rituximab - adverse effects</topic><topic>Treatment Outcome</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Kanwar, A.J.</creatorcontrib><creatorcontrib>Vinay, K.</creatorcontrib><creatorcontrib>Sawatkar, G.U.</creatorcontrib><creatorcontrib>Dogra, S.</creatorcontrib><creatorcontrib>Minz, R.W.</creatorcontrib><creatorcontrib>Shear, N.H.</creatorcontrib><creatorcontrib>Koga, H.</creatorcontrib><creatorcontrib>Ishii, N.</creatorcontrib><creatorcontrib>Hashimoto, T.</creatorcontrib><collection>Istex</collection><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 dermatology (1951)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Kanwar, A.J.</au><au>Vinay, K.</au><au>Sawatkar, G.U.</au><au>Dogra, S.</au><au>Minz, R.W.</au><au>Shear, N.H.</au><au>Koga, H.</au><au>Ishii, N.</au><au>Hashimoto, T.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Clinical and immunological outcomes of high- and low-dose rituximab treatments in patients with pemphigus: a randomized, comparative, observer-blinded study</atitle><jtitle>British journal of dermatology (1951)</jtitle><addtitle>Br J Dermatol</addtitle><date>2014-06</date><risdate>2014</risdate><volume>170</volume><issue>6</issue><spage>1341</spage><epage>1349</epage><pages>1341-1349</pages><issn>0007-0963</issn><eissn>1365-2133</eissn><coden>BJDEAZ</coden><notes>Plain language summary available online.</notes><notes>ArticleID:BJD12972</notes><notes>ark:/67375/WNG-MC363P8Z-Z</notes><notes>istex:57B198AE6C69699DEB9C3157D91414060A69E678</notes><notes>ObjectType-Article-2</notes><notes>SourceType-Scholarly Journals-1</notes><notes>ObjectType-News-1</notes><notes>ObjectType-Feature-3</notes><notes>content type line 23</notes><notes>ObjectType-Article-1</notes><notes>ObjectType-Feature-2</notes><abstract>Summary
Background
Rituximab is a promising therapy in pemphigus. However, there is no consensus on optimum dose.
Objectives
To compare the efficacy, in terms of clinical and immunological outcomes in patients with pemphigus, of a high (2 × 1000 mg) vs. a low dose (2 × 500 mg) of rituximab.
Methods
This was a randomized, observer‐blinded trial wherein 22 patients with pemphigus were randomized into two treatment groups. Patients received either two doses (day 0 and day 15) of 1000 mg rituximab or 500 mg rituximab, and were followed up for 48 weeks. Clinical activity was assessed by a blinded investigator. Indices of enzyme‐linked immunosorbent assays (ELISAs) for desmoglein (Dsg)1 and Dsg3, and CD19 cell count were examined at regular intervals.
Results
There was no statistically significant difference in early and late clinical end points, and total cumulative dose of corticosteroids between the two groups. At week 40, the fall in Ikeda severity score was significantly more in the 2 × 1000 mg group than in 2 × 500 mg group (P = 0·049). Patients in the 2 × 500 mg group received a significantly higher cumulative dose of azathioprine (P = 0·018). The ELISA indices of Dsg1 and Dsg3 showed a statistically significant decline in the 2 × 1000 mg group only. B cell repopulation occurred earlier in the 2 × 500 mg group by 8 weeks.
Conclusions
A few clinical and immunological study parameters have suggested improved outcomes in patients receiving high‐dose (2 × 1000 mg) rituximab.
What's already known about this topic?
There is no agreement on the optimum dose of rituximab to be used in treating patients with pemphigus.
A single study has reported low‐dose rituximab (2 × 500 mg) to be effective in patients with pemphigus.
What does this study add?
A few clinical (relapse rate, adjuvant requirement) and immunological (fall in desmoglein indices, CD19 cell repopulation) outcomes suggest improved outcomes in patients with pemphigus receiving 2 × 1000 mg rituximab compared with a dose of 2 × 500 mg.</abstract><cop>Oxford</cop><pub>Blackwell Publishing Ltd</pub><pmid>24640990</pmid><doi>10.1111/bjd.12972</doi><tpages>5</tpages></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0007-0963 |
| ispartof | British journal of dermatology (1951), 2014-06, Vol.170 (6), p.1341-1349 |
| issn | 0007-0963 1365-2133 |
| language | eng |
| recordid | cdi_proquest_miscellaneous_1551623504 |
| source | Wiley; Oxford Journals Online |
| subjects | Adolescent Adrenal Cortex Hormones - therapeutic use Adult Aged Antigens, CD19 - metabolism B-Lymphocytes - immunology Biological and medical sciences Bullous diseases of the skin Dermatologic Agents - administration & dosage Dermatologic Agents - adverse effects Dermatology Desmoglein 1 - metabolism Desmoglein 3 - metabolism Drug Administration Schedule Enzyme-Linked Immunosorbent Assay Female Humans Lymphopenia - chemically induced Lymphopenia - immunology Male Medical sciences Middle Aged Pemphigus - drug therapy Pemphigus - immunology Pilot Projects Recurrence Rituximab - administration & dosage Rituximab - adverse effects Treatment Outcome Young Adult |
| title | Clinical and immunological outcomes of high- and low-dose rituximab treatments in patients with pemphigus: a randomized, comparative, observer-blinded study |
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