Off-label use of rituximab in 196 patients with severe, refractory systemic autoimmune diseases
To analyse the safety and efficacy of the off-label use of rituximab in patients with severe, refractory systemic autoimmune diseases. In 2006, the Study Group on Autoimmune Diseases of the Spanish Society of Internal Medicine created the BIOGEAS project, a multicenter study devoted to collecting da...
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| Veröffentlicht in: | Clinical and experimental rheumatology 2010-07, Vol.28 (4), p.468-476 |
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| creator | RAMOS-CASALS, M GARCIA-HERNANDEZ, F. J PEREZ-ALVAREZ, R MICO, M. L MEDRANO, F GOMEZ-DE-LA-TORRE, R DIAZ-LAGARES, C CAMPS, M ORTEGO, N SANCHEZ-ROMAN, J DE RAMON, E CALLEJAS, J. L MARTINEZ-BERRIOTXOA, A PALLARES, L CAMINAL-MONTERO, L SELVA-O'CALLAGHAN, A ORISTRELL, J HIDALGO, C |
| description | To analyse the safety and efficacy of the off-label use of rituximab in patients with severe, refractory systemic autoimmune diseases.
In 2006, the Study Group on Autoimmune Diseases of the Spanish Society of Internal Medicine created the BIOGEAS project, a multicenter study devoted to collecting data on the use of biological agents in adult patients with systemic autoimmune diseases refractory to standard therapies (failure of at least two immunosuppressive agents).
One hundred and ninety-six patients with systemic autoimmune diseases treated with rituximab have been included in the Registry (158 women and 38 men, mean age 43 years). Systemic autoimmune diseases included systemic lupus erythematosus (107 cases), inflammatory myopathies (20 cases), ANCA-related vasculitides (19 cases), Sjögren's syndrome (15 cases) and other diseases (35 cases). A therapeutic response was evaluable in 194 cases: 99 (51%) achieved a complete response, 51 (26%) a partial response and 44 (23%) were classified as non-responders. After a mean follow-up of 27.56+/-1.32 months, 44 (29%) out of the 150 responders patients relapsed. There were 40 adverse events reported in 33 (16%) of the 196 patients. The most frequent adverse events were infections, with 24 episodes being described in 19 patients. Thirteen (7%) patients died, mainly due to disease progression (7 cases) and infection (3 cases).
Although not yet licensed for this use, rituximab is currently used to treat severe, refractory systemic autoimmune diseases, with the most favourable results being observed in Sjögren's syndrome, inflammatory myopathies, systemic lupus erythematosus and cryoglobulinemia. |
| format | Article |
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In 2006, the Study Group on Autoimmune Diseases of the Spanish Society of Internal Medicine created the BIOGEAS project, a multicenter study devoted to collecting data on the use of biological agents in adult patients with systemic autoimmune diseases refractory to standard therapies (failure of at least two immunosuppressive agents).
One hundred and ninety-six patients with systemic autoimmune diseases treated with rituximab have been included in the Registry (158 women and 38 men, mean age 43 years). Systemic autoimmune diseases included systemic lupus erythematosus (107 cases), inflammatory myopathies (20 cases), ANCA-related vasculitides (19 cases), Sjögren's syndrome (15 cases) and other diseases (35 cases). A therapeutic response was evaluable in 194 cases: 99 (51%) achieved a complete response, 51 (26%) a partial response and 44 (23%) were classified as non-responders. After a mean follow-up of 27.56+/-1.32 months, 44 (29%) out of the 150 responders patients relapsed. There were 40 adverse events reported in 33 (16%) of the 196 patients. The most frequent adverse events were infections, with 24 episodes being described in 19 patients. Thirteen (7%) patients died, mainly due to disease progression (7 cases) and infection (3 cases).
Although not yet licensed for this use, rituximab is currently used to treat severe, refractory systemic autoimmune diseases, with the most favourable results being observed in Sjögren's syndrome, inflammatory myopathies, systemic lupus erythematosus and cryoglobulinemia.</description><identifier>ISSN: 0392-856X</identifier><identifier>EISSN: 1593-098X</identifier><identifier>PMID: 20525449</identifier><language>eng</language><publisher>Pisa: Clinical and Experimental Rheumatology</publisher><subject>Adolescent ; Adult ; Aged ; Aged, 80 and over ; Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis - drug therapy ; Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis - ethnology ; Antibodies, Monoclonal, Murine-Derived - adverse effects ; Antibodies, Monoclonal, Murine-Derived - therapeutic use ; Autoimmune Diseases - drug therapy ; Autoimmune Diseases - ethnology ; Biological and medical sciences ; Cryoglobulinemia - drug therapy ; Cryoglobulinemia - ethnology ; Diseases of the osteoarticular system ; Female ; Humans ; Immunologic Factors - adverse effects ; Immunologic Factors - therapeutic use ; Immunomodulators ; Lupus Erythematosus, Systemic - drug therapy ; Lupus Erythematosus, Systemic - ethnology ; Male ; Medical sciences ; Middle Aged ; Myositis - drug therapy ; Myositis - ethnology ; Off-Label Use ; Pharmacology. Drug treatments ; Retrospective Studies ; Rituximab ; Sarcoidosis. Granulomatous diseases of unproved etiology. Connective tissue diseases. Elastic tissue diseases. Vasculitis ; Severity of Illness Index ; Sjogren's Syndrome - drug therapy ; Sjogren's Syndrome - ethnology ; Spain ; Treatment Outcome ; Young Adult</subject><ispartof>Clinical and experimental rheumatology, 2010-07, Vol.28 (4), p.468-476</ispartof><rights>2015 INIST-CNRS</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=23248380$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/20525449$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>RAMOS-CASALS, M</creatorcontrib><creatorcontrib>GARCIA-HERNANDEZ, F. J</creatorcontrib><creatorcontrib>PEREZ-ALVAREZ, R</creatorcontrib><creatorcontrib>MICO, M. L</creatorcontrib><creatorcontrib>MEDRANO, F</creatorcontrib><creatorcontrib>GOMEZ-DE-LA-TORRE, R</creatorcontrib><creatorcontrib>DIAZ-LAGARES, C</creatorcontrib><creatorcontrib>CAMPS, M</creatorcontrib><creatorcontrib>ORTEGO, N</creatorcontrib><creatorcontrib>SANCHEZ-ROMAN, J</creatorcontrib><creatorcontrib>DE RAMON, E</creatorcontrib><creatorcontrib>CALLEJAS, J. L</creatorcontrib><creatorcontrib>MARTINEZ-BERRIOTXOA, A</creatorcontrib><creatorcontrib>PALLARES, L</creatorcontrib><creatorcontrib>CAMINAL-MONTERO, L</creatorcontrib><creatorcontrib>SELVA-O'CALLAGHAN, A</creatorcontrib><creatorcontrib>ORISTRELL, J</creatorcontrib><creatorcontrib>HIDALGO, C</creatorcontrib><creatorcontrib>BIOGEAS Study Group</creatorcontrib><title>Off-label use of rituximab in 196 patients with severe, refractory systemic autoimmune diseases</title><title>Clinical and experimental rheumatology</title><addtitle>Clin Exp Rheumatol</addtitle><description>To analyse the safety and efficacy of the off-label use of rituximab in patients with severe, refractory systemic autoimmune diseases.
In 2006, the Study Group on Autoimmune Diseases of the Spanish Society of Internal Medicine created the BIOGEAS project, a multicenter study devoted to collecting data on the use of biological agents in adult patients with systemic autoimmune diseases refractory to standard therapies (failure of at least two immunosuppressive agents).
One hundred and ninety-six patients with systemic autoimmune diseases treated with rituximab have been included in the Registry (158 women and 38 men, mean age 43 years). Systemic autoimmune diseases included systemic lupus erythematosus (107 cases), inflammatory myopathies (20 cases), ANCA-related vasculitides (19 cases), Sjögren's syndrome (15 cases) and other diseases (35 cases). A therapeutic response was evaluable in 194 cases: 99 (51%) achieved a complete response, 51 (26%) a partial response and 44 (23%) were classified as non-responders. After a mean follow-up of 27.56+/-1.32 months, 44 (29%) out of the 150 responders patients relapsed. There were 40 adverse events reported in 33 (16%) of the 196 patients. The most frequent adverse events were infections, with 24 episodes being described in 19 patients. Thirteen (7%) patients died, mainly due to disease progression (7 cases) and infection (3 cases).
Although not yet licensed for this use, rituximab is currently used to treat severe, refractory systemic autoimmune diseases, with the most favourable results being observed in Sjögren's syndrome, inflammatory myopathies, systemic lupus erythematosus and cryoglobulinemia.</description><subject>Adolescent</subject><subject>Adult</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis - drug therapy</subject><subject>Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis - ethnology</subject><subject>Antibodies, Monoclonal, Murine-Derived - adverse effects</subject><subject>Antibodies, Monoclonal, Murine-Derived - therapeutic use</subject><subject>Autoimmune Diseases - drug therapy</subject><subject>Autoimmune Diseases - ethnology</subject><subject>Biological and medical sciences</subject><subject>Cryoglobulinemia - drug therapy</subject><subject>Cryoglobulinemia - ethnology</subject><subject>Diseases of the osteoarticular system</subject><subject>Female</subject><subject>Humans</subject><subject>Immunologic Factors - adverse effects</subject><subject>Immunologic Factors - therapeutic use</subject><subject>Immunomodulators</subject><subject>Lupus Erythematosus, Systemic - drug therapy</subject><subject>Lupus Erythematosus, Systemic - ethnology</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Myositis - drug therapy</subject><subject>Myositis - ethnology</subject><subject>Off-Label Use</subject><subject>Pharmacology. Drug treatments</subject><subject>Retrospective Studies</subject><subject>Rituximab</subject><subject>Sarcoidosis. Granulomatous diseases of unproved etiology. Connective tissue diseases. Elastic tissue diseases. Vasculitis</subject><subject>Severity of Illness Index</subject><subject>Sjogren's Syndrome - drug therapy</subject><subject>Sjogren's Syndrome - ethnology</subject><subject>Spain</subject><subject>Treatment Outcome</subject><subject>Young Adult</subject><issn>0392-856X</issn><issn>1593-098X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2010</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpF0M1KxDAUBeAgijOOvoJkI24spEmbNEsZdBQGZqMwu5KkNxjpn7mpOm9vwRFXZ_Nx4JwTssxLLTKmq_0pWTKheVaVcr8gF4jvjHFZSnVOFpyVvCwKvST1zvusNRZaOiHQwdMY0vQdOmNp6GmuJR1NCtAnpF8hvVGET4hwRyP4aFwa4oHiARN0wVEzpSF03dQDbQKCQcBLcuZNi3B1zBV5fXx4WT9l293meX2_zUZesJRp5wAcKCVz0XCbay6NYE5XZVNpUWlf5CCZYtYboawtVOGlFULKXDNlnRcrcvvbO8bhYwJMdRfQQduaHoYJa1UKrTWv2Cyvj3KyHTT1GOex8VD_fTKDmyMw6Ew7z-xdwH8neFGJuegHraFr9A</recordid><startdate>20100701</startdate><enddate>20100701</enddate><creator>RAMOS-CASALS, M</creator><creator>GARCIA-HERNANDEZ, F. J</creator><creator>PEREZ-ALVAREZ, R</creator><creator>MICO, M. L</creator><creator>MEDRANO, F</creator><creator>GOMEZ-DE-LA-TORRE, R</creator><creator>DIAZ-LAGARES, C</creator><creator>CAMPS, M</creator><creator>ORTEGO, N</creator><creator>SANCHEZ-ROMAN, J</creator><creator>DE RAMON, E</creator><creator>CALLEJAS, J. L</creator><creator>MARTINEZ-BERRIOTXOA, A</creator><creator>PALLARES, L</creator><creator>CAMINAL-MONTERO, L</creator><creator>SELVA-O'CALLAGHAN, A</creator><creator>ORISTRELL, J</creator><creator>HIDALGO, C</creator><general>Clinical and Experimental Rheumatology</general><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>7X8</scope></search><sort><creationdate>20100701</creationdate><title>Off-label use of rituximab in 196 patients with severe, refractory systemic autoimmune diseases</title><author>RAMOS-CASALS, M ; GARCIA-HERNANDEZ, F. J ; PEREZ-ALVAREZ, R ; MICO, M. L ; MEDRANO, F ; GOMEZ-DE-LA-TORRE, R ; DIAZ-LAGARES, C ; CAMPS, M ; ORTEGO, N ; SANCHEZ-ROMAN, J ; DE RAMON, E ; CALLEJAS, J. L ; MARTINEZ-BERRIOTXOA, A ; PALLARES, L ; CAMINAL-MONTERO, L ; SELVA-O'CALLAGHAN, A ; ORISTRELL, J ; HIDALGO, C</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-p240t-9cceece77613d2b1926a30c985d89389f41e6070bfa37bb474f6b33661907bcf3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2010</creationdate><topic>Adolescent</topic><topic>Adult</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis - drug therapy</topic><topic>Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis - ethnology</topic><topic>Antibodies, Monoclonal, Murine-Derived - adverse effects</topic><topic>Antibodies, Monoclonal, Murine-Derived - therapeutic use</topic><topic>Autoimmune Diseases - drug therapy</topic><topic>Autoimmune Diseases - ethnology</topic><topic>Biological and medical sciences</topic><topic>Cryoglobulinemia - drug therapy</topic><topic>Cryoglobulinemia - ethnology</topic><topic>Diseases of the osteoarticular system</topic><topic>Female</topic><topic>Humans</topic><topic>Immunologic Factors - adverse effects</topic><topic>Immunologic Factors - therapeutic use</topic><topic>Immunomodulators</topic><topic>Lupus Erythematosus, Systemic - drug therapy</topic><topic>Lupus Erythematosus, Systemic - ethnology</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Myositis - drug therapy</topic><topic>Myositis - ethnology</topic><topic>Off-Label Use</topic><topic>Pharmacology. Drug treatments</topic><topic>Retrospective Studies</topic><topic>Rituximab</topic><topic>Sarcoidosis. Granulomatous diseases of unproved etiology. Connective tissue diseases. Elastic tissue diseases. Vasculitis</topic><topic>Severity of Illness Index</topic><topic>Sjogren's Syndrome - drug therapy</topic><topic>Sjogren's Syndrome - ethnology</topic><topic>Spain</topic><topic>Treatment Outcome</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>RAMOS-CASALS, M</creatorcontrib><creatorcontrib>GARCIA-HERNANDEZ, F. J</creatorcontrib><creatorcontrib>PEREZ-ALVAREZ, R</creatorcontrib><creatorcontrib>MICO, M. 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L</creatorcontrib><creatorcontrib>MARTINEZ-BERRIOTXOA, A</creatorcontrib><creatorcontrib>PALLARES, L</creatorcontrib><creatorcontrib>CAMINAL-MONTERO, L</creatorcontrib><creatorcontrib>SELVA-O'CALLAGHAN, A</creatorcontrib><creatorcontrib>ORISTRELL, J</creatorcontrib><creatorcontrib>HIDALGO, C</creatorcontrib><creatorcontrib>BIOGEAS Study Group</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>MEDLINE - Academic</collection><jtitle>Clinical and experimental rheumatology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>RAMOS-CASALS, M</au><au>GARCIA-HERNANDEZ, F. J</au><au>PEREZ-ALVAREZ, R</au><au>MICO, M. L</au><au>MEDRANO, F</au><au>GOMEZ-DE-LA-TORRE, R</au><au>DIAZ-LAGARES, C</au><au>CAMPS, M</au><au>ORTEGO, N</au><au>SANCHEZ-ROMAN, J</au><au>DE RAMON, E</au><au>CALLEJAS, J. L</au><au>MARTINEZ-BERRIOTXOA, A</au><au>PALLARES, L</au><au>CAMINAL-MONTERO, L</au><au>SELVA-O'CALLAGHAN, A</au><au>ORISTRELL, J</au><au>HIDALGO, C</au><aucorp>BIOGEAS Study Group</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Off-label use of rituximab in 196 patients with severe, refractory systemic autoimmune diseases</atitle><jtitle>Clinical and experimental rheumatology</jtitle><addtitle>Clin Exp Rheumatol</addtitle><date>2010-07-01</date><risdate>2010</risdate><volume>28</volume><issue>4</issue><spage>468</spage><epage>476</epage><pages>468-476</pages><issn>0392-856X</issn><eissn>1593-098X</eissn><abstract>To analyse the safety and efficacy of the off-label use of rituximab in patients with severe, refractory systemic autoimmune diseases.
In 2006, the Study Group on Autoimmune Diseases of the Spanish Society of Internal Medicine created the BIOGEAS project, a multicenter study devoted to collecting data on the use of biological agents in adult patients with systemic autoimmune diseases refractory to standard therapies (failure of at least two immunosuppressive agents).
One hundred and ninety-six patients with systemic autoimmune diseases treated with rituximab have been included in the Registry (158 women and 38 men, mean age 43 years). Systemic autoimmune diseases included systemic lupus erythematosus (107 cases), inflammatory myopathies (20 cases), ANCA-related vasculitides (19 cases), Sjögren's syndrome (15 cases) and other diseases (35 cases). A therapeutic response was evaluable in 194 cases: 99 (51%) achieved a complete response, 51 (26%) a partial response and 44 (23%) were classified as non-responders. After a mean follow-up of 27.56+/-1.32 months, 44 (29%) out of the 150 responders patients relapsed. There were 40 adverse events reported in 33 (16%) of the 196 patients. The most frequent adverse events were infections, with 24 episodes being described in 19 patients. Thirteen (7%) patients died, mainly due to disease progression (7 cases) and infection (3 cases).
Although not yet licensed for this use, rituximab is currently used to treat severe, refractory systemic autoimmune diseases, with the most favourable results being observed in Sjögren's syndrome, inflammatory myopathies, systemic lupus erythematosus and cryoglobulinemia.</abstract><cop>Pisa</cop><pub>Clinical and Experimental Rheumatology</pub><pmid>20525449</pmid><tpages>9</tpages></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0392-856X |
| ispartof | Clinical and experimental rheumatology, 2010-07, Vol.28 (4), p.468-476 |
| issn | 0392-856X 1593-098X |
| language | eng |
| recordid | cdi_proquest_miscellaneous_753999280 |
| source | MEDLINE; Alma/SFX Local Collection |
| subjects | Adolescent Adult Aged Aged, 80 and over Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis - drug therapy Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis - ethnology Antibodies, Monoclonal, Murine-Derived - adverse effects Antibodies, Monoclonal, Murine-Derived - therapeutic use Autoimmune Diseases - drug therapy Autoimmune Diseases - ethnology Biological and medical sciences Cryoglobulinemia - drug therapy Cryoglobulinemia - ethnology Diseases of the osteoarticular system Female Humans Immunologic Factors - adverse effects Immunologic Factors - therapeutic use Immunomodulators Lupus Erythematosus, Systemic - drug therapy Lupus Erythematosus, Systemic - ethnology Male Medical sciences Middle Aged Myositis - drug therapy Myositis - ethnology Off-Label Use Pharmacology. Drug treatments Retrospective Studies Rituximab Sarcoidosis. Granulomatous diseases of unproved etiology. Connective tissue diseases. Elastic tissue diseases. Vasculitis Severity of Illness Index Sjogren's Syndrome - drug therapy Sjogren's Syndrome - ethnology Spain Treatment Outcome Young Adult |
| title | Off-label use of rituximab in 196 patients with severe, refractory systemic autoimmune diseases |
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