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Safety of efalizumab in patients with moderate to severe chronic plaque psoriasis : Review of clinical data. Part II
The efficacy and safety of efalizumab have been evaluated in multiple clinical trials. The purpose of this review is to provide an overview of the safety profile of efalizumab during the clinical trials. Twelve-week data from four placebo-controlled trials were pooled and analyzed. Data from patient...
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| Published in: | Journal of cutaneous medicine and surgery 2005-12, Vol.9 (6), p.313-323 |
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| Main Authors: | , , , , , , , |
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| cited_by | cdi_FETCH-LOGICAL-c356t-d5801c2d555090036c3f4c65e1449b81004669446628c8800ee987f8c05040143 |
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| cites | cdi_FETCH-LOGICAL-c356t-d5801c2d555090036c3f4c65e1449b81004669446628c8800ee987f8c05040143 |
| container_end_page | 323 |
| container_issue | 6 |
| container_start_page | 313 |
| container_title | Journal of cutaneous medicine and surgery |
| container_volume | 9 |
| creator | PAPP, Kim A CAMISA, Charles STONE, Stephen P CARO, Ivor XIAOLIN WANG COMPTON, Peter WALICKE, Patricia A GOTTLIEB, Alice B |
| description | The efficacy and safety of efalizumab have been evaluated in multiple clinical trials.
The purpose of this review is to provide an overview of the safety profile of efalizumab during the clinical trials.
Twelve-week data from four placebo-controlled trials were pooled and analyzed. Data from patients receiving 13-60 weeks of efalizumab therapy were pooled to evaluate longer-term safety.
The most common adverse events were mild to moderate, self-limiting, flu-like symptoms that were most frequent following the first two efalizumab doses; by the third dose the incidence was comparable to placebo. Serious adverse events were observed in 2.2% and 1.7% of efalizumab- and placebo-treated patients, respectively. Nonserious adverse events leading to withdrawal were infrequent and similar to placebo (2.8% vs 1.8%). There does not appear to be increased risk of end-organ toxicity, infection, or malignancy in efalizumab-treated patients.
Efalizumab was well tolerated, with a favorable safety profile. |
| doi_str_mv | 10.1007/s10227-005-0117-0 |
| format | article |
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The purpose of this review is to provide an overview of the safety profile of efalizumab during the clinical trials.
Twelve-week data from four placebo-controlled trials were pooled and analyzed. Data from patients receiving 13-60 weeks of efalizumab therapy were pooled to evaluate longer-term safety.
The most common adverse events were mild to moderate, self-limiting, flu-like symptoms that were most frequent following the first two efalizumab doses; by the third dose the incidence was comparable to placebo. Serious adverse events were observed in 2.2% and 1.7% of efalizumab- and placebo-treated patients, respectively. Nonserious adverse events leading to withdrawal were infrequent and similar to placebo (2.8% vs 1.8%). There does not appear to be increased risk of end-organ toxicity, infection, or malignancy in efalizumab-treated patients.
Efalizumab was well tolerated, with a favorable safety profile.</description><identifier>ISSN: 1203-4754</identifier><identifier>EISSN: 1615-7109</identifier><identifier>DOI: 10.1007/s10227-005-0117-0</identifier><identifier>PMID: 16699903</identifier><language>eng</language><publisher>Hamilton, ON: Decker</publisher><subject>Adolescent ; Adult ; Aged ; Antibodies, Monoclonal - administration & dosage ; Antibodies, Monoclonal - adverse effects ; Antibodies, Monoclonal - therapeutic use ; Biological and medical sciences ; Chronic Disease ; Clinical trials ; Clinical Trials, Phase I as Topic ; Clinical Trials, Phase II as Topic ; Data Interpretation, Statistical ; Dermatology ; Double-Blind Method ; Female ; Humans ; Injections, Intravenous ; Injections, Subcutaneous ; Male ; Medical research ; Medical sciences ; Middle Aged ; Pharmaceuticals ; Placebos ; Psoriasis ; Psoriasis - drug therapy ; Psoriasis. Parapsoriasis. Lichen ; Randomized Controlled Trials as Topic ; Safety ; Time Factors</subject><ispartof>Journal of cutaneous medicine and surgery, 2005-12, Vol.9 (6), p.313-323</ispartof><rights>2006 INIST-CNRS</rights><rights>Canadian Dermatology Association 2005</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c356t-d5801c2d555090036c3f4c65e1449b81004669446628c8800ee987f8c05040143</citedby><cites>FETCH-LOGICAL-c356t-d5801c2d555090036c3f4c65e1449b81004669446628c8800ee987f8c05040143</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,27903,27904</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=18016941$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/16699903$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>PAPP, Kim A</creatorcontrib><creatorcontrib>CAMISA, Charles</creatorcontrib><creatorcontrib>STONE, Stephen P</creatorcontrib><creatorcontrib>CARO, Ivor</creatorcontrib><creatorcontrib>XIAOLIN WANG</creatorcontrib><creatorcontrib>COMPTON, Peter</creatorcontrib><creatorcontrib>WALICKE, Patricia A</creatorcontrib><creatorcontrib>GOTTLIEB, Alice B</creatorcontrib><title>Safety of efalizumab in patients with moderate to severe chronic plaque psoriasis : Review of clinical data. Part II</title><title>Journal of cutaneous medicine and surgery</title><addtitle>J Cutan Med Surg</addtitle><description>The efficacy and safety of efalizumab have been evaluated in multiple clinical trials.
The purpose of this review is to provide an overview of the safety profile of efalizumab during the clinical trials.
Twelve-week data from four placebo-controlled trials were pooled and analyzed. Data from patients receiving 13-60 weeks of efalizumab therapy were pooled to evaluate longer-term safety.
The most common adverse events were mild to moderate, self-limiting, flu-like symptoms that were most frequent following the first two efalizumab doses; by the third dose the incidence was comparable to placebo. Serious adverse events were observed in 2.2% and 1.7% of efalizumab- and placebo-treated patients, respectively. Nonserious adverse events leading to withdrawal were infrequent and similar to placebo (2.8% vs 1.8%). There does not appear to be increased risk of end-organ toxicity, infection, or malignancy in efalizumab-treated patients.
Efalizumab was well tolerated, with a favorable safety profile.</description><subject>Adolescent</subject><subject>Adult</subject><subject>Aged</subject><subject>Antibodies, Monoclonal - administration & dosage</subject><subject>Antibodies, Monoclonal - adverse effects</subject><subject>Antibodies, Monoclonal - therapeutic use</subject><subject>Biological and medical sciences</subject><subject>Chronic Disease</subject><subject>Clinical trials</subject><subject>Clinical Trials, Phase I as Topic</subject><subject>Clinical Trials, Phase II as Topic</subject><subject>Data Interpretation, Statistical</subject><subject>Dermatology</subject><subject>Double-Blind Method</subject><subject>Female</subject><subject>Humans</subject><subject>Injections, Intravenous</subject><subject>Injections, Subcutaneous</subject><subject>Male</subject><subject>Medical research</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Pharmaceuticals</subject><subject>Placebos</subject><subject>Psoriasis</subject><subject>Psoriasis - drug therapy</subject><subject>Psoriasis. Parapsoriasis. Lichen</subject><subject>Randomized Controlled Trials as Topic</subject><subject>Safety</subject><subject>Time Factors</subject><issn>1203-4754</issn><issn>1615-7109</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2005</creationdate><recordtype>article</recordtype><recordid>eNpFkE1LAzEQhoMofv8ALxIEj1snu8nuxpsUPwqC4sc5pNlZGml31yRV6q93Sgu9JHN45p2Zh7ELASMBUN1EAXleZQAqAyGo2GPHohQqqwTofapzKDJZKXnETmL8AiBKyUN2JMpSaw3FMUvvtsW04n3LsbVz_7dc2Cn3HR9s8tilyH99mvFF32CwCXnqecQfDMjdLPSdd3yY2-8l8iH2wdvoI7_lb_jj8Xed6eaeGDvnjU12xF9tSHwyOWMHNCvi-fY_ZZ8P9x_jp-z55XEyvnvOXKHKlDWqBuHyRikFGqAoXdFKVyoUUuppTQok3SHpyWtX1wCIuq7a2oECCUIWp-xqkzuEnnaMyXz1y9DRSJPnui60zjVBYgO50McYsDVD8AsbVkaAWWs2G82GNJu1ZgPUc7kNXk4X2Ow6tl4JuN4CNtL5bbCd83HH0WG0uSj-AcB0gwg</recordid><startdate>20051201</startdate><enddate>20051201</enddate><creator>PAPP, Kim A</creator><creator>CAMISA, Charles</creator><creator>STONE, Stephen P</creator><creator>CARO, Ivor</creator><creator>XIAOLIN WANG</creator><creator>COMPTON, Peter</creator><creator>WALICKE, Patricia A</creator><creator>GOTTLIEB, Alice B</creator><general>Decker</general><general>SAGE PUBLICATIONS, INC</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><scope>K9.</scope></search><sort><creationdate>20051201</creationdate><title>Safety of efalizumab in patients with moderate to severe chronic plaque psoriasis : Review of clinical data. Part II</title><author>PAPP, Kim A ; CAMISA, Charles ; STONE, Stephen P ; CARO, Ivor ; XIAOLIN WANG ; COMPTON, Peter ; WALICKE, Patricia A ; GOTTLIEB, Alice B</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c356t-d5801c2d555090036c3f4c65e1449b81004669446628c8800ee987f8c05040143</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2005</creationdate><topic>Adolescent</topic><topic>Adult</topic><topic>Aged</topic><topic>Antibodies, Monoclonal - administration & dosage</topic><topic>Antibodies, Monoclonal - adverse effects</topic><topic>Antibodies, Monoclonal - therapeutic use</topic><topic>Biological and medical sciences</topic><topic>Chronic Disease</topic><topic>Clinical trials</topic><topic>Clinical Trials, Phase I as Topic</topic><topic>Clinical Trials, Phase II as Topic</topic><topic>Data Interpretation, Statistical</topic><topic>Dermatology</topic><topic>Double-Blind Method</topic><topic>Female</topic><topic>Humans</topic><topic>Injections, Intravenous</topic><topic>Injections, Subcutaneous</topic><topic>Male</topic><topic>Medical research</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Pharmaceuticals</topic><topic>Placebos</topic><topic>Psoriasis</topic><topic>Psoriasis - drug therapy</topic><topic>Psoriasis. Parapsoriasis. Lichen</topic><topic>Randomized Controlled Trials as Topic</topic><topic>Safety</topic><topic>Time Factors</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>PAPP, Kim A</creatorcontrib><creatorcontrib>CAMISA, Charles</creatorcontrib><creatorcontrib>STONE, Stephen P</creatorcontrib><creatorcontrib>CARO, Ivor</creatorcontrib><creatorcontrib>XIAOLIN WANG</creatorcontrib><creatorcontrib>COMPTON, Peter</creatorcontrib><creatorcontrib>WALICKE, Patricia A</creatorcontrib><creatorcontrib>GOTTLIEB, Alice B</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>ProQuest Health & Medical Complete (Alumni)</collection><jtitle>Journal of cutaneous medicine and surgery</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>PAPP, Kim A</au><au>CAMISA, Charles</au><au>STONE, Stephen P</au><au>CARO, Ivor</au><au>XIAOLIN WANG</au><au>COMPTON, Peter</au><au>WALICKE, Patricia A</au><au>GOTTLIEB, Alice B</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Safety of efalizumab in patients with moderate to severe chronic plaque psoriasis : Review of clinical data. Part II</atitle><jtitle>Journal of cutaneous medicine and surgery</jtitle><addtitle>J Cutan Med Surg</addtitle><date>2005-12-01</date><risdate>2005</risdate><volume>9</volume><issue>6</issue><spage>313</spage><epage>323</epage><pages>313-323</pages><issn>1203-4754</issn><eissn>1615-7109</eissn><abstract>The efficacy and safety of efalizumab have been evaluated in multiple clinical trials.
The purpose of this review is to provide an overview of the safety profile of efalizumab during the clinical trials.
Twelve-week data from four placebo-controlled trials were pooled and analyzed. Data from patients receiving 13-60 weeks of efalizumab therapy were pooled to evaluate longer-term safety.
The most common adverse events were mild to moderate, self-limiting, flu-like symptoms that were most frequent following the first two efalizumab doses; by the third dose the incidence was comparable to placebo. Serious adverse events were observed in 2.2% and 1.7% of efalizumab- and placebo-treated patients, respectively. Nonserious adverse events leading to withdrawal were infrequent and similar to placebo (2.8% vs 1.8%). There does not appear to be increased risk of end-organ toxicity, infection, or malignancy in efalizumab-treated patients.
Efalizumab was well tolerated, with a favorable safety profile.</abstract><cop>Hamilton, ON</cop><pub>Decker</pub><pmid>16699903</pmid><doi>10.1007/s10227-005-0117-0</doi><tpages>11</tpages></addata></record> |
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| subjects | Adolescent Adult Aged Antibodies, Monoclonal - administration & dosage Antibodies, Monoclonal - adverse effects Antibodies, Monoclonal - therapeutic use Biological and medical sciences Chronic Disease Clinical trials Clinical Trials, Phase I as Topic Clinical Trials, Phase II as Topic Data Interpretation, Statistical Dermatology Double-Blind Method Female Humans Injections, Intravenous Injections, Subcutaneous Male Medical research Medical sciences Middle Aged Pharmaceuticals Placebos Psoriasis Psoriasis - drug therapy Psoriasis. Parapsoriasis. Lichen Randomized Controlled Trials as Topic Safety Time Factors |
| title | Safety of efalizumab in patients with moderate to severe chronic plaque psoriasis : Review of clinical data. Part II |
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