Lecanemab: A Humanized Monoclonal Antibody for the Treatment of Early Alzheimer Disease
Objective: To review current pharmacology, pharmacokinetics/pharmacodynamics, safety, and efficacy of lecanemab in patients with Alzheimer disease. Data sources: A literature search of PubMed (April 1, 2016-November 15, 2023) and ClinicalTrials.gov search were conducted using the following search te...
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| Veröffentlicht in: | Annals of Pharmacotherapy 2024-10, Vol.58 (10), p.1045-1053 |
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| container_title | Annals of Pharmacotherapy |
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| creator | Park, Juliane Simpson, Carson Patel, Katie |
| description | Objective:
To review current pharmacology, pharmacokinetics/pharmacodynamics, safety, and efficacy of lecanemab in patients with Alzheimer disease.
Data sources:
A literature search of PubMed (April 1, 2016-November 15, 2023) and ClinicalTrials.gov search were conducted using the following search terms: lecanemab and BAN2401. Additional articles were identified by hand from references.
Study selection and data extraction:
We included English-language clinical trials, randomized controlled trials, reviews, and systematic reviews evaluating lecanemab pharmacology, efficacy, or safety in humans for the management of Alzheimer disease.
Data synthesis:
In the Clarity AD phase III trial, lecanemab led to a decrease in brain amyloid levels and showed moderate improvement in clinical measures of cognition and function. At 18 months, lecanemab 10 mg/kg biweekly exhibited a lower least squares mean change from baseline (1.21) compared to placebo (1.66) of Clinical Dementia Rating-Sum of Boxes score, signifying a significant difference of −0.45 (95% CI, −0.67 to −0.23; P < 0.001). In a subset of 698 participants, lecanemab reduced brain amyloid burden by −59.1 Centiloids (95% CI, −62.6 to −55.6). Lecanemab demonstrated favorable differences in Alzheimer Disease Assessment Scale-cognitive subscale 14, Alzheimer Disease Composite Score, and Alzheimer Disease Cooperative Study—Mild Cognitive Impairment—Activities of Daily Living scores. Adverse events included infusion-related reactions (26.4%) and amyloid-related imaging abnormalities (12.6%).
Relevance to patient care and clinical practice:
Lecanemab reduces cognitive decline but raises concerns about intravenous administration, cost, and magnetic resonance imaging needs. Ongoing trials exploring subcutaneous dosing and positron emission tomography scans may offer solutions.
Conclusion:
Lecanemab is a humanized monoclonal antibody that is selective for soluble amyloid-beta (Aβ) aggregates. Lecanemab has exhibited a decrease in brain Aβ plaques and moderately less decline on clinical measures of cognitive function. |
| doi_str_mv | 10.1177/10600280231218253 |
| format | Article |
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To review current pharmacology, pharmacokinetics/pharmacodynamics, safety, and efficacy of lecanemab in patients with Alzheimer disease.
Data sources:
A literature search of PubMed (April 1, 2016-November 15, 2023) and ClinicalTrials.gov search were conducted using the following search terms: lecanemab and BAN2401. Additional articles were identified by hand from references.
Study selection and data extraction:
We included English-language clinical trials, randomized controlled trials, reviews, and systematic reviews evaluating lecanemab pharmacology, efficacy, or safety in humans for the management of Alzheimer disease.
Data synthesis:
In the Clarity AD phase III trial, lecanemab led to a decrease in brain amyloid levels and showed moderate improvement in clinical measures of cognition and function. At 18 months, lecanemab 10 mg/kg biweekly exhibited a lower least squares mean change from baseline (1.21) compared to placebo (1.66) of Clinical Dementia Rating-Sum of Boxes score, signifying a significant difference of −0.45 (95% CI, −0.67 to −0.23; P < 0.001). In a subset of 698 participants, lecanemab reduced brain amyloid burden by −59.1 Centiloids (95% CI, −62.6 to −55.6). Lecanemab demonstrated favorable differences in Alzheimer Disease Assessment Scale-cognitive subscale 14, Alzheimer Disease Composite Score, and Alzheimer Disease Cooperative Study—Mild Cognitive Impairment—Activities of Daily Living scores. Adverse events included infusion-related reactions (26.4%) and amyloid-related imaging abnormalities (12.6%).
Relevance to patient care and clinical practice:
Lecanemab reduces cognitive decline but raises concerns about intravenous administration, cost, and magnetic resonance imaging needs. Ongoing trials exploring subcutaneous dosing and positron emission tomography scans may offer solutions.
Conclusion:
Lecanemab is a humanized monoclonal antibody that is selective for soluble amyloid-beta (Aβ) aggregates. Lecanemab has exhibited a decrease in brain Aβ plaques and moderately less decline on clinical measures of cognitive function.</description><identifier>ISSN: 1060-0280</identifier><identifier>ISSN: 1542-6270</identifier><identifier>EISSN: 1542-6270</identifier><identifier>DOI: 10.1177/10600280231218253</identifier><identifier>PMID: 38095619</identifier><language>eng</language><publisher>Los Angeles, CA: SAGE Publications</publisher><subject>Alzheimer Disease - drug therapy ; Antibodies, Monoclonal, Humanized - pharmacology ; Antibodies, Monoclonal, Humanized - therapeutic use ; Humans</subject><ispartof>Annals of Pharmacotherapy, 2024-10, Vol.58 (10), p.1045-1053</ispartof><rights>The Author(s) 2023</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c340t-aaea5a90f4bbd1cd3bd320370174fb0abb1109e37eac0ccf7701f0fdcae08ee3</citedby><cites>FETCH-LOGICAL-c340t-aaea5a90f4bbd1cd3bd320370174fb0abb1109e37eac0ccf7701f0fdcae08ee3</cites><orcidid>0000-0001-8350-8392</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://journals.sagepub.com/doi/pdf/10.1177/10600280231218253$$EPDF$$P50$$Gsage$$H</linktopdf><linktohtml>$$Uhttps://journals.sagepub.com/doi/10.1177/10600280231218253$$EHTML$$P50$$Gsage$$H</linktohtml><link.rule.ids>313,314,780,784,792,21817,27920,27922,27923,43619,43620</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/38095619$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Park, Juliane</creatorcontrib><creatorcontrib>Simpson, Carson</creatorcontrib><creatorcontrib>Patel, Katie</creatorcontrib><title>Lecanemab: A Humanized Monoclonal Antibody for the Treatment of Early Alzheimer Disease</title><title>Annals of Pharmacotherapy</title><addtitle>Ann Pharmacother</addtitle><description>Objective:
To review current pharmacology, pharmacokinetics/pharmacodynamics, safety, and efficacy of lecanemab in patients with Alzheimer disease.
Data sources:
A literature search of PubMed (April 1, 2016-November 15, 2023) and ClinicalTrials.gov search were conducted using the following search terms: lecanemab and BAN2401. Additional articles were identified by hand from references.
Study selection and data extraction:
We included English-language clinical trials, randomized controlled trials, reviews, and systematic reviews evaluating lecanemab pharmacology, efficacy, or safety in humans for the management of Alzheimer disease.
Data synthesis:
In the Clarity AD phase III trial, lecanemab led to a decrease in brain amyloid levels and showed moderate improvement in clinical measures of cognition and function. At 18 months, lecanemab 10 mg/kg biweekly exhibited a lower least squares mean change from baseline (1.21) compared to placebo (1.66) of Clinical Dementia Rating-Sum of Boxes score, signifying a significant difference of −0.45 (95% CI, −0.67 to −0.23; P < 0.001). In a subset of 698 participants, lecanemab reduced brain amyloid burden by −59.1 Centiloids (95% CI, −62.6 to −55.6). Lecanemab demonstrated favorable differences in Alzheimer Disease Assessment Scale-cognitive subscale 14, Alzheimer Disease Composite Score, and Alzheimer Disease Cooperative Study—Mild Cognitive Impairment—Activities of Daily Living scores. Adverse events included infusion-related reactions (26.4%) and amyloid-related imaging abnormalities (12.6%).
Relevance to patient care and clinical practice:
Lecanemab reduces cognitive decline but raises concerns about intravenous administration, cost, and magnetic resonance imaging needs. Ongoing trials exploring subcutaneous dosing and positron emission tomography scans may offer solutions.
Conclusion:
Lecanemab is a humanized monoclonal antibody that is selective for soluble amyloid-beta (Aβ) aggregates. Lecanemab has exhibited a decrease in brain Aβ plaques and moderately less decline on clinical measures of cognitive function.</description><subject>Alzheimer Disease - drug therapy</subject><subject>Antibodies, Monoclonal, Humanized - pharmacology</subject><subject>Antibodies, Monoclonal, Humanized - therapeutic use</subject><subject>Humans</subject><issn>1060-0280</issn><issn>1542-6270</issn><issn>1542-6270</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2024</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kD1PwzAQhi0EolD4ASzII0vK2W6amq2C8iEVsVRijM7OmaZKYrCTof31pGphQWK6k-55X-kexq4EjITIslsBEwA5BamEFFOZqiN2JtKxTCYyg-N-7-_JDhiw8xjXAKCF1KdsoKag04nQZ-x9QRYbqtHc8Rl_7mpsyi0V_NU33la-wYrPmrY0vthw5wNvV8SXgbCtqWm5d3yOodrwWbVdUVlT4A9lJIx0wU4cVpEuD3PIlo_z5f1zsnh7ermfLRKrxtAmiIQpanBjYwphC2UKJUFlILKxM4DGCAGaVEZowVqX9RcHrrBIMCVSQ3azr_0M_quj2OZ1GS1VVf-T72IuNUg9SbUUPSr2qA0-xkAu_wxljWGTC8h3OvM_OvvM9aG-MzUVv4kffz0w2gMRPyhf-y70xuI_jd-2Pn1Q</recordid><startdate>20241001</startdate><enddate>20241001</enddate><creator>Park, Juliane</creator><creator>Simpson, Carson</creator><creator>Patel, Katie</creator><general>SAGE Publications</general><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><orcidid>https://orcid.org/0000-0001-8350-8392</orcidid></search><sort><creationdate>20241001</creationdate><title>Lecanemab: A Humanized Monoclonal Antibody for the Treatment of Early Alzheimer Disease</title><author>Park, Juliane ; Simpson, Carson ; Patel, Katie</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c340t-aaea5a90f4bbd1cd3bd320370174fb0abb1109e37eac0ccf7701f0fdcae08ee3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2024</creationdate><topic>Alzheimer Disease - drug therapy</topic><topic>Antibodies, Monoclonal, Humanized - pharmacology</topic><topic>Antibodies, Monoclonal, Humanized - therapeutic use</topic><topic>Humans</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Park, Juliane</creatorcontrib><creatorcontrib>Simpson, Carson</creatorcontrib><creatorcontrib>Patel, Katie</creatorcontrib><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><jtitle>Annals of Pharmacotherapy</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Park, Juliane</au><au>Simpson, Carson</au><au>Patel, Katie</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Lecanemab: A Humanized Monoclonal Antibody for the Treatment of Early Alzheimer Disease</atitle><jtitle>Annals of Pharmacotherapy</jtitle><addtitle>Ann Pharmacother</addtitle><date>2024-10-01</date><risdate>2024</risdate><volume>58</volume><issue>10</issue><spage>1045</spage><epage>1053</epage><pages>1045-1053</pages><issn>1060-0280</issn><issn>1542-6270</issn><eissn>1542-6270</eissn><abstract>Objective:
To review current pharmacology, pharmacokinetics/pharmacodynamics, safety, and efficacy of lecanemab in patients with Alzheimer disease.
Data sources:
A literature search of PubMed (April 1, 2016-November 15, 2023) and ClinicalTrials.gov search were conducted using the following search terms: lecanemab and BAN2401. Additional articles were identified by hand from references.
Study selection and data extraction:
We included English-language clinical trials, randomized controlled trials, reviews, and systematic reviews evaluating lecanemab pharmacology, efficacy, or safety in humans for the management of Alzheimer disease.
Data synthesis:
In the Clarity AD phase III trial, lecanemab led to a decrease in brain amyloid levels and showed moderate improvement in clinical measures of cognition and function. At 18 months, lecanemab 10 mg/kg biweekly exhibited a lower least squares mean change from baseline (1.21) compared to placebo (1.66) of Clinical Dementia Rating-Sum of Boxes score, signifying a significant difference of −0.45 (95% CI, −0.67 to −0.23; P < 0.001). In a subset of 698 participants, lecanemab reduced brain amyloid burden by −59.1 Centiloids (95% CI, −62.6 to −55.6). Lecanemab demonstrated favorable differences in Alzheimer Disease Assessment Scale-cognitive subscale 14, Alzheimer Disease Composite Score, and Alzheimer Disease Cooperative Study—Mild Cognitive Impairment—Activities of Daily Living scores. Adverse events included infusion-related reactions (26.4%) and amyloid-related imaging abnormalities (12.6%).
Relevance to patient care and clinical practice:
Lecanemab reduces cognitive decline but raises concerns about intravenous administration, cost, and magnetic resonance imaging needs. Ongoing trials exploring subcutaneous dosing and positron emission tomography scans may offer solutions.
Conclusion:
Lecanemab is a humanized monoclonal antibody that is selective for soluble amyloid-beta (Aβ) aggregates. Lecanemab has exhibited a decrease in brain Aβ plaques and moderately less decline on clinical measures of cognitive function.</abstract><cop>Los Angeles, CA</cop><pub>SAGE Publications</pub><pmid>38095619</pmid><doi>10.1177/10600280231218253</doi><tpages>9</tpages><orcidid>https://orcid.org/0000-0001-8350-8392</orcidid></addata></record> |
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| issn | 1060-0280 1542-6270 1542-6270 |
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| source | MEDLINE; SAGE Complete A-Z List |
| subjects | Alzheimer Disease - drug therapy Antibodies, Monoclonal, Humanized - pharmacology Antibodies, Monoclonal, Humanized - therapeutic use Humans |
| title | Lecanemab: A Humanized Monoclonal Antibody for the Treatment of Early Alzheimer Disease |
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