A phase Ib multiple ascending dose study evaluating safety, pharmacokinetics, and early clinical response of brodalumab, a human anti-IL-17R antibody, in methotrexate-resistant rheumatoid arthritis
The aim of this study was to evaluate the safety, pharmacokinetics, and clinical response of brodalumab (AMG 827), a human, anti-IL-17 receptor A (IL-17RA) monoclonal antibody in subjects with moderate-to-severe rheumatoid arthritis (RA). This phase Ib, randomized, placebo-controlled, double-blind m...
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creator | Martin, David A Churchill, Melvin Flores-Suarez, Luis Cardiel, Mario H Wallace, Daniel Martin, Richard Phillips, Kristine Kaine, Jeffrey L Dong, Hua Salinger, David Stevens, Erin Russell, Chris B Chung, James B |
description | The aim of this study was to evaluate the safety, pharmacokinetics, and clinical response of brodalumab (AMG 827), a human, anti-IL-17 receptor A (IL-17RA) monoclonal antibody in subjects with moderate-to-severe rheumatoid arthritis (RA).
This phase Ib, randomized, placebo-controlled, double-blind multiple ascending dose study enrolled subjects with moderate to severe RA (≥ 6/66 swollen and ≥ 8/68 tender joints). Subjects were randomized 3:1 to receive brodalumab (50 mg, 140 mg, or 210 mg subcutaneously every two weeks for 6 doses per group; or 420 mg or 700 mg intravenously every 4 weeks for two doses per group) or placebo. Endpoints included incidence of adverse events (AEs) and pharmacokinetics. Exploratory endpoints included pharmacodynamics, and improvements in RA clinical metrics.
Forty subjects were randomized to investigational product; one subject discontinued due to worsening of RA (placebo). The study was not designed to assess efficacy. AEs were reported by 70% (7/10) of placebo subjects and 77% (22/30) of brodalumab subjects. Three serious AEs were reported in two subjects; there were no opportunistic infections. Brodalumab treatment resulted in inhibition of IL-17 receptor signaling and receptor occupancy on circulating leukocytes. No treatment effects were observed with individual measures of RA disease activity. On day 85 (week 13) 37% (11/30) of brodalumab subjects and 22% (2/9) of placebo subjects achieved ACR20; 7% (2/30) brodalumab subjects and 11% (1/9) of placebo subjects achieved ACR50; and 0% (0/30) brodalumab subjects and 0% (0/9) of placebo subjects achieved ACR70.
Multiple dose administration of brodalumab was tolerated in subjects with active RA. There was no evidence of a clinical response to brodalumab in subjects with RA.
ClinicalTrials.gov, NCT00771030. |
doi_str_mv | 10.1186/ar4347 |
format | Article |
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This phase Ib, randomized, placebo-controlled, double-blind multiple ascending dose study enrolled subjects with moderate to severe RA (≥ 6/66 swollen and ≥ 8/68 tender joints). Subjects were randomized 3:1 to receive brodalumab (50 mg, 140 mg, or 210 mg subcutaneously every two weeks for 6 doses per group; or 420 mg or 700 mg intravenously every 4 weeks for two doses per group) or placebo. Endpoints included incidence of adverse events (AEs) and pharmacokinetics. Exploratory endpoints included pharmacodynamics, and improvements in RA clinical metrics.
Forty subjects were randomized to investigational product; one subject discontinued due to worsening of RA (placebo). The study was not designed to assess efficacy. AEs were reported by 70% (7/10) of placebo subjects and 77% (22/30) of brodalumab subjects. Three serious AEs were reported in two subjects; there were no opportunistic infections. Brodalumab treatment resulted in inhibition of IL-17 receptor signaling and receptor occupancy on circulating leukocytes. No treatment effects were observed with individual measures of RA disease activity. On day 85 (week 13) 37% (11/30) of brodalumab subjects and 22% (2/9) of placebo subjects achieved ACR20; 7% (2/30) brodalumab subjects and 11% (1/9) of placebo subjects achieved ACR50; and 0% (0/30) brodalumab subjects and 0% (0/9) of placebo subjects achieved ACR70.
Multiple dose administration of brodalumab was tolerated in subjects with active RA. There was no evidence of a clinical response to brodalumab in subjects with RA.
ClinicalTrials.gov, NCT00771030.</description><identifier>ISSN: 1478-6354</identifier><identifier>EISSN: 1478-6362</identifier><identifier>EISSN: 1478-6354</identifier><identifier>DOI: 10.1186/ar4347</identifier><identifier>PMID: 24286136</identifier><language>eng</language><publisher>England: BioMed Central Ltd</publisher><subject>Abdominal Pain - chemically induced ; Adult ; Aged ; Antibodies ; Antibodies, Monoclonal - adverse effects ; Antibodies, Monoclonal - pharmacokinetics ; Antibodies, Monoclonal - therapeutic use ; Antibodies, Monoclonal, Humanized ; Antirheumatic Agents - therapeutic use ; Area Under Curve ; Arthritis, Rheumatoid - drug therapy ; Arthritis, Rheumatoid - immunology ; Arthritis, Rheumatoid - metabolism ; B cells ; Care and treatment ; Cough - chemically induced ; Diagnosis ; Dose-Response Relationship, Drug ; Double-Blind Method ; Drug Administration Schedule ; Drug Resistance ; Drug therapy ; Female ; Headache - chemically induced ; Health aspects ; Humans ; Injections, Subcutaneous ; Male ; Metabolic Clearance Rate ; Methotrexate - therapeutic use ; Middle Aged ; Pharmacokinetics ; Receptors, Interleukin-17 - antagonists & inhibitors ; Receptors, Interleukin-17 - immunology ; Rheumatoid arthritis ; Safety and security measures ; Treatment Outcome ; Viral antibodies</subject><ispartof>Arthritis research & therapy, 2013-10, Vol.15 (5), p.R164-R164, Article R164</ispartof><rights>COPYRIGHT 2013 BioMed Central Ltd.</rights><rights>Copyright © 2013 Martin et al.; licensee BioMed Central Ltd. 2013 Martin et al.; licensee BioMed Central Ltd.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c499t-e14dd92835a8d8a9698c36d07562b4ea4223b64959d0d4c5c4c9f223e645e47c3</citedby><cites>FETCH-LOGICAL-c499t-e14dd92835a8d8a9698c36d07562b4ea4223b64959d0d4c5c4c9f223e645e47c3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC3979125/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC3979125/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,727,780,784,864,885,27924,27925,53791,53793</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/24286136$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Martin, David A</creatorcontrib><creatorcontrib>Churchill, Melvin</creatorcontrib><creatorcontrib>Flores-Suarez, Luis</creatorcontrib><creatorcontrib>Cardiel, Mario H</creatorcontrib><creatorcontrib>Wallace, Daniel</creatorcontrib><creatorcontrib>Martin, Richard</creatorcontrib><creatorcontrib>Phillips, Kristine</creatorcontrib><creatorcontrib>Kaine, Jeffrey L</creatorcontrib><creatorcontrib>Dong, Hua</creatorcontrib><creatorcontrib>Salinger, David</creatorcontrib><creatorcontrib>Stevens, Erin</creatorcontrib><creatorcontrib>Russell, Chris B</creatorcontrib><creatorcontrib>Chung, James B</creatorcontrib><title>A phase Ib multiple ascending dose study evaluating safety, pharmacokinetics, and early clinical response of brodalumab, a human anti-IL-17R antibody, in methotrexate-resistant rheumatoid arthritis</title><title>Arthritis research & therapy</title><addtitle>Arthritis Res Ther</addtitle><description>The aim of this study was to evaluate the safety, pharmacokinetics, and clinical response of brodalumab (AMG 827), a human, anti-IL-17 receptor A (IL-17RA) monoclonal antibody in subjects with moderate-to-severe rheumatoid arthritis (RA).
This phase Ib, randomized, placebo-controlled, double-blind multiple ascending dose study enrolled subjects with moderate to severe RA (≥ 6/66 swollen and ≥ 8/68 tender joints). Subjects were randomized 3:1 to receive brodalumab (50 mg, 140 mg, or 210 mg subcutaneously every two weeks for 6 doses per group; or 420 mg or 700 mg intravenously every 4 weeks for two doses per group) or placebo. Endpoints included incidence of adverse events (AEs) and pharmacokinetics. Exploratory endpoints included pharmacodynamics, and improvements in RA clinical metrics.
Forty subjects were randomized to investigational product; one subject discontinued due to worsening of RA (placebo). The study was not designed to assess efficacy. AEs were reported by 70% (7/10) of placebo subjects and 77% (22/30) of brodalumab subjects. Three serious AEs were reported in two subjects; there were no opportunistic infections. Brodalumab treatment resulted in inhibition of IL-17 receptor signaling and receptor occupancy on circulating leukocytes. No treatment effects were observed with individual measures of RA disease activity. On day 85 (week 13) 37% (11/30) of brodalumab subjects and 22% (2/9) of placebo subjects achieved ACR20; 7% (2/30) brodalumab subjects and 11% (1/9) of placebo subjects achieved ACR50; and 0% (0/30) brodalumab subjects and 0% (0/9) of placebo subjects achieved ACR70.
Multiple dose administration of brodalumab was tolerated in subjects with active RA. There was no evidence of a clinical response to brodalumab in subjects with RA.
ClinicalTrials.gov, NCT00771030.</description><subject>Abdominal Pain - chemically induced</subject><subject>Adult</subject><subject>Aged</subject><subject>Antibodies</subject><subject>Antibodies, Monoclonal - adverse effects</subject><subject>Antibodies, Monoclonal - pharmacokinetics</subject><subject>Antibodies, Monoclonal - therapeutic use</subject><subject>Antibodies, Monoclonal, Humanized</subject><subject>Antirheumatic Agents - therapeutic use</subject><subject>Area Under Curve</subject><subject>Arthritis, Rheumatoid - drug therapy</subject><subject>Arthritis, Rheumatoid - immunology</subject><subject>Arthritis, Rheumatoid - metabolism</subject><subject>B cells</subject><subject>Care and treatment</subject><subject>Cough - chemically induced</subject><subject>Diagnosis</subject><subject>Dose-Response Relationship, Drug</subject><subject>Double-Blind Method</subject><subject>Drug Administration Schedule</subject><subject>Drug Resistance</subject><subject>Drug therapy</subject><subject>Female</subject><subject>Headache - chemically induced</subject><subject>Health aspects</subject><subject>Humans</subject><subject>Injections, Subcutaneous</subject><subject>Male</subject><subject>Metabolic Clearance Rate</subject><subject>Methotrexate - therapeutic use</subject><subject>Middle Aged</subject><subject>Pharmacokinetics</subject><subject>Receptors, Interleukin-17 - antagonists & inhibitors</subject><subject>Receptors, Interleukin-17 - immunology</subject><subject>Rheumatoid arthritis</subject><subject>Safety and security measures</subject><subject>Treatment Outcome</subject><subject>Viral antibodies</subject><issn>1478-6354</issn><issn>1478-6362</issn><issn>1478-6354</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2013</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNptkm-L1DAQxoso3nnqR5CA4Kvr2SZp2rwRlsM_CwuC6OsyTabbaJssSfa4_YB-L2ddXTyQvMgw8zw_ZpIpipd1dVPXnXoLUQrZPioua9l2pRKKPz7HjbwonqX0vao411w-LS645J2qhbosfq7YboKEbD2wZT9nt5uRQTLorfNbZgOVUt7bA8M7mPeQj9kEI-bD9dEZFzDhh_OYnUnXDLxlCHE-MDM77wzMLGLaBU-YMLIhBkuUBQaSsokCT5bsyvWmrNsvv-MhWEI7zxbMU8gR7yFjSRSXMtVZnJB8OTjLIOYpuuzS8-LJCHPCF3_uq-Lbh_dfbz-Vm88f17erTWmk1rnEWlqreSca6GwHWunOCGWrtlF8kAiSczEoqRttKytNY6TRI-VQyQZla8RV8e7E3e2HBS29Uo4w97voFoiHPoDrH1a8m_ptuOuFbnXNGwK8PgG2MGPv_EgDgllcMv2qoQ_sBClJdfMfFR2LizPB4-go_8Dw5mQwMaQUcTy3VFf9cT_6036Q8NW_A5xlfxdC_AIP4rm1</recordid><startdate>20131025</startdate><enddate>20131025</enddate><creator>Martin, David A</creator><creator>Churchill, Melvin</creator><creator>Flores-Suarez, Luis</creator><creator>Cardiel, Mario H</creator><creator>Wallace, Daniel</creator><creator>Martin, Richard</creator><creator>Phillips, Kristine</creator><creator>Kaine, Jeffrey L</creator><creator>Dong, Hua</creator><creator>Salinger, David</creator><creator>Stevens, Erin</creator><creator>Russell, Chris B</creator><creator>Chung, James B</creator><general>BioMed Central Ltd</general><general>BioMed Central</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>5PM</scope></search><sort><creationdate>20131025</creationdate><title>A phase Ib multiple ascending dose study evaluating safety, pharmacokinetics, and early clinical response of brodalumab, a human anti-IL-17R antibody, in methotrexate-resistant rheumatoid arthritis</title><author>Martin, David A ; Churchill, Melvin ; Flores-Suarez, Luis ; Cardiel, Mario H ; Wallace, Daniel ; Martin, Richard ; Phillips, Kristine ; Kaine, Jeffrey L ; Dong, Hua ; Salinger, David ; Stevens, Erin ; Russell, Chris B ; Chung, James B</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c499t-e14dd92835a8d8a9698c36d07562b4ea4223b64959d0d4c5c4c9f223e645e47c3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2013</creationdate><topic>Abdominal Pain - chemically induced</topic><topic>Adult</topic><topic>Aged</topic><topic>Antibodies</topic><topic>Antibodies, Monoclonal - adverse effects</topic><topic>Antibodies, Monoclonal - pharmacokinetics</topic><topic>Antibodies, Monoclonal - therapeutic use</topic><topic>Antibodies, Monoclonal, Humanized</topic><topic>Antirheumatic Agents - therapeutic use</topic><topic>Area Under Curve</topic><topic>Arthritis, Rheumatoid - drug therapy</topic><topic>Arthritis, Rheumatoid - immunology</topic><topic>Arthritis, Rheumatoid - metabolism</topic><topic>B cells</topic><topic>Care and treatment</topic><topic>Cough - chemically induced</topic><topic>Diagnosis</topic><topic>Dose-Response Relationship, Drug</topic><topic>Double-Blind Method</topic><topic>Drug Administration Schedule</topic><topic>Drug Resistance</topic><topic>Drug therapy</topic><topic>Female</topic><topic>Headache - chemically induced</topic><topic>Health aspects</topic><topic>Humans</topic><topic>Injections, Subcutaneous</topic><topic>Male</topic><topic>Metabolic Clearance Rate</topic><topic>Methotrexate - therapeutic use</topic><topic>Middle Aged</topic><topic>Pharmacokinetics</topic><topic>Receptors, Interleukin-17 - antagonists & inhibitors</topic><topic>Receptors, Interleukin-17 - immunology</topic><topic>Rheumatoid arthritis</topic><topic>Safety and security measures</topic><topic>Treatment Outcome</topic><topic>Viral antibodies</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Martin, David A</creatorcontrib><creatorcontrib>Churchill, Melvin</creatorcontrib><creatorcontrib>Flores-Suarez, Luis</creatorcontrib><creatorcontrib>Cardiel, Mario H</creatorcontrib><creatorcontrib>Wallace, Daniel</creatorcontrib><creatorcontrib>Martin, Richard</creatorcontrib><creatorcontrib>Phillips, Kristine</creatorcontrib><creatorcontrib>Kaine, Jeffrey L</creatorcontrib><creatorcontrib>Dong, Hua</creatorcontrib><creatorcontrib>Salinger, David</creatorcontrib><creatorcontrib>Stevens, Erin</creatorcontrib><creatorcontrib>Russell, Chris B</creatorcontrib><creatorcontrib>Chung, James B</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Arthritis research & therapy</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Martin, David A</au><au>Churchill, Melvin</au><au>Flores-Suarez, Luis</au><au>Cardiel, Mario H</au><au>Wallace, Daniel</au><au>Martin, Richard</au><au>Phillips, Kristine</au><au>Kaine, Jeffrey L</au><au>Dong, Hua</au><au>Salinger, David</au><au>Stevens, Erin</au><au>Russell, Chris B</au><au>Chung, James B</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>A phase Ib multiple ascending dose study evaluating safety, pharmacokinetics, and early clinical response of brodalumab, a human anti-IL-17R antibody, in methotrexate-resistant rheumatoid arthritis</atitle><jtitle>Arthritis research & therapy</jtitle><addtitle>Arthritis Res Ther</addtitle><date>2013-10-25</date><risdate>2013</risdate><volume>15</volume><issue>5</issue><spage>R164</spage><epage>R164</epage><pages>R164-R164</pages><artnum>R164</artnum><issn>1478-6354</issn><eissn>1478-6362</eissn><eissn>1478-6354</eissn><abstract>The aim of this study was to evaluate the safety, pharmacokinetics, and clinical response of brodalumab (AMG 827), a human, anti-IL-17 receptor A (IL-17RA) monoclonal antibody in subjects with moderate-to-severe rheumatoid arthritis (RA).
This phase Ib, randomized, placebo-controlled, double-blind multiple ascending dose study enrolled subjects with moderate to severe RA (≥ 6/66 swollen and ≥ 8/68 tender joints). Subjects were randomized 3:1 to receive brodalumab (50 mg, 140 mg, or 210 mg subcutaneously every two weeks for 6 doses per group; or 420 mg or 700 mg intravenously every 4 weeks for two doses per group) or placebo. Endpoints included incidence of adverse events (AEs) and pharmacokinetics. Exploratory endpoints included pharmacodynamics, and improvements in RA clinical metrics.
Forty subjects were randomized to investigational product; one subject discontinued due to worsening of RA (placebo). The study was not designed to assess efficacy. AEs were reported by 70% (7/10) of placebo subjects and 77% (22/30) of brodalumab subjects. Three serious AEs were reported in two subjects; there were no opportunistic infections. Brodalumab treatment resulted in inhibition of IL-17 receptor signaling and receptor occupancy on circulating leukocytes. No treatment effects were observed with individual measures of RA disease activity. On day 85 (week 13) 37% (11/30) of brodalumab subjects and 22% (2/9) of placebo subjects achieved ACR20; 7% (2/30) brodalumab subjects and 11% (1/9) of placebo subjects achieved ACR50; and 0% (0/30) brodalumab subjects and 0% (0/9) of placebo subjects achieved ACR70.
Multiple dose administration of brodalumab was tolerated in subjects with active RA. There was no evidence of a clinical response to brodalumab in subjects with RA.
ClinicalTrials.gov, NCT00771030.</abstract><cop>England</cop><pub>BioMed Central Ltd</pub><pmid>24286136</pmid><doi>10.1186/ar4347</doi><oa>free_for_read</oa></addata></record> |
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subjects | Abdominal Pain - chemically induced Adult Aged Antibodies Antibodies, Monoclonal - adverse effects Antibodies, Monoclonal - pharmacokinetics Antibodies, Monoclonal - therapeutic use Antibodies, Monoclonal, Humanized Antirheumatic Agents - therapeutic use Area Under Curve Arthritis, Rheumatoid - drug therapy Arthritis, Rheumatoid - immunology Arthritis, Rheumatoid - metabolism B cells Care and treatment Cough - chemically induced Diagnosis Dose-Response Relationship, Drug Double-Blind Method Drug Administration Schedule Drug Resistance Drug therapy Female Headache - chemically induced Health aspects Humans Injections, Subcutaneous Male Metabolic Clearance Rate Methotrexate - therapeutic use Middle Aged Pharmacokinetics Receptors, Interleukin-17 - antagonists & inhibitors Receptors, Interleukin-17 - immunology Rheumatoid arthritis Safety and security measures Treatment Outcome Viral antibodies |
title | A phase Ib multiple ascending dose study evaluating safety, pharmacokinetics, and early clinical response of brodalumab, a human anti-IL-17R antibody, in methotrexate-resistant rheumatoid arthritis |
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