A Phase IIb Study of ABT‐494, a Selective JAK‐1 Inhibitor, in Patients With Rheumatoid Arthritis and an Inadequate Response to Anti–Tumor Necrosis Factor Therapy
Objective To compare the efficacy and safety of ABT‐494, a novel selective JAK‐1 inhibitor, with placebo in patients with moderate‐to‐severe rheumatoid arthritis (RA) and an inadequate response or intolerance to at least 1 anti–tumor necrosis factor (anti‐TNF) agent. Methods In this 12‐week, double‐...
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| Veröffentlicht in: | Arthritis & rheumatology (Hoboken, N.J.) N.J.), 2016-12, Vol.68 (12), p.2867-2877 |
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| container_title | Arthritis & rheumatology (Hoboken, N.J.) |
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| creator | Kremer, Joel M. Emery, Paul Camp, Heidi S. Friedman, Alan Wang, Li Othman, Ahmed A. Khan, Nasser Pangan, Aileen L. Jungerwirth, Steven Keystone, Edward C. |
| description | Objective
To compare the efficacy and safety of ABT‐494, a novel selective JAK‐1 inhibitor, with placebo in patients with moderate‐to‐severe rheumatoid arthritis (RA) and an inadequate response or intolerance to at least 1 anti–tumor necrosis factor (anti‐TNF) agent.
Methods
In this 12‐week, double‐blind, placebo‐controlled, dose‐ranging study, 276 RA patients receiving a stable dose of methotrexate (MTX) who had previously received treatment with at least 1 anti‐TNF agent were randomized equally to receive immediate‐release ABT‐494 at 3, 6, 12, or 18 mg twice daily or matching placebo twice daily. The primary end point was the proportion of patients meeting the American College of Rheumatology 20% improvement criteria (achieving an ACR20 response) at week 12.
Results
At week 12, significantly more patients receiving ABT‐494 (53–71%) than those receiving placebo (34%) achieved an ACR20 response (by nonresponder imputation analysis) (P |
| doi_str_mv | 10.1002/art.39801 |
| format | Article |
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To compare the efficacy and safety of ABT‐494, a novel selective JAK‐1 inhibitor, with placebo in patients with moderate‐to‐severe rheumatoid arthritis (RA) and an inadequate response or intolerance to at least 1 anti–tumor necrosis factor (anti‐TNF) agent.
Methods
In this 12‐week, double‐blind, placebo‐controlled, dose‐ranging study, 276 RA patients receiving a stable dose of methotrexate (MTX) who had previously received treatment with at least 1 anti‐TNF agent were randomized equally to receive immediate‐release ABT‐494 at 3, 6, 12, or 18 mg twice daily or matching placebo twice daily. The primary end point was the proportion of patients meeting the American College of Rheumatology 20% improvement criteria (achieving an ACR20 response) at week 12.
Results
At week 12, significantly more patients receiving ABT‐494 (53–71%) than those receiving placebo (34%) achieved an ACR20 response (by nonresponder imputation analysis) (P < 0.05), with a dose‐response relationship among all ABT‐494 doses (P < 0.001). ACR50 and ACR70 response rates were significantly higher in those receiving ABT‐494 (36–42% and 22–26%, respectively) than in those receiving placebo (16% and 4%, respectively). Changes from baseline in the Disease Activity Score in 28 joints using the C‐reactive protein level (DAS28‐CRP) were significantly greater for all doses of ABT‐494 than for placebo (P ≤ 0.01). Onset of action of ABT‐494 was rapid, with significant differences from placebo at week 2 both in ACR20 response rate (for 12 and 18 mg) and in change in the DAS28‐CRP (P < 0.001 for 6–18 mg). The most frequent adverse events (AEs) were headache, nausea, upper respiratory tract infection, and urinary tract infection. Infection rates were higher at higher doses of ABT‐494, but no infections were serious. No deaths were reported among those receiving ABT‐494.
Conclusion
In patients with an inadequate response or intolerance to anti‐TNF agents, ABT‐494 added to MTX showed rapid, dose‐dependent improvements in RA signs and symptoms, with safety and tolerability similar to those of other drugs of this class. No new AEs were identified.</description><identifier>ISSN: 2326-5191</identifier><identifier>EISSN: 2326-5205</identifier><identifier>DOI: 10.1002/art.39801</identifier><identifier>PMID: 27389975</identifier><language>eng</language><publisher>United States: Wiley Subscription Services, Inc</publisher><subject>Adult ; Aged ; Antirheumatic Agents - therapeutic use ; Arthritis, Rheumatoid - drug therapy ; Arthritis, Rheumatoid - immunology ; Arthritis, Rheumatoid - physiopathology ; C-Reactive Protein - immunology ; Dose-Response Relationship, Drug ; Double-Blind Method ; Drug Therapy, Combination ; Female ; Gangrene ; Headache - chemically induced ; Heterocyclic Compounds, 3-Ring - administration & dosage ; Heterocyclic Compounds, 3-Ring - adverse effects ; Humans ; Infections ; Janus Kinase 1 - antagonists & inhibitors ; Male ; Methotrexate - therapeutic use ; Middle Aged ; Nausea - chemically induced ; Pharmaceutical industry ; Protein Kinase Inhibitors - administration & dosage ; Protein Kinase Inhibitors - adverse effects ; Respiratory Tract Infections - chemically induced ; Rheumatoid Arthritis ; Treatment Failure ; Treatment Outcome ; Tumor Necrosis Factor-alpha - antagonists & inhibitors ; Tumor necrosis factor-TNF ; Urinary Tract Infections - chemically induced</subject><ispartof>Arthritis & rheumatology (Hoboken, N.J.), 2016-12, Vol.68 (12), p.2867-2877</ispartof><rights>2016 The Authors. Arthritis & Rheumatology published by Wiley Periodicals, Inc. on behalf of the American College of Rheumatology.</rights><rights>2016, American College of Rheumatology</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4761-ee1516c948e375acd1ca279ae53a8e1cce2e9df861cddcd2f77385fdf9adc3e93</citedby><cites>FETCH-LOGICAL-c4761-ee1516c948e375acd1ca279ae53a8e1cce2e9df861cddcd2f77385fdf9adc3e93</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1002%2Fart.39801$$EPDF$$P50$$Gwiley$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1002%2Fart.39801$$EHTML$$P50$$Gwiley$$Hfree_for_read</linktohtml><link.rule.ids>230,314,776,780,881,1411,27901,27902,45550,45551</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/27389975$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Kremer, Joel M.</creatorcontrib><creatorcontrib>Emery, Paul</creatorcontrib><creatorcontrib>Camp, Heidi S.</creatorcontrib><creatorcontrib>Friedman, Alan</creatorcontrib><creatorcontrib>Wang, Li</creatorcontrib><creatorcontrib>Othman, Ahmed A.</creatorcontrib><creatorcontrib>Khan, Nasser</creatorcontrib><creatorcontrib>Pangan, Aileen L.</creatorcontrib><creatorcontrib>Jungerwirth, Steven</creatorcontrib><creatorcontrib>Keystone, Edward C.</creatorcontrib><title>A Phase IIb Study of ABT‐494, a Selective JAK‐1 Inhibitor, in Patients With Rheumatoid Arthritis and an Inadequate Response to Anti–Tumor Necrosis Factor Therapy</title><title>Arthritis & rheumatology (Hoboken, N.J.)</title><addtitle>Arthritis Rheumatol</addtitle><description>Objective
To compare the efficacy and safety of ABT‐494, a novel selective JAK‐1 inhibitor, with placebo in patients with moderate‐to‐severe rheumatoid arthritis (RA) and an inadequate response or intolerance to at least 1 anti–tumor necrosis factor (anti‐TNF) agent.
Methods
In this 12‐week, double‐blind, placebo‐controlled, dose‐ranging study, 276 RA patients receiving a stable dose of methotrexate (MTX) who had previously received treatment with at least 1 anti‐TNF agent were randomized equally to receive immediate‐release ABT‐494 at 3, 6, 12, or 18 mg twice daily or matching placebo twice daily. The primary end point was the proportion of patients meeting the American College of Rheumatology 20% improvement criteria (achieving an ACR20 response) at week 12.
Results
At week 12, significantly more patients receiving ABT‐494 (53–71%) than those receiving placebo (34%) achieved an ACR20 response (by nonresponder imputation analysis) (P < 0.05), with a dose‐response relationship among all ABT‐494 doses (P < 0.001). ACR50 and ACR70 response rates were significantly higher in those receiving ABT‐494 (36–42% and 22–26%, respectively) than in those receiving placebo (16% and 4%, respectively). Changes from baseline in the Disease Activity Score in 28 joints using the C‐reactive protein level (DAS28‐CRP) were significantly greater for all doses of ABT‐494 than for placebo (P ≤ 0.01). Onset of action of ABT‐494 was rapid, with significant differences from placebo at week 2 both in ACR20 response rate (for 12 and 18 mg) and in change in the DAS28‐CRP (P < 0.001 for 6–18 mg). The most frequent adverse events (AEs) were headache, nausea, upper respiratory tract infection, and urinary tract infection. Infection rates were higher at higher doses of ABT‐494, but no infections were serious. No deaths were reported among those receiving ABT‐494.
Conclusion
In patients with an inadequate response or intolerance to anti‐TNF agents, ABT‐494 added to MTX showed rapid, dose‐dependent improvements in RA signs and symptoms, with safety and tolerability similar to those of other drugs of this class. No new AEs were identified.</description><subject>Adult</subject><subject>Aged</subject><subject>Antirheumatic Agents - therapeutic use</subject><subject>Arthritis, Rheumatoid - drug therapy</subject><subject>Arthritis, Rheumatoid - immunology</subject><subject>Arthritis, Rheumatoid - physiopathology</subject><subject>C-Reactive Protein - immunology</subject><subject>Dose-Response Relationship, Drug</subject><subject>Double-Blind Method</subject><subject>Drug Therapy, Combination</subject><subject>Female</subject><subject>Gangrene</subject><subject>Headache - chemically induced</subject><subject>Heterocyclic Compounds, 3-Ring - administration & dosage</subject><subject>Heterocyclic Compounds, 3-Ring - adverse effects</subject><subject>Humans</subject><subject>Infections</subject><subject>Janus Kinase 1 - antagonists & inhibitors</subject><subject>Male</subject><subject>Methotrexate - therapeutic use</subject><subject>Middle Aged</subject><subject>Nausea - chemically induced</subject><subject>Pharmaceutical industry</subject><subject>Protein Kinase Inhibitors - administration & dosage</subject><subject>Protein Kinase Inhibitors - adverse effects</subject><subject>Respiratory Tract Infections - chemically induced</subject><subject>Rheumatoid Arthritis</subject><subject>Treatment Failure</subject><subject>Treatment Outcome</subject><subject>Tumor Necrosis Factor-alpha - antagonists & inhibitors</subject><subject>Tumor necrosis factor-TNF</subject><subject>Urinary Tract Infections - chemically induced</subject><issn>2326-5191</issn><issn>2326-5205</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2016</creationdate><recordtype>article</recordtype><sourceid>24P</sourceid><sourceid>EIF</sourceid><recordid>eNqNkt9qFDEUxgdRbKm98AUk4I1Ct51k_mRyI0yL1dWiZTviZTibnHFSZibbJFPZuz6C4EP4Xn0SU7ctKggGQkLyO9_JOfmS5ClN92masgNwYT8TVUofJNssY-WsYGnx8G5PBd1Kdr0_T-MQPC3T4nGyxXhWCcGL7eRHTU478Ejm8yU5C5NeE9uS-rC5vvqWi3yPADnDHlUwl0je1e_jMSXzsTNLE6zbI2YkpxAMjsGTzyZ0ZNHhNECwRpPahc6ZYDyBUccZ40DjxQQByQL9yo4xb7CkHoO5vvreTIN15AMqZ32MOQYVM5CmQwer9ZPkUQu9x93bdSf5dPy6OXo7O_n4Zn5Un8xUzks6Q6QFLZXIK8x4AUpTBYwLwCKDCqlSyFDotiqp0lpp1vLYiaLVrQCtMhTZTvJqo7ualgNqFQtz0MuVMwO4tbRg5J83o-nkF3spC5oxSsso8OJWwNmLCX2Qg_EK-x5GtJOXtCqrLE95zv8DZSVnNH5aRJ__hZ7byY2xE5HKc55X8Xcj9XJD3bTQO2zv301TeWMWGc0if5klss9-L_SevLNGBA42wFfT4_rfSrJeNBvJnwRAzJY</recordid><startdate>201612</startdate><enddate>201612</enddate><creator>Kremer, Joel M.</creator><creator>Emery, Paul</creator><creator>Camp, Heidi S.</creator><creator>Friedman, Alan</creator><creator>Wang, Li</creator><creator>Othman, Ahmed A.</creator><creator>Khan, Nasser</creator><creator>Pangan, Aileen L.</creator><creator>Jungerwirth, Steven</creator><creator>Keystone, Edward C.</creator><general>Wiley Subscription Services, Inc</general><general>John Wiley and Sons Inc</general><scope>24P</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>7QL</scope><scope>7QP</scope><scope>7T5</scope><scope>7TM</scope><scope>7U7</scope><scope>C1K</scope><scope>H94</scope><scope>K9.</scope><scope>7X8</scope><scope>5PM</scope></search><sort><creationdate>201612</creationdate><title>A Phase IIb Study of ABT‐494, a Selective JAK‐1 Inhibitor, in Patients With Rheumatoid Arthritis and an Inadequate Response to Anti–Tumor Necrosis Factor Therapy</title><author>Kremer, Joel M. ; Emery, Paul ; Camp, Heidi S. ; Friedman, Alan ; Wang, Li ; Othman, Ahmed A. ; Khan, Nasser ; Pangan, Aileen L. ; Jungerwirth, Steven ; Keystone, Edward C.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4761-ee1516c948e375acd1ca279ae53a8e1cce2e9df861cddcd2f77385fdf9adc3e93</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2016</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Antirheumatic Agents - therapeutic use</topic><topic>Arthritis, Rheumatoid - drug therapy</topic><topic>Arthritis, Rheumatoid - immunology</topic><topic>Arthritis, Rheumatoid - physiopathology</topic><topic>C-Reactive Protein - immunology</topic><topic>Dose-Response Relationship, Drug</topic><topic>Double-Blind Method</topic><topic>Drug Therapy, Combination</topic><topic>Female</topic><topic>Gangrene</topic><topic>Headache - chemically induced</topic><topic>Heterocyclic Compounds, 3-Ring - administration & dosage</topic><topic>Heterocyclic Compounds, 3-Ring - adverse effects</topic><topic>Humans</topic><topic>Infections</topic><topic>Janus Kinase 1 - antagonists & inhibitors</topic><topic>Male</topic><topic>Methotrexate - therapeutic use</topic><topic>Middle Aged</topic><topic>Nausea - chemically induced</topic><topic>Pharmaceutical industry</topic><topic>Protein Kinase Inhibitors - administration & dosage</topic><topic>Protein Kinase Inhibitors - adverse effects</topic><topic>Respiratory Tract Infections - chemically induced</topic><topic>Rheumatoid Arthritis</topic><topic>Treatment Failure</topic><topic>Treatment Outcome</topic><topic>Tumor Necrosis Factor-alpha - antagonists & inhibitors</topic><topic>Tumor necrosis factor-TNF</topic><topic>Urinary Tract Infections - chemically induced</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Kremer, Joel M.</creatorcontrib><creatorcontrib>Emery, Paul</creatorcontrib><creatorcontrib>Camp, Heidi S.</creatorcontrib><creatorcontrib>Friedman, Alan</creatorcontrib><creatorcontrib>Wang, Li</creatorcontrib><creatorcontrib>Othman, Ahmed A.</creatorcontrib><creatorcontrib>Khan, Nasser</creatorcontrib><creatorcontrib>Pangan, Aileen L.</creatorcontrib><creatorcontrib>Jungerwirth, Steven</creatorcontrib><creatorcontrib>Keystone, Edward C.</creatorcontrib><collection>Wiley Online Library Open Access</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Bacteriology Abstracts (Microbiology B)</collection><collection>Calcium & Calcified Tissue Abstracts</collection><collection>Immunology Abstracts</collection><collection>Nucleic Acids Abstracts</collection><collection>Toxicology Abstracts</collection><collection>Environmental Sciences and Pollution Management</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Arthritis & rheumatology (Hoboken, N.J.)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Kremer, Joel M.</au><au>Emery, Paul</au><au>Camp, Heidi S.</au><au>Friedman, Alan</au><au>Wang, Li</au><au>Othman, Ahmed A.</au><au>Khan, Nasser</au><au>Pangan, Aileen L.</au><au>Jungerwirth, Steven</au><au>Keystone, Edward C.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>A Phase IIb Study of ABT‐494, a Selective JAK‐1 Inhibitor, in Patients With Rheumatoid Arthritis and an Inadequate Response to Anti–Tumor Necrosis Factor Therapy</atitle><jtitle>Arthritis & rheumatology (Hoboken, N.J.)</jtitle><addtitle>Arthritis Rheumatol</addtitle><date>2016-12</date><risdate>2016</risdate><volume>68</volume><issue>12</issue><spage>2867</spage><epage>2877</epage><pages>2867-2877</pages><issn>2326-5191</issn><eissn>2326-5205</eissn><abstract>Objective
To compare the efficacy and safety of ABT‐494, a novel selective JAK‐1 inhibitor, with placebo in patients with moderate‐to‐severe rheumatoid arthritis (RA) and an inadequate response or intolerance to at least 1 anti–tumor necrosis factor (anti‐TNF) agent.
Methods
In this 12‐week, double‐blind, placebo‐controlled, dose‐ranging study, 276 RA patients receiving a stable dose of methotrexate (MTX) who had previously received treatment with at least 1 anti‐TNF agent were randomized equally to receive immediate‐release ABT‐494 at 3, 6, 12, or 18 mg twice daily or matching placebo twice daily. The primary end point was the proportion of patients meeting the American College of Rheumatology 20% improvement criteria (achieving an ACR20 response) at week 12.
Results
At week 12, significantly more patients receiving ABT‐494 (53–71%) than those receiving placebo (34%) achieved an ACR20 response (by nonresponder imputation analysis) (P < 0.05), with a dose‐response relationship among all ABT‐494 doses (P < 0.001). ACR50 and ACR70 response rates were significantly higher in those receiving ABT‐494 (36–42% and 22–26%, respectively) than in those receiving placebo (16% and 4%, respectively). Changes from baseline in the Disease Activity Score in 28 joints using the C‐reactive protein level (DAS28‐CRP) were significantly greater for all doses of ABT‐494 than for placebo (P ≤ 0.01). Onset of action of ABT‐494 was rapid, with significant differences from placebo at week 2 both in ACR20 response rate (for 12 and 18 mg) and in change in the DAS28‐CRP (P < 0.001 for 6–18 mg). The most frequent adverse events (AEs) were headache, nausea, upper respiratory tract infection, and urinary tract infection. Infection rates were higher at higher doses of ABT‐494, but no infections were serious. No deaths were reported among those receiving ABT‐494.
Conclusion
In patients with an inadequate response or intolerance to anti‐TNF agents, ABT‐494 added to MTX showed rapid, dose‐dependent improvements in RA signs and symptoms, with safety and tolerability similar to those of other drugs of this class. No new AEs were identified.</abstract><cop>United States</cop><pub>Wiley Subscription Services, Inc</pub><pmid>27389975</pmid><doi>10.1002/art.39801</doi><tpages>11</tpages><oa>free_for_read</oa></addata></record> |
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| ispartof | Arthritis & rheumatology (Hoboken, N.J.), 2016-12, Vol.68 (12), p.2867-2877 |
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| language | eng |
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| source | MEDLINE; Wiley Online Library Journals Frontfile Complete; Alma/SFX Local Collection |
| subjects | Adult Aged Antirheumatic Agents - therapeutic use Arthritis, Rheumatoid - drug therapy Arthritis, Rheumatoid - immunology Arthritis, Rheumatoid - physiopathology C-Reactive Protein - immunology Dose-Response Relationship, Drug Double-Blind Method Drug Therapy, Combination Female Gangrene Headache - chemically induced Heterocyclic Compounds, 3-Ring - administration & dosage Heterocyclic Compounds, 3-Ring - adverse effects Humans Infections Janus Kinase 1 - antagonists & inhibitors Male Methotrexate - therapeutic use Middle Aged Nausea - chemically induced Pharmaceutical industry Protein Kinase Inhibitors - administration & dosage Protein Kinase Inhibitors - adverse effects Respiratory Tract Infections - chemically induced Rheumatoid Arthritis Treatment Failure Treatment Outcome Tumor Necrosis Factor-alpha - antagonists & inhibitors Tumor necrosis factor-TNF Urinary Tract Infections - chemically induced |
| title | A Phase IIb Study of ABT‐494, a Selective JAK‐1 Inhibitor, in Patients With Rheumatoid Arthritis and an Inadequate Response to Anti–Tumor Necrosis Factor Therapy |
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