Effects of the oral Janus kinase inhibitor tofacitinib on patient-reported outcomes in patients with active rheumatoid arthritis: results of two Phase 2 randomised controlled trials
Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). Here we investigated the effects of tofacitinib on patient-reported outcomes (PRO) in patients with active RA. Two, 6-month, double-blind, placebo-controlled Phase 2b studies were performed. The combination...
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| Veröffentlicht in: | Clinical and experimental rheumatology 2016-05, Vol.34 (3), p.430-442 |
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| creator | Wallenstein, Gene V Kanik, Keith S Wilkinson, Bethanie Cohen, Stanley Cutolo, Maurizio Fleischmann, Roy Genovese, Mark C Gomez Reino, Juan Gruben, David Kremer, Joel Krishnaswami, Sriram Lee, Eun Bong Pascual-Ramos, Virginia Strand, Vibeke Zwillich, Samuel H |
| description | Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). Here we investigated the effects of tofacitinib on patient-reported outcomes (PRO) in patients with active RA.
Two, 6-month, double-blind, placebo-controlled Phase 2b studies were performed. The combination study evaluated patients with inadequate response to methotrexate who received tofacitinib 1-15 mg twice daily (BID), 20 mg once daily or placebo, on background methotrexate. In the monotherapy study, patients with inadequate response to disease-modifying anti-rheumatic drugs received tofacitinib 1-15 mg BID, adalimumab 40 mg once every other week or placebo. PROs measured were: Patient's Assessment of Arthritis Pain (PAAP), Patient's Assessment of Disease Activity, HAQ-DI, FACIT-F and SF-36.
In the combination study (n=507), significant improvements (p |
| format | Article |
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Two, 6-month, double-blind, placebo-controlled Phase 2b studies were performed. The combination study evaluated patients with inadequate response to methotrexate who received tofacitinib 1-15 mg twice daily (BID), 20 mg once daily or placebo, on background methotrexate. In the monotherapy study, patients with inadequate response to disease-modifying anti-rheumatic drugs received tofacitinib 1-15 mg BID, adalimumab 40 mg once every other week or placebo. PROs measured were: Patient's Assessment of Arthritis Pain (PAAP), Patient's Assessment of Disease Activity, HAQ-DI, FACIT-F and SF-36.
In the combination study (n=507), significant improvements (p<0.05) versus placebo were observed at Week 12 in PAAP (visual analogue scale) and HAQ-DI for all tofacitinib groups. In the monotherapy study (n=384), significant improvements in PAAP were observed at Week 12 for tofacitinib 5, 10 and 15 mg BID, and in HAQ-DI for tofacitinib 3, 5, 10 and 15 mg BID. Significant improvements versus placebo were seen at Week 2 in PAAP (both studies) and HAQ‑DI (monotherapy study) with tofacitinib, and were maintained throughout each study. In both studies, improvements in several domains of the SF-36 in the tofacitinib groups were observed at Weeks 12 and 24.
In patients with active RA, tofacitinib, either in combination with methotrexate or as monotherapy, demonstrated rapid and sustained improvement in pain, physical functioning and health-related quality of life.</description><identifier>ISSN: 0392-856X</identifier><identifier>PMID: 27156561</identifier><language>eng</language><publisher>Italy</publisher><subject>Adult ; Aged ; Antirheumatic Agents - administration & dosage ; Antirheumatic Agents - adverse effects ; Arthralgia - drug therapy ; Arthralgia - physiopathology ; Arthralgia - psychology ; Arthritis, Rheumatoid - diagnosis ; Arthritis, Rheumatoid - drug therapy ; Arthritis, Rheumatoid - immunology ; Arthritis, Rheumatoid - physiopathology ; Disease Resistance ; Drug Administration Schedule ; Drug Monitoring ; Female ; Humans ; Janus Kinases - antagonists & inhibitors ; Male ; Middle Aged ; Pain Measurement - methods ; Piperidines - administration & dosage ; Piperidines - adverse effects ; Pyrimidines - administration & dosage ; Pyrimidines - adverse effects ; Pyrroles - administration & dosage ; Pyrroles - adverse effects ; Quality of Life ; Treatment Outcome</subject><ispartof>Clinical and experimental rheumatology, 2016-05, Vol.34 (3), p.430-442</ispartof><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/27156561$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Wallenstein, Gene V</creatorcontrib><creatorcontrib>Kanik, Keith S</creatorcontrib><creatorcontrib>Wilkinson, Bethanie</creatorcontrib><creatorcontrib>Cohen, Stanley</creatorcontrib><creatorcontrib>Cutolo, Maurizio</creatorcontrib><creatorcontrib>Fleischmann, Roy</creatorcontrib><creatorcontrib>Genovese, Mark C</creatorcontrib><creatorcontrib>Gomez Reino, Juan</creatorcontrib><creatorcontrib>Gruben, David</creatorcontrib><creatorcontrib>Kremer, Joel</creatorcontrib><creatorcontrib>Krishnaswami, Sriram</creatorcontrib><creatorcontrib>Lee, Eun Bong</creatorcontrib><creatorcontrib>Pascual-Ramos, Virginia</creatorcontrib><creatorcontrib>Strand, Vibeke</creatorcontrib><creatorcontrib>Zwillich, Samuel H</creatorcontrib><title>Effects of the oral Janus kinase inhibitor tofacitinib on patient-reported outcomes in patients with active rheumatoid arthritis: results of two Phase 2 randomised controlled trials</title><title>Clinical and experimental rheumatology</title><addtitle>Clin Exp Rheumatol</addtitle><description>Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). Here we investigated the effects of tofacitinib on patient-reported outcomes (PRO) in patients with active RA.
Two, 6-month, double-blind, placebo-controlled Phase 2b studies were performed. The combination study evaluated patients with inadequate response to methotrexate who received tofacitinib 1-15 mg twice daily (BID), 20 mg once daily or placebo, on background methotrexate. In the monotherapy study, patients with inadequate response to disease-modifying anti-rheumatic drugs received tofacitinib 1-15 mg BID, adalimumab 40 mg once every other week or placebo. PROs measured were: Patient's Assessment of Arthritis Pain (PAAP), Patient's Assessment of Disease Activity, HAQ-DI, FACIT-F and SF-36.
In the combination study (n=507), significant improvements (p<0.05) versus placebo were observed at Week 12 in PAAP (visual analogue scale) and HAQ-DI for all tofacitinib groups. In the monotherapy study (n=384), significant improvements in PAAP were observed at Week 12 for tofacitinib 5, 10 and 15 mg BID, and in HAQ-DI for tofacitinib 3, 5, 10 and 15 mg BID. Significant improvements versus placebo were seen at Week 2 in PAAP (both studies) and HAQ‑DI (monotherapy study) with tofacitinib, and were maintained throughout each study. In both studies, improvements in several domains of the SF-36 in the tofacitinib groups were observed at Weeks 12 and 24.
In patients with active RA, tofacitinib, either in combination with methotrexate or as monotherapy, demonstrated rapid and sustained improvement in pain, physical functioning and health-related quality of life.</description><subject>Adult</subject><subject>Aged</subject><subject>Antirheumatic Agents - administration & dosage</subject><subject>Antirheumatic Agents - adverse effects</subject><subject>Arthralgia - drug therapy</subject><subject>Arthralgia - physiopathology</subject><subject>Arthralgia - psychology</subject><subject>Arthritis, Rheumatoid - diagnosis</subject><subject>Arthritis, Rheumatoid - drug therapy</subject><subject>Arthritis, Rheumatoid - immunology</subject><subject>Arthritis, Rheumatoid - physiopathology</subject><subject>Disease Resistance</subject><subject>Drug Administration Schedule</subject><subject>Drug Monitoring</subject><subject>Female</subject><subject>Humans</subject><subject>Janus Kinases - antagonists & inhibitors</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Pain Measurement - methods</subject><subject>Piperidines - administration & dosage</subject><subject>Piperidines - adverse effects</subject><subject>Pyrimidines - administration & dosage</subject><subject>Pyrimidines - adverse effects</subject><subject>Pyrroles - administration & dosage</subject><subject>Pyrroles - adverse effects</subject><subject>Quality of Life</subject><subject>Treatment Outcome</subject><issn>0392-856X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2016</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNo1UMtOwzAQzAFES-EX0B65RMqjdmJuqCovVYIDSNwix94ohsQO9gbEh_F_GNFedkba2dnZPUqWWSmKtGb8dZGchvCWZQVnvDpJFkWVs0jzZfKz7TpUFMB1QD2C83KAB2nnAO_GyoBgbG9aQ84DuU4qQ8aaFpyFSZJBS6nHyXlCDW4m5UYMceTQDPBlqAepyHwi-B7nUZIzGqSn3kevcAUewzzsE3w5eOr_thbgpdVuNCEaK2fJu2GIlLyRQzhLjrsIeL7HVfJys33e3KW7x9v7zfUunYo6p1TWZd3mdSYyppExzVvRdRWvWKt4Ec_Xa9VxibzGdl2VsQiRyYKjyrVoVcbKVXL57zt59zFjoCYGUjgM0qKbQ5NXgtVMcF5G6cVeOrcj6mbyZpT-uzm8uvwFW1F_EQ</recordid><startdate>20160501</startdate><enddate>20160501</enddate><creator>Wallenstein, Gene V</creator><creator>Kanik, Keith S</creator><creator>Wilkinson, Bethanie</creator><creator>Cohen, Stanley</creator><creator>Cutolo, Maurizio</creator><creator>Fleischmann, Roy</creator><creator>Genovese, Mark C</creator><creator>Gomez Reino, Juan</creator><creator>Gruben, David</creator><creator>Kremer, Joel</creator><creator>Krishnaswami, Sriram</creator><creator>Lee, Eun Bong</creator><creator>Pascual-Ramos, Virginia</creator><creator>Strand, Vibeke</creator><creator>Zwillich, Samuel H</creator><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>7X8</scope></search><sort><creationdate>20160501</creationdate><title>Effects of the oral Janus kinase inhibitor tofacitinib on patient-reported outcomes in patients with active rheumatoid arthritis: results of two Phase 2 randomised controlled trials</title><author>Wallenstein, Gene V ; Kanik, Keith S ; Wilkinson, Bethanie ; Cohen, Stanley ; Cutolo, Maurizio ; Fleischmann, Roy ; Genovese, Mark C ; Gomez Reino, Juan ; Gruben, David ; Kremer, Joel ; Krishnaswami, Sriram ; Lee, Eun Bong ; Pascual-Ramos, Virginia ; Strand, Vibeke ; Zwillich, Samuel H</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-p281t-a838b180905de55d6b9ff7675bc62561d4cf6ae68eb473eb4990a26ec1d9bc053</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2016</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Antirheumatic Agents - administration & dosage</topic><topic>Antirheumatic Agents - adverse effects</topic><topic>Arthralgia - drug therapy</topic><topic>Arthralgia - physiopathology</topic><topic>Arthralgia - psychology</topic><topic>Arthritis, Rheumatoid - diagnosis</topic><topic>Arthritis, Rheumatoid - drug therapy</topic><topic>Arthritis, Rheumatoid - immunology</topic><topic>Arthritis, Rheumatoid - physiopathology</topic><topic>Disease Resistance</topic><topic>Drug Administration Schedule</topic><topic>Drug Monitoring</topic><topic>Female</topic><topic>Humans</topic><topic>Janus Kinases - antagonists & inhibitors</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Pain Measurement - methods</topic><topic>Piperidines - administration & dosage</topic><topic>Piperidines - adverse effects</topic><topic>Pyrimidines - administration & dosage</topic><topic>Pyrimidines - adverse effects</topic><topic>Pyrroles - administration & dosage</topic><topic>Pyrroles - adverse effects</topic><topic>Quality of Life</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Wallenstein, Gene V</creatorcontrib><creatorcontrib>Kanik, Keith S</creatorcontrib><creatorcontrib>Wilkinson, Bethanie</creatorcontrib><creatorcontrib>Cohen, Stanley</creatorcontrib><creatorcontrib>Cutolo, Maurizio</creatorcontrib><creatorcontrib>Fleischmann, Roy</creatorcontrib><creatorcontrib>Genovese, Mark C</creatorcontrib><creatorcontrib>Gomez Reino, Juan</creatorcontrib><creatorcontrib>Gruben, David</creatorcontrib><creatorcontrib>Kremer, Joel</creatorcontrib><creatorcontrib>Krishnaswami, Sriram</creatorcontrib><creatorcontrib>Lee, Eun Bong</creatorcontrib><creatorcontrib>Pascual-Ramos, Virginia</creatorcontrib><creatorcontrib>Strand, Vibeke</creatorcontrib><creatorcontrib>Zwillich, Samuel H</creatorcontrib><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>Wallenstein, Gene V</au><au>Kanik, Keith S</au><au>Wilkinson, Bethanie</au><au>Cohen, Stanley</au><au>Cutolo, Maurizio</au><au>Fleischmann, Roy</au><au>Genovese, Mark C</au><au>Gomez Reino, Juan</au><au>Gruben, David</au><au>Kremer, Joel</au><au>Krishnaswami, Sriram</au><au>Lee, Eun Bong</au><au>Pascual-Ramos, Virginia</au><au>Strand, Vibeke</au><au>Zwillich, Samuel H</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Effects of the oral Janus kinase inhibitor tofacitinib on patient-reported outcomes in patients with active rheumatoid arthritis: results of two Phase 2 randomised controlled trials</atitle><jtitle>Clinical and experimental rheumatology</jtitle><addtitle>Clin Exp Rheumatol</addtitle><date>2016-05-01</date><risdate>2016</risdate><volume>34</volume><issue>3</issue><spage>430</spage><epage>442</epage><pages>430-442</pages><issn>0392-856X</issn><abstract>Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). Here we investigated the effects of tofacitinib on patient-reported outcomes (PRO) in patients with active RA.
Two, 6-month, double-blind, placebo-controlled Phase 2b studies were performed. The combination study evaluated patients with inadequate response to methotrexate who received tofacitinib 1-15 mg twice daily (BID), 20 mg once daily or placebo, on background methotrexate. In the monotherapy study, patients with inadequate response to disease-modifying anti-rheumatic drugs received tofacitinib 1-15 mg BID, adalimumab 40 mg once every other week or placebo. PROs measured were: Patient's Assessment of Arthritis Pain (PAAP), Patient's Assessment of Disease Activity, HAQ-DI, FACIT-F and SF-36.
In the combination study (n=507), significant improvements (p<0.05) versus placebo were observed at Week 12 in PAAP (visual analogue scale) and HAQ-DI for all tofacitinib groups. In the monotherapy study (n=384), significant improvements in PAAP were observed at Week 12 for tofacitinib 5, 10 and 15 mg BID, and in HAQ-DI for tofacitinib 3, 5, 10 and 15 mg BID. Significant improvements versus placebo were seen at Week 2 in PAAP (both studies) and HAQ‑DI (monotherapy study) with tofacitinib, and were maintained throughout each study. In both studies, improvements in several domains of the SF-36 in the tofacitinib groups were observed at Weeks 12 and 24.
In patients with active RA, tofacitinib, either in combination with methotrexate or as monotherapy, demonstrated rapid and sustained improvement in pain, physical functioning and health-related quality of life.</abstract><cop>Italy</cop><pmid>27156561</pmid><tpages>13</tpages></addata></record> |
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| subjects | Adult Aged Antirheumatic Agents - administration & dosage Antirheumatic Agents - adverse effects Arthralgia - drug therapy Arthralgia - physiopathology Arthralgia - psychology Arthritis, Rheumatoid - diagnosis Arthritis, Rheumatoid - drug therapy Arthritis, Rheumatoid - immunology Arthritis, Rheumatoid - physiopathology Disease Resistance Drug Administration Schedule Drug Monitoring Female Humans Janus Kinases - antagonists & inhibitors Male Middle Aged Pain Measurement - methods Piperidines - administration & dosage Piperidines - adverse effects Pyrimidines - administration & dosage Pyrimidines - adverse effects Pyrroles - administration & dosage Pyrroles - adverse effects Quality of Life Treatment Outcome |
| title | Effects of the oral Janus kinase inhibitor tofacitinib on patient-reported outcomes in patients with active rheumatoid arthritis: results of two Phase 2 randomised controlled trials |
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