Upadacitinib monotherapy improves patient-reported outcomes in rheumatoid arthritis: results from SELECT-EARLY and SELECT-MONOTHERAPY
Abstract Objective To evaluate the effect of upadacitinib (UPA) monotherapy vs MTX on patient-reported outcomes (PROs) in patients with RA who were MTX-naïve or who had an inadequate response to MTX (MTX-IR). Methods PROs from the SELECT-EARLY and SELECT-MONOTHERAPY randomized controlled trials were...
Gespeichert in:
| Veröffentlicht in: | Rheumatology (Oxford, England) England), 2021-07, Vol.60 (7), p.3209-3221 |
|---|---|
| Hauptverfasser: | , , , , , , , , , , |
| Format: | Artikel |
| Sprache: | eng |
| Schlagworte: | |
| Online-Zugang: | Volltext |
| Tags: |
Tag hinzufügen
Keine Tags, Fügen Sie den ersten Tag hinzu!
|
| container_end_page | 3221 |
|---|---|
| container_issue | 7 |
| container_start_page | 3209 |
| container_title | Rheumatology (Oxford, England) |
| container_volume | 60 |
| creator | Strand, Vibeke Tundia, Namita Wells, Alvin Buch, Maya H Radominski, Sebastiao C Camp, Heidi S Friedman, Alan Suboticki, Jessica L Dunlap, Kendall Goldschmidt, Debbie Bergman, Martin |
| description | Abstract
Objective
To evaluate the effect of upadacitinib (UPA) monotherapy vs MTX on patient-reported outcomes (PROs) in patients with RA who were MTX-naïve or who had an inadequate response to MTX (MTX-IR).
Methods
PROs from the SELECT-EARLY and SELECT-MONOTHERAPY randomized controlled trials were evaluated at Weeks 2 and 12/14. Patients were ≥18 years of age with RA symptoms for ≥6 weeks (SELECT-EARLY, MTX-naïve) or diagnosed RA for ≥3 months (SELECT-MONOTHERAPY, MTX-IR) and received UPA monotherapy (15 or 30 mg) or MTX. PROs included Patient Global Assessment of Disease Activity (PtGA), pain visual analogue scale, HAQ Disability Index (HAQ-DI), morning stiffness duration/severity, Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue (SELECT-EARLY), health-related quality of life (HRQOL) by the 36-iem Short Form Health Survey and Work Productivity and Activity Impairment (WPAI; SELECT-EARLY). Least square mean (LSM) changes and proportions of patients reporting improvements greater than or equal to the minimum clinically important differences and normative values were determined.
Results
In 945 MTX-naïve and 648 MTX-IR patients, UPA monotherapy (15 mg, 30 mg) vs MTX resulted in greater reported LSM changes from baseline at Weeks 12/14 in PtGA, pain, HAQ-DI, morning stiffness duration/severity, FACIT-F (SELECT-EARLY), HRQOL and WPAI (SELECT-EARLY). These changes were statistically significant with both doses of UPA vs MTX at Weeks 12/14 in both RCTs. Improvements were reported as early as week 2. Compared with MTX, more UPA-treated MTX-naïve and MTX-IR patients reported improvements greater than or equal to the minimum clinically important differences and scores greater than or equal to normative values.
Conclusion
Among MTX-naïve and MTX-IR patients with active RA, UPA monotherapy at 15 or 30 mg for 12/14 weeks resulted in statistically significant and clinically meaningful improvements in pain, physical function, morning stiffness, HRQOL and WPAI compared with MTX alone.
Clinical trial registration number
SELECT-EARLY (NCT02706873) and SELECT-MONOTHERAPY (NCT02706951) are registered with ClinicalTrials.gov. |
| doi_str_mv | 10.1093/rheumatology/keaa770 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_8516509</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><oup_id>10.1093/rheumatology/keaa770</oup_id><sourcerecordid>2470023578</sourcerecordid><originalsourceid>FETCH-LOGICAL-c542t-155b38d037c5e5aab60e52facdcd5909492b1d81cb53fe194b6a92bbfe262a863</originalsourceid><addsrcrecordid>eNqNkctu1DAUhi0EomXgDRCyxIZNGF_iXFggjUahRRoYVKaLrqwTx-m4JHFqO5XmAXjvGs1FhRUrH53znV_n94_QW0o-UlLyudvqqYdgO3u7m__SAHlOnqFzmmYsIZyz56eapWfolfd3hBBBefESnXHOY1EW5-j39QgNKBPMYGrc28GGrXYw7rDpR2cftMcjBKOHkDg9Whd0g-0UlO3jxAz4eIVpMLiwdVHIf8JO-6kLHrfO9vhntaqWm6RaXK1uMAzNsfFt_X29uayuFj9uXqMXLXRevzm8M3T9pdosL5PV-uLrcrFKlEhZSKgQNS8awnMltACoM6IFa0E1qhElKdOS1bQpqKoFbzUt0zqD2KpbzTIGRcZn6PNed5zqXjcq2nLQydGZHtxOWjDy78lgtvLWPshC0EzEX5-hDwcBZ-8n7YPsjVe662DQdvKSpTkhjIu8iOj7f9A7O7kh2pOcsoLQPC95pNI9pZz13un2dAwl8k_O8mnO8pBzXHv31Mhp6RhsBOZ7wE7j_0k-ArCqvEU</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>3128017793</pqid></control><display><type>article</type><title>Upadacitinib monotherapy improves patient-reported outcomes in rheumatoid arthritis: results from SELECT-EARLY and SELECT-MONOTHERAPY</title><source>Oxford University Press Journals All Titles (1996-Current)</source><source>Alma/SFX Local Collection</source><creator>Strand, Vibeke ; Tundia, Namita ; Wells, Alvin ; Buch, Maya H ; Radominski, Sebastiao C ; Camp, Heidi S ; Friedman, Alan ; Suboticki, Jessica L ; Dunlap, Kendall ; Goldschmidt, Debbie ; Bergman, Martin</creator><creatorcontrib>Strand, Vibeke ; Tundia, Namita ; Wells, Alvin ; Buch, Maya H ; Radominski, Sebastiao C ; Camp, Heidi S ; Friedman, Alan ; Suboticki, Jessica L ; Dunlap, Kendall ; Goldschmidt, Debbie ; Bergman, Martin</creatorcontrib><description>Abstract
Objective
To evaluate the effect of upadacitinib (UPA) monotherapy vs MTX on patient-reported outcomes (PROs) in patients with RA who were MTX-naïve or who had an inadequate response to MTX (MTX-IR).
Methods
PROs from the SELECT-EARLY and SELECT-MONOTHERAPY randomized controlled trials were evaluated at Weeks 2 and 12/14. Patients were ≥18 years of age with RA symptoms for ≥6 weeks (SELECT-EARLY, MTX-naïve) or diagnosed RA for ≥3 months (SELECT-MONOTHERAPY, MTX-IR) and received UPA monotherapy (15 or 30 mg) or MTX. PROs included Patient Global Assessment of Disease Activity (PtGA), pain visual analogue scale, HAQ Disability Index (HAQ-DI), morning stiffness duration/severity, Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue (SELECT-EARLY), health-related quality of life (HRQOL) by the 36-iem Short Form Health Survey and Work Productivity and Activity Impairment (WPAI; SELECT-EARLY). Least square mean (LSM) changes and proportions of patients reporting improvements greater than or equal to the minimum clinically important differences and normative values were determined.
Results
In 945 MTX-naïve and 648 MTX-IR patients, UPA monotherapy (15 mg, 30 mg) vs MTX resulted in greater reported LSM changes from baseline at Weeks 12/14 in PtGA, pain, HAQ-DI, morning stiffness duration/severity, FACIT-F (SELECT-EARLY), HRQOL and WPAI (SELECT-EARLY). These changes were statistically significant with both doses of UPA vs MTX at Weeks 12/14 in both RCTs. Improvements were reported as early as week 2. Compared with MTX, more UPA-treated MTX-naïve and MTX-IR patients reported improvements greater than or equal to the minimum clinically important differences and scores greater than or equal to normative values.
Conclusion
Among MTX-naïve and MTX-IR patients with active RA, UPA monotherapy at 15 or 30 mg for 12/14 weeks resulted in statistically significant and clinically meaningful improvements in pain, physical function, morning stiffness, HRQOL and WPAI compared with MTX alone.
Clinical trial registration number
SELECT-EARLY (NCT02706873) and SELECT-MONOTHERAPY (NCT02706951) are registered with ClinicalTrials.gov.</description><identifier>ISSN: 1462-0324</identifier><identifier>EISSN: 1462-0332</identifier><identifier>DOI: 10.1093/rheumatology/keaa770</identifier><identifier>PMID: 33313898</identifier><language>eng</language><publisher>England: Oxford University Press</publisher><subject>Clinical outcomes ; Clinical Science ; Clinical trials ; Pain ; Patients ; Quality of life ; Rheumatoid arthritis ; Statistical analysis</subject><ispartof>Rheumatology (Oxford, England), 2021-07, Vol.60 (7), p.3209-3221</ispartof><rights>The Author(s) 2020. Published by Oxford University Press on behalf of the British Society for Rheumatology. 2020</rights><rights>The Author(s) 2020. Published by Oxford University Press on behalf of the British Society for Rheumatology.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c542t-155b38d037c5e5aab60e52facdcd5909492b1d81cb53fe194b6a92bbfe262a863</citedby><cites>FETCH-LOGICAL-c542t-155b38d037c5e5aab60e52facdcd5909492b1d81cb53fe194b6a92bbfe262a863</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>230,314,776,780,881,1578,27901,27902</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/33313898$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Strand, Vibeke</creatorcontrib><creatorcontrib>Tundia, Namita</creatorcontrib><creatorcontrib>Wells, Alvin</creatorcontrib><creatorcontrib>Buch, Maya H</creatorcontrib><creatorcontrib>Radominski, Sebastiao C</creatorcontrib><creatorcontrib>Camp, Heidi S</creatorcontrib><creatorcontrib>Friedman, Alan</creatorcontrib><creatorcontrib>Suboticki, Jessica L</creatorcontrib><creatorcontrib>Dunlap, Kendall</creatorcontrib><creatorcontrib>Goldschmidt, Debbie</creatorcontrib><creatorcontrib>Bergman, Martin</creatorcontrib><title>Upadacitinib monotherapy improves patient-reported outcomes in rheumatoid arthritis: results from SELECT-EARLY and SELECT-MONOTHERAPY</title><title>Rheumatology (Oxford, England)</title><addtitle>Rheumatology (Oxford)</addtitle><description>Abstract
Objective
To evaluate the effect of upadacitinib (UPA) monotherapy vs MTX on patient-reported outcomes (PROs) in patients with RA who were MTX-naïve or who had an inadequate response to MTX (MTX-IR).
Methods
PROs from the SELECT-EARLY and SELECT-MONOTHERAPY randomized controlled trials were evaluated at Weeks 2 and 12/14. Patients were ≥18 years of age with RA symptoms for ≥6 weeks (SELECT-EARLY, MTX-naïve) or diagnosed RA for ≥3 months (SELECT-MONOTHERAPY, MTX-IR) and received UPA monotherapy (15 or 30 mg) or MTX. PROs included Patient Global Assessment of Disease Activity (PtGA), pain visual analogue scale, HAQ Disability Index (HAQ-DI), morning stiffness duration/severity, Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue (SELECT-EARLY), health-related quality of life (HRQOL) by the 36-iem Short Form Health Survey and Work Productivity and Activity Impairment (WPAI; SELECT-EARLY). Least square mean (LSM) changes and proportions of patients reporting improvements greater than or equal to the minimum clinically important differences and normative values were determined.
Results
In 945 MTX-naïve and 648 MTX-IR patients, UPA monotherapy (15 mg, 30 mg) vs MTX resulted in greater reported LSM changes from baseline at Weeks 12/14 in PtGA, pain, HAQ-DI, morning stiffness duration/severity, FACIT-F (SELECT-EARLY), HRQOL and WPAI (SELECT-EARLY). These changes were statistically significant with both doses of UPA vs MTX at Weeks 12/14 in both RCTs. Improvements were reported as early as week 2. Compared with MTX, more UPA-treated MTX-naïve and MTX-IR patients reported improvements greater than or equal to the minimum clinically important differences and scores greater than or equal to normative values.
Conclusion
Among MTX-naïve and MTX-IR patients with active RA, UPA monotherapy at 15 or 30 mg for 12/14 weeks resulted in statistically significant and clinically meaningful improvements in pain, physical function, morning stiffness, HRQOL and WPAI compared with MTX alone.
Clinical trial registration number
SELECT-EARLY (NCT02706873) and SELECT-MONOTHERAPY (NCT02706951) are registered with ClinicalTrials.gov.</description><subject>Clinical outcomes</subject><subject>Clinical Science</subject><subject>Clinical trials</subject><subject>Pain</subject><subject>Patients</subject><subject>Quality of life</subject><subject>Rheumatoid arthritis</subject><subject>Statistical analysis</subject><issn>1462-0324</issn><issn>1462-0332</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2021</creationdate><recordtype>article</recordtype><sourceid>TOX</sourceid><recordid>eNqNkctu1DAUhi0EomXgDRCyxIZNGF_iXFggjUahRRoYVKaLrqwTx-m4JHFqO5XmAXjvGs1FhRUrH53znV_n94_QW0o-UlLyudvqqYdgO3u7m__SAHlOnqFzmmYsIZyz56eapWfolfd3hBBBefESnXHOY1EW5-j39QgNKBPMYGrc28GGrXYw7rDpR2cftMcjBKOHkDg9Whd0g-0UlO3jxAz4eIVpMLiwdVHIf8JO-6kLHrfO9vhntaqWm6RaXK1uMAzNsfFt_X29uayuFj9uXqMXLXRevzm8M3T9pdosL5PV-uLrcrFKlEhZSKgQNS8awnMltACoM6IFa0E1qhElKdOS1bQpqKoFbzUt0zqD2KpbzTIGRcZn6PNed5zqXjcq2nLQydGZHtxOWjDy78lgtvLWPshC0EzEX5-hDwcBZ-8n7YPsjVe662DQdvKSpTkhjIu8iOj7f9A7O7kh2pOcsoLQPC95pNI9pZz13un2dAwl8k_O8mnO8pBzXHv31Mhp6RhsBOZ7wE7j_0k-ArCqvEU</recordid><startdate>20210701</startdate><enddate>20210701</enddate><creator>Strand, Vibeke</creator><creator>Tundia, Namita</creator><creator>Wells, Alvin</creator><creator>Buch, Maya H</creator><creator>Radominski, Sebastiao C</creator><creator>Camp, Heidi S</creator><creator>Friedman, Alan</creator><creator>Suboticki, Jessica L</creator><creator>Dunlap, Kendall</creator><creator>Goldschmidt, Debbie</creator><creator>Bergman, Martin</creator><general>Oxford University Press</general><general>Oxford Publishing Limited (England)</general><scope>TOX</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7QP</scope><scope>K9.</scope><scope>NAPCQ</scope><scope>7X8</scope><scope>5PM</scope></search><sort><creationdate>20210701</creationdate><title>Upadacitinib monotherapy improves patient-reported outcomes in rheumatoid arthritis: results from SELECT-EARLY and SELECT-MONOTHERAPY</title><author>Strand, Vibeke ; Tundia, Namita ; Wells, Alvin ; Buch, Maya H ; Radominski, Sebastiao C ; Camp, Heidi S ; Friedman, Alan ; Suboticki, Jessica L ; Dunlap, Kendall ; Goldschmidt, Debbie ; Bergman, Martin</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c542t-155b38d037c5e5aab60e52facdcd5909492b1d81cb53fe194b6a92bbfe262a863</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2021</creationdate><topic>Clinical outcomes</topic><topic>Clinical Science</topic><topic>Clinical trials</topic><topic>Pain</topic><topic>Patients</topic><topic>Quality of life</topic><topic>Rheumatoid arthritis</topic><topic>Statistical analysis</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Strand, Vibeke</creatorcontrib><creatorcontrib>Tundia, Namita</creatorcontrib><creatorcontrib>Wells, Alvin</creatorcontrib><creatorcontrib>Buch, Maya H</creatorcontrib><creatorcontrib>Radominski, Sebastiao C</creatorcontrib><creatorcontrib>Camp, Heidi S</creatorcontrib><creatorcontrib>Friedman, Alan</creatorcontrib><creatorcontrib>Suboticki, Jessica L</creatorcontrib><creatorcontrib>Dunlap, Kendall</creatorcontrib><creatorcontrib>Goldschmidt, Debbie</creatorcontrib><creatorcontrib>Bergman, Martin</creatorcontrib><collection>Oxford Journals Open Access Collection</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Calcium & Calcified Tissue Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Premium</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Rheumatology (Oxford, England)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Strand, Vibeke</au><au>Tundia, Namita</au><au>Wells, Alvin</au><au>Buch, Maya H</au><au>Radominski, Sebastiao C</au><au>Camp, Heidi S</au><au>Friedman, Alan</au><au>Suboticki, Jessica L</au><au>Dunlap, Kendall</au><au>Goldschmidt, Debbie</au><au>Bergman, Martin</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Upadacitinib monotherapy improves patient-reported outcomes in rheumatoid arthritis: results from SELECT-EARLY and SELECT-MONOTHERAPY</atitle><jtitle>Rheumatology (Oxford, England)</jtitle><addtitle>Rheumatology (Oxford)</addtitle><date>2021-07-01</date><risdate>2021</risdate><volume>60</volume><issue>7</issue><spage>3209</spage><epage>3221</epage><pages>3209-3221</pages><issn>1462-0324</issn><eissn>1462-0332</eissn><abstract>Abstract
Objective
To evaluate the effect of upadacitinib (UPA) monotherapy vs MTX on patient-reported outcomes (PROs) in patients with RA who were MTX-naïve or who had an inadequate response to MTX (MTX-IR).
Methods
PROs from the SELECT-EARLY and SELECT-MONOTHERAPY randomized controlled trials were evaluated at Weeks 2 and 12/14. Patients were ≥18 years of age with RA symptoms for ≥6 weeks (SELECT-EARLY, MTX-naïve) or diagnosed RA for ≥3 months (SELECT-MONOTHERAPY, MTX-IR) and received UPA monotherapy (15 or 30 mg) or MTX. PROs included Patient Global Assessment of Disease Activity (PtGA), pain visual analogue scale, HAQ Disability Index (HAQ-DI), morning stiffness duration/severity, Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue (SELECT-EARLY), health-related quality of life (HRQOL) by the 36-iem Short Form Health Survey and Work Productivity and Activity Impairment (WPAI; SELECT-EARLY). Least square mean (LSM) changes and proportions of patients reporting improvements greater than or equal to the minimum clinically important differences and normative values were determined.
Results
In 945 MTX-naïve and 648 MTX-IR patients, UPA monotherapy (15 mg, 30 mg) vs MTX resulted in greater reported LSM changes from baseline at Weeks 12/14 in PtGA, pain, HAQ-DI, morning stiffness duration/severity, FACIT-F (SELECT-EARLY), HRQOL and WPAI (SELECT-EARLY). These changes were statistically significant with both doses of UPA vs MTX at Weeks 12/14 in both RCTs. Improvements were reported as early as week 2. Compared with MTX, more UPA-treated MTX-naïve and MTX-IR patients reported improvements greater than or equal to the minimum clinically important differences and scores greater than or equal to normative values.
Conclusion
Among MTX-naïve and MTX-IR patients with active RA, UPA monotherapy at 15 or 30 mg for 12/14 weeks resulted in statistically significant and clinically meaningful improvements in pain, physical function, morning stiffness, HRQOL and WPAI compared with MTX alone.
Clinical trial registration number
SELECT-EARLY (NCT02706873) and SELECT-MONOTHERAPY (NCT02706951) are registered with ClinicalTrials.gov.</abstract><cop>England</cop><pub>Oxford University Press</pub><pmid>33313898</pmid><doi>10.1093/rheumatology/keaa770</doi><tpages>13</tpages><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 1462-0324 |
| ispartof | Rheumatology (Oxford, England), 2021-07, Vol.60 (7), p.3209-3221 |
| issn | 1462-0324 1462-0332 |
| language | eng |
| recordid | cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_8516509 |
| source | Oxford University Press Journals All Titles (1996-Current); Alma/SFX Local Collection |
| subjects | Clinical outcomes Clinical Science Clinical trials Pain Patients Quality of life Rheumatoid arthritis Statistical analysis |
| title | Upadacitinib monotherapy improves patient-reported outcomes in rheumatoid arthritis: results from SELECT-EARLY and SELECT-MONOTHERAPY |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-02-21T18%3A03%3A53IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_pubme&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Upadacitinib%20monotherapy%20improves%20patient-reported%20outcomes%20in%20rheumatoid%20arthritis:%20results%20from%20SELECT-EARLY%20and%20SELECT-MONOTHERAPY&rft.jtitle=Rheumatology%20(Oxford,%20England)&rft.au=Strand,%20Vibeke&rft.date=2021-07-01&rft.volume=60&rft.issue=7&rft.spage=3209&rft.epage=3221&rft.pages=3209-3221&rft.issn=1462-0324&rft.eissn=1462-0332&rft_id=info:doi/10.1093/rheumatology/keaa770&rft_dat=%3Cproquest_pubme%3E2470023578%3C/proquest_pubme%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=3128017793&rft_id=info:pmid/33313898&rft_oup_id=10.1093/rheumatology/keaa770&rfr_iscdi=true |