{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,12]],"date-time":"2026-10-12T18:09:48Z","timestamp":1791828588911,"version":"4.3.4"},"reference-count":50,"publisher":"BMJ","issue":"2","license":[{"start":{"date-parts":[[2022,6,1]],"date-time":"2022-06-01T00:00:00Z","timestamp":1654041600000},"content-version":"unspecified","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"Pfizer Inc"}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["RMD Open"],"accepted":{"date-parts":[[2022,3,31]]},"published-print":{"date-parts":[[2022,6]]},"abstract":"<jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>Ankylosing spondylitis (AS) impacts quality of life. We assessed patient-reported outcomes (PROs), pain, fatigue, health-related quality of life (HRQoL) and work productivity in a phase III trial of tofacitinib.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>Adults with AS and with inadequate response\/intolerance to \u22652 non-steroidal anti-inflammatory drugs received tofacitinib 5\u2009mg twice daily or placebo for 16 weeks. Afterwards, all received open-label tofacitinib until week 48. Change from baseline to week 48 was determined for PROs: total back pain; nocturnal spinal pain; Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) overall spinal pain (Q2); Functional Assessment of Chronic Illness Therapy-Fatigue; BASDAI fatigue (Q1); AS Quality of Life (ASQoL); Short Form-36 Health Survey Version 2 (SF-36v2); EuroQoL-Five Dimension-Three Level health profile and Visual Analogue Scale; and the Work Productivity and Activity Impairment (WPAI) questionnaire. Improvements from baseline \u2265minimum clinically important difference, and scores \u2265normative values at week 16 were evaluated.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>In 269 randomised and treated patients, at week 16, there were greater least squares mean improvements from baseline with tofacitinib 5\u2009mg twice daily versus placebo in BASDAI overall spinal pain (\u20132.85 vs \u20131.34), BASDAI fatigue (\u20132.36 vs \u20131.08), ASQoL (\u20134.03 vs \u20132.01) and WPAI overall work impairment (\u201321.49 vs \u20137.64) (all p&lt;0.001); improvements continued\/increased to week 48. Improved spinal pain with tofacitinib was seen by week 2. Patients receiving tofacitinib reported clinically meaningful PRO improvements at week 16. Percentages with PRO scores \u2265normative values at week 16 were greater with tofacitinib in SF-36v2 Physical Component Summary, physical functioning and bodily pain domains (p\u22640.05).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>In patients with AS, treatment with tofacitinib 5\u2009mg twice daily resulted in clinically meaningful improvements in pain, fatigue, HRQoL and work productivity versus placebo to week 16, which were sustained to week 48.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Trial registration number<\/jats:title>\n                  <jats:p>\n                     <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT03502616\">NCT03502616<\/jats:ext-link>.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1136\/rmdopen-2022-002253","type":"journal-article","created":{"date-parts":[[2022,6,2]],"date-time":"2022-06-02T11:28:15Z","timestamp":1654169295000},"page":"e002253","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":36,"title":["Effect of tofacitinib on pain, fatigue, health-related quality of life and work productivity in patients with active ankylosing spondylitis: results from a phase III, randomised, double-blind, placebo-controlled trial"],"prefix":"10.1136","volume":"8","clinical-trial-number":[{"clinical-trial-number":"nct03502616","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct01786668","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct03502616","registry":"10.18810\/clinical-trials-gov"}],"author":[{"given":"Victoria","family":"Navarro-Comp\u00e1n","sequence":"first","affiliation":[{"name":"Rheumatology Department, University Hospital La Paz, IdiPaz, Madrid, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"James Cheng-\u00adChung","family":"Wei","sequence":"additional","affiliation":[{"name":"Department of Allergy, Immunology & Rheumatology and Institute of Medicine, College of Medicine, Chung Shan Medical University Hospital, Taichung, Taiwan"},{"name":"Graduate Institute of Integrated Medicine, China Medical University, Taichung, Taiwan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Filip","family":"Van den Bosch","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine and Pediatrics, Ghent University, Ghent, Belgium"},{"name":"VIB Center for Inflammation Research, Ghent, Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marina","family":"Magrey","sequence":"additional","affiliation":[{"name":"Case Western Reserve University School of Medicine, Division of Rheumatology, University Hospital of Cleveland, Cleveland, Ohio, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lisy","family":"Wang","sequence":"additional","affiliation":[{"name":"Pfizer Inc, Groton, Connecticut, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dona","family":"Fleishaker","sequence":"additional","affiliation":[{"name":"Pfizer Inc, Groton, Connecticut, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joseph C","family":"Cappelleri","sequence":"additional","affiliation":[{"name":"Pfizer Inc, Groton, Connecticut, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cunshan","family":"Wang","sequence":"additional","affiliation":[{"name":"Pfizer Inc, Groton, Connecticut, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joseph","family":"Wu","sequence":"additional","affiliation":[{"name":"Pfizer Inc, Groton, Connecticut, 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