{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,26]],"date-time":"2026-08-26T16:23:54Z","timestamp":1787761434425,"version":"build-2784847793"},"reference-count":20,"publisher":"Wiley","issue":"12","license":[{"start":{"date-parts":[[2023,9,29]],"date-time":"2023-09-29T00:00:00Z","timestamp":1695945600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/100004319","name":"Pfizer","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004319","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["acrjournals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["ACR Open Rheumatology"],"published-print":{"date-parts":[[2023,12]]},"abstract":"<jats:sec><jats:title>Objective<\/jats:title><jats:p>To evaluate the efficacy and safety of tofacitinib in patients with ankylosing spondylitis (AS) by prior biologic disease\u2010modifying antirheumatic drug (bDMARD) use.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Data from a placebo\u2010controlled, double\u2010blind study of patients with active AS were analyzed. Patients received tofacitinib 5 mg twice daily (BID) or placebo to week 16; all received open\u2010label tofacitinib 5 mg BID to week 48 and were stratified by prior treatment (bDMARD\u2010naive or tumor necrosis factor inhibitor [TNFi]\u2013inadequate responder [IR], including bDMARD\u2010experienced [non\u2010IR]). Disease activity\/safety were assessed throughout.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Of 269 patients, 207 (77%) were bDMARD\u2010naive; 62\u00a0(23%) were in the TNFi\u2010IR subgroup. TNFi\u2010IR patients had higher baseline BMI (28.0 vs. 26.1 kg\/m<jats:sup>2<\/jats:sup>), longer symptom duration (14.4 vs. 13.2\u2009years), and lower concomitant conventional synthetic DMARD use (14.5% vs. 30.9%) than bDMARD\u2010naive patients. At week 16, for most outcomes, tofacitinib efficacy exceeded placebo for both subgroups and was sustained to week 48. At week 16, tofacitinib versus placebo differences were similar between bDMARD\u2010naive and TNFi\u2010IR patients (Assessment in Spondyloarthritis international Society 40 treatment difference [95% confidence interval]: 30.8% [19.1%\u201042.6%] vs. 19.4% [1.7%\u201037.0%]). Adverse event (AE) proportions were similar between tofacitinib\u2010treated bDMARD\u2010naive\/TNFi\u2010IR patients (77.5%\/77.4%) at week 48 with no deaths. A numerically higher proportion of tofacitinib\u2010treated TNFi\u2010IR versus bDMARD\u2010naive patients discontinued study drug (12.9% vs. 3.9%) or dose reduced\/temporarily discontinued due to AEs (19.4% vs. 11.8%).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>Tofacitinib efficacy exceeded placebo at week 16 for bDMARD\u2010naive\/TNFi\u2010IR patients and was sustained to week 48. The absolute magnitude of responses was generally greater in bDMARD\u2010naive patients versus TNFi\u2010IR patients. More TNFi\u2010IR versus bDMARD\u2010naive patients discontinued or dose reduced\/temporarily discontinued tofacitinib due to AEs. Small sample size and sample size differences between subgroups limited the interpretation.<\/jats:p><\/jats:sec>","DOI":"10.1002\/acr2.11601","type":"journal-article","created":{"date-parts":[[2023,9,30]],"date-time":"2023-09-30T01:45:37Z","timestamp":1696038337000},"page":"632-643","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":7,"title":["Tofacitinib Efficacy and Safety in Patients With Ankylosing Spondylitis by Prior Biologic <scp>Disease\u2010Modifying<\/scp> Antirheumatic Drug Use: A Post Hoc Analysis"],"prefix":"10.1002","volume":"5","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-2130-1246","authenticated-orcid":false,"given":"Atul","family":"Deodhar","sequence":"first","affiliation":[{"name":"Oregon Health &amp; Science University  Portland Oregon"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Helena","family":"Marzo\u2010Ortega","sequence":"additional","affiliation":[{"name":"University of Leeds  Leeds United Kingdom"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joseph","family":"Wu","sequence":"additional","affiliation":[{"name":"Pfizer Inc  Groton Connecticut"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cunshan","family":"Wang","sequence":"additional","affiliation":[{"name":"Pfizer Inc  Groton Connecticut"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Oluwaseyi","family":"Dina","sequence":"additional","affiliation":[{"name":"Pfizer Inc  New York New York"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Keith S.","family":"Kanik","sequence":"additional","affiliation":[{"name":"Pfizer Inc  Groton Connecticut"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lara","family":"Fallon","sequence":"additional","affiliation":[{"name":"Pfizer Inc  Kirkland, Montreal, Quebec Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6314-5336","authenticated-orcid":false,"given":"Lianne S.","family":"Gensler","sequence":"additional","affiliation":[{"name":"University of California at San Francisco"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2023,9,29]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2019-215707"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12891-022-05073-7"},{"issue":"3","key":"e_1_2_8_4_1","article-title":"Ankylosing spondylitis: an overview","volume":"61","author":"Sieper J","year":"2002","journal-title":"Ann Rheum Dis"},{"key":"e_1_2_8_5_1","doi-asserted-by":"publisher","DOI":"10.1002\/acr.21621"},{"key":"e_1_2_8_6_1","doi-asserted-by":"publisher","DOI":"10.1002\/acr.24025"},{"key":"e_1_2_8_7_1","doi-asserted-by":"publisher","DOI":"10.1136\/ard-2022-223296"},{"key":"e_1_2_8_8_1","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2016-210322"},{"key":"e_1_2_8_9_1","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2020-219601"},{"key":"e_1_2_8_10_1","unstructured":"PfizerInc.U.S. FDA approves Pfizer's XELJANZ\u00ae (tofacitinib) for the treatment of active ankylosing spondylitis. 2021. URL:https:\/\/www.pfizer.com\/news\/press-release\/press-release-detail\/us-fda-approves-pfizers-xeljanzr-tofacitinib-treatment-0."},{"key":"e_1_2_8_11_1","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2019-216118"},{"key":"e_1_2_8_12_1","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2016-210023"},{"key":"e_1_2_8_13_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(18)31946-9"},{"key":"e_1_2_8_14_1","doi-asserted-by":"publisher","DOI":"10.1002\/art.40753"},{"key":"e_1_2_8_15_1","doi-asserted-by":"publisher","DOI":"10.1136\/ard-2022-222608"},{"key":"e_1_2_8_16_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(19)32534-6"},{"key":"e_1_2_8_17_1","unstructured":"US Food and Drug Administration.XELJANZ\u00ae (tofacitinib): highlights of prescribing information. 2022. URL:http:\/\/labeling.pfizer.com\/ShowLabeling.aspx?id=959."},{"key":"e_1_2_8_18_1","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2014-207178"},{"key":"e_1_2_8_19_1","doi-asserted-by":"publisher","DOI":"10.1186\/ar3249"},{"key":"e_1_2_8_20_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2109927"},{"key":"e_1_2_8_21_1","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2022-eular.2076"}],"container-title":["ACR Open Rheumatology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/acrjournals.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/acr2.11601","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,2]],"date-time":"2025-10-02T15:48:38Z","timestamp":1759420118000},"score":1,"resource":{"primary":{"URL":"https:\/\/acrjournals.onlinelibrary.wiley.com\/doi\/10.1002\/acr2.11601"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,9,29]]},"references-count":20,"journal-issue":{"issue":"12","published-print":{"date-parts":[[2023,12]]}},"alternative-id":["10.1002\/acr2.11601"],"URL":"https:\/\/doi.org\/10.1002\/acr2.11601","archive":["Portico"],"relation":{},"ISSN":["2578-5745","2578-5745"],"issn-type":[{"value":"2578-5745","type":"print"},{"value":"2578-5745","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,9,29]]},"assertion":[{"value":"2023-03-13","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2023-06-26","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2023-09-29","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}