{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,31]],"date-time":"2026-10-31T20:43:07Z","timestamp":1793479387863,"version":"4.5.0"},"reference-count":40,"publisher":"BMJ","issue":"1","funder":[{"name":"Pfizer Inc"}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["RMD Open"],"accepted":{"date-parts":[[2018,12,3]]},"published-print":{"date-parts":[[2019,2]]},"abstract":"<jats:sec>\n                    <jats:title>Objectives<\/jats:title>\n                    <jats:p>Tofacitinib is an oral JAK inhibitor for the treatment of rheumatoid arthritis (RA). We examined response to tofacitinib 5 or 10\u2009mg two times a day in patients with seropositive vs seronegative RA.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      Data were pooled from five Phase III studies of conventional synthetic disease-modifying antirheumatic drug (csDMARD)- or biological DMARD-inadequate responders (ORAL Step [\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT00960440\">NCT00960440<\/jats:ext-link>\n                      ]; ORAL Scan [\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT00847613\">NCT00847613<\/jats:ext-link>\n                      ]; ORAL Solo [\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT00814307\">NCT00814307<\/jats:ext-link>\n                      ]; ORAL Sync [\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT00856544\">NCT00856544<\/jats:ext-link>\n                      ]; ORAL Standard [\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT00853385\">NCT00853385<\/jats:ext-link>\n                      ]). \u2018Serotype\u2019 subgroups were: anticyclic citrullinated peptide (CCP) and rheumatoid factor (RF) positive (anti-CCP+\/RF+); anti-CCP+\/RF negative (-); anti-CCP-\/RF+; anti-CCP-\/RF-. At month 3, ACR20\/50\/70 response rates, Disease Activity Score (DAS28-4[ESR])-defined remission (DAS28-4[ESR]&lt;2.6) and low disease activity (LDA; DAS28-4[ESR]\u22643.2), changes from baseline (CFB) in Health Assessment Questionnaire-Disability Index (HAQ-DI), Short Form-36 Health Survey (SF-36) physical functioning and Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) were evaluated. Safety endpoints were compared.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Baseline demographics\/characteristics were similar across subgroups. Tofacitinib significantly improved ACR20\/50\/70 response rates, DAS28-4(ESR) LDA rates and CFB in HAQ-DI and FACIT-F vs placebo across subgroups. More anti-CCP+\/RF+ than anti-CCP-\/RF- patients had ACR20\/50\/70 responses (ACR20\/50: both tofacitinib doses; ACR70: 10\u2009mg two times a day). SF-36 physical functioning improved in anti-CCP+\/RF+, anti-CCP+\/RF- and anti-CCP-\/RF+ patients (both tofacitinib doses) and anti-CCP-\/RF- patients (10\u2009mg two times a day) vs placebo. More anti-CCP+\/RF+ and anti-CCP+\/RF- than anti-CCP-\/RF- patients achieved DAS28-4(ESR) remission and LDA with tofacitinib 10\u2009mg two times a day. Frequency of adverse events (AEs), serious AEs and discontinuations due to AEs were similar across subgroups.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>Generally, tofacitinib efficacy (ACR20\/50\/70 responses) and safety were similar across subgroups. DAS28-4(ESR) remission rates and SF-36 physical functioning appeared lower in anti-CCP- patients.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/rmdopen-2018-000742","type":"journal-article","created":{"date-parts":[[2019,2,23]],"date-time":"2019-02-23T11:59:26Z","timestamp":1550923166000},"page":"e000742","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":58,"title":["Treatment outcomes in patients with seropositive versus seronegative rheumatoid arthritis in Phase III randomised clinical trials of 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