{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,24]],"date-time":"2026-04-24T22:39:49Z","timestamp":1777070389736,"version":"3.51.4"},"reference-count":33,"publisher":"Springer Science and Business Media LLC","issue":"2","license":[{"start":{"date-parts":[[2021,9,12]],"date-time":"2021-09-12T00:00:00Z","timestamp":1631404800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2021,9,12]],"date-time":"2021-09-12T00:00:00Z","timestamp":1631404800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"name":"Pfizer Inc"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Clin Rheumatol"],"published-print":{"date-parts":[[2022,2]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>Analyze tofacitinib efficacy and safety by background methotrexate (MTX) dose in patients with psoriatic arthritis (PsA).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>This post hoc analysis pooled data from two phase III, double-blind trials (OPAL Broaden, NCT01877668; OPAL Beyond, NCT01882439) including patients receiving tofacitinib 5 or 10\u00a0mg twice daily (BID), or placebo, with stable MTX. Efficacy outcomes at month 3 stratified by MTX dose (\u2264 15 month 3 stratified by MTX dose vs &gt;\u200915\u00a0mg\/week) were American College of Rheumatology (ACR)20\/50\/70, Health Assessment Questionnaire-Disability Index (HAQ-DI); Psoriasis Area and Severity Index (PASI)50\/75; change from baseline in HAQ-DI; physician\u2019s global assessment of PsA (PGA-PsA-visual analog scale [VAS]); patient\u2019s global joint and skin assessment (PGJS-VAS), Leeds Enthesitis Index (LEI); and Dactylitis Severity Score (DSS). Safety assessments included adverse events and laboratory parameters.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Five hundred fifty-six patients received tofacitinib 5\u00a0mg BID (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u2009186), 10\u00a0mg BID (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u2009178), or placebo (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u2009192), plus MTX (\u2264\u200915\u00a0mg\/week,\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u2009371; &gt;\u200915\u00a0mg\/week,\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u2009185). At month 3, tofacitinib efficacy was generally greater than placebo. Patients receiving tofacitinib 5\u00a0mg BID demonstrated greater numerical improvements in efficacy outcomes at month 3 with MTX\u2009&gt;\u200915\u00a0mg\/week vs MTX\u2009\u2264\u200915\u00a0mg\/week; patients receiving tofacitinib 10\u00a0mg BID displayed the opposite. The safety profile was generally consistent between groups; headache was associated with MTX\u2009&gt;\u200915\u00a0mg\/week; decreased hemoglobin levels were observed in patients receiving tofacitinib 10\u00a0mg BID and MTX\u2009\u2264\u200915\u00a0mg\/week.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>Efficacy of tofacitinib was generally numerically greater than placebo, regardless of MTX dose. Tofacitinib 5\u00a0mg BID was generally more efficacious with MTX\u2009&gt;\u200915\u00a0mg\/week vs\u2009\u2264\u200915\u00a0mg\/week; the opposite was observed for tofacitinib 10\u00a0mg BID. Headache was more frequent with MTX\u2009&gt;\u200915\u00a0mg\/week.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration<\/jats:title>\n                    <jats:p>\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"http:\/\/clinicaltrials.gov\">ClinicalTrials.gov<\/jats:ext-link>\n                      . Identifier: NCT01877668 (registration: June 14, 2013) and NCT01882439 (registration: June 20, 2013).\n                      <jats:table-wrap>\n                        <jats:table>\n                          <jats:tbody>\n                            <jats:tr>\n                              <jats:td colspan=\"2\">\n                                <jats:bold>Key Points<\/jats:bold>\n                                <jats:italic>\u2022 Methotrexate is widely used in the treatment of psoriatic arthritis; however, there are limited data on the impact of varying background methotrexate doses on the efficacy and safety of Janus kinase inhibitors in patients with psoriatic arthritis.<\/jats:italic>\n                                <jats:italic>\u2022 This<\/jats:italic>\n                                post hoc\n                                <jats:italic>analysis assessed the impact of background methotrexate dose (\u2264 15 or\u2009&gt;\u200915\u00a0mg\/week) on tofacitinib efficacy and safety in patients with psoriatic arthritis.<\/jats:italic>\n                                <jats:italic>\u2022 Results indicated that tofacitinib efficacy was generally numerically greater than placebo, regardless of methotrexate dose. Tofacitinib 5\u00a0mg twice daily, in combination with a higher dose of background methotrexate, was more efficacious compared with a lower dose of background methotrexate; the opposite was observed for tofacitinib 10\u00a0mg twice daily.<\/jats:italic>\n                                <jats:italic>\u2022 Headache was more frequent with the higher methotrexate dose. Data should be interpreted with caution due to the small sample sizes.<\/jats:italic>\n                              <\/jats:td>\n                            <\/jats:tr>\n                          <\/jats:tbody>\n                        <\/jats:table>\n                      <\/jats:table-wrap>\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1007\/s10067-021-05894-2","type":"journal-article","created":{"date-parts":[[2021,9,12]],"date-time":"2021-09-12T09:05:37Z","timestamp":1631437537000},"page":"499-511","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":9,"title":["Efficacy and safety of tofacitinib by background methotrexate dose in psoriatic arthritis: post hoc exploratory analysis from two phase III trials"],"prefix":"10.1007","volume":"41","author":[{"given":"Alan J.","family":"Kivitz","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Oliver","family":"FitzGerald","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Peter","family":"Nash","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shirley","family":"Pang","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Valderilio F.","family":"Azevedo","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Cunshan","family":"Wang","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6296-7685","authenticated-orcid":false,"given":"Liza","family":"Takiya","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2021,9,12]]},"reference":[{"issue":"10","key":"5894_CR1","doi-asserted-by":"publisher","first-page":"957","DOI":"10.1056\/NEJMra1505557","volume":"376","author":"CT Ritchlin","year":"2017","unstructured":"Ritchlin CT, Colbert RA, Gladman DD (2017) Psoriatic arthritis. 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OF has received research grants from AbbVie, Bristol-Myers Squibb, Novartis, and Pfizer Inc. and has been a consultant for AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Novartis, Pfizer Inc., and UCB. PN has received research grants and honoraria for lectures and advice on behalf of AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Novartis, Roche, Sanofi, Pfizer Inc., and UCB and has received consulting fees from AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, MSD, Novartis, Pfizer Inc., Sun Pharma, and UCB. SP has been involved in speakers\u2019 bureaus for Celgene and Novartis. VFA has been a consultant for AbbVie, Eli Lilly, Genentech, GSK, Pfizer Inc., and UCB and has been involved in speakers\u2019 bureaus for AbbVie, Janssen, Merck-Serono, Novartis, Pfizer Inc., and Sanofi. CW and LT are employees and shareholders of Pfizer Inc.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}}]}}