{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,3]],"date-time":"2026-06-03T07:45:51Z","timestamp":1780472751026,"version":"3.54.1"},"reference-count":17,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2005,2,3]],"date-time":"2005-02-03T00:00:00Z","timestamp":1107388800000},"content-version":"vor","delay-in-days":2,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Arthritis &amp; Rheumatism"],"published-print":{"date-parts":[[2005,2]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Objective<\/jats:title><jats:p>To obtain preliminary data regarding the efficacy and long\u2010term safety of leflunomide in patients with refractory polyarticular\u2010course juvenile rheumatoid arthritis (JRA).<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Twenty\u2010seven patients were entered into the initial 26\u2010week open\u2010label study of leflunomide therapy; 17 entered the extension phase (maximum 107 weeks). Mean disease duration at study entry was 7.0 years. All patients had \u22655 joints with active arthritis and had received methotrexate for a mean of 36.0 months. Following a loading dose, patients initially received leflunomide at a dosage of 10 mg\/1.73 m<jats:sup>2<\/jats:sup>\/day, which could be increased to 20 mg\/1.73 m<jats:sup>2<\/jats:sup>\/day (maximum 20 mg\/day) beginning at week 8. The primary efficacy outcome was the American College of Rheumatology (ACR) Pediatric 30 (Pedi 30) criteria for improvement. Last observation carried forward (LOCF) analysis was used, and all patients were entered into an intent\u2010to\u2010treat analysis. Intraarticular corticosteroids (maximum of 2 in the initial 26 weeks) were allowed, but no new disease\u2010modifying antirheumatic drug or change in nonsteroidal antiinflammatory drug was allowed throughout the study.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Seventeen of the 27 patients (63%) completed the initial 26\u2010week study. Fourteen patients (52%) met the ACR Pedi 30 response criteria at week 26. Seventeen patients entered into the extension phase (13 who met response criteria and 4 who failed to meet response criteria but decided to continue). Nine of the 17 patients (53%) who entered the extension phase either completed all 30 months of study or the study ended prior to the month 30 visit. Five patients withdrew because of failure to maintain efficacy, 2 withdrew their consent, and 1 withdrew because of an adverse event. Using LOCF analysis, 65% of patients met ACR Pedi 30 response criteria at 1 year and 2 years (weeks 50 and 106, respectively) and 53% at the end of the study. Good response rates were also seen using ACR Pedi 50 and ACR Pedi 70 criteria (47% and 24% at week 106, respectively).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>In this open\u2010label study of JRA patients who either failed to respond to, or were intolerant of, methotrexate, the majority met the ACR Pedi 30 response criteria at week 26. The response was durable, since 53% of patients who entered into the extension phase (maximum 30 months) responded at the end of this phase. Our findings support the further study of the role of leflunomide in the treatment of polyarticular\u2010course JRA.<\/jats:p><\/jats:sec>","DOI":"10.1002\/art.20861","type":"journal-article","created":{"date-parts":[[2005,2,3]],"date-time":"2005-02-03T22:51:12Z","timestamp":1107471072000},"page":"554-562","source":"Crossref","is-referenced-by-count":66,"title":["Long\u2010term open\u2010label preliminary study of the safety and efficacy of leflunomide in patients with polyarticular\u2010course juvenile rheumatoid arthritis"],"prefix":"10.1002","volume":"52","author":[{"given":"Earl","family":"Silverman","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lynn","family":"Spiegel","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David","family":"Hawkins","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ross","family":"Petty","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Donald","family":"Goldsmith","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Laura","family":"Schanberg","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ciaran","family":"Duffy","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paul","family":"Howard","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vibeke","family":"Strand","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2005,2,3]]},"reference":[{"key":"e_1_2_5_2_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJM199204163261602"},{"key":"e_1_2_5_3_2","doi-asserted-by":"publisher","DOI":"10.1002\/1529-0131(199805)41:5<808::AID-ART6>3.0.CO;2-T"},{"key":"e_1_2_5_4_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJM200003163421103"},{"key":"e_1_2_5_5_2","doi-asserted-by":"publisher","DOI":"10.1021\/bi952168g"},{"key":"e_1_2_5_6_2","doi-asserted-by":"crossref","first-page":"22","DOI":"10.4049\/jimmunol.159.1.22","article-title":"The immunosuppressive metabolite of leflunomide, A77 1726, affects murine T cells through two biochemical mechanisms","volume":"159","author":"Elder RT","year":"1997","journal-title":"J Immunol"},{"key":"e_1_2_5_7_2","doi-asserted-by":"publisher","DOI":"10.4049\/jimmunol.169.6.3392"},{"key":"e_1_2_5_8_2","doi-asserted-by":"publisher","DOI":"10.1002\/1529-0131(199909)42:9<1870::AID-ANR11>3.0.CO;2-D"},{"key":"e_1_2_5_9_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(98)09403-3"},{"key":"e_1_2_5_10_2","doi-asserted-by":"publisher","DOI":"10.1002\/1529-0131(200109)44:9<1984::AID-ART346>3.0.CO;2-B"},{"key":"e_1_2_5_11_2","doi-asserted-by":"publisher","DOI":"10.1093\/rheumatology\/39.6.655"},{"key":"e_1_2_5_12_2","doi-asserted-by":"publisher","DOI":"10.1136\/ard.60.10.913"},{"key":"e_1_2_5_13_2","doi-asserted-by":"publisher","DOI":"10.1002\/art.1780400703"},{"key":"e_1_2_5_14_2","doi-asserted-by":"publisher","DOI":"10.1002\/1529-0131(200008)43:8<1849::AID-ANR22>3.0.CO;2-F"},{"key":"e_1_2_5_15_2","doi-asserted-by":"publisher","DOI":"10.1002\/art.10710"},{"key":"e_1_2_5_16_2","doi-asserted-by":"publisher","DOI":"10.1002\/art.10885"},{"key":"e_1_2_5_17_2","doi-asserted-by":"publisher","DOI":"10.1002\/art.1780371209"},{"key":"e_1_2_5_18_2","doi-asserted-by":"publisher","DOI":"10.1002\/1529-0131(200108)44:8<1768::AID-ART312>3.0.CO;2-Q"}],"container-title":["Arthritis &amp; Rheumatism"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1002%2Fart.20861","content-type":"unspecified","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/art.20861","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,10,11]],"date-time":"2023-10-11T18:34:58Z","timestamp":1697049298000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/art.20861"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2005,2]]},"references-count":17,"journal-issue":{"issue":"2","published-print":{"date-parts":[[2005,2]]}},"alternative-id":["10.1002\/art.20861"],"URL":"https:\/\/doi.org\/10.1002\/art.20861","archive":["Portico"],"relation":{},"ISSN":["0004-3591","1529-0131"],"issn-type":[{"value":"0004-3591","type":"print"},{"value":"1529-0131","type":"electronic"}],"subject":[],"published":{"date-parts":[[2005,2]]}}}