{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,27]],"date-time":"2026-10-27T06:56:17Z","timestamp":1793084177464,"version":"4.5.0"},"reference-count":29,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2017,3,29]],"date-time":"2017-03-29T00:00:00Z","timestamp":1490745600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Arthritis &amp; Rheumatology"],"published-print":{"date-parts":[[2017,4]]},"abstract":"<jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>To assess the efficacy and tolerability of hydroxychloroquine (HCQ) in patients with cutaneous lupus erythematosus (CLE), in a phase III clinical trial conducted in Japan.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>We conducted a double\u2010blind, randomized, parallel\u2010group clinical trial. This was a baseline\u2010controlled study, and the group differences were evaluated in an exploratory analysis. A total of 103 patients with active CLE (according to a Cutaneous Lupus Erythematosus Disease Area and Severity Index [CLASI] activity score of \u22654) were included. Patients were randomized 3:1 to receive HCQ or placebo during the 16\u2010week double\u2010blind period, and all patients were given HCQ during the following 36\u2010week single\u2010blind period. The primary efficacy end point was a reduction in the CLASI activity score at week 16. The secondary end points included the central photo evaluation (5\u2010point scale), patient's global assessment (7\u2010point scale), the Skindex\u201029 score, and investigator's global assessment (7\u2010point scale, based on the other 3 secondary end points). In patients with systemic lupus erythematosus, fatigue and musculoskeletal pain were assessed. Safety was assessed up to week 55.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      The mean CLASI score at week 16 was significantly improved from baseline in both the HCQ group and the placebo group: mean change \u22124.6 (95% confidence interval [95% CI] \u22126.1, \u22123.1) (\n                      <jats:italic>P<\/jats:italic>\n                      \u2009&lt;\u20090.0001), and mean change \u22123.2 (95% CI \u22125.1, \u22121.3) (\n                      <jats:italic>P<\/jats:italic>\n                      \u2009=\u20090.002), respectively, without between\u2010group difference (\n                      <jats:italic>P<\/jats:italic>\n                      \u2009=\u20090.197). The investigator's global assessment demonstrated a greater proportion of \u201cimproved\u201d and \u201cremarkably improved\u201d patients in the HCQ group (51.4% versus 8.7% in the placebo group [\n                      <jats:italic>P<\/jats:italic>\n                      \u2009=\u20090.0002 between groups]). The other secondary end points supported the efficacy of HCQ. Cellulitis, drug eruption, hepatic dysfunction, and Stevens\u2010Johnson syndrome were shown to be serious adverse events related to HCQ use.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>The results of this randomized clinical trial support the efficacy and tolerability of HCQ in patients with CLE.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/art.40018","type":"journal-article","created":{"date-parts":[[2016,12,19]],"date-time":"2016-12-19T16:19:21Z","timestamp":1482164361000},"page":"791-799","source":"Crossref","is-referenced-by-count":110,"title":["Effects of Hydroxychloroquine in Patients With Cutaneous Lupus Erythematosus: A Multicenter, Double\u2010Blind, Randomized, Parallel\u2010Group Trial"],"prefix":"10.1002","volume":"69","author":[{"given":"N.","family":"Yokogawa","sequence":"first","affiliation":[{"name":"Tokyo Metropolitan Tama Medical Center Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"H.","family":"Eto","sequence":"additional","affiliation":[{"name":"St. Luke's International Hospital Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"A.","family":"Tanikawa","sequence":"additional","affiliation":[{"name":"Keio University School of Medicine Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"T.","family":"Ikeda","sequence":"additional","affiliation":[{"name":"Wakayama Medical University Wakayama Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"K.","family":"Yamamoto","sequence":"additional","affiliation":[{"name":"University of Tokyo Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"T.","family":"Takahashi","sequence":"additional","affiliation":[{"name":"Sanofi K.K. Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"H.","family":"Mizukami","sequence":"additional","affiliation":[{"name":"Sanofi K.K. Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"T.","family":"Sato","sequence":"additional","affiliation":[{"name":"Sanofi K.K. Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"N.","family":"Yokota","sequence":"additional","affiliation":[{"name":"Sanofi K.K. Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"F.","family":"Furukawa","sequence":"additional","affiliation":[{"name":"Wakayama Medical University Wakayama Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2017,3,29]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.4049\/jimmunol.1000702"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJM199101173240303"},{"key":"e_1_2_8_4_1","doi-asserted-by":"publisher","DOI":"10.1191\/096120398678919778"},{"key":"e_1_2_8_5_1","doi-asserted-by":"publisher","DOI":"10.1002\/art.21039"},{"key":"e_1_2_8_6_1","doi-asserted-by":"publisher","DOI":"10.1002\/art.24538"},{"key":"e_1_2_8_7_1","doi-asserted-by":"publisher","DOI":"10.1177\/0961203306071872"},{"key":"e_1_2_8_8_1","doi-asserted-by":"publisher","DOI":"10.1002\/art.27289"},{"key":"e_1_2_8_9_1","doi-asserted-by":"publisher","DOI":"10.1186\/ar2764"},{"key":"e_1_2_8_10_1","doi-asserted-by":"publisher","DOI":"10.1002\/art.27300"},{"key":"e_1_2_8_11_1","doi-asserted-by":"publisher","DOI":"10.1136\/ard.2006.068676"},{"key":"e_1_2_8_12_1","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2013-205139"},{"key":"e_1_2_8_13_1","doi-asserted-by":"publisher","DOI":"10.1177\/096120339700600204"},{"key":"e_1_2_8_14_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.autrev.2012.10.005"},{"key":"e_1_2_8_15_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(79)92044-0"},{"key":"e_1_2_8_16_1","doi-asserted-by":"publisher","DOI":"10.3899\/jrheum.111569"},{"key":"e_1_2_8_17_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.0022-202X.2005.23889.x"},{"key":"e_1_2_8_18_1","doi-asserted-by":"publisher","DOI":"10.3109\/s10165-012-0656-3"},{"key":"e_1_2_8_19_1","doi-asserted-by":"publisher","DOI":"10.1001\/archdermatol.2010.435"},{"key":"e_1_2_8_20_1","doi-asserted-by":"publisher","DOI":"10.1111\/1523-1747.ep12365600"},{"key":"e_1_2_8_21_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.berh.2007.02.009"},{"key":"e_1_2_8_22_1","doi-asserted-by":"publisher","DOI":"10.3899\/jrheum.101091"},{"issue":"85","key":"e_1_2_8_23_1","first-page":"85","article-title":"Indices to assess patients with systemic lupus erythematosus in clinical trials, long\u2010term observational studies, and clinical care","volume":"32","author":"Castrejon I","year":"2014","journal-title":"Clin Exp Rheumatol"},{"key":"e_1_2_8_24_1","doi-asserted-by":"publisher","DOI":"10.1002\/art.22162"},{"key":"e_1_2_8_25_1","doi-asserted-by":"publisher","DOI":"10.1001\/archdermatol.2011.191"},{"key":"e_1_2_8_26_1","doi-asserted-by":"publisher","DOI":"10.1002\/art.1780400928"},{"key":"e_1_2_8_27_1","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2015-208562"},{"key":"e_1_2_8_28_1","first-page":"1457","article-title":"Comparison of hydroxychloroquine and placebo in the treatment of the arthropathy of mild systemic lupus erythematosus","volume":"21","author":"Williams HJ","year":"1994","journal-title":"J Rheumatol"},{"key":"e_1_2_8_29_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2014.7682"},{"key":"e_1_2_8_30_1","doi-asserted-by":"publisher","DOI":"10.1097\/FTD.0000000000000261"}],"container-title":["Arthritis &amp; Rheumatology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1002%2Fart.40018","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1002%2Fart.40018","content-type":"unspecified","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/art.40018","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/art.40018","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/acrjournals.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/art.40018","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,8]],"date-time":"2025-10-08T15:55:33Z","timestamp":1759938933000},"score":1,"resource":{"primary":{"URL":"https:\/\/acrjournals.onlinelibrary.wiley.com\/doi\/10.1002\/art.40018"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2017,3,29]]},"references-count":29,"journal-issue":{"issue":"4","published-print":{"date-parts":[[2017,4]]}},"alternative-id":["10.1002\/art.40018"],"URL":"https:\/\/doi.org\/10.1002\/art.40018","archive":["Portico"],"relation":{},"ISSN":["2326-5191","2326-5205"],"issn-type":[{"value":"2326-5191","type":"print"},{"value":"2326-5205","type":"electronic"}],"subject":[],"published":{"date-parts":[[2017,3,29]]}}}