{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,25]],"date-time":"2026-08-25T19:47:09Z","timestamp":1787687229928,"version":"build-2784847793"},"reference-count":38,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2022,12,14]],"date-time":"2022-12-14T00:00:00Z","timestamp":1670976000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["acrjournals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Arthritis &amp; Rheumatology"],"published-print":{"date-parts":[[2023,3]]},"abstract":"<jats:sec><jats:title>Objective<\/jats:title><jats:p>To determine whether a single session of botulinum toxin type A (BTA) injections into both hands more effectively decreases the frequency of systemic sclerosis\u2013associated Raynaud's phenomenon (SSc\u2010RP) episodes than placebo.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>This multicenter, randomized, double\u2010blind, placebo\u2010controlled, parallel\u2010group phase III trial in patients with SSc\u2010RP assessed the effect of 50\u2010unit BTA or placebo injections into the palms of both hands around each neurovascular bundle during 1 session in winter. The primary end point was the between\u2010group difference in the median change in the number of RP episodes from baseline (day 0) to 4\u2009weeks postinjection. Values between the groups were compared with the Wilcoxon rank\u2010sum test.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>The intent\u2010to\u2010treat analysis included 46 BTA\u2010treated patients and 44 placebo recipients. At 4\u2009weeks after assigned treatment injections, the median number of daily RP episodes decreased comparably in the BTA and placebo groups (median change \u20131 episode\/day [interquartile range (IQR) \u20131.5, 0 episodes\/day] and \u20131 episode\/day [IQR \u20132.5, 0 episodes\/day], respectively) (<jats:italic>P<\/jats:italic>\u00a0=\u00a00.77 versus placebo). Moreover, change in Raynaud's Condition Score, quality of life assessed by Health Assessment Questionnaire disability index, and hand function assessed by shortened Disabilities of the Arm, Shoulder, and Hand (QuickDASH) and Cochin Hand Function Scale from baseline to follow\u2010up weeks 4, 12, and 24 did not differ significantly between groups. The BTA group experienced transient hand muscle weakness significantly more frequently (<jats:italic>P<\/jats:italic>\u00a0=\u00a00.003).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>Neither the primary nor secondary end points were reached, and our results do not support any beneficial effect of palmar BTA injections to treat SSc\u2010RP.<\/jats:p><jats:p><jats:boxed-text content-type=\"graphic\" position=\"anchor\"><jats:graphic xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" mimetype=\"image\/png\" position=\"anchor\" specific-use=\"enlarged-web-image\" xlink:href=\"graphic\/art42342-toc-0001-m.png\"><jats:alt-text>image<\/jats:alt-text><\/jats:graphic><\/jats:boxed-text><\/jats:p><\/jats:sec>","DOI":"10.1002\/art.42342","type":"journal-article","created":{"date-parts":[[2022,9,6]],"date-time":"2022-09-06T11:20:34Z","timestamp":1662463234000},"page":"459-467","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":29,"title":["Efficacy and Safety of Botulinum Toxin in Adults with Raynaud's Phenomenon Secondary to Systemic Sclerosis: A Multicenter, Randomized, <scp>Double\u2010Blind<\/scp>, <scp>Placebo\u2010Controlled<\/scp> Study"],"prefix":"10.1002","volume":"75","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-9253-8419","authenticated-orcid":false,"given":"Patricia","family":"Senet","sequence":"first","affiliation":[{"name":"Assistance Publique\u2013H\u00f4pitaux de Paris, and Service de Dermatologie, Centre Hospitalier Universitaire Tenon, Groupe Hospitalier Sorbonne Universit\u00e9  Paris France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Herv\u00e9","family":"Maillard","sequence":"additional","affiliation":[{"name":"Service de Dermatologie Centre Hospitalier Le Mans  Le Mans France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elisabeth","family":"Diot","sequence":"additional","affiliation":[{"name":"Service de M\u00e9decine Interne et Immunologie Clinique Centre Hospitalier Universitaire Bretonneau\u2013Tours  Tours France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Isabelle","family":"Lazareth","sequence":"additional","affiliation":[{"name":"Service de M\u00e9decine Vasculaire H\u00f4pital Saint\u2010Joseph  Paris France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7238-112X","authenticated-orcid":false,"given":"Sophie","family":"Blaise","sequence":"additional","affiliation":[{"name":"Universit\u00e9 Grenoble Alpes, Inserm, HP2  Grenoble France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jean\u2010Philippe","family":"Arnault","sequence":"additional","affiliation":[{"name":"Service de Dermatologie Centre Hospitalier Universitaire Amiens\u2013Picardie  Amiens France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marc\u2010Antoine","family":"Pistorius","sequence":"additional","affiliation":[{"name":"Service de M\u00e9decine Interne Centre Hospitalier Universitaire  Nantes France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carine","family":"Boulon","sequence":"additional","affiliation":[{"name":"Service de M\u00e9decine Vasculaire Centre Hospitalier Universitaire St\u2010Andr\u00e9  Bordeaux France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Olivier","family":"Cogrel","sequence":"additional","affiliation":[{"name":"Unit\u00e9 de Dermatologie Interventionnelle, Service de Dermatologie Centre Hospitalier Universitaire  Bordeaux France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ursula","family":"Warzocha","sequence":"additional","affiliation":[{"name":"Assistance Publique\u2013H\u00f4pitaux de Paris, and Service de M\u00e9decine Interne Centre Hospitalier Universitaire Avicenne  Bobigny France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"S\u00e9bastien","family":"Rivi\u00e8re","sequence":"additional","affiliation":[{"name":"Assistance Publique\u2013H\u00f4pitaux de Paris, and Service de M\u00e9decine Interne, Centre Hospitalier Universitaire Saint\u2010Antoine, Groupe Hospitalier Sorbonne Universit\u00e9  Paris France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Julie","family":"Malloizel\u2010Delaunay","sequence":"additional","affiliation":[{"name":"Service de M\u00e9decine Vasculaire Centre Hospitalier Universitaire  Toulouse France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Am\u00e9lie","family":"Servettaz","sequence":"additional","affiliation":[{"name":"Service de M\u00e9decine Interne Maladies Infectieuses, Immunologie Clinique, H\u00f4pital Robert\u2010Debr\u00e9, Centre Hospitalier Universitaire  Reims France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bruno","family":"Sassolas","sequence":"additional","affiliation":[{"name":"D\u00e9partement de M\u00e9decine Interne et Pneumologie H\u00f4pital de la Cavale Blanche, Centre Hospitalier R\u00e9gional Universitaire  Brest France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Manuelle","family":"Viguier","sequence":"additional","affiliation":[{"name":"Service de Dermatologie\u2013V\u00e9n\u00e9r\u00e9ologie H\u00f4pital Robert\u2010Debr\u00e9, Universit\u00e9 Reims Champagne Ardenne, IRMAIC, EA7509  Reims France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jean\u2010Benoit","family":"Monfort","sequence":"additional","affiliation":[{"name":"Assistance Publique\u2013H\u00f4pitaux de Paris, and Service de Dermatologie, Centre Hospitalier Universitaire Tenon, Groupe Hospitalier Sorbonne Universit\u00e9  Paris France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sol\u00e8ne","family":"Janique","sequence":"additional","affiliation":[{"name":"Assistance Publique\u2013H\u00f4pitaux de Paris, Unit\u00e9 de Recherche Clinique, Centre Hospitalier Universitaire Fernand\u2010Widal  Paris France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eric","family":"Vicaut","sequence":"additional","affiliation":[{"name":"Assistance Publique\u2013H\u00f4pitaux de Paris, Unit\u00e9 de Recherche Clinique, Centre Hospitalier Universitaire Fernand\u2010Widal  Paris France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"the BRASS collaborators","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2022,12,14]]},"reference":[{"key":"e_1_2_7_2_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMra1507638"},{"key":"e_1_2_7_3_1","doi-asserted-by":"publisher","DOI":"10.1097\/BOR.0000000000000332"},{"key":"e_1_2_7_4_1","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2021-220702"},{"key":"e_1_2_7_5_1","doi-asserted-by":"publisher","DOI":"10.1093\/rheumatology\/keq310"},{"key":"e_1_2_7_6_1","doi-asserted-by":"publisher","DOI":"10.1002\/acr.24710"},{"key":"e_1_2_7_7_1","doi-asserted-by":"publisher","DOI":"10.1186\/s41927-020-00142-7"},{"key":"e_1_2_7_8_1","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2016-209909"},{"key":"e_1_2_7_9_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41584-020-0386-4"},{"key":"e_1_2_7_10_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.berh.2019.101474"},{"key":"e_1_2_7_11_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaad.2016.11.012"},{"key":"e_1_2_7_12_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jhsa.2012.01.021"},{"key":"e_1_2_7_13_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.semarthrit.2011.07.006"},{"key":"e_1_2_7_14_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jhsa.2011.07.011"},{"key":"e_1_2_7_15_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2362.2004.01324.x"},{"key":"e_1_2_7_16_1","doi-asserted-by":"publisher","DOI":"10.1097\/01.prs.0000244860.00674.57"},{"key":"e_1_2_7_17_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jhsa.2008.11.026"},{"key":"e_1_2_7_18_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00296-020-04606-4"},{"key":"e_1_2_7_19_1","doi-asserted-by":"publisher","DOI":"10.5152\/eurjrheum.2018.18013"},{"key":"e_1_2_7_20_1","doi-asserted-by":"publisher","DOI":"10.1097\/PRS.0b013e3181a80576"},{"key":"e_1_2_7_21_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jhsa.2010.09.019"},{"key":"e_1_2_7_22_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.anplas.2011.11.001"},{"key":"e_1_2_7_23_1","doi-asserted-by":"publisher","DOI":"10.1177\/1753193413516242"},{"key":"e_1_2_7_24_1","doi-asserted-by":"publisher","DOI":"10.1111\/1346-8138.13030"},{"key":"e_1_2_7_25_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaad.2013.06.029"},{"key":"e_1_2_7_26_1","doi-asserted-by":"publisher","DOI":"10.1007\/s10067-019-04762-4"},{"key":"e_1_2_7_27_1","doi-asserted-by":"publisher","DOI":"10.1002\/art.40123"},{"key":"e_1_2_7_28_1","first-page":"CD011813","article-title":"Drug interventions versus placebo for the treatment of Raynaud's phenomenon: generic protocol","volume":"5","author":"Rirash F","year":"2021","journal-title":"Cochrane Database Syst Rev"},{"key":"e_1_2_7_29_1","doi-asserted-by":"publisher","DOI":"10.1002\/art.38098"},{"key":"e_1_2_7_30_1","first-page":"1573","article-title":"Criteria for classification of early systemic sclerosis","volume":"28","author":"LeRoy EC","year":"2001","journal-title":"J Rheumatol"},{"key":"e_1_2_7_31_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.therap.2019.03.002"},{"key":"e_1_2_7_32_1","doi-asserted-by":"publisher","DOI":"10.1002\/art.1780401110"},{"key":"e_1_2_7_33_1","first-page":"1038","article-title":"Upper Extremity Collaborative Group. Development of the QuickDASH: comparison of three item\u2010reduction approaches","volume":"87","author":"Beaton DE","year":"2005","journal-title":"J Bone Joint Surg Am"},{"key":"e_1_2_7_34_1","doi-asserted-by":"publisher","DOI":"10.1002\/acr.22893"},{"key":"e_1_2_7_35_1","doi-asserted-by":"publisher","DOI":"10.1097\/SAP.0000000000000715"},{"key":"e_1_2_7_36_1","doi-asserted-by":"publisher","DOI":"10.1002\/art.40242"},{"key":"e_1_2_7_37_1","doi-asserted-by":"publisher","DOI":"10.1093\/rheumatology\/keab584"},{"key":"e_1_2_7_38_1","doi-asserted-by":"publisher","DOI":"10.1093\/rheumatology\/keab437"},{"key":"e_1_2_7_39_1","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2014-207001"}],"container-title":["Arthritis &amp; Rheumatology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/art.42342","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/art.42342","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/acrjournals.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/art.42342","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,8]],"date-time":"2025-10-08T18:40:15Z","timestamp":1759948815000},"score":1,"resource":{"primary":{"URL":"https:\/\/acrjournals.onlinelibrary.wiley.com\/doi\/10.1002\/art.42342"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,12,14]]},"references-count":38,"journal-issue":{"issue":"3","published-print":{"date-parts":[[2023,3]]}},"alternative-id":["10.1002\/art.42342"],"URL":"https:\/\/doi.org\/10.1002\/art.42342","archive":["Portico"],"relation":{},"ISSN":["2326-5191","2326-5205"],"issn-type":[{"value":"2326-5191","type":"print"},{"value":"2326-5205","type":"electronic"}],"subject":[],"published":{"date-parts":[[2022,12,14]]},"assertion":[{"value":"2022-04-07","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2022-08-31","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2022-12-14","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}