{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,19]],"date-time":"2026-08-19T19:36:53Z","timestamp":1787168213198,"version":"build-2736575974"},"reference-count":40,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2024,1,17]],"date-time":"2024-01-17T00:00:00Z","timestamp":1705449600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2024,1,17]],"date-time":"2024-01-17T00:00:00Z","timestamp":1705449600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"name":"Octapharma Pharmazeutika Produktionsges.m.b.H"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Arthritis Res Ther"],"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Dermatomyositis is an idiopathic inflammatory myopathy characterised by rashes and progressive muscle weakness. The recent ProDERM (Progress in DERMatomyositis) study is the first large randomised, placebo-controlled trial to establish the efficacy and safety of intravenous immunoglobulin (IVIg) in adult patients with dermatomyositis. Objectives of this analysis were to closely examine the safety and tolerability of IVIg in patients from the ProDERM study.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>ProDERM was a double-blind, randomised, placebo-controlled, multicentre, phase 3 study. In the first period (weeks 0\u201316), adults with active dermatomyositis received 2.0\u00a0g\/kg IVIg (Octagam 10%; Octapharma AG) or placebo every 4\u00a0weeks. In the open-label extension period (weeks 16\u201340), all patients received IVIg for 6 additional cycles; dose reduction (1.0\u00a0g\/kg) was permitted if patients were stable. Treatment-emergent adverse events (TEAEs) were documented.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      The 95 patients enrolled were randomised to receive IVIg (\n                      <jats:italic>N<\/jats:italic>\n                      \u2009=\u200947) or placebo (\n                      <jats:italic>N<\/jats:italic>\n                      \u2009=\u200948) in the first period, with 5 switching from placebo to IVIg. Overall, 664 IVIg infusion cycles were administered. During the first period, 113 TEAEs were possibly\/probably related to treatment in 30\/52 patients (57.7%) receiving IVIg and 38 in 11 patients (22.9%) on placebo. Eight patients discontinued therapy due to IVIg-related TEAEs. Eight thromboembolic events (TEEs) occurred in six patients on IVIg; six in five patients were deemed possibly\/probably related to IVIg. Patients with TEEs exhibited more baseline TEE risk factors than those without TEEs (2.4\u201315.2-fold higher). Lowering infusion rate reduced the rate of TEEs, and none occurred at the lower IVIg dose. No haemolytic transfusion reactions or deaths occurred.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Results from this study demonstrate that IVIg has a favourable safety profile for treatment of adult dermatomyositis patients and provides evidence that will help to inform treatment choice for these patients. Dermatomyositis patients receiving high-dose IVIg should be monitored for TEEs, and a low rate of infusion should be used to minimise TEE risk, particularly in those with pre-existing risk factors.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration<\/jats:title>\n                    <jats:p>ProDERM study (NCT02728752).<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1186\/s13075-023-03232-2","type":"journal-article","created":{"date-parts":[[2024,1,17]],"date-time":"2024-01-17T00:03:14Z","timestamp":1705449794000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":23,"title":["Safety and tolerability of intravenous immunoglobulin in patients with active dermatomyositis: results from the randomised, placebo-controlled ProDERM study"],"prefix":"10.1186","volume":"26","author":[{"given":"Rohit","family":"Aggarwal","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joachim","family":"Schessl","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christina","family":"Charles-Schoeman","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zsuzsanna","family":"Bata-Cs\u00f6rg\u0151","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mazen M.","family":"Dimachkie","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zoltan","family":"Griger","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sergey","family":"Moiseev","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chester V.","family":"Oddis","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elena","family":"Schiopu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jiri","family":"Vencovsk\u00fd","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Irene","family":"Beckmann","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elisabeth","family":"Clodi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Todd","family":"Levine","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"the ProDERM investigators","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2024,1,17]]},"reference":[{"issue":"18","key":"3232_CR1","doi-asserted-by":"publisher","first-page":"1734","DOI":"10.1056\/NEJMra1402225","volume":"372","author":"MC Dalakas","year":"2015","unstructured":"Dalakas MC. Inflammatory muscle diseases. N Engl J Med. 2015;372(18):1734\u201347.","journal-title":"N Engl J Med"},{"key":"3232_CR2","unstructured":"Orphanet. Dermatomyositis. Last updated February 2021. Available from: https:\/\/www.orpha.net\/consor\/cgi-bin\/OC_Exp.php?lng=EN&Expert=221."},{"issue":"2","key":"3232_CR3","doi-asserted-by":"publisher","first-page":"348","DOI":"10.1002\/acr.24786","volume":"75","author":"VL Kronzer","year":"2023","unstructured":"Kronzer VL, Kimbrough BA, Crowson CS, Davis JM 3rd, Holmqvist M, Ernste FC. Incidence, prevalence, and mortality of dermatomyositis: a population-based cohort study. Arthritis Care Res (Hoboken). 2023;75(2):348\u201355. https:\/\/doi.org\/10.1002\/acr.24786.","journal-title":"Arthritis Care Res (Hoboken)"},{"key":"3232_CR4","unstructured":"Qudsiya Z, Waseem M. Dermatomyositis. [Updated 2023 Aug 7]. In: StatPearls. Treasure Island: StatPearls Publishing; 2023. Available from: https:\/\/www.ncbi.nlm.nih.gov\/books\/NBK558917\/."},{"issue":"3","key":"3232_CR5","doi-asserted-by":"publisher","first-page":"114","DOI":"10.1097\/RHU.0000000000001214","volume":"27","author":"H Muhammed","year":"2021","unstructured":"Muhammed H, Gupta L, Zanwar AA, Misra DP, Lawrence A, Agarwal V, et al. Infections are leading cause of in-hospital mortality in Indian patients with inflammatory myopathy. J Clin Rheumatol. 2021;27(3):114\u20139.","journal-title":"J Clin Rheumatol"},{"issue":"11","key":"3232_CR6","doi-asserted-by":"publisher","first-page":"1853","DOI":"10.1007\/s00296-017-3799-x","volume":"37","author":"L Nuno-Nuno","year":"2017","unstructured":"Nuno-Nuno L, Joven BE, Carreira PE, Maldonado-Romero V, Larena-Grijalba C, Cubas IL, et al. Mortality and prognostic factors in idiopathic inflammatory myositis: a retrospective analysis of a large multicenter cohort of Spain. Rheumatol Int. 2017;37(11):1853\u201361.","journal-title":"Rheumatol Int"},{"issue":"2","key":"3232_CR7","doi-asserted-by":"publisher","first-page":"315","DOI":"10.1016\/j.jaci.2010.10.030","volume":"127","author":"M Ballow","year":"2011","unstructured":"Ballow M. The IgG molecule as a biological immune response modifier: mechanisms of action of intravenous immune serum globulin in autoimmune and inflammatory disorders. J Allergy Clin Immunol. 2011;127(2):315\u201323.","journal-title":"J Allergy Clin Immunol"},{"issue":"4","key":"3232_CR8","doi-asserted-by":"publisher","first-page":"387","DOI":"10.1046\/j.1365-2567.2002.01545.x","volume":"107","author":"WA Sewell","year":"2002","unstructured":"Sewell WA, Jolles S. Immunomodulatory action of intravenous immunoglobulin. Immunology. 2002;107(4):387\u201393.","journal-title":"Immunology"},{"issue":"9","key":"3232_CR9","doi-asserted-by":"publisher","first-page":"893","DOI":"10.1111\/j.1468-1331.2008.02246.x","volume":"15","author":"I Elovaara","year":"2008","unstructured":"Elovaara I, Apostolski S, van Doorn P, Gilhus NE, Hietaharju A, Honkaniemi J, et al. EFNS guidelines for the use of intravenous immunoglobulin in treatment of neurological diseases: EFNS task force on the use of intravenous immunoglobulin in treatment of neurological diseases. Eur J Neurol. 2008;15(9):893\u2013908.","journal-title":"Eur J Neurol"},{"issue":"1","key":"3232_CR10","doi-asserted-by":"publisher","first-page":"90","DOI":"10.1684\/ejd.2008.0580","volume":"19","author":"A Enk","year":"2009","unstructured":"Enk A. Guidelines on the use of high-dose intravenous immunoglobulin in dermatology. Eur J Dermatol. 2009;19(1):90\u20138.","journal-title":"Eur J Dermatol"},{"issue":"2","key":"3232_CR11","doi-asserted-by":"publisher","first-page":"124","DOI":"10.1016\/j.autrev.2009.04.003","volume":"9","author":"MG Danieli","year":"2009","unstructured":"Danieli MG, Calcabrini L, Calabrese V, Marchetti A, Logullo F, Gabrielli A. Intravenous immunoglobulin as add on treatment with mycophenolate mofetil in severe myositis. Autoimmun Rev. 2009;9(2):124\u20137.","journal-title":"Autoimmun Rev"},{"key":"3232_CR12","doi-asserted-by":"publisher","first-page":"1264","DOI":"10.1056\/NEJMoa2117912","volume":"387","author":"R Aggarwal","year":"2022","unstructured":"Aggarwal R, Charles-Schoeman C, Schessl J, Bata-Cs\u00f6rg\u0151 Z, Dimachkie MM, Griger Z, et al. Trial of intravenous immunoglobulin in dermatomyositis. New Eng J Med. 2022;387:1264\u201378.","journal-title":"New Eng J Med"},{"issue":"1","key":"3232_CR13","doi-asserted-by":"publisher","DOI":"10.1097\/MD.0000000000023677","volume":"100","author":"R Aggarwal","year":"2021","unstructured":"Aggarwal R, Charles-Schoeman C, Schessl J, Dimachkie MM, Beckmann I, Levine T. Prospective, double-blind, randomized, placebo-controlled phase III study evaluating efficacy and safety of octagam 10% in patients with dermatomyositis (\u201cProDERM study\u201d). Medicine (Baltimore). 2021;100(1): e23677.","journal-title":"Medicine (Baltimore)"},{"key":"3232_CR14","unstructured":"OCTAGAM 10%, solution for infusion [19 November 2021]. Available from: https:\/\/www.medicines.org.uk\/emc\/product\/4701\/smpc#PRODUCTINFO."},{"key":"3232_CR15","unstructured":"OCTAGAM 10% [immune globulin intravenous (human)] liquid solution for intravenous administration [19 November 2021]. Available from: https:\/\/www.fda.gov\/media\/70911\/download."},{"key":"3232_CR16","unstructured":"Octagam\u00ae product monograph. Octapharma Pharmazeutika Produktionsges, m.b.H. Revised May 6, 2022. Available from: https:\/\/pdf.hres.ca\/dpd_pm\/00065990.PDF."},{"issue":"7","key":"3232_CR17","doi-asserted-by":"publisher","first-page":"344","DOI":"10.1056\/NEJM197502132920706","volume":"292","author":"A Bohan","year":"1975","unstructured":"Bohan A, Peter JB. Polymyositis and dermatomyositis (first of two parts). N Engl J Med. 1975;292(7):344\u20137.","journal-title":"N Engl J Med"},{"issue":"8","key":"3232_CR18","doi-asserted-by":"publisher","first-page":"403","DOI":"10.1056\/NEJM197502202920807","volume":"292","author":"A Bohan","year":"1975","unstructured":"Bohan A, Peter JB. Polymyositis and dermatomyositis (second of two parts). N Engl J Med. 1975;292(8):403\u20137.","journal-title":"N Engl J Med"},{"issue":"2","key":"3232_CR19","doi-asserted-by":"publisher","first-page":"314","DOI":"10.1002\/art.37754","volume":"65","author":"CV Oddis","year":"2013","unstructured":"Oddis CV, Reed AM, Aggarwal R, Rider LG, Ascherman DP, Levesque MC, et al. Rituximab in the treatment of refractory adult and juvenile dermatomyositis and adult polymyositis: a randomized, placebo-phase trial. Arthritis Rheum. 2013;65(2):314\u201324.","journal-title":"Arthritis Rheum"},{"issue":"13","key":"3232_CR20","doi-asserted-by":"publisher","first-page":"1227","DOI":"10.1056\/NEJMoa023153","volume":"349","author":"PS Wells","year":"2003","unstructured":"Wells PS, Anderson DR, Rodger M, Forgie M, Kearon C, Dreyer J, et al. Evaluation of D-dimer in the diagnosis of suspected deep-vein thrombosis. N Engl J Med. 2003;349(13):1227\u201335.","journal-title":"N Engl J Med"},{"key":"3232_CR21","unstructured":"National Institute for Health and Care Excellence. Venous thromboembolic diseases: diagnosis, management and thrombophilia testing. Clinical guideline (CG144); published 27 June 2012. Available from: https:\/\/www.nice.org.uk\/guidance\/cg144."},{"issue":"27","key":"3232_CR22","doi-asserted-by":"publisher","first-page":"1993","DOI":"10.1056\/NEJM199312303292704","volume":"329","author":"MC Dalakas","year":"1993","unstructured":"Dalakas MC, Illa I, Dambrosia JM, Soueidan SA, Stein DP, Otero C, et al. A controlled trial of high-dose intravenous immune globulin infusions as treatment for dermatomyositis. N Engl J Med. 1993;329(27):1993\u20132000.","journal-title":"N Engl J Med"},{"issue":"1","key":"3232_CR23","doi-asserted-by":"publisher","first-page":"25","DOI":"10.1136\/adc.72.1.25","volume":"72","author":"A Sansome","year":"1995","unstructured":"Sansome A, Dubowitz V. Intravenous immunoglobulin in juvenile dermatomyositis\u2013four year review of nine cases. Arch Dis Child. 1995;72(1):25\u20138.","journal-title":"Arch Dis Child"},{"issue":"1","key":"3232_CR24","doi-asserted-by":"publisher","first-page":"37","DOI":"10.1136\/ard.61.1.37","volume":"61","author":"MG Danieli","year":"2002","unstructured":"Danieli MG, Malcangi G, Palmieri C, Logullo F, Salvi A, Piani M, et al. Cyclosporin A and intravenous immunoglobulin treatment in polymyositis\/dermatomyositis. Ann Rheum Dis. 2002;61(1):37\u201341.","journal-title":"Ann Rheum Dis"},{"issue":"4","key":"3232_CR25","doi-asserted-by":"publisher","first-page":"1784","DOI":"10.1093\/rheumatology\/keaa459","volume":"60","author":"J Lim","year":"2021","unstructured":"Lim J, Eftimov F, Verhamme C, Brusse E, Hoogendijk JE, Saris CGJ, et al. Intravenous immunoglobulins as first-line treatment in idiopathic inflammatory myopathies: a pilot study. Rheumatology (Oxford). 2021;60(4):1784\u201392.","journal-title":"Rheumatology (Oxford)"},{"issue":"3","key":"3232_CR26","doi-asserted-by":"publisher","first-page":"382","DOI":"10.3109\/s10165-011-0534-4","volume":"22","author":"N Miyasaka","year":"2012","unstructured":"Miyasaka N, Hara M, Koike T, Saito E, Yamada M, Tanaka Y. Effects of intravenous immunoglobulin therapy in Japanese patients with polymyositis and dermatomyositis resistant to corticosteroids: a randomized double-blind placebo-controlled trial. Mod Rheumatol. 2012;22(3):382\u201393.","journal-title":"Mod Rheumatol"},{"key":"3232_CR27","doi-asserted-by":"publisher","first-page":"1299","DOI":"10.3389\/fimmu.2018.01299","volume":"9","author":"Y Guo","year":"2018","unstructured":"Guo Y, Tian X, Wang X, Xiao Z. Adverse effects of immunoglobulin therapy. Front Immunol. 2018;9:1299.","journal-title":"Front Immunol"},{"issue":"5","key":"3232_CR28","doi-asserted-by":"publisher","first-page":"528","DOI":"10.1002\/mus.26678","volume":"60","author":"W Waheed","year":"2019","unstructured":"Waheed W, Ayer GA, Jadoo CL, Badger GJ, Aboukhatwa M, Brannagan TH 3rd, et al. Safety of intravenous immune globulin in an outpatient setting for patients with neuromuscular disease. Muscle Nerve. 2019;60(5):528\u201337.","journal-title":"Muscle Nerve"},{"issue":"2","key":"3232_CR29","doi-asserted-by":"publisher","first-page":"200","DOI":"10.1182\/blood-2015-05-647552","volume":"127","author":"EM Ammann","year":"2016","unstructured":"Ammann EM, Jones MP, Link BK, Carnahan RM, Winiecki SK, Torner JC, et al. Intravenous immune globulin and thromboembolic adverse events in patients with hematologic malignancy. Blood. 2016;127(2):200\u20137.","journal-title":"Blood"},{"issue":"4","key":"3232_CR30","doi-asserted-by":"publisher","first-page":"249","DOI":"10.5415\/apallergy.2013.3.4.249","volume":"3","author":"FR Palabrica","year":"2013","unstructured":"Palabrica FR, Kwong SL, Padua FR. Adverse events of intravenous immunoglobulin infusions: a ten-year retrospective study. Asia Pac Allergy. 2013;3(4):249\u201356.","journal-title":"Asia Pac Allergy"},{"key":"3232_CR31","doi-asserted-by":"crossref","unstructured":"Frenzel W, Wietek S, Svae TE, Debes A, Svorc D. Tolerability and safety of Octagam(R) (IVIG): a post-authorization safety analysis of four non-interventional phase IV trials\u2029Int J Clin Pharmacol Ther. 2016;54(11):847\u201355.","DOI":"10.5414\/CP202782"},{"issue":"4","key":"3232_CR32","doi-asserted-by":"publisher","first-page":"227","DOI":"10.2217\/nmt-2018-0006","volume":"8","author":"S Wietek","year":"2018","unstructured":"Wietek S. Octagam((R)) for chronic inflammatory demyelinating polyneuropathy: results from three observational studies. Neurodegener Dis Manag. 2018;8(4):227\u201331.","journal-title":"Neurodegener Dis Manag"},{"issue":"4","key":"3232_CR33","doi-asserted-by":"publisher","first-page":"242","DOI":"10.1080\/10245332.2017.1385892","volume":"23","author":"S Wietek","year":"2018","unstructured":"Wietek S, Svorc D, Debes A, Svae TE. Tolerability and safety of the intravenous immunoglobulin octagam((R)) 10% in patients with immune thrombocytopenia: a post-authorisation safety analysis of two non-interventional phase IV trials. Hematology. 2018;23(4):242\u20137.","journal-title":"Hematology"},{"issue":"6","key":"3232_CR34","doi-asserted-by":"publisher","first-page":"666","DOI":"10.1001\/jamadermatol.2023.1105","volume":"159","author":"ET Rotrosen","year":"2023","unstructured":"Rotrosen ET, Zahedi Niaki O, Kassamali B, et al. Intravenous immunoglobulin and dermatomyositis-associated venous thromboembolism. JAMA Dermatol. 2023;159(6):666\u20137. https:\/\/doi.org\/10.1001\/jamadermatol.2023.1105.","journal-title":"JAMA Dermatol"},{"issue":"8","key":"3232_CR35","doi-asserted-by":"publisher","first-page":"876","DOI":"10.1136\/jnnp-2022-328881","volume":"93","author":"M Kapoor","year":"2022","unstructured":"Kapoor M, Hunt I, Spillane J, Bonnett LJ, Hutton EJ, McFadyen J, et al. IVIg-exposure and thromboembolic event risk: findings from the UK Biobank. J Neurol Neurosurg Psychiatry. 2022;93(8):876\u201385.","journal-title":"J Neurol Neurosurg Psychiatry"},{"key":"3232_CR36","doi-asserted-by":"crossref","unstructured":"Xu J, Lupu F, Esmon CT. Inflammation, innate immunity and blood coagulation. Hamostaseologie. 2010;30(1):5\u20136, 8\u20139.","DOI":"10.1055\/s-0037-1617146"},{"issue":"1","key":"3232_CR37","doi-asserted-by":"publisher","first-page":"110","DOI":"10.1136\/annrheumdis-2014-205800","volume":"75","author":"EC Carruthers","year":"2016","unstructured":"Carruthers EC, Choi HK, Sayre EC, Avi\u00f1a-Zubieta JA. Risk of deep venous thrombosis and pulmonary embolism in individuals with polymyositis and dermatomyositis: a general population-based study. Ann Rheum Dis. 2016;75(1):110\u20136.","journal-title":"Ann Rheum Dis"},{"issue":"3","key":"3232_CR38","doi-asserted-by":"publisher","first-page":"622","DOI":"10.1016\/j.thromres.2014.06.021","volume":"134","author":"WS Chung","year":"2014","unstructured":"Chung WS, Lin CL, Sung FC, Lu CC, Kao CH. Increased risk of venous thromboembolism in patients with dermatomyositis\/polymyositis: a nationwide cohort study. Thromb Res. 2014;134(3):622\u20136.","journal-title":"Thromb Res"},{"issue":"11","key":"3232_CR39","doi-asserted-by":"publisher","first-page":"2288","DOI":"10.3899\/jrheum.080478","volume":"35","author":"SD Gaitonde","year":"2008","unstructured":"Gaitonde SD, Ballou SP. Deep venous thrombosis in dermatomyositis. J Rheumatol. 2008;35(11):2288.","journal-title":"J Rheumatol"},{"issue":"12","key":"3232_CR40","doi-asserted-by":"publisher","first-page":"1849","DOI":"10.1002\/acr.23560","volume":"70","author":"A Antovic","year":"2018","unstructured":"Antovic A, Notarnicola A, Svensson J, Lundberg IE, Holmqvist M. Venous thromboembolic events in idiopathic inflammatory myopathy: occurrence and relation to disease onset. Arthritis Care Res (Hoboken). 2018;70(12):1849\u201355.","journal-title":"Arthritis Care Res (Hoboken)"}],"container-title":["Arthritis Research &amp; Therapy"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s13075-023-03232-2.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1186\/s13075-023-03232-2\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s13075-023-03232-2.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,1,17]],"date-time":"2024-01-17T00:05:12Z","timestamp":1705449912000},"score":1,"resource":{"primary":{"URL":"https:\/\/arthritis-research.biomedcentral.com\/articles\/10.1186\/s13075-023-03232-2"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,1,17]]},"references-count":40,"journal-issue":{"issue":"1","published-online":{"date-parts":[[2024,12]]}},"alternative-id":["3232"],"URL":"https:\/\/doi.org\/10.1186\/s13075-023-03232-2","relation":{},"ISSN":["1478-6362"],"issn-type":[{"value":"1478-6362","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,1,17]]},"assertion":[{"value":"8 June 2023","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"6 December 2023","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"17 January 2024","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"The study was conducted in accordance with the Declaration of Helsinki, in compliance with good clinical practice guidelines. Informed consent was obtained from each patient before any study-related procedures were conducted.The study was approved by the following ethics committees: Ethik-Kommission des Landes, Berlin, Germany; Bioethics Committee at the National Institute of Geriatrics, Rheumatology and Rehabilitation in Warsaw, Poland; Medical Research Council, Ethics Committee for Clinical Pharmacology (ECCP), Budapest, Hungary; Ethics Committee for Multi-Centric Clinical Trials, The University Hospital Kralovske Vinohrady, Prague, Czech Republic; Ministry of Health of the Russian Federation (MOH) Council of Ethics, Moscow, Russia; Amsterdam UMC, Medical Review Committee AMC, Amsterdam, Netherlands; National Bioethics Committee for Medicines and Medical Devices, Bucharest, Romania; Ethics Committee at Sumy Regional Clinical Hospital, Public Institution of Sumy Regional Council 18, Ukraine; Ethics Committee Ternopil University Hospital, Ternopil, Ukraine; Ethics Committee at the Ivano-Frankivsk City, Clinical Hospital No. 1, Ivano-Frankivsk, Ukraine; Jewish General Hospital - Research Ethics Committee, Quebec, Canada; Western Institutional Review Board, Puyallup, WA, USA; IntegReview, Austin, TX, USA; UCLA IRB, Institutional Review Board, University of California LA, USA; The University of Kansas Medical Center Institutional Review Board, KS, USA; University of Michigan Medical School Institutional Review Board; Mayo Clinic Institutional Review Board, Rochester, MN, USA; Oregon Health & Science University Independent Review Board, Portland, OR, USA; and UMiami Human Subject Research Office (M809), Miami, FL, USA.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Specific consent for publication was not provided as all data in this international study (from 36 European and North American centres) is fully anonymised.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"RA has received grants or contracts from Mallinckrodt, Pfizer, Bristol Myers-Squibb, Boehringer Ingelheim, Q32, EMD Serono and Janssen; and consulting fees from Mallinckrodt, Octapharma, CSL Behring, Bristol Myers-Squibb, Alexion, Boehringer Ingelheim, Janssen, Roivant, Galapagos, Abbvie, Horizontal Therapeutics, Biogen, ANI Pharmaceutical, Capella, Ililli, Medicxi, EMD Serono, Kezar, Pfizer, Astra Zeneca, Argenx, Corbus, Kyverna, Merck, Actigraph, Scipher, Teva, Beigene, Nuvig, Cabaletta Bio and Sanofi. JS has received support for the current manuscript and funding and consultancy fees from Octapharma; and honoraria for presentations, from Pfizer. CC-S has received grants or contracts from Pfizer, Bristol Myers Squibb, Abbvie, CSL Behring, Alexion and Priovant; consulting fees from Pfizer, Bristol Myers Squibb, Abbvie, Octapharma, Priovant, Galapagos, Recludix and Boehringer Ingelheim Pharmaceuticals; and participated on a Data Safety Monitoring Board or Advisory Board for Bristol Myers Squibb. ZB-C has received payment or honoraria for lectures from Sanofi, Berlin-Chemie and Abbvie; support for attending meetings from Sanofi and Biotest AG; and unpaid board membership in the Hungarian Dermatology and Immunology and Allergy Societies. MMD has received grants or contracts from Alexion, Alnylam Pharmaceuticals, Amicus, Biomarin, Bristol-Myers Squibb, Catalyst, Corbus, CSL-Behring, FDA\/OOPD, GlaxoSmithKline, Genentech, Grifols, Kezar, Mitsubishi Tanabe Pharma, MDA, NIH, Novartis, Octapharma, Orphazyme, Ra Pharma\/UCB, Sanofi Genzyme, Sarepta Therapeutics, Shire Takeda, Spark Therapeutics, The Myositis Association, UCB Biopharma\/RaPharma, Viromed\/Healixmith and TMA; consultancy fees, payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events, and participated on a Data Safety Monitoring Board or Advisory Board for Abcuro, Amazentis, ArgenX, Astellas, Catalyst, Cello, Covance\/Labcorp, CSL-Behring, EcoR1, Janssen, Kezar, MDA, Medlink, Momenta, NuFactor, Octapharma, Priovant, RaPharma\/UCB, Roivant Sciences Inc, Sanofi Genzyme, Shire Takeda, Scholar Rock, Spark Therapeutics, Abata\/Third Rock and UCB Biopharma; and received royalty fees or licenses, consultancy fees, and payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from UpToDate. ZG has received payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Abbvie, Lilly, Novartis, Roche; received support for attending meetings and\/or travel from Biotest, CSL Behring, Novartis, Abbvie and Lilly; and participated on a Data Safety Monitoring Board or Advisory Board for Octapharma. CVO has received research support from Genentech and consulting fees from Pfizer. JV has received support for the current manuscript from the Czech Ministry of Health; grants or contracts from Abbvie; consulting fees from Argenx; payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Werfen and Octapharma; and Participated on a Data Safety Monitoring Board or Advisory Board for Horizon, Kezar, Boehringer and Octapharma. IB was an employee of Octapharma Pharmazeutika Produktionsges.m.b.H until June 2022; and has subsequently received Consulting fees from Octapharma. EC is an employee of Octapharma Pharmazeutika Produktionsges.m.b.H. TL is a consultant for FFF Enterprises. SM and ES have no conflicts of interest to declare.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"27"}}