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dc.contributor.authorBurmester, Gerd R
dc.contributor.authorKaeley, Gurjit S
dc.contributor.authorKavanaugh, Arthur F
dc.contributor.authorGabay, Cem
dc.contributor.authorMacCarter, Daryl K
dc.contributor.authorNash, Peter
dc.contributor.authorTakeuchi, Tsutomu
dc.contributor.authorGoss, Sandra L
dc.contributor.authorRodila, Ramona
dc.contributor.authorChen, Kun
dc.contributor.authorKupper, Hartmut
dc.contributor.authorKalabic, Jasmina
dc.date.accessioned2021-12-16T05:43:01Z
dc.date.available2021-12-16T05:43:01Z
dc.date.issued2017
dc.identifier.issn2056-5933en_US
dc.identifier.doi10.1136/rmdopen-2017-000465en_US
dc.identifier.urihttp://hdl.handle.net/10072/410958
dc.description.abstractBackground Treatment of rheumatoid arthritis (RA) with a combination of methotrexate (MTX)+adalimumab (ADA) is more effective than ADA monotherapy. We assessed the toxicity of different doses of MTX and treatment efficacy of ADA+MTX in two trials. Methods Data originated from CONCERTO, in patients with early RA initiating ADA+ 2.5, 5, 10 or 20 mg/week MTX for 26 weeks; and MUSICA, in patients with an inadequate response to MTX initiating ADA+ 7.5 or 20 mg/week MTX for 24 weeks. Efficacy was assessed by the American College of Rheumatology 50 (ACR50). Patient-reported MTX-related toxicity information was collected at each visit on 18 prespecified MTX-related adverse events (AE) in the MTX label. Results In CONCERTO, ACR50 rates increased over time, ranging from 54% to 68% at week 26, while AE rates remained steady, ranging from 2.4% to 17.8% at week 26. Of 395 patients, 113 (28.6%) reported 345 MTX-related AEs, including one serious AE (SAE, excessive fatigue and/or malaise); 10 AEs (in two patients) led to study discontinuation. In MUSICA, ACR50 rates increased over time, and were 32.3% and 37.5% at week 24, while MTX-related AE rates remained steady and were 6.5% at week 24. Of 309 patients, 71 (23%) reported 185 MTX-related AEs, including 5 SAEs (four infections and one fever/chills); six AEs (in four patients) led to study discontinuation. Conclusion In patients with RA initiating ADA+MTX combination, treatment efficacy was achieved and increased throughout both trials, while rates of MTX-related AEs remained steady. MTX-related AEs were observed in up to 30% of patients and most were mild. MTX was discontinued by 0.5%-1.3% of patients. Trial registration number MUSICA (NCT01185288), CONCERTO (NCT01185301), Post results.en_US
dc.description.peerreviewedYesen_US
dc.languageEnglishen_US
dc.publisherBMJ Publishing Group Ltden_US
dc.relation.ispartofpagefrom000465en_US
dc.relation.ispartofissue2en_US
dc.relation.ispartofjournalRMD Openen_US
dc.relation.ispartofvolume3en_US
dc.subject.fieldofresearchClinical sciencesen_US
dc.subject.fieldofresearchcode3202en_US
dc.subject.keywordsScience & Technologyen_US
dc.subject.keywordsLife Sciences & Biomedicineen_US
dc.subject.keywordsRheumatologyen_US
dc.subject.keywordsMONOCLONAL-ANTIBODYen_US
dc.subject.keywordsMULTICENTERen_US
dc.titleTreatment efficacy and methotrexate-related toxicity in patients with rheumatoid arthritis receiving methotrexate in combination with adalimumaben_US
dc.typeJournal articleen_US
dc.type.descriptionC1 - Articlesen_US
dcterms.bibliographicCitationBurmester, GR; Kaeley, GS; Kavanaugh, AF; Gabay, C; MacCarter, DK; Nash, P; Takeuchi, T; Goss, SL; Rodila, R; Chen, K; Kupper, H; Kalabic, J, Treatment efficacy and methotrexate-related toxicity in patients with rheumatoid arthritis receiving methotrexate in combination with adalimumab, RMD Open, 2017, 3 (2), pp. 000465en_US
dcterms.dateAccepted2017-08-23
dcterms.licensehttp://creativecommons.org/licenses/by-nc/4.0/en_US
dc.date.updated2021-12-16T00:35:15Z
dc.description.versionVersion of Record (VoR)en_US
gro.rights.copyright© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/en_US
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gro.griffith.authorNash, Peter


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