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dc.contributor.authorØstergaard, Mikkel
dc.contributor.authorVan Vollenhoven, Ronald F
dc.contributor.authorRudin, Anna
dc.contributor.authorHetland, Merete Lund
dc.contributor.authorSchrumpf, Marte
dc.contributor.authorNordström, Dan C
dc.contributor.authorNurmohamed, Michael T
dc.contributor.authorGudbjornsson, Bjorn
dc.contributor.authorØrnbjerg, Lykke Midtbøll
dc.contributor.authorBøyesen, Pernille
dc.contributor.authorLend, Kristina
dc.contributor.authorHørslev-Petersen, Kim
dc.contributor.authorUhlig, Till
dc.contributor.authorSokka, Tuulikki
dc.contributor.authorGrondal, Gerdur
dc.contributor.authorKrabbe, Simon
dc.contributor.authorLindqvist, Joakim
dc.contributor.authorGjertsson, Inger
dc.contributor.authorGlinatsi, Daniel
dc.contributor.authorKapetanovic, Meliha Crnkic
dc.contributor.authorAga, Anna-Birgitte
dc.contributor.authorFaustini, Francesca
dc.contributor.authorParmanne, Pinja
dc.contributor.authorLorenzen, Tove
dc.contributor.authorGiovanni, Cagnotto
dc.contributor.authorBack, Johan
dc.contributor.authorHendricks, Oliver
dc.contributor.authorVedder, Daisy
dc.contributor.authorRannio, Tuomas
dc.contributor.authorGrenholm, Emma
dc.contributor.authorLjoså, Maud-Kristine Aga
dc.contributor.authorBrodin, Eli
dc.contributor.authorLindegaard, Hanne
dc.contributor.authorSöderbergh, Annika
dc.contributor.authorRizk, Milad
dc.contributor.authorKastbom, Alf
dc.contributor.authorLarsson, Per
dc.contributor.authorUhrenholt, Line
dc.contributor.authorJust, Søren Andreas
dc.contributor.authorStevens, David John
dc.contributor.authorBay Laurbjerg, Trine
dc.contributor.authorBakland, Gunnstein
dc.contributor.authorOlsen, Inge Christoffer
dc.contributor.authorHaavardsholm, Espen A.
dc.contributor.authorLampa, Jon
dc.date.accessioned2024-02-05T09:43:46Z
dc.date.available2024-02-05T09:43:46Z
dc.date.issued2023-07-09
dc.description.abstractBackground - The optimal first-line treatment in early rheumatoid arthritis (RA) is debated. We compared clinical and radiographic outcomes of active conventional therapy with each of three biological treatments with different modes of action.<p> <p>Methods - Investigator-initiated, randomised, blinded-assessor study. Patients with treatment-naïve early RA with moderate–severe disease activity were randomised 1:1:1:1 to methotrexate combined with (1) active conventional therapy: oral prednisolone (tapered quickly, discontinued at week 36) or sulfasalazine, hydroxychloroquine and intra-articular glucocorticoid injections in swollen joints; (2) certolizumab pegol; (3) abatacept or (4) tocilizumab. Coprimary endpoints were week 48 Clinical Disease Activity Index (CDAI) remission (CDAI ≤2.8) and change in radiographic van der Heijde-modified Sharp Score, estimated using logistic regression and analysis of covariance, adjusted for sex, anticitrullinated protein antibody status and country. Bonferroni’s and Dunnet’s procedures adjusted for multiple testing (significance level: 0.025).<p> <p>Results - Eight hundred and twelve patients were randomised. Adjusted CDAI remission rates at week 48 were: 59.3% (abatacept), 52.3% (certolizumab), 51.9% (tocilizumab) and 39.2% (active conventional therapy). Compared with active conventional therapy, CDAI remission rates were significantly higher for abatacept (adjusted difference +20.1%, p<0.001) and certolizumab (+13.1%, p=0.021), but not for tocilizumab (+12.7%, p=0.030). Key secondary clinical outcomes were consistently better in biological groups. Radiographic progression was low, without group differences.<p> <p>The proportions of patients with serious adverse events were abatacept, 8.3%; certolizumab, 12.4%; tocilizumab, 9.2%; and active conventional therapy, 10.7%.<p> <p>Conclusions - Compared with active conventional therapy, clinical remission rates were superior for abatacept and certolizumab pegol, but not for tocilizumab. Radiographic progression was low and similar between treatments.en_US
dc.identifier.citationØstergaard, Van Vollenhoven, Rudin, Hetland, Schrumpf, Nordström, Nurmohamed, Gudbjornsson, Ørnbjerg, Bøyesen, Lend, Hørslev-Petersen, Uhlig, Sokka, Grondal, Krabbe, Lindqvist, Gjertsson, Glinatsi, Kapetanovic, Aga, Faustini, Parmanne, Lorenzen, Giovanni, Back, Hendricks, Vedder, Rannio, Grenholm, Ljoså, Brodin, Lindegaard, Söderbergh, Rizk, Kastbom, Larsson, Uhrenholt, Just, Stevens, Bay Laurbjerg, Bakland, Olsen, Haavardsholm, Lampa. Certolizumab pegol, abatacept, tocilizumab or active conventional treatment in early rheumatoid arthritis: 48-week clinical and radiographic results of the investigator-initiated randomised controlled NORD-STAR trial. Annals of the Rheumatic Diseases. 2023en_US
dc.identifier.cristinIDFRIDAID 2176566
dc.identifier.doi10.1136/ard-2023-224116
dc.identifier.issn0003-4967
dc.identifier.issn1468-2060
dc.identifier.urihttps://hdl.handle.net/10037/32840
dc.language.isoengen_US
dc.publisherBMJ Publishing Groupen_US
dc.relation.journalAnnals of the Rheumatic Diseases
dc.relation.projectIDNorges forskningsråd: 328657en_US
dc.rights.accessRightsopenAccessen_US
dc.rights.holderCopyright 2023 The Author(s)en_US
dc.titleCertolizumab pegol, abatacept, tocilizumab or active conventional treatment in early rheumatoid arthritis: 48-week clinical and radiographic results of the investigator-initiated randomised controlled NORD-STAR trialen_US
dc.type.versionacceptedVersionen_US
dc.typeJournal articleen_US
dc.typeTidsskriftartikkelen_US
dc.typePeer revieweden_US


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