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dc.contributor.authorStamm, Tanja A
dc.contributor.authorMachold, Klaus P
dc.contributor.authorAletaha, Daniel
dc.contributor.authorAlasti, Farideh
dc.contributor.authorLipsky, Peter
dc.contributor.authorPisetsky, David
dc.contributor.authorLandewe, Robert
dc.contributor.authorvan der Heijde, Desiree
dc.contributor.authorSepriano, Alexandre
dc.contributor.authorAringer, Martin
dc.contributor.authorBoumpas, Dimitri
dc.contributor.authorBurmester, Gerd
dc.contributor.authorCutolo, Maurizio
dc.contributor.authorEbner, Wolfgang
dc.contributor.authorGraninger, Winfried
dc.contributor.authorHuizinga, Tom
dc.contributor.authorSchett, Georg
dc.contributor.authorSchulze-Koops, Hendrik
dc.contributor.authorTak, Paul-Peter
dc.contributor.authorMartin-Mola, Emilio
dc.contributor.authorBreedveld, Ferdinand
dc.contributor.authorSmolen, Josef
dc.date.accessioned2018-08-10T06:06:15Z
dc.date.available2018-08-10T06:06:15Z
dc.date.issued2018-08-09
dc.identifier.citationArthritis Research & Therapy. 2018 Aug 09;20(1):174
dc.identifier.urihttps://www.repository.cam.ac.uk/handle/1810/278771
dc.description.abstractAbstract Background In the present study, we explored the effects of immediate induction therapy with the anti-tumour necrosis factor (TNF)α antibody infliximab (IFX) plus methotrexate (MTX) compared with MTX alone and with placebo (PL) in patients with very early inflammatory arthritis. Methods In an investigator-initiated, double-blind, randomised, placebo-controlled, multi-centre trial (ISRCTN21272423, http://www.isrctn.com/ISRCTN21272423 ), patients with synovitis of 12 weeks duration in at least two joints underwent 1 year of treatment with IFX in combination with MTX, MTX monotherapy, or PL randomised in a 2:2:1 ratio. The primary endpoint was clinical remission after 1 year (sustained for at least two consecutive visits 8 weeks apart) with remission defined as no swollen joints, 0–2 tender joints, and an acute-phase reactant within the normal range. Results Ninety patients participated in the present study. At week 54 (primary endpoint), 32% of the patients in the IFX + MTX group achieved sustained remission compared with 14% on MTX alone and 0% on PL. This difference (p < 0.05 over all three groups) was statistically significant for IFX + MTX vs PL (p < 0.05), but not for IFX + MTX vs MTX (p = 0.10), nor for MTX vs PL (p = 0.31). Remission was maintained during the second year on no therapy in 75% of the IFX + MTX patients compared with 20% of the MTX-only patients. Conclusions These results indicate that patients with early arthritis can benefit from induction therapy with anti-TNF plus MTX compared with MTX alone, suggesting that intensive treatment can alter the disease evolution. Trial registration The trial was registered at http://www.isrctn.com/ISRCTN21272423 on 4 October 2007 (date applied)/12 December 2007 (date assigned). The first patient was included on 24 October 2007.
dc.titleInduction of sustained remission in early inflammatory arthritis with the combination of infliximab plus methotrexate: the DINORA trial
dc.typeJournal Article
dc.date.updated2018-08-10T06:06:12Z
dc.language.rfc3066en
dc.rights.holderThe Author(s).
dc.identifier.doi10.17863/CAM.26138
rioxxterms.versionofrecord10.1186/s13075-018-1667-z


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