Induction of sustained remission in early inflammatory arthritis with the combination of infliximab plus methotrexate: the DINORA trial.

Journal Article (Journal Article;Multicenter Study)

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, ), 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 on 4 October 2007 (date applied)/12 December 2007 (date assigned). The first patient was included on 24 October 2007.

Full Text

Duke Authors

Cited Authors

  • Stamm, TA; Machold, KP; Aletaha, D; Alasti, F; Lipsky, P; Pisetsky, D; Landewe, R; van der Heijde, D; Sepriano, A; Aringer, M; Boumpas, D; Burmester, G; Cutolo, M; Ebner, W; Graninger, W; Huizinga, T; Schett, G; Schulze-Koops, H; Tak, P-P; Martin-Mola, E; Breedveld, F; Smolen, J

Published Date

  • August 9, 2018

Published In

Volume / Issue

  • 20 / 1

Start / End Page

  • 174 -

PubMed ID

  • 30092827

Pubmed Central ID

  • PMC6085639

Electronic International Standard Serial Number (EISSN)

  • 1478-6362

Digital Object Identifier (DOI)

  • 10.1186/s13075-018-1667-z


  • eng

Conference Location

  • England