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

Publication ,  Journal Article
Stamm, TA; Machold, KP; Aletaha, D; Alasti, F; Lipsky, P; Pisetsky, D; Landewe, R; van der Heijde, D; Sepriano, A; Aringer, M; Boumpas, D ...
Published in: Arthritis Res Ther
August 9, 2018

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.

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Published In

Arthritis Res Ther

DOI

EISSN

1478-6362

Publication Date

August 9, 2018

Volume

20

Issue

1

Start / End Page

174

Location

England

Related Subject Headings

  • Treatment Outcome
  • Remission Induction
  • Middle Aged
  • Methotrexate
  • Male
  • Infliximab
  • Humans
  • Female
  • Drug Therapy, Combination
  • Double-Blind Method
 

Citation

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Stamm, T. A., Machold, K. P., Aletaha, D., Alasti, F., Lipsky, P., Pisetsky, D., … Smolen, J. (2018). Induction of sustained remission in early inflammatory arthritis with the combination of infliximab plus methotrexate: the DINORA trial. Arthritis Res Ther, 20(1), 174. https://doi.org/10.1186/s13075-018-1667-z
Stamm, Tanja Alexandra, Klaus Peter Machold, Daniel Aletaha, Farideh Alasti, Peter Lipsky, David Pisetsky, Robert Landewe, et al. “Induction of sustained remission in early inflammatory arthritis with the combination of infliximab plus methotrexate: the DINORA trial.Arthritis Res Ther 20, no. 1 (August 9, 2018): 174. https://doi.org/10.1186/s13075-018-1667-z.
Stamm TA, Machold KP, Aletaha D, Alasti F, Lipsky P, Pisetsky D, et al. Induction of sustained remission in early inflammatory arthritis with the combination of infliximab plus methotrexate: the DINORA trial. Arthritis Res Ther. 2018 Aug 9;20(1):174.
Stamm, Tanja Alexandra, et al. “Induction of sustained remission in early inflammatory arthritis with the combination of infliximab plus methotrexate: the DINORA trial.Arthritis Res Ther, vol. 20, no. 1, Aug. 2018, p. 174. Pubmed, doi:10.1186/s13075-018-1667-z.
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. Induction of sustained remission in early inflammatory arthritis with the combination of infliximab plus methotrexate: the DINORA trial. Arthritis Res Ther. 2018 Aug 9;20(1):174.

Published In

Arthritis Res Ther

DOI

EISSN

1478-6362

Publication Date

August 9, 2018

Volume

20

Issue

1

Start / End Page

174

Location

England

Related Subject Headings

  • Treatment Outcome
  • Remission Induction
  • Middle Aged
  • Methotrexate
  • Male
  • Infliximab
  • Humans
  • Female
  • Drug Therapy, Combination
  • Double-Blind Method