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09-08-2018 | Rheumatoid arthritis | Article

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

Journal: Arthritis Research & Therapy

Authors: Tanja Alexandra Stamm, Klaus Peter Machold, Daniel Aletaha, Farideh Alasti, Peter Lipsky, David Pisetsky, Robert Landewe, Desiree van der Heijde, Alexandre Sepriano, Martin Aringer, Dimitri Boumpas, Gerd Burmester, Maurizio Cutolo, Wolfgang Ebner, Winfried Graninger, Tom Huizinga, Georg Schett, Hendrik Schulze-Koops, Paul-Peter Tak, Emilio Martin-Mola, Ferdinand Breedveld, Josef Smolen

Publisher: BioMed Central

Abstract

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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