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

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 PP, Martin-Mola E, Breedveld F, Smolen J (2018)

Publication Type: Journal article

Publication year: 2018

Journal

Arthritis Research & Therapy BioMed Central

Book Volume: 20

Journal Issue: 1

DOI: 10.1186/s13075-018-1667-z

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.

Authors with CRIS profile

Georg Schett Lehrstuhl für Innere Medizin III

Involved external institutions

Medizinische Universität Wien AT Austria (AT) RILITE Research Institute US United States (USA) (US) Durham VA Medical Center US United States (USA) (US) Academic Medical Centre / Academisch Medisch Centrum (AMC) NL Netherlands (NL) Leiden University NL Netherlands (NL) Technische Universität Dresden DE Germany (DE) Ludwig-Maximilians-Universität (LMU) DE Germany (DE) Hospital Universitario La Paz ES Spain (ES) National and Kapodistrian University of Athens GR Greece (GR) Freie Universität Berlin DE Germany (DE) University of Genova / Università degli Studi di Genova IT Italy (IT) Krankenhaus Hietzing mit Neurologischem Zentrum Rosenhügel AT Austria (AT) University of Amsterdam NL Netherlands (NL)

How to cite

APA:

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 Research & Therapy, 20(1). https://dx.doi.org/10.1186/s13075-018-1667-z

MLA:

Stamm, Tanja Alexandra, et al. "Induction of sustained remission in early inflammatory arthritis with the combination of infliximab plus methotrexate: the DINORA trial." Arthritis Research & Therapy 20.1 (2018).

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