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

Arthritis Research & Therapy

Paul-Peter Tak¹  Georg Schett²  Wolfgang Ebner³  Klaus Peter Machold⁴  Josef Smolen⁴  Daniel Aletaha⁴  Farideh Alasti⁴  Robert Landewe⁵  Gerd Burmester⁶  Desiree van der Heijde⁷  Alexandre Sepriano⁷  Tom Huizinga⁷  Winfried Graninger⁸  Hendrik Schulze-Koops⁹  Martin Aringer^1,10  Emilio Martin-Mola^1,11  Ferdinand Breedveld^1,12  David Pisetsky^1,13  Peter Lipsky^1,14  Maurizio Cutolo^1,15  Dimitri Boumpas^1,16  Tanja Alexandra Stamm^1,17 

[1] Amsterdam Rheumatology and Immunology Center, Academic Medical Centre, University of Amsterdam;Department of Internal Medicine 3, Rheumatology and Immunology, Friedrich-Alexander-University Erlangen-Nürnberg (FAU) and Universitätsklinikum Erlangen;Department of Internal Medicine, Centre for Rheumatic Diseases, Hietzing Hospital;Department of Medicine III, Division of Rheumatology, Medical University of Vienna;Department of Medicine, Division of Rheumatology, Academic Medical Center Amsterdam;Department of Rheumatology and Clinical Immunology, Charité - University Medicine Berlin, Free University and Humboldt University Berlin;Department of Rheumatology, Leiden University Medical Centre;Department of Rheumatology, Medical University of Graz;Division of Rheumatology and Clinical Immunology, Department of Internal Medicine IV, Ludwig Maximilians University of Munich;Division of Rheumatology, Department of Medicine III, University Medical Center and Faculty of Medicine Carl Gustav Carus at the TU Dresden;Hospital Universitario La Paz;Leiden University Medical Center;Medical Research Service Durham VA Medical Center, and Duke University Medical Center, 151G Durham VA Medical Center;RILITE Research Institute;Research Laboratory and Division of Rheumatology, Department of Internal Medicine, University of Genova;Rheumatology Medical School University of Crete, Heraklion and Joint Rheumatology Program, National and Kapodestrian University of Athens;Section for Outcomes Research, Center for Medical Statistics, Informatics, and Intelligent Systems, Medical University of Vienna;

关键词: Clinical remission;    Early arthritis;    Rheumatoid arthritis;   

DOI  :  10.1186/s13075-018-1667-z

来源: DOAJ

【 摘 要 】

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.

【 授权许可】

Unknown