Induction of sustained remission in early inflammatory arthritis with the combination of infliximab plus methotrexate: the DINORA trial.
Induction of sustained remission in early inflammatory arthritis with the combination of infliximab plus methotrexate: the DINORA trial.
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DOI：
10.1186/s13075-018-1667-z
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发表时间：
2018-08-09
影响因子：
4.9
通讯作者：
Smolen J
中科院分区：
文献类型：
--
作者：
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
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. 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. 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. 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. 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. The online version of this article (10.1186/s13075-018-1667-z) contains supplementary material, which is available to authorized users.
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影响因子：
27.4
作者：
Emery P;Burmester GR;Bykerk VP;Combe BG;Furst DE;Barré E;Karyekar CS;Wong DA;Huizinga TW
通讯作者：
Huizinga TW
影响因子：
--
作者：
Goekoop-Ruiterman, YPM;de Vries-Bouwstra, JK;Dijkmans, C
通讯作者：
Dijkmans, C
影响因子：
4.9
作者：
Raza K;Falciani F;Curnow SJ;Ross EJ;Lee CY;Akbar AN;Lord JM;Gordon C;Buckley CD;Salmon M
通讯作者：
Salmon M
影响因子：
13.3
作者：
de Hair, M. J. H.;van de Sande, M. G. H.;Ramwadhdoebe, T. H.;Hansson, M.;Landewe, R.;van der Leij, C.;Maas, M.;Serre, G.;van Schaardenburg, D.;Klareskog, L.;Gerlag, D. M.;van Baarsen, L. G. M.;Tak, P. P.
通讯作者：
Tak, P. P.
影响因子：
27.4
作者：
Goekoop-Ruiterman, Y. P. M.;de Vries-Bouwstra, J. K.;Dijkmans, B. A. C.
通讯作者：
Dijkmans, B. A. C.