Medizinische Universität Graz Austria/Österreich - Forschungsportal - Medical University of Graz
Gewählte Publikation:
SHR Neuro Krebs Kardio Lipid Stoffw Microb
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.
Induction of sustained remission in early inflammatory arthritis with the combination of infliximab plus methotrexate: the DINORA trial.
Arthritis Res Ther. 2018; 20(1):174-174
Doi: 10.1186/s13075-018-1667-z
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- Co-Autor*innen der Med Uni Graz
- Graninger Winfried
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- Abstract:
- 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.
- Find related publications in this database (using NLM MeSH Indexing)
- Adult -
- Aged -
- Antirheumatic Agents - administration & dosage
- Arthritis, Rheumatoid - drug therapy
- Double-Blind Method -
- Drug Therapy, Combination -
- Female -
- Humans -
- Infliximab - administration & dosage
- Male -
- Methotrexate - administration & dosage
- Middle Aged -
- Remission Induction -
- Treatment Outcome -
- Find related publications in this database (Keywords)
- Clinical remission
- Early arthritis
- Rheumatoid arthritis