Randomized trial of stopping TNF-inhibitors in rheumatoid arthrisis: patients with stable low disease activity in the Netherlands

Harald E. Vonkeman, Marjan Ghiti Moghadam, Mart A.F.J. van de Laar, Peter M. ten Klooster, Tim Jansen, P. van Riel

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    Background/Purpose: The effectiveness of TNF-inhibitors (TNFi) in the treatment of rheumatoid arthritis has already been demonstrated in many studies. However, little is known on stopping TNFi in patients with stable lowdisease activity and the subsequent likelihood of exacerbation of rheumatoid arthritis. In addition, it is not clear whether TNFi can be restarted effectively and safely. Given the potential risk of serious side-effects and complications and the high costs of TNFi, it is important to examine whether patients in stable low disease activity can effectively stop TNFi.

    Methods: Multicenter open-label randomized study. Patients diagnosed with rheumatoid arthritis according to the ACR 1987 criteria were included. Patients had been treated with a TNFi for at least 1 year and with stable dose DMARDs for at least 6 months. All included patients had low disease activity in the 6 months prior to inclusion, with at least 2 DAS28 scores 3.2 in this period. Patients were randomized to discontinuing or continuing their current TNFi in a 2:1 ratio. DAS28 flare was defined as DAS283.2 with an increase 0.6 compared to the previous DAS28.

    Results: In total 817 patients from 47 centers were included: 531 patients (65%) in the discontinuation group and 286 patients (35%) in the continuation group. In the discontinuation group significantly more patients (30.8%) experienced a DAS28 flare within the first 6 months than in the continuation group (9.4%, P 0.0001). At 12 months, 46.9% of the patients experienced a DAS28 flare in the discontinuation group vs. 16.6% in the continuation group (P 0.0001). Median time to the first flare in the discontinuation group was 24 weeks. Survival analyses confirmed that flare free survival was significantly (P 0.0001) lower in the discontinuation group. The hazard ratio of DAS28 flare after discontinuing TNFi was 2.15 (95% CI: 1.59–2.91), after adjusting for disease duration, age, sex, and anti-CCP status.

    Conclusion:Flare-free discontinuation of TNF-inhibitors was possible in 53% of patients with stable low disease activity rheumatoid arthritis during a period of 12 months.

    Disclosure: H. E. Vonkeman, None; M. Ghiti Moghadam, None; M. A. F. J. van De Laar, None; P. M. ten Klooster, None; T. Jansen, Abbvie, 2, UCB, 2, Abbvie, 5, AstraZeneca, 5, UMS, 5, Janssen Pharmaceutica Product, L.P., 5, Menarini, 5, Novartis Pharmaceutical Corporation, 5, Pfizer Inc, 5, Roche Pharmaceuticals, 5, Abbvie, 8; P. van Riel, None.
    Original languageEnglish
    Article numberL19
    Pages (from-to)3537-3537
    Number of pages1
    JournalArthritis & rheumatology
    Issue number12
    Publication statusPublished - 2014


    • METIS-307448
    • IR-93392


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